Comparison robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell transplantation and traditional surgery for treatment of osteonecrosis of the femoral head. A retrospective study

Comparison robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell transplantation and traditional surgery for treatment of osteonecrosis of the femoral head. 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A retrospective study Qin Hu, Juan Shi, Chao Zhu, Hailong Zhang, Bin Wang, Jian Yin, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3286442/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective To compare the difference in the effect betweeen robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell (hUC-MSC) transplantation and traditional core decompression surgery for osteonecrosis of the femoral head. Methods : Thirty-eight patients with a total of 50 hips who were diagnosed with Association Research Circulation Osseous stage 2 avascular necrosis of the femoral head were included for retrospective analysis. According to the treatment method, they were divided into 2 groups. Twenty patients (28 femoral heads) in the robot group were treated with core decompression assisted by robots combined with human umbilical cord-derived mesenchymal stem cell transplantation (observation group) . The traditional surgery group consisted of 18 patients (22 femoral heads), they were received traditional core decompression operation (control group). Preoperative and postoperative visual analogue scale (VAS) scores, the Harris hip score (HHS) and MRI examination were compared between two groups. Results : The mean follow-up was 17.6 months (12–28 months). There was no significant difference in preoperative VAS and HHS scores and necrotic volume of femoral heads between the two groups. Of note, VAS scores and necrotic volume of femoral heads in robot group were significantly lower than those in traditional surgery group at the last follow-up, HHS scores in robot group were significantly highter than those in traditional surgery group at the last follow-up. Conclusion : Robot-assisted core decompression combined with hUC-MSC transplantation is more effective than traditional core decompression operation for the treatment of femoral head necrosis. Biological sciences/Stem cells Health sciences/Diseases Necrosis of the femoral head Robot Core decompression mesenchymal stem cell Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction Osteonecrosis of the femoral head (ONFH) is a progressive and refractory disease 1 . The progression of the disease often leads to serious collapse of the subchondral bone and articular surface of the femoral head, even the degenerative disease of the hip joint, and ultimately has to be treated with osteotomy (OT), hemiarthroplasty (Hemi), or total hip arthroplasty (THA) 2 .The etiology and pathogenesis of avascular necrosis of the femoral head have always been the focus of debate. There is quite a lot of evidence that the increase of femoral head internal pressure plays an important role in the development of femoral head necrosis 3 . In 1985, Ficat designed the core decompression operation with open and closed medullary cavity 4 . After long-term clinical application, it has been proved that it can effectively alleviate the progress of osteonecrosis. Traditional core decompression surgery requires complex hand-eye coordination, and doctors need to manually control the guide needle, which may have a large deviation 5,6 .With the rapid development of intelligent robots, robot-assisted surgical treatment is gradually applied to clinical practice, which can achieve minimally invasive, accurate and personalized surgical operation to a greater extent 7,8 . In addition to successfully completing thoracolumbar fracture surgery and atlantoaxial joint internal fixation surgery, TiRobot ™, the orthopedic navigation robot can be used to precisely implant different guide wires and screws in the proximal femur 9,10 . Although some effects have been achieved, core decompression has not fundamentally solved the problem of repairing necrotic bone 11 . In recent years, the treatment of ONFH with stem cell transplantation has become a research hotspot in many hip preservation therapies 12 . Its principle is to promote the regeneration of blood vessels and tissues in the necrotic region through the paracrine function and proliferation and differentiation ability of stem cells 13 . We isolated MSCs from Wharton's jelly of the human umbilical cord (UC) and use orthopedic surgical robot navigation assisted core decompression combined with stem cell transplantation to treat early femoral head necrosis. In the present study, we retrospectively analysed the difference in the effect betweeen robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell (hUC-MSC) transplantation and traditional core decompression surgery for osteonecrosis of the femoral head. Methods Study design This retrospective study was performed in accordance with the ethical standards stipulated in the 1964 Declaration of Helsinki and was approved by the Ethics Committee of Human Experimentation of our hospital. The prove reg. number was 2016056. All of the patients signed corresponding informed consent before the study. Patients All patients underwent anteroposterior bilateral hip plain film and magnetic resonance imaging (MRI) examinations. We obtained the diagnosis of ONFH according to the clinical history and imaging findings of the femoral head. All imaging findings were interpreted by two experienced orthopaedic physicians in a blinded manne. The inclusion criteria were as follows: the subjects ( 1 ) were 18 to 60 years old; ( 2 ) had notable hip pain (VAS ≥ 2); ( 3 ) were diagnosed with ONFH through hip plain radiographs and MRI; and ( 4 ) had stopped steroid treatment for more than 6 months. The exclusion criteria were as follows: ( 1 ) 60 years old; ( 2 ) ARCO stages 3 and 4; ( 3 ) patients with systemic infection or local skin infection around the incision; ( 4 ) patients who had received steroid treatment in the last 6 months; ( 5 ) patients complicated with inflammatory arthritis; ( 6 ) patients with a previous history of fracture or tumour in the proximal femur; ( 7 ) patients who had previously or still received other conservative treatments, such as hyperbaric oxygen and extracorporeal shock wave therapy; and ( 8 ) pregnant women. Whether patients with ONFH would receive the TiRobot ™ robot system and hUC-MSC transplantation was determined randomly before surgery by the surgeons. The participants were divided into two groups according to whether surgery was conducted with the TiRobot ™ robot system and performed hUC-MSC transplantation. A total of 18 patients (26 femoral heads) underwent robot assisted core decompression combined hUC-MSC transplantation (observation group), while the other 20 patients (28 femoral heads) underwent a traditional core decompression operation (control group). Surgical technique Robot component The orthopaedic surgery robot TiRobot™ (TINAVI Medical Technologies Co., Ltd., Beijing, China) was used. This robot system consists of a workstation for surgical planning and control, an optical tracking device, a robot arm and surgical instruments (Fig. 1 ) 14 . The surgeon plans the surgical path through the master control system based on the images collected by the imaging device. Then, the master control system controlled the multi-degree-of-freedom manipulator to move to the target point according to the spatial position of the planned surgical path. The optical tracking system monitored the path deviation of the manipulator and the changes of the patient's position during the operation in real time, and automatically performed the feedback compensation calculation of positioning errors to achieve accurate positioning during the operation. The end of the manipulator is equipped with a surgical tool to facilitate accurate insertion of the guide needle during the operation. hUC-MSCs isolation and culture hUC-MSCs were obtained from the clinical Stem Cell Center of the Afliated Drum Tower Hospital of Nanjing University Medical School. Six human umbilical cords were collected after obtaining the informed consent of healthy parturients, according to the Ethics Committee of Human Experimentation of the Afliated Drum Tower Hospital of Nanjing University Medical School. The residual blood in umbilical tissue and blood vessels was washed with phosphate buffered saline (PBS) containing 300U/ml penicillin and 0.3mg/ml streptomycin. The UCs were chopped and digested at 37°C using collagen A (Roche, Mannheim, Germany) from DMEM (Gibco, Rockville, MD, USA) under agitation. Cells were centrifuged at 200×g for 10 min through a 70µm mesh filter (BD Falcon, San Jose, CA, USA) and then suspended in StemCell specific proliferating media (StemCell Technologies, Inc., Vancouver, BC, Canada). A 6-well plate with a density of 1x106 cells/well and 5%CO2 was inoculated in a 37°C incubator. Cells were observed under a phase contrast microscope (Olympus Tokyo, Japan). When the cells reached 80–90% confluence, subculture was performed Cell identification The expression of typical protein markers on the cell surface was detected by flow cytometry to identify the hUC-MSCs 15 (Fig. 2 ). The cells at the fourth passage were washed twice with PBS and resuspended in 1× binding buffer at a concentration of 10 6 cells/ml. Then, 5 µl of anti-human primary antibodies and 5 µl of PI were added to 100 µl of the cell solution, and the solution was incubated for 30 min at 25°C in the dark. After incubation, cells were washed three times by 1×PBS and resuspended in washing buffer for flow cytometry analysis. Information on anti-human primary antibodies was as follows:CD34, CD11b, CD45, CD19, CD73, CD105, CD90, and HLA-DR (BD, USA). Becton Dickinson FACS Aria flow cytometer (BD Biosciences, San Jose, CA, USA) and BD FACS Diva software 8.0.1 (BD Biosciences) was used to detect the expression of typical protein markers on cell surface. HUCMSCs at the fourth passage were harvested and replated at a density of 1 × 104 cells/well in a 24-well culture plate to multilineage differentiation. When the degree of cell fusion reached 50–70%, lipid formation and osteogenesis were induced by replacement of lipogenic medium and osteogenic medium (Gibco, USA), respectively. After 21 days, cells were fixed in 4% formaldehyde and stained with Oil red O (Sigma-Aldrich, USA) or Alizarin Red S (Sigma-Aldrich, USA) to evaluate the adipogenic or osteogenic differentiations, respectively.In addition, 2 × 105 cells at the fourth passage were centrifuged in vitro at 1200 rpm/min for 5 min. After the supernatant was removed, cartilage medium (Gibco, USA) was added to the granules to evaluate the chondrogenic differentiation of HUCMSCs. After 21 days, the pellet was fixed in 4% formaldehyde, continuous dehydrated through ethanol dilutions, and embedded in optimal cutting temperature compound (OCT). Blocks were cut into 5- mm-thick sections and stained with Alcian Blue (Sigma-Aldrich, USA). B , Forth-passaged cells show typical fibroblastshaped morphology. Alizarin Red S staining, and Oil red O staining showed HUCMSCs were induced into osteogenic C and adipogenic D , respectively. Robot-assisted core decompression and hUC-MSC transplantation Surgical path planning: After general anesthesia, the patient was placed in the supine position. Disinfection should include the ipsilateral superior iliac spine where the tracer is placed. X-ray findings of the hip joint in upright and lateral positions were observed with C-arm fluoroscopy. Import this information into the workstation planning software and mark the registration points according to the prompts on the software interface. The X-ray image must contain all 10 anchor points on the locator ruler. According to the preoperative X-ray and MRI results, the orientation of the insertion needle from the lower part of the femur greater trochanter to the center of the necrotic area of the femoral head was planned, and then the appropriate insertion point, angle and length were calculated automatically by the software. Core decompression and hUC-MSC transplantation: After the surgical path is planned, the robotic arm is operated, which automatically moves the guide sleeve to the skin surface according to the planned needle direction and insertion point. The guide needle was inserted through this point and direction. The surgeon made an incision about 1–2 centimeters into the skin where the needle was inserted. According to the position of femoral head and necrotic lesion measured by the robot, a Kirschner wire of appropriate length was drilled, and then the robot was moved to insert the soft tissue protective sleeve along the guide wire. In the soft tissue sleeve, the guide needle is drilled into the trephine. The solid trephine was removed and replaced with a hollow trephine. The surgeon followed the needle into the neck of the femur and the femoral head, through the hardened area around the necrotic area, and into the necrotic area until approximately 5mm below the articular surface. The core decompression tube was cureted to remove the necrotic tissue (Fig. 2 ). The extracted hUC-MSCs, autogenous cancellous bone particles and calcium sulfate (CaSO4) -calcium phosphate (CaPO4) bone graft replacements (PRO-DENSE®, Wright Medical Technology™, Inc.) are included. Arlington, TN, USA) were completely mixed and sent with special compression bone grafts into the decompression tunnel and C-arm X-ray was performed to ensure they reached the decompression bone passage (Fig. 3 ). Traditional core decompression surgery The direction, position and depth of drilling holes were designed in advance according to X-ray film, CT or MRI and preoperative C-arm X-ray fluoroscopy. The rest of the procedure is similar to robot-assisted core decompression.The necrotic area of the filling contains autogenous cancellous bone particles and calcium sulfate (CaSO4) -calcium phosphate (CaPO4) bone graft replacements (PRO-DENSE®, Wright Medical Technology™, Inc.) Postoperative management After recovery from anesthesia, the affected limb can move freely without weight bearing. After three months, the affected limb was able to walk with partial load. About 6 months after surgery, full weight-bearing activities can be initiated if radiographs show that the bone tunnel has formed and healed. Observation Indicators Operation-relative indexes: Two groups were compared in terms of the operation time, the number of guidewire attempts, the number of intraoperative fluoroscopies and intraoperative blood loss. Efficacy evaluation The visual analogue scale (VAS) score and Harris hip score (HHS) were recorded preoperatively and at the last follow-up. All patients underwent MRI at least twice preoperation and at the last follow-up.The overall effective rate were calculated. Statistical analysis All of the statistical analyses in this study were performed using SPSS 22.0 statistical software (IBM SPSS, New York, NY, USA). The variables with continuous data are reported as the means and standard deviations. Statistical analyses were conducted using a paired t-test to compare the means if they were normally distributed. Comparisons between count datas were performed using χ2 -test analysis. P < 0.05 indicated statistical significance. Results The general characteristics of the two groups were shown in Table 1 , and no significant differences were observed. The operation-relative indexes were shown in Table 2 , the operation time, guide wire insertion time, intraoperative fluoroscopies and intraoperative blood loss in observation group were all less than that in control group. There were no significant differences in preoperative HHS, VAS scores and necrotic volume of femoral heads between the two groups. The HHS, VAS scores and necrotic volume of femoral heads (Fig. 4 ) at the last follow-up were also no significant differences. The survival rate in observation group was 82.1%, which is higher than that in control group (72.7%), however there was also no statistical difference between them (Table 3 ). Table 1 Comparison of the general data between two groups Control group Observation group t -value P value Age (years) 45.6 ± 2.1 43.7 ± 1.8 0.699 0.489 Gender 0.85 0.358 Male 11 15 Female 7 5 BMI (kg/m 2 ) Smoking history(%) 0.92 0.338 Yes 8 12 No 10 8 Drinking history(%) 0.35 0.552 Yes 10 13 No 8 7 ARCO classification 0.53 0.767 2a 5 5 2b 9 10 2c 8 13 Aetiology(no. of patients) 1.164 0.762 Idiopathic 5 5 Alcohol 4 6 Trauma 0 1 Corticosteroids 9 8 Table 2 Comparison of the operation-relative indexes between two groups Control group Observation group t -value P value operation time 65.83 ± 1.82 49.25 ± 2.21 5.710 < 0.001 guide wire insertion time 23.5 ± 1.26 6.15 ± 0.57 13.004 < 0.001 intraoperative fluoroscopies 23.78 ± 1.07 13.25 ± 0.85 7.765 < 0.001 intraoperative blood loss 76.39 ± 3.74 26.25 ± 2.11 11.969 < 0.001 Table 3 Comparison of efficacy evaluation between two groups Control group Observation group χ 2 / t-value P value HHS (preoperative) 67.83 ± 6.55 68.95 ± 6.29 0.32 0.751 VAS (preoperative) 4.06 ± 0.62 4.25 ± 0.78 0.344 0.733 HHS (last follow-up 84.17 ± 5.09 87.9 ± 5.26 0.99 0.329 VAS (last follow-up) 1.24 ± 0.48 1.23 ± 0.52 0.233 0.865 Necrotic volume of femoral heads (preoperative, cm) 6.52 ± 0.78 6.83 ± 0.82 0.221 0.893 Necrotic volume of femoral heads (preoperative, cm 3 ) 4.63 ± 0.96 4.23 ± 1.15 0.356 0.681 Survival/ no survival 16/6 23/5 0.64 0.425 Discussion Once ONFH occurs, most will gradually deteriorate 16 .There is no evidence that conservative treatment is effective in delaying progression, therefore, surgery to delay or even reverse the disease progression has always been a hot topic in orthopedics field1 17,18 . Arlet and Float first described femoral head core decompression (CD) 19,20 . CD has been proved to be an effective treatment for hip preservation. Common CD operation has large incision and tissue damage and long recovery time.The placement of traditional core decompression guide needle mainly depends on intraoperative X-ray fluoroscopy, which often requires multiple adjustments to determine the direction and position of the guide needle, thus increasing radiation exposure for both the operator and the patient and operation time 21 . TiRobot™ was first introduced by Tian 14 and is an orthopaedic surgical robot that can be used to implant different guide wires and screws, especially for guide wire insertion of the proximal femur and spine. With the application of the robot-assisted system, the guide needle can be accurately placed into the necrotic area of the femoral head with the guidance of the robotic arm only once the anterior and lateral perspective of the hip joint is theoretically required. Since the robotic system can provide the precise length of guide pin entry, it does not repeated fluoroscopy is required to monitor the depth of placement 22 . In the initial use of orthopedic robots, there may be some delay in preoperative planning, overall, the operation time was significantly reduced 23 . The operation time, intraoperative fluoroscopy times and blood loss of the robot-assisted surgery group were all better than those of the traditional surgery group. However, multiple fluoroscopy was still required during decompression and bone grafting because there was no reference point for determining the position of the drill and pressure bone graft in the femoral head. More importantly, the robot can determine the direction of the puncture and guide the surgeon precisely to the desired location.There was a correlation between the necrotic area of femoral head before operation and the residual dead bone volume after operation and the failure rate 24 . Core decompression can reduce the intraosseous pressure by decompression and open up the sclerosis zone that hinders the repair of osteonecrosis. However, this repair is limited to a local area and does not completely solve the problem of femoral head repair 25 . Recent studies have shown that stem cells are capable of multiple differentiation and can be directed to differentiate into other cells under the action of specific cytokines, thus promoting the repair of damaged tissues 26,27 . Mesenchymal stem cells (MSCs) are considered as perfect candidate for cell-based therapy and regenerative medicine 28,29 . Some studies have pointed out that the use of autologous MSCs for patients with ONFH disease is feasible, safe in the long term, and potentially effective 30,31 .As an excellent representative of MSCs, hUC-MSCs have the subomnipotent differentiation potential, and can differentiate into a variety of tissue cells such as heart, liver, kidney, lung, pancreas, nerve, bone, muscle and fat, almost covering all the tissue cells in the human body 32 .In addition to the strong differentiation potential and proliferation ability, hUC-MSCs have many other advantages: sufficient sources, simple isolation, strong cell vitality, lower immunogenicity, short amplification time, and have become the focus of treatment for various tissue repair containing ONFH 30,33 . Le et al. 34 found hUC-MSCs transplantation showed positive effects on the cartilage regeneration in osteochondral femoral head defect. Li et al. 35 found that hUC-MSCs can increase the expression of bone morphogenetic protein-2 (BMP-2) and vascular endothelial growth factor (VEGF), thus be able improve steroid-induced necrosis of the femoral head (SNFH) in rats In our study, hUC-MSCs has been proven that it can differentiate to osteoblasts annd adipocytes in vitro and can be plastic-adherent when maintained in standard culture conditions, at last, flow cytometry confirmed it express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 and HLA-DR surface molecules 22 . All of this shows that hUC-MSCs in our study meet the minimal criteria for Cellular Therapy proposes. Intravenous delivery, targeted intra-arterial injection and local injectionare three methods to transplant MSCs. Targeted intra-arterial injection seems have the best effect, however, it is clear that local injection is the best for safety and tolerance 36 . Chen et al. 15 reported intraarterial infusion of hUCMSCs is a feasible and relatively safe method for the treatment of femoral head necrosis. In their study, the survival rate was 100% (5/5) in ARCO stage 2 patients and 75% (3/4) in ARCO stage 3 patients.Although the number of cases they reported was small, the results were encouraging.All patients in our study had stage 2 ONFH according to the ARCO and Steinberg classifications. The effective rate in observation group was 82.1% (23/28), which was lower than Chen 's report but slightly higher than that in control group (72.7%, 16/22). Limitations Our study has some limitations. First, it was a single center study with small sample size. Second, this study was a retrospective cohort study, so the cases were easily lost to follow-up. Third, we did not set up a robot-assisted core decompression group (without stem cell transplantation) Robot-assisted core decompression also has some drawbacks.First, under the guidance of the robot arm, the number of X-ray fluoroscopy was reduced during the placement of guide pins, however, during decompression and bone grafting, multiple fluoroscopy is still required to determine the position of the drill and pressure implant in the femoral head. Second, preoperative necrotic area of femoral head and the residual necrotic bone volume was highly correlated with the rate of surgical failure. Due to the defect of the decompression bit, there are still some necrotic areas that have not been effectively intervened. Conclusion Robot-assisted core decompression can improve the precision of early decompression and core marrow bone grafting of femoral head necrosis, reduce surgical trauma, reduce intraoperative fluoroscopy damage to doctors and patients, and show better efficiency than traditional core decompression when combined with human umbilical cord-derived mesenchymal stem cell transplantation. Declarations Funding This study was funded by the grants from Health science and Technology development special fund project of Nanjing, China (No. YKK20201). Conflict of Interest All authors declare they have no conflict of interest. Ethics approval and consent to participate The study was approved by the Research Ethics Board of the Affiliated Jiangning Hospital with Nanjing Medical University (permit number: 2016056). Informed consent All umbilical cord samples were taken after informed and written consent was obtained. All of the patients signed corresponding informed consent before the study. 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Eur Rev Med Pharmacol Sci, 2019, 23(7):2935–2943. Freyman T, Polin G, Osman H, Crary J, Lu M, Cheng L, Palasis M, Wilensky RL. A quantitative, randomized study evaluating three methods of mesenchymal stem cell delivery following myocardial infarction. Eur Heart J, 2006, 27(9):1114–22. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3286442","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":229638793,"identity":"b911e2da-be4d-4563-94c3-58bc85928fd4","order_by":0,"name":"Qin Hu","email":"","orcid":"","institution":"The Affiliated Jiangning Hospital with Nanjing Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Qin","middleName":"","lastName":"Hu","suffix":""},{"id":229638795,"identity":"0ab401f8-14f5-4aad-8dc1-020af2c5a523","order_by":1,"name":"Juan Shi","email":"","orcid":"","institution":"The Affiliated Jiangning Hospital with Nanjing Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Juan","middleName":"","lastName":"Shi","suffix":""},{"id":229638797,"identity":"8cb6b43d-6221-4c75-a45c-4424ca935c8e","order_by":2,"name":"Chao Zhu","email":"","orcid":"","institution":"The Affiliated Jiangning Hospital with Nanjing Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Chao","middleName":"","lastName":"Zhu","suffix":""},{"id":229638799,"identity":"b69bbd53-cafa-437c-a4ad-51c12725dfaa","order_by":3,"name":"Hailong Zhang","email":"","orcid":"","institution":"The Affiliated Jiangning Hospital with Nanjing Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Hailong","middleName":"","lastName":"Zhang","suffix":""},{"id":229638801,"identity":"cf526811-2038-4f58-bece-a46d6aa75dbf","order_by":4,"name":"Bin Wang","email":"","orcid":"","institution":"The Afliated Drum Tower Hospital of Nanjing University Medical School","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Bin","middleName":"","lastName":"Wang","suffix":""},{"id":229638802,"identity":"5b2de9bf-173e-47e6-8c0e-db21ae62d6e1","order_by":5,"name":"Jian Yin","email":"","orcid":"","institution":"The Affiliated Jiangning Hospital with Nanjing Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jian","middleName":"","lastName":"Yin","suffix":""},{"id":229638803,"identity":"61adb221-bd98-482e-aa6e-fd36fbb8685b","order_by":6,"name":"bin wang","email":"","orcid":"","institution":"The Affiliated Jiangning Hospital with Nanjing Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"bin","middleName":"","lastName":"wang","suffix":""},{"id":229638804,"identity":"df0d9f5d-6617-4a56-91de-5796a166ba4c","order_by":7,"name":"xinhui liu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAt0lEQVRIiWNgGAWjYBACPgYeBgMgLcfG3n6AOC1sUC3GfDxnEojXAgKJ8yQcDIjUIpF7oLiw7XB6mwRDAsOPim1EaOE5l2A8s+1wbpt04wHGnjO3idDC3mNgzAvSInMggZmxjRgtzDxgLelsEgkGRGqB2pJAghaeMwbGPOfSDduAgXyQKL/wS+SYGfOUWcvLt7cffPCjgggtIIsMGNmawawDRKkHAuYHDH/qiFU8CkbBKBgFIxEAAHHoNRLPXBkGAAAAAElFTkSuQmCC","orcid":"","institution":"The Affiliated Jiangning Hospital with Nanjing Medical University","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"xinhui","middleName":"","lastName":"liu","suffix":""}],"badges":[],"createdAt":"2023-08-22 15:29:20","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3286442/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3286442/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":42499744,"identity":"6fd061ce-e005-427e-8a5f-bbcc543035ad","added_by":"auto","created_at":"2023-09-01 14:39:21","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":98308,"visible":true,"origin":"","legend":"\u003cp\u003eTiRobot, mainly composed of a workstation, an optical tracking system, a robotic arm and surgical instruments (photo provided by Tianzhihang Medical Technology, Beijing, China).\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-3286442/v1/6770178db6ba7d714ab29da4.png"},{"id":42498328,"identity":"ecf2c8f9-d341-47a5-8e04-dfcf01c301f3","added_by":"auto","created_at":"2023-09-01 14:23:21","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":265242,"visible":true,"origin":"","legend":"\u003cp\u003eThe characteristics of HUC-MSCs. \u003cstrong\u003eA, \u003c/strong\u003eForth‑passaged cells were analysis of CD14, CD19, CD34, CD45, CD73, CD90, CD105, and HLA-DR by flow cytometry.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eB, \u003c/strong\u003eForth-passaged cells show typical fibroblast‑shaped morphology. Alizarin Red S staining, and Oil red O staining showed HUCMSCs were induced into osteogenic \u003cstrong\u003eC \u003c/strong\u003eand adipogenic \u003cstrong\u003eD\u003c/strong\u003e, respectively.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-3286442/v1/2479dd2e5ffe3bdce924d63d.png"},{"id":42501566,"identity":"e9777de8-b150-4781-a48d-0f15ce1c0fbd","added_by":"auto","created_at":"2023-09-01 14:47:21","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":352759,"visible":true,"origin":"","legend":"\u003cp\u003eIllustration of the robot-assisted core decompression. \u003cstrong\u003eA,B\u003c/strong\u003e:Anteroposterior and lateral intraoperative fluoroscopic images of the hip were performed.\u003cstrong\u003eC,D\u003c/strong\u003e: After fluoroscopic imaging information was imported into the workstation planning software, surgical trajectory for guidewire was planned. \u003cstrong\u003eE\u003c/strong\u003e:Guide wire was inserted.\u003cstrong\u003eF\u003c/strong\u003e:Solid trephine was inserted along the guidewire.\u003cstrong\u003eG,H\u003c/strong\u003e:Hollow trephine was inserted along the guidewire into the necrotic area of the femoral head.\u003cstrong\u003eI\u003c/strong\u003e:\u003cstrong\u003e \u003c/strong\u003eImpaction cancellous bone grafting.\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-3286442/v1/63be6f7aa7f02882762a9b2f.png"},{"id":42498891,"identity":"99e284f8-75fa-4bc4-8152-7b5ec1814a5b","added_by":"auto","created_at":"2023-09-01 14:31:21","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":160176,"visible":true,"origin":"","legend":"\u003cp\u003eRegression of a necrotic lesion after robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell transplantation on MRI . (A) MRI scan pre-operation. (B) MRI scan 12months postoperation.\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-3286442/v1/b7d91b029330716558c53d1b.png"},{"id":45350840,"identity":"613722b0-71f7-4070-b2d9-d184687e4b3e","added_by":"auto","created_at":"2023-10-28 05:37:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1326569,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3286442/v1/b4a6d18f-0c61-4793-b213-00554ab06e5c.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Comparison robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell transplantation and traditional surgery for treatment of osteonecrosis of the femoral head. A retrospective study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eOsteonecrosis of the femoral head (ONFH) is a progressive and refractory disease\u003csup\u003e1\u003c/sup\u003e. The progression of the disease often leads to serious collapse of the subchondral bone and articular surface of the femoral head, even the degenerative disease of the hip joint, and ultimately has to be treated with osteotomy (OT), hemiarthroplasty (Hemi), or total hip arthroplasty (THA)\u003csup\u003e2\u003c/sup\u003e.The etiology and pathogenesis of avascular necrosis of the femoral head have always been the focus of debate. There is quite a lot of evidence that the increase of femoral head internal pressure plays an important role in the development of femoral head necrosis\u003csup\u003e3\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn 1985, Ficat designed the core decompression operation with open and closed medullary cavity\u003csup\u003e4\u003c/sup\u003e. After long-term clinical application, it has been proved that it can effectively alleviate the progress of osteonecrosis. Traditional core decompression surgery requires complex hand-eye coordination, and doctors need to manually control the guide needle, which may have a large deviation\u003csup\u003e5,6\u003c/sup\u003e.With the rapid development of intelligent robots, robot-assisted surgical treatment is gradually applied to clinical practice, which can achieve minimally invasive, accurate and personalized surgical operation to a greater extent\u003csup\u003e7,8\u003c/sup\u003e. In addition to successfully completing thoracolumbar fracture surgery and atlantoaxial joint internal fixation surgery, TiRobot \u0026trade;, the orthopedic navigation robot can be used to precisely implant different guide wires and screws in the proximal femur\u003csup\u003e9,10\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAlthough some effects have been achieved, core decompression has not fundamentally solved the problem of repairing necrotic bone\u003csup\u003e11\u003c/sup\u003e. In recent years, the treatment of ONFH with stem cell transplantation has become a research hotspot in many hip preservation therapies\u003csup\u003e12\u003c/sup\u003e. Its principle is to promote the regeneration of blood vessels and tissues in the necrotic region through the paracrine function and proliferation and differentiation ability of stem cells\u003csup\u003e13\u003c/sup\u003e. We isolated MSCs from Wharton's jelly of the human umbilical cord (UC) and use orthopedic surgical robot navigation assisted core decompression combined with stem cell transplantation to treat early femoral head necrosis.\u003c/p\u003e \u003cp\u003eIn the present study, we retrospectively analysed the difference in the effect betweeen robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell (hUC-MSC) transplantation and traditional core decompression surgery for osteonecrosis of the femoral head.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003e This retrospective study was performed in accordance with the ethical standards stipulated in the 1964 Declaration of Helsinki and was approved by the Ethics Committee of Human Experimentation of our hospital. The prove reg. number was 2016056. All of the patients signed corresponding informed consent before the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003ePatients\u003c/h2\u003e \u003cp\u003eAll patients underwent anteroposterior bilateral hip plain film and magnetic resonance imaging (MRI) examinations. We obtained the diagnosis of ONFH according to the clinical history and imaging findings of the femoral head. All imaging findings were interpreted by two experienced orthopaedic physicians in a blinded manne.\u003c/p\u003e \u003cp\u003eThe inclusion criteria were as follows: the subjects (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) were 18 to 60 years old; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) had notable hip pain (VAS\u0026thinsp;\u0026ge;\u0026thinsp;2); (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) were diagnosed with ONFH through hip plain radiographs and MRI; and (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) had stopped steroid treatment for more than 6 months.\u003c/p\u003e \u003cp\u003eThe exclusion criteria were as follows: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u0026thinsp;\u0026lt;\u0026thinsp;18 or \u0026gt;\u0026thinsp;60 years old; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) ARCO stages 3 and 4; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) patients with systemic infection or local skin infection around the incision; (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) patients who had received steroid treatment in the last 6 months; (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) patients complicated with inflammatory arthritis; (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) patients with a previous history of fracture or tumour in the proximal femur; (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) patients who had previously or still received other conservative treatments, such as hyperbaric oxygen and extracorporeal shock wave therapy; and (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) pregnant women.\u003c/p\u003e \u003cp\u003eWhether patients with ONFH would receive the TiRobot \u0026trade; robot system and hUC-MSC transplantation was determined randomly before surgery by the surgeons. The participants were divided into two groups according to whether surgery was conducted with the TiRobot \u0026trade; robot system and performed hUC-MSC transplantation. A total of 18 patients (26 femoral heads) underwent robot assisted core decompression combined hUC-MSC transplantation (observation group), while the other 20 patients (28 femoral heads) underwent a traditional core decompression operation (control group).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSurgical technique\u003c/h2\u003e \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e \u003ch2\u003eRobot component\u003c/h2\u003e \u003cp\u003eThe orthopaedic surgery robot TiRobot\u0026trade; (TINAVI Medical Technologies Co., Ltd., Beijing, China) was used. This robot system consists of a workstation for surgical planning and control, an optical tracking device, a robot arm and surgical instruments (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003csup\u003e14\u003c/sup\u003e. The surgeon plans the surgical path through the master control system based on the images collected by the imaging device. Then, the master control system controlled the multi-degree-of-freedom manipulator to move to the target point according to the spatial position of the planned surgical path. The optical tracking system monitored the path deviation of the manipulator and the changes of the patient's position during the operation in real time, and automatically performed the feedback compensation calculation of positioning errors to achieve accurate positioning during the operation. The end of the manipulator is equipped with a surgical tool to facilitate accurate insertion of the guide needle during the operation.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003ehUC-MSCs isolation and culture\u003c/h2\u003e \u003cp\u003e hUC-MSCs were obtained from the clinical Stem Cell Center of the Afliated Drum Tower Hospital of Nanjing University Medical School. Six human umbilical cords were collected after obtaining the informed consent of healthy parturients, according to the Ethics Committee of Human Experimentation of the Afliated Drum Tower Hospital of Nanjing University Medical School. The residual blood in umbilical tissue and blood vessels was washed with phosphate buffered saline (PBS) containing 300U/ml penicillin and 0.3mg/ml streptomycin. The UCs were chopped and digested at 37\u0026deg;C using collagen A (Roche, Mannheim, Germany) from DMEM (Gibco, Rockville, MD, USA) under agitation. Cells were centrifuged at 200\u0026times;g for 10 min through a 70\u0026micro;m mesh filter (BD Falcon, San Jose, CA, USA) and then suspended in StemCell specific proliferating media (StemCell Technologies, Inc., Vancouver, BC, Canada). A 6-well plate with a density of 1x106 cells/well and 5%CO2 was inoculated in a 37\u0026deg;C incubator. Cells were observed under a phase contrast microscope (Olympus Tokyo, Japan). When the cells reached 80\u0026ndash;90% confluence, subculture was performed\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eCell identification\u003c/h2\u003e \u003cp\u003eThe expression of typical protein markers on the cell surface was detected by flow cytometry to identify the hUC-MSCs\u003csup\u003e15\u003c/sup\u003e (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The cells at the fourth passage were washed twice with PBS and resuspended in 1\u0026times; binding buffer at a concentration of 10\u003csup\u003e6\u003c/sup\u003e cells/ml. Then, 5 \u0026micro;l of anti-human primary antibodies and 5 \u0026micro;l of PI were added to 100 \u0026micro;l of the cell solution, and the solution was incubated for 30 min at 25\u0026deg;C in the dark. After incubation, cells were washed three times by 1\u0026times;PBS and resuspended in washing buffer for flow cytometry analysis. Information on anti-human primary antibodies was as follows:CD34, CD11b, CD45, CD19, CD73, CD105, CD90, and HLA-DR (BD, USA). Becton Dickinson FACS Aria flow cytometer (BD Biosciences, San Jose, CA, USA) and BD FACS Diva software 8.0.1 (BD Biosciences) was used to detect the expression of typical protein markers on cell surface. HUCMSCs at the fourth passage were harvested and replated at a density of 1 \u0026times; 104 cells/well in a 24-well culture plate to multilineage differentiation. When the degree of cell fusion reached 50\u0026ndash;70%, lipid formation and osteogenesis were induced by replacement of lipogenic medium and osteogenic medium (Gibco, USA), respectively. After 21 days, cells were fixed in 4% formaldehyde and stained with Oil red O (Sigma-Aldrich, USA) or Alizarin Red S (Sigma-Aldrich, USA) to evaluate the adipogenic or osteogenic differentiations, respectively.In addition, 2 \u0026times; 105 cells at the fourth passage were centrifuged in vitro at 1200 rpm/min for 5 min. After the supernatant was removed, cartilage medium (Gibco, USA) was added to the granules to evaluate the chondrogenic differentiation of HUCMSCs. After 21 days, the pellet was fixed in 4% formaldehyde, continuous dehydrated through ethanol dilutions, and embedded in optimal cutting temperature compound (OCT). Blocks were cut into 5- mm-thick sections and stained with Alcian Blue (Sigma-Aldrich, USA).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eB\u003c/b\u003e, Forth-passaged cells show typical fibroblastshaped morphology. Alizarin Red S staining, and Oil red O staining showed HUCMSCs were induced into osteogenic \u003cb\u003eC\u003c/b\u003e and adipogenic \u003cb\u003eD\u003c/b\u003e, respectively.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eRobot-assisted core decompression and hUC-MSC transplantation\u003c/h2\u003e \u003cp\u003eSurgical path planning: After general anesthesia, the patient was placed in the supine position. Disinfection should include the ipsilateral superior iliac spine where the tracer is placed. X-ray findings of the hip joint in upright and lateral positions were observed with C-arm fluoroscopy.\u003c/p\u003e \u003cp\u003eImport this information into the workstation planning software and mark the registration points according to the prompts on the software interface. The X-ray image must contain all 10 anchor points on the locator ruler. According to the preoperative X-ray and MRI results, the orientation of the insertion needle from the lower part of the femur greater trochanter to the center of the necrotic area of the femoral head was planned, and then the appropriate insertion point, angle and length were calculated automatically by the software. Core decompression and hUC-MSC transplantation: After the surgical path is planned, the robotic arm is operated, which automatically moves the guide sleeve to the skin surface according to the planned needle direction and insertion point.\u003c/p\u003e \u003cp\u003eThe guide needle was inserted through this point and direction. The surgeon made an incision about 1\u0026ndash;2 centimeters into the skin where the needle was inserted. According to the position of femoral head and necrotic lesion measured by the robot, a Kirschner wire of appropriate length was drilled, and then the robot was moved to insert the soft tissue protective sleeve along the guide wire. In the soft tissue sleeve, the guide needle is drilled into the trephine. The solid trephine was removed and replaced with a hollow trephine. The surgeon followed the needle into the neck of the femur and the femoral head, through the hardened area around the necrotic area, and into the necrotic area until approximately 5mm below the articular surface. The core decompression tube was cureted to remove the necrotic tissue (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The extracted hUC-MSCs, autogenous cancellous bone particles and calcium sulfate (CaSO4) -calcium phosphate (CaPO4) bone graft replacements (PRO-DENSE\u0026reg;, Wright Medical Technology\u0026trade;, Inc.) are included. Arlington, TN, USA) were completely mixed and sent with special compression bone grafts into the decompression tunnel and C-arm X-ray was performed to ensure they reached the decompression bone passage (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eTraditional core decompression surgery\u003c/h2\u003e \u003cp\u003eThe direction, position and depth of drilling holes were designed in advance according to X-ray film, CT or MRI and preoperative C-arm X-ray fluoroscopy. The rest of the procedure is similar to robot-assisted core decompression.The necrotic area of the filling contains autogenous cancellous bone particles and calcium sulfate (CaSO4) -calcium phosphate (CaPO4) bone graft replacements (PRO-DENSE\u0026reg;, Wright Medical Technology\u0026trade;, Inc.)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003ePostoperative management\u003c/h2\u003e \u003cp\u003eAfter recovery from anesthesia, the affected limb can move freely without weight bearing. After three months, the affected limb was able to walk with partial load. About 6 months after surgery, full weight-bearing activities can be initiated if radiographs show that the bone tunnel has formed and healed.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eObservation Indicators\u003c/h2\u003e \u003cp\u003eOperation-relative indexes: Two groups were compared in terms of the operation time, the number of guidewire attempts, the number of intraoperative fluoroscopies and intraoperative blood loss.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eEfficacy evaluation\u003c/strong\u003e \u003cp\u003eThe visual analogue scale (VAS) score and Harris hip score (HHS) were recorded preoperatively and at the last follow-up. All patients underwent MRI at least twice preoperation and at the last follow-up.The overall effective rate were calculated.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAll of the statistical analyses in this study were performed using SPSS 22.0 statistical software (IBM SPSS, New York, NY, USA). The variables with continuous data are reported as the means and standard deviations. Statistical analyses were conducted using a paired t-test to compare the means if they were normally distributed. Comparisons between count datas were performed using χ2 -test\u003c/p\u003e \u003cp\u003eanalysis. P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicated statistical significance.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThe general characteristics of the two groups were shown in Table \u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, and no significant differences were observed.\u003c/p\u003e \u003cp\u003eThe operation-relative indexes were shown in Table \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the operation time, guide wire insertion time, intraoperative fluoroscopies and intraoperative blood loss in observation group were all less than that in control group.\u003c/p\u003e \u003cp\u003eThere were no significant differences in preoperative HHS, VAS scores and necrotic volume of femoral heads between the two groups. The HHS, VAS scores and necrotic volume of femoral heads (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e at the last follow-up were also no significant differences. The survival rate in observation group was 82.1%, which is higher than that in control group (72.7%), however there was also no statistical difference between them (Table \u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of the general data between two groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eObservation group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003et\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP value\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e45.6\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e43.7\u0026thinsp;\u0026plusmn;\u0026thinsp;1.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.699\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.489\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.358\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSmoking history(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.338\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDrinking history(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.552\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eARCO classification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.767\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2a\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2b\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2c\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAetiology(no. of patients)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.164\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.762\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIdiopathic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAlcohol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTrauma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCorticosteroids\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of the operation-relative indexes between two groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eObservation group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003et\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP value\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eoperation time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e65.83\u0026thinsp;\u0026plusmn;\u0026thinsp;1.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e49.25\u0026thinsp;\u0026plusmn;\u0026thinsp;2.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5.710\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eguide wire insertion time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e23.5\u0026thinsp;\u0026plusmn;\u0026thinsp;1.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e6.15\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e13.004\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eintraoperative fluoroscopies\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e23.78\u0026thinsp;\u0026plusmn;\u0026thinsp;1.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e13.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e7.765\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eintraoperative blood loss\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e76.39\u0026thinsp;\u0026plusmn;\u0026thinsp;3.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e26.25\u0026thinsp;\u0026plusmn;\u0026thinsp;2.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e11.969\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of efficacy evaluation between two groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eObservation group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eχ\u003csup\u003e2\u003c/sup\u003e/ t-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP value\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHHS (preoperative)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e67.83\u0026thinsp;\u0026plusmn;\u0026thinsp;6.55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e68.95\u0026thinsp;\u0026plusmn;\u0026thinsp;6.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.751\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS (preoperative)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.344\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.733\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHHS (last follow-up\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e84.17\u0026thinsp;\u0026plusmn;\u0026thinsp;5.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e87.9\u0026thinsp;\u0026plusmn;\u0026thinsp;5.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.329\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS (last follow-up)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.24\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.23\u0026thinsp;\u0026plusmn;\u0026thinsp;0.52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.233\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.865\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNecrotic\u003c/p\u003e \u003cp\u003evolume of femoral heads (preoperative, cm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6.52\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.83\u0026thinsp;\u0026plusmn;\u0026thinsp;0.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.221\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.893\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNecrotic\u003c/p\u003e \u003cp\u003evolume of femoral heads (preoperative, cm\u003csup\u003e3\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.63\u0026thinsp;\u0026plusmn;\u0026thinsp;0.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.23\u0026thinsp;\u0026plusmn;\u0026thinsp;1.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.356\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.681\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurvival/ no survival\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16/6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23/5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.425\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOnce ONFH occurs, most will gradually deteriorate\u003csup\u003e16\u003c/sup\u003e.There is no evidence that conservative treatment is effective in delaying progression, therefore, surgery to delay or even reverse the disease progression has always been a hot topic in orthopedics field1\u003csup\u003e17,18\u003c/sup\u003e. Arlet and Float first described femoral head core decompression (CD)\u003csup\u003e19,20\u003c/sup\u003e. CD has been proved to be an effective treatment for hip preservation.\u003c/p\u003e \u003cp\u003eCommon CD operation has large incision and tissue damage and long recovery time.The placement of traditional core decompression guide needle mainly depends on intraoperative X-ray fluoroscopy, which often requires multiple adjustments to determine the direction and position of the guide needle, thus increasing radiation exposure for both the operator and the patient and operation time\u003csup\u003e21\u003c/sup\u003e. TiRobot\u0026trade; was first introduced by Tian\u003csup\u003e14\u003c/sup\u003e and is an orthopaedic surgical robot that can be used to implant different guide wires and screws, especially for guide wire insertion of the proximal femur and spine. With the application of the robot-assisted system, the guide needle can be accurately placed into the necrotic area of the femoral head with the guidance of the robotic arm only once the anterior and lateral perspective of the hip joint is theoretically required. Since the robotic system can provide the precise length of guide pin entry, it does not repeated fluoroscopy is required to monitor the depth of placement\u003csup\u003e22\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn the initial use of orthopedic robots, there may be some delay in preoperative planning, overall, the operation time was significantly reduced\u003csup\u003e23\u003c/sup\u003e. The operation time, intraoperative fluoroscopy times and blood loss of the robot-assisted surgery group were all better than those of the traditional surgery group. However, multiple fluoroscopy was still required during decompression and bone grafting because there was no reference point for determining the position of the drill and pressure bone graft in the femoral head. More importantly, the robot can determine the direction of the puncture and guide the surgeon precisely to the desired location.There was a correlation between the necrotic area of femoral head before operation and the residual dead bone volume after operation and the failure rate\u003csup\u003e24\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eCore decompression can reduce the intraosseous pressure by decompression and open up the sclerosis zone that hinders the repair of osteonecrosis. However, this repair is limited to a local area and does not completely solve the problem of femoral head repair\u003csup\u003e25\u003c/sup\u003e. Recent studies have shown that stem cells are capable of multiple differentiation and can be directed to differentiate into other cells under the action of specific cytokines, thus promoting the repair of damaged tissues\u003csup\u003e26,27\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eMesenchymal stem cells (MSCs) are considered as perfect candidate for cell-based therapy and regenerative medicine\u003csup\u003e28,29\u003c/sup\u003e. Some studies have pointed out that the use of autologous MSCs for patients with ONFH disease is feasible, safe in the long term, and potentially effective\u003csup\u003e30,31\u003c/sup\u003e.As an excellent representative of MSCs, hUC-MSCs have the subomnipotent differentiation potential, and can differentiate into a variety of tissue cells such as heart, liver, kidney, lung, pancreas, nerve, bone, muscle and fat, almost covering all the tissue cells in the human body\u003csup\u003e32\u003c/sup\u003e.In addition to the strong differentiation potential and proliferation ability, hUC-MSCs have many other advantages: sufficient sources, simple isolation, strong cell vitality, lower immunogenicity, short amplification time, and have become the focus of treatment for various tissue repair containing ONFH\u003csup\u003e30,33\u003c/sup\u003e. Le et al.\u003csup\u003e34\u003c/sup\u003e found hUC-MSCs transplantation showed positive effects on the cartilage regeneration in osteochondral femoral head defect. Li et al. \u003csup\u003e35\u003c/sup\u003e found that hUC-MSCs can increase the expression of bone morphogenetic protein-2 (BMP-2) and vascular endothelial growth factor (VEGF), thus be able improve steroid-induced necrosis of the femoral head (SNFH) in rats\u003c/p\u003e \u003cp\u003eIn our study, hUC-MSCs has been proven that it can differentiate to osteoblasts annd adipocytes in vitro and can be plastic-adherent when maintained in standard culture conditions, at last, flow cytometry confirmed it express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 and HLA-DR surface molecules\u003csup\u003e22\u003c/sup\u003e. All of this shows that hUC-MSCs in our study meet the minimal criteria for Cellular Therapy proposes. Intravenous delivery, targeted intra-arterial injection and local injectionare three methods to transplant MSCs. Targeted intra-arterial injection seems have the best effect, however, it is clear that local injection is the best for safety and tolerance\u003csup\u003e36\u003c/sup\u003e. Chen et al.\u003csup\u003e15\u003c/sup\u003e reported intraarterial infusion of hUCMSCs is a feasible and relatively safe method for the treatment of femoral head necrosis. In their study, the survival rate was 100% (5/5) in ARCO stage 2 patients and 75% (3/4) in ARCO stage 3 patients.Although the number of cases they reported was small, the results were encouraging.All patients in our study had stage 2 ONFH according to the ARCO and Steinberg classifications. The effective rate in observation group was 82.1% (23/28), which was lower than Chen 's report but slightly higher than that in control group (72.7%, 16/22).\u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eOur study has some limitations. First, it was a single center study with small sample size. Second, this study was a retrospective cohort study, so the cases were easily lost to follow-up. Third, we did not set up a robot-assisted core decompression group (without stem cell transplantation)\u003c/p\u003e \u003cp\u003eRobot-assisted core decompression also has some drawbacks.First, under the guidance of the robot arm, the number of X-ray fluoroscopy was reduced during the placement of guide pins, however, during decompression and bone grafting, multiple fluoroscopy is still required to determine the position of the drill and pressure implant in the femoral head. Second, preoperative necrotic area of femoral head and the residual necrotic bone volume was highly correlated with the rate of surgical failure. Due to the defect of the decompression bit, there are still some necrotic areas that have not been effectively intervened.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eRobot-assisted core decompression can improve the precision of early decompression and core marrow bone grafting of femoral head necrosis, reduce surgical trauma, reduce intraoperative fluoroscopy damage to doctors and patients, and show better efficiency than traditional core decompression when combined with human umbilical cord-derived mesenchymal stem cell transplantation.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by the grants from Health science and Technology development special fund project of Nanjing, China (No. YKK20201).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors declare they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was approved by the Research Ethics Board of\u0026nbsp;the Affiliated Jiangning Hospital with Nanjing Medical University\u0026nbsp;(permit number: 2016056).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll umbilical cord samples were taken after informed and written consent was obtained.\u0026nbsp;All of the patients signed corresponding informed consent before the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;statement\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and analysed during the current study available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eZhao J, Meng H, Liao S, Su Y, Guo L, Wang A, Xu W, Zhou H, Peng J. Therapeutic effect of human umbilical cord mesenchymal stem cells in early traumatic osteonecrosis of the femoral head. J Orthop Translat, 2022, 37:126\u0026ndash;142.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaneko S, Takegami Y, Seki T, Fukushima W, Sakai T, Ando W, Ishiguro N, Sugano N. Surgery trends for osteonecrosis of the femoral head: a fifteen-year multi-centre study in Japan. Int Orthop, 2020, 44(4):761\u0026ndash;769.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJi Q, Li X, Luo S, Geng L, Ren P, Ni M, Zheng Q, Xin P, Wang Y, Zhang G. Long-term outcomes of arthroscopic synovectomy and core decompression through multiple small bone holes for early-stage avascular necrosis of the femoral head. Arthroplasty, 2023, 5(1):17.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFicat RP. Idiopathic bone necrosis of the femoral head. Early diagnosis and treatment. J Bone Joint Surg Br, 1985, 67(1):3\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang JQ, Wang Y, Feng Y, Han W, Su YG, Liu WY, Zhang WJ, Wu XB, Wang MY, Fan YB. Percutaneous Sacroiliac Screw Placement: A Prospective Randomized Comparison of Robot-assisted Navigation Procedures with a Conventional Technique. Chin Med J (Engl), 2017, 130(21):2527\u0026ndash;2534.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBastian JD, Jost J, Cullmann JL, Aghayev E, Keel MJ, Benneker LM. Percutaneous screw fixation of the iliosacral joint: optimal screw pathways are frequently not completely intraosseous. Injury, 2015, 46(10):2003\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKarampinas P, Galanis A, Papagrigorakis E, Vavourakis M, Vlachos C, Zachariou D, Pneumaticos S, Vlamis J. Osteonecrosis of the Femoral Head. Optimizing the Early-Stage Joint-Preserving Surgical Treatment? Maedica (Bucur), 2022, 17(4):948\u0026ndash;954.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eI\u0026ntilde;iguez M, Negr\u0026iacute;n R, Duboy J, Reyes NO, D\u0026iacute;az R. Robot-Assisted Unicompartmental Knee Arthroplasty: Increasing Surgical Accuracy? A Cadaveric Study. J Knee Surg, 2021, 34(6):628\u0026ndash;634.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhu ZD, Xiao CW, Tan B, Tang XM, Wei D, Yuan JB, Hu J, Feng L. TiRobot-Assisted Percutaneous Cannulated Screw Fixation in the Treatment of Femoral Neck Fractures: A Minimum 2-Year Follow-up of 50 Patients. Orthop Surg, 2021, 13(1):244\u0026ndash;252.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu XB, Wang JQ, Sun X, Han W. Guidance for the Treatment of Femoral Neck Fracture with Precise Minimally Invasive Internal Fixation Based on the Orthopaedic Surgery Robot Positioning System. 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A quantitative, randomized study evaluating three methods of mesenchymal stem cell delivery following myocardial infarction. Eur Heart J, 2006, 27(9):1114\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Necrosis of the femoral head, Robot, Core decompression, mesenchymal stem cell","lastPublishedDoi":"10.21203/rs.3.rs-3286442/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3286442/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e \u003cb\u003eObjective\u003c/b\u003e To compare the difference in the effect betweeen robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell (hUC-MSC) transplantation and traditional core decompression surgery for osteonecrosis of the femoral head.\u003c/p\u003e \u003cp\u003e \u003cb\u003eMethods\u003c/b\u003e: Thirty-eight patients with a total of 50 hips who were diagnosed with Association Research Circulation Osseous stage 2 avascular necrosis of the femoral head were included for retrospective analysis. According to the treatment method, they were divided into 2 groups. Twenty patients (28 femoral heads) in the robot group were treated with core decompression assisted by robots combined with human umbilical cord-derived mesenchymal stem cell transplantation (observation group)\u003c/p\u003e \u003cp\u003e. The traditional surgery group consisted of 18 patients (22 femoral heads), they were received traditional core decompression operation (control group). Preoperative and postoperative visual analogue scale (VAS) scores, the Harris hip score (HHS) and MRI examination were compared between two groups.\u003c/p\u003e \u003cp\u003e \u003cb\u003eResults\u003c/b\u003e: The mean follow-up was 17.6 months (12\u0026ndash;28 months). There was no significant difference in preoperative VAS and HHS scores and necrotic\u003c/p\u003e \u003cp\u003evolume of femoral heads between the two groups. Of note, VAS scores and necrotic\u003c/p\u003e \u003cp\u003evolume of femoral heads in robot group were significantly lower than those in traditional surgery group at the last follow-up, HHS scores in robot group were significantly highter than those in traditional surgery group at the last follow-up.\u003c/p\u003e \u003cp\u003e \u003cb\u003eConclusion\u003c/b\u003e: Robot-assisted core decompression combined with hUC-MSC transplantation is more effective than traditional core decompression operation for the treatment of femoral head necrosis.\u003c/p\u003e","manuscriptTitle":"Comparison robot-assisted core decompression combined with human umbilical cord-derived mesenchymal stem cell transplantation and traditional surgery for treatment of osteonecrosis of the femoral head. 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