Evaluation of Positioning Accuracy and Clinical Outcomes in 3D Printing- Assisted Ankle Ligament Surgery

Evaluation of Positioning Accuracy and Clinical Outcomes in 3D Printing- Assisted Ankle Ligament Surgery | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Evaluation of Positioning Accuracy and Clinical Outcomes in 3D Printing- Assisted Ankle Ligament Surgery Kai Luo, Yi Xiang, Kang Lu, zhongbao Du, Yanmei Ren, Liqin Sun, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4756719/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 Background: To investigate the positioning accuracy and clinical efficacy of 3D-printed, personalized guide plate assisted lateral ankle ligament reconstruction. Methods: We retrospectively studied 48 patients with chronic lateral ankle instability and divided them into two groups: the template group (24 patients) and the conventional group (24 patients). The operation time, intraoperative X-ray exposure time, American Orthopedic Foot and Ankle Society and Foot and Ankle Outcome Score (FAOS) were compared between the two groups. Results: All patients were followed up for 12-20 months (14.5 ± 5.5). The operation time in the template group was 32-55 min (38.6 ± 9.7), the operation time in the conventional group was 48-73 min (58.3 ± 12.6), and there was a significant difference between the two groups (P<0.05). The number of X-ray exposures in the template group was 1-3 (1.2 ± 0.6), the number of X-ray exposures in the conventional group was 3-6 (3.8 ± 2.2), and there was a significant difference between the two groups (p<0.05). There was no significant difference in the AOFAS score or FAOS score between the two groups before the operation orat the last follow-up after the operation. There was no significant difference in the talar anteversion distance or talar varus angle between the two groups at the last follow-up after the operation. Conclusion: Comparedwith conventional surgery, 3D-printedtemplate surgery has a shorter operation time, higher positioning accuracy, and shorterradiation exposure time. 3D printing template surgery is a successful treatment option with the same satisfactory effect on patients with chronic lateral ankle instability. Ankle Sprains and strains Lateral ligament ankle Reconstruction 3D printing Localization Figures Figure 1 Introduction Ankle sprain is a common injury in sports[1]. After conservative treatment and physical therapy, ankle function can improve. Current research on the effective treatment of ankle ligaments has progressed; however, there are still some limitations. The high incidence of chronic ankle instability shows that conservative treatment was not sufficient to solve the stability problem of the ankle [2]. Instability of the ankle often occurs due to injury of the lateral ankle ligament, especially the rupture of the anterior talofibular ligament (ATL) and calcaneo fibular ligament (CFL). Treatments for chronic lateral ankle instability, including nonanatomical reconstruction, anatomical repair, and anatomical reconstruction, have achieved good results[3-5]. However, there are certain limitations of surgical treatment in managing chronic lateral ankle instability. Considering the different anatomical types of the ankle lateral ligament, individualized treatments can optimally adapt and accurately treat chronic lateral ankle instability. Bone tunnel problems are the main cause of failure in ATFL and CFL reconstruction, and an abnormal bone tunnel position can lead to damage of the graft and cause joint instability. In the context of precision medicine[6,7], our study aimed to develop a personalized treatment approach for CLAI therapy. The radiation exposure time can be reduced, and the procedure time can be reduced by using 3D-printed guide plates. The choice of the attachments of the reconstructed ligament is often determined by the clinical experience of the operator and intraoperative X-ray fluoroscopy. Incorrect bone tunnel positioning may lead to surgical failure and iatrogenic injury. Lateral ankle ligament reconstruction surgery requires a precise insertion location and tendon tension; otherwise, this may affect the biomechanical recovery of the ligament. Inaccurate positioning will affect the biomechanical effect of tendon reconstruction, especially for the talus and calcaneus attachment points of the tendon. In view of the urgent need for precision medicine and personalized treatment, this study focused on introducing innovative technologies to improve the accuracy and personalization of ankle ligament reconstruction. With the help of a 3D-printed personalized guide plate, the talus and calcaneus attachment points of the tendon can be made more accurate, the number of perspective times can be effectively reduced, and the difficulty of the procedure can be reduced. This study focused on the application of 3D-printed personalized guide plates in the reconstruction of the lateral ligament of the ankle joint, aiming to improve the precise positioning of the tendon attachment point during the operation process through this technology and subsequently improve the surgical effect and clinical curative effect. Materials and methods patients We retrospectively analysed 48 patients in our hospital (The 985th Hospital People’s Liberation Army Joint Logistics Support Force) who underwent anatomic reconstruction of the anterior talofibular ligament and calcaneofibular ligament with lateral ankle instability treated with semitendinosus tendon autografts. The basic information of the patients is shown in Table 1 . Table 1 Patient demographic data Template group (n = 24) Conventional group (n = 24) P value Sides left 17, right 7 left 11, right 13 0.625 Age (years) 19–34 (average 23) 21–33(average 24) 0.528 Mean weight (SD) (kg) 72.5 (SD, 5.2) 70.2 (SD, 6.1) 0.546 Classification of CAI Level II 10, Level III14 Level II 8, Level III 16 0.746 A P value < 0.05 was considered to indicate statistical significance. The classification of CAI (American Medical Association, AMA) was as follows: Level I, ligament overstretching; Level II, partial ligament tear; and Level III, complete ligament tear. SD – standard deviation. Values are presented as the mean ± standard deviation, unless otherwise indicated. In the template group (24 patients, 17 patients in the left ankle and 7 patients in the right ankle, aged 19–34 years, with an average age of 23.0 ± 7.3 years), 3D-printed templates were used to establish the talus end channel of the anterior talofibular ligament and the calcaneal end channel of the calcaneal fibular ligament. The conventional group (24 patients, 11 patients with left ankle involvement and 13 patients with right ankle involvement, aged 21–33 years, average age 24.20 ± 8.8 years) was treated with traditional intraoperative fluoroscopy-guided surgery. The inclusion criteria were as follows: (1) history of recurrent ankle sprains > 6 months and ineffective conservative treatment; (2) chronic pain or tenderness of the lateral ankle; (3) MRI showing grade II or III injury of the lateral ankle ligament with or without calcaneofibular ligament injury; and (4) previous simple lateral ligament repair surgery failure[8–9]. The exclusion criteria were as follows: (1) ankle fracture; (2) ankle arthritis or multiple medial and lateral ligament injuries to the ankle joint; (3) open trauma or ankle infection; and (4) ankle and foot deformities. Template design and printing From March 2020 to March 2022, CT data for 24 patients (from the template group) with ankle joints were collected from the impact database, and the data were output in DICOM format. The data were imported into Mimics 19.0 software to reconstruct 3D models of the foot and ankle, including soft tissue. 3-Metric medical 13.0 software and materialize magics21.0 software were used to design and mark the talus attachment point of the anterior talofibular ligament and the calcaneal attachment point of the talofibular ligament, and a guide pin positioning channel was added. Positioning channel is shown in Fig. 1 A. The guide plate was made of polylactic acid at a ratio of 1:1. The preparation of the guide plate at the patient's ankle joint was verified before surgery, and the fit between the guide plate and the ankle joint was observed. Preoperative wearing photos is shown in Fig. 1 B. The guide plate was sterilized before surgery. Surgical technique and postoperative treatment All patients were treated by the same senior surgeon. The operation was performed under epidural anaesthesia, and the patient was placed in the lateral position. After anaesthesia, the anterior posterior drawer test and varus stress test were performed to further confirm the diagnosis. The ipsilateral semitendinosus tendon was harvested, and a "Y" shape was used. A 1 cm incision was made at the anterior edge of the fibula to expose the fibular attachment point from the anterior fibular ligament (the lateral process of the talus), and the guide pin was inserted diagonally backwards and upwards. After C-arm fluoroscopy confirmed that the position of the guide pin was normal, holes were drilled with a 4.5 mm hollow drill trephine, and leads were inserted into the bone tunnels. Then, the "Y" shaped graft tendon connecting the single Endobutton plate was pulled into the fibular channel with the lead wire. The affected foot was placed in the neutral position, a 3D-printed guide plate was placed, a 2.0 mm guide pin was inserted along the talar and calcaneal positioning points of the guide plate, the bone tunnel was established with a 4.5 mm drill, and the transplanted tendon was guided subcutaneously. The foot was placed in a neutral position and slightly rotated outwards, and the ligaments of the talus and calcaneal bone tunnel were fixed with an interference screw. The wound was sutured layer-by-layer after rinsing. The ankle was held in place with plaster support of 90° dorsal flexion and 10° eversion. Practical operation during surgery is shown in Fig. 1C1, C2, C3. In the conventional group, a C-arm X-ray machine was used for fluoroscopic positioning before the operation. The location of the talus attachment point of the anterior fibular ligament and the calcaneus attachment point of the calcaneus fibular ligament was the same as that in the template group. A 2.0 mm guide pin was inserted into the talus and calcaneus on the body surface. It is necessary to conduct C-arm fluoroscopy again to confirm that the position and direction of the guide pin are normal. The remaining steps were the same as above. Routine prophylactic antibiotics were used for 2 days. After 2 weeks of non-weight-bearing gypsum use, the weight-bearing capacity gradually increased. Protective walking boots were used for 4 weeks. Rehabilitation started 4 weeks after surgery. Ankle activity, tibial strength, and varus resistance training gradually increased. Walking, jumping and running started 8 weeks after the operation. Statistical analysis IBM SPSS statistical software (version 19.0, IBM, Somers, NY, USA) was used for the statistical analysis. The mean and standard deviation (SD) were used for continuous variables, and numbers were used for categorical measurements. We performed an independent samples t test to compare the data between the template group and the conventional group. P < 0.05 indicated that the difference was statistically significant. Results All patients were followed up for 12–20 months. All participants achieved primary healing after the operation. All patients had no cases of iatrogenic fracture, incision infection, skin necrosis, internal fixator loosening or other complications. The average operation time was 38.6 ± 9.7 min, and the average number of radiation exposures was 1.2 ± 0.6 in the template group. The average operation time was 58.3 ± 12.6 min, and the average number of radiation exposures was 3.8 ± 2.2 in the conventional group (P < 0.05). The AOFAS score, FAOS score, anterior talar displacement, and talar tilt angle of the two groups before the operation and at the last follow-up after the operation were significantly greater than those before the operation (p 0.05). (Table 2 ) Table 2 Comparison between the 2 groups. Template group Conventional group P value Operation time (min) 38.6 ± 9.7 58.3 ± 12.6 < 0.01 Exposure intraoperative (times) 1.2 ± 0.6 3.8 ± 2.2 < 0.01 AOFAS score 92.1 ± 5.3 91.0 ± 4.2 NS FAOS score 36.5 ± 5.1 37.6 ± 4.8 NS Anterior drawer (stress radiography) (mm) 4.6 ± 2.5 4.3 ± 1.5 NS Talar tilt test (stress radiography) (degrees) 8.5 ± 2.3 7.6 ± 2.6 NS Discussion 3D printing guide technology has significant advantages for ankle surgery. The preoperatively designed guide plate can provide precise localization of the bone tunnel and reduce surgical failure. This technology reduces the number of radiation exposures and operation time and provides safer and more effective surgical options for patients and doctors. Conservative treatment can improve functional recovery in patients with lateral ligament injury of the ankle joint. Patients who undergo conservative treatment have a long recovery time. The prevalence of habitual sprain of the ankle joint increases after ligament scar repair, and repeated sprains can lead to ligament injury. Therefore, surgical treatment provides another option for lateral ligament injury of the ankle joint. At present, there are two main surgical methods, anatomical repair and reconstructive surgery. Anatomic repair surgery is mostly based on the Broström operation with a support belt or periosteal reinforcement suture [10]. Numerous studies have reported that anatomical reconstruction of CLAI is superior to nonanatomical reconstruction[11–14]. Anatomical reconstruction can prevent anteversion and entropion of the talus without affecting the subtalar joint[15]. At present, ankle ligament reconstruction surgery includes arthroscopic reconstruction of the ankle lateral ligament and percutaneous reconstruction of the ankle lateral ligament. Arthroscopic surgery has the advantages of less trauma, fast postoperative recovery, and the ability to treat intra-articular lesions, such as talus osteochondral injuries, ankle loosening and ankle synovial hyperplasia, but it has the disadvantages of high technical difficulty, a long operation time, and limited exposure of the arthroscopic field. Percutaneous reconstruction of the lateral ankle ligament reduces the technical difficulty and training time of surgery and is widely used. At the same time, some scholars have applied hybrid surgery involving ankle arthroscopy and percutaneous reconstruction[16]. Our hospital mainly performs percutaneous reconstruction surgery. During the operation, we found that the establishment of a bone tunnel is the key point of the operation. During the operation, the anterior single outlet peroneal ligament was used for reconstruction. We found that the talar and calcaneal tunnel designs of the anterior talofibular ligament and the calcaneal ligament were very different. Accurate anatomical reconstruction design can significantly reduce the problems caused by abnormal bone channel design, such as deviation of bone channels, iatrogenic fracture, and repeated puncture, which can lead to tendon fixation failure. The repeated establishment of a bone tunnel can cause many problems. The first is radiation exposure. Excessive radiation can cause many health risks to doctors and patients [17]. Computer-assisted surgery (CAS) allows surgeons to leave the operating room during image acquisition and reduces radiation exposure. However, expensive CAS equipment, preoperative preparation and increased patient radiation are also inevitable factors. In the past, several scholars have designed 3D guide plates to establish a ligament bone tunnel at the lateral malleolus and reduce the impact of radiation. The design of guide plates at the starting point of the fibula from the anterior fibular ligament and calcaneofibular ligament requires a larger incision, which can cause great trauma to patients due to the limitations of guide plate positioning. The second is deviation of the bone channel on bone tendon healing. In percutaneous reconstruction surgery, the design and positioning of the channel have a significant impact on the success of the operation. Inaccurate positioning of the channel will lead to the inability to complete anatomical reconstruction, resulting in movement disorders in patients after ankle surgery. The weak bone of the talus and calcaneus of the channels will have adverse effects on the healing of the transplanted tendon. Finally, repeated punctures can lead to iatrogenic injury, such as iatrogenic fracture and vascular injury. These problems can be avoided by individually designed guide plate technology while reducing the operation time. Compared with C-arm X-ray machine intraoperative auxiliary positioning, 3D-printed guide plate-assisted positioning has the same clinical efficacy. Its advantages are that it can significantly shorten the operation time, reduce the risk of tourniquet complications, and greatly reduce the number of intraoperative X-ray irradiations of patients. At the same time, the accuracy of talar tunnel positioning is greater, avoiding possible iatrogenic injury. However, we also found many problems when using the 3D-printed guide plate intraoperatively. For example, the patient's ankle joint may have inaccurate guide plate positioning due to insufficient detumescence of the ankle joint, which requires a short interval between the guide plate measurement and the operation time. Second, the starting points of the anterior talofibular ligament and calcaneofibular ligament were designed based on CT data and bone landmarks. It is not as accurate as the combination of CT and MRI, and even the location of the ligament starting point under arthroscopy in hybrid surgery. Finally, the number of patients included in this study was relatively small, and the follow-up time was relatively short. Conclusion In conclusion, template technology is a minimally invasive anatomic reconstruction technique for chronic instability of the ankle. Compared to those of conventional methods, the shorter operative time and less radiation exposure in the guide plate-assisted operation suggest that it is a better choice for the treatment of CLAI. Declarations Contributions Conceptualization: KL and YX; Data curation: ZD,JZ,WQ,YR and LS; Resources: KL and XT; Supervision: YX; Writing – original draft: KL; Writing – review & editing: KL and YX. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Conflicts of Interest The authors declare no conflict of interest. Availability of data All raw data and code are available upon request. Funding None. Ethics approval and consent to participate All procedures involving human participants in this study were in accordance with the Declaration of Helsinki (revised in 2013). This study was approved by the medical ethics committee of the 985th Hospital People’s Liberation Army Joint Logistics Support Force [(2020) ethics review No. 56]. All patients provided written consent. References Giuseppe, M., Ugo, F., Emanuela, F., Angelo, G., Luca, S., & Bruno, S. . (2005). Increased cancer risk among surgeons in an orthopaedic hospital. Occup Med(6), 498-500. Iwashita, K., Jujo, Y., Inokuchi, R., Glazebrook, M., & Perera, A. (2021). Hybrid ankle reconstruction of lateral ligaments. Arthroscopy Techniques, 10(3). Colville, M. R. . (1994). Instructional course lectures, the american academy of orthopaedic surgeons. reconstruction of the lateral ankle ligaments. The Journal of Bone and Joint Surgery, 76(7), 1092-1102. Vuurberg, G., Pereira, H., Blankevoort, L., & Van Dijk, C. N. . (2017). Anatomic stabilization techniques provide superior results in terms of functional outcome in patients suffering from chronic ankle instability compared to non-anatomic techniques. Knee Surgery Sports Traumatology Arthroscopy. Song, B. , Li, C. , Chen, N. , Chen, Z. , Zhang, Y. , & Zhou, Y. , et al. (2017). All-arthroscopic anatomical reconstruction of anterior talofibular ligament using semitendinosus autografts. International Orthopaedics, 41(5), 975-982. Krips, R. , Dijk, C. N. V. , Halasi, T. , Lehtonen, H. , Moyen, B. , & Lanzetta, A. , et al. (2000). Anatomical reconstruction versus tenodesis for the treatment of chronic anterolateral instability of the ankle joint: a 2- to 10-year follow-up, multicenter study. Knee Surgery Sports Traumatology Arthroscopy, 8(3), 173-179. Boyer, D. S. , & Younger, A. S. E. . (2006). Anatomic reconstruction of the lateral ligament complex of the ankle using a gracilis autograft. Foot & Ankle Clinics, 11(3), 585-595. Thès, André, Odagiri, H. , Elkaïm, Marc, Lopes, R. , Andrieu, M. , & Cordier, G. , et al. (2018). Arthroscopic classification of chronic anterior talo-fibular ligament lesions in chronic ankle instability. Orthopaedics & Traumatology Surgery & Research, 104. Grambart, S. T. , & Brown, J. R. . (2020). Revision surgery for failed lateral ankle stabilization. Clinics in Podiatric Medicine and Surgery, 37(3). Lee, Keun-Bae, & He-Xing. (2016). Modified Brostrom procedure for chronic lateral ankle instability in patients with generalized joint laxity. American Journal of Sports Medicine, 44(12), 3152-3157. Blackstone, E. H. . (2019). Precision medicine versus evidence-based medicine. Circulation, 140(15), 1236-1238. K? Nig, I. R., Fuchs, O., Hansen, G., Von Mutius, E., & Kopp, M. V. . (2017). What is precision medicine?. European Respiratory Journal, 50(4), 1700391. Guillo, S., Bauer, T., Lee, J. W., Takao, M., Kong, S. W., & Stone, J. W., et al. (2013). Consensus in chronic ankle instability: aetiology, assessment, surgical indications and place for arthroscopy. Orthopaedics & Traumatology Surgery & Research Otsr, 99(8), S411-S419. Chrisman, O. D. . (1969). Reconstruction of lateral ligament tears of the ankle. Journal of Bone & Joint Surgery-american Volume, 51. Al-Mohrej, O. A., & Al-Kenani, N. S. . (2016). Chronic ankle instability: current perspectives. Avicenna Journal of Medicine, 6(4), 103-108. Sammarco, & V J. (2001). Complications of lateral ankle ligament reconstruction. Clinical Orthopaedics & Related Research(391), 123-32. Gerber, J. P., Williams, G. N., Scoville, C. R., Arciero, R. A., & Taylor, D. C. . (1998). Persistent disability associated with ankle sprains: a prospective examination of an athletic population. Foot & Ankle International, 19(10), 653. 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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-4756719","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":343570641,"identity":"97a69fce-e080-4c39-ae35-38208be9be99","order_by":0,"name":"Kai Luo","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"Kai","middleName":"","lastName":"Luo","suffix":""},{"id":343570642,"identity":"ab48ff43-8be1-48b9-8205-fcff421718c4","order_by":1,"name":"Yi Xiang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8UlEQVRIiWNgGAWjYDACZjApwcAGpisk5ORJ1HLGwtiwgSQrGdsqEhkOEFBkcJz52cOvbRaJfexnD7/mnSeRwNjA/PDRDTxaJJvZzI1l2ySM2Xjy0qx5t0nksTOwGRvn4NHCz8xgJi3ZJiHHxpBjZgzUUszYwMMmjU8LGzP7N5AWHjb+N0AtcyQSGw4Q0MLPzGMm+RFki0SO8WPeBiK0SDbzlEkznAP6ReKNGeOcYxLGhs0E/GJw/vg2yR9ldYnz+3OMP7ypqZOTZ29++BifFhBg5oXEI5sUD5hLQDkIMP74A9H68QcRqkfBKBgFo2DkAQAT+D9NlzaSdAAAAABJRU5ErkJggg==","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":true,"prefix":"","firstName":"Yi","middleName":"","lastName":"Xiang","suffix":""},{"id":343570643,"identity":"625b6657-f15f-414f-a0a8-60647f20e8b0","order_by":2,"name":"Kang Lu","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"Kang","middleName":"","lastName":"Lu","suffix":""},{"id":343570644,"identity":"268d0516-057f-462c-b6a5-fddbf741ab48","order_by":3,"name":"zhongbao Du","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"zhongbao","middleName":"","lastName":"Du","suffix":""},{"id":343570645,"identity":"e12ebe7c-1b7a-4d36-89a2-8dd64d364b01","order_by":4,"name":"Yanmei Ren","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"Yanmei","middleName":"","lastName":"Ren","suffix":""},{"id":343570646,"identity":"3d10af98-fda3-446a-a3bf-bba83203d15c","order_by":5,"name":"Liqin Sun","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"Liqin","middleName":"","lastName":"Sun","suffix":""},{"id":343570647,"identity":"91dff7b1-380b-4592-9fc1-d6f446148645","order_by":6,"name":"Jian Zhang","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"Jian","middleName":"","lastName":"Zhang","suffix":""},{"id":343570648,"identity":"00873055-99ce-461a-a015-f7fc6043b8f1","order_by":7,"name":"Wenjie Qiao","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"Wenjie","middleName":"","lastName":"Qiao","suffix":""},{"id":343570649,"identity":"fafb215b-e481-44c5-b7b3-6618e10d2f23","order_by":8,"name":"Xiangyu Tang","email":"","orcid":"","institution":"The 985th Hospital People’s Liberation Army Joint Logistics Support Force","correspondingAuthor":false,"prefix":"","firstName":"Xiangyu","middleName":"","lastName":"Tang","suffix":""}],"badges":[],"createdAt":"2024-07-17 13:51:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4756719/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4756719/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":64166484,"identity":"44c8b0e6-8338-4db1-b032-77f0424e9e0c","added_by":"auto","created_at":"2024-09-09 09:36:01","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":81390,"visible":true,"origin":"","legend":"\u003cp\u003eImages showing the individualized template. (A) Virtual display design for planning the trajectory of the talus and calcaneus channels; (B) preoperative wearing photos; (C1, C2, C3) practical operation during surgery.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4756719/v1/1db32a014048871d6227bef3.jpg"},{"id":66943032,"identity":"1c904544-468d-43cc-99e4-75c9cb498b09","added_by":"auto","created_at":"2024-10-18 09:17:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":418105,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4756719/v1/f4514211-cc93-4c90-8f8a-e5884c80d951.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Evaluation of Positioning Accuracy and Clinical Outcomes in 3D Printing- Assisted Ankle Ligament Surgery","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAnkle sprain is a common injury in sports[1]. After conservative treatment and physical therapy, ankle function can\u0026nbsp;improve. Current\u0026nbsp;research on the\u0026nbsp;effective\u0026nbsp;treatment of ankle ligaments has\u0026nbsp;progressed;\u0026nbsp;however, there are still some\u0026nbsp;limitations. The high incidence of chronic ankle instability shows that conservative treatment was not\u0026nbsp;sufficient\u0026nbsp;to solve the stability problem\u0026nbsp;of the ankle\u0026nbsp;[2]. Instability of the ankle often\u0026nbsp;occurs due\u0026nbsp;to injury of the lateral ankle ligament, especially the rupture of the anterior talofibular ligament (ATL) and calcaneo fibular ligament (CFL).\u003c/p\u003e\n\u003cp\u003eTreatments for chronic lateral ankle instability, including\u0026nbsp;nonanatomical\u0026nbsp;reconstruction, anatomical repair, and anatomical reconstruction,\u0026nbsp;have achieved good results[3-5].\u0026nbsp;However, there are certain limitations of surgical treatment in managing chronic lateral ankle instability.\u0026nbsp;Considering the different anatomical types of\u0026nbsp;the\u0026nbsp;ankle lateral ligament, individualized treatments can optimally adapt and accurately treat chronic lateral ankle instability.\u0026nbsp;Bone tunnel problems are the main cause of failure in ATFL and CFL reconstruction, and\u0026nbsp;an\u0026nbsp;abnormal bone tunnel position can lead to damage of the graft and cause joint instability.\u003c/p\u003e\n\u003cp\u003eIn the context of precision medicine[6,7], our study\u0026nbsp;aimed\u0026nbsp;to\u0026nbsp;develop\u0026nbsp;a personalized treatment approach for CLAI therapy.\u0026nbsp;The radiation exposure time can be\u0026nbsp;reduced, and the procedure time\u0026nbsp;can be\u0026nbsp;reduced by using 3D-printed guide plates. The choice of the attachments of the reconstructed ligament is often determined by the clinical experience of the operator and intraoperative X-ray fluoroscopy. Incorrect bone tunnel positioning may lead to surgical failure and iatrogenic injury.\u0026nbsp;Lateral\u0026nbsp;ankle ligament reconstruction surgery\u0026nbsp;requires a\u0026nbsp;precise insertion location and tendon tension;\u0026nbsp;otherwise,\u0026nbsp;this\u0026nbsp;may affect the biomechanical recovery of\u0026nbsp;the\u0026nbsp;ligament.\u0026nbsp;Inaccurate positioning will affect the biomechanical effect of tendon reconstruction, especially for the talus and calcaneus attachment points of the tendon.\u003c/p\u003e\n\u003cp\u003eIn view of the urgent need for precision medicine and personalized treatment, this study\u0026nbsp;focused\u0026nbsp;on introducing innovative technologies to improve the accuracy and personalization of ankle ligament reconstruction. With the help of\u0026nbsp;a\u0026nbsp;3D-printed personalized guide plate, the talus and calcaneus attachment points of\u0026nbsp;the\u0026nbsp;tendon\u0026nbsp;can be made\u0026nbsp;more accurate, the number of perspective\u0026nbsp;times\u0026nbsp;can be effectively reduced, and the difficulty of the procedure\u0026nbsp;can be reduced.\u003c/p\u003e\n\u003cp\u003eThis study focused on the application of 3D-printed personalized guide plates in the reconstruction of the lateral ligament of the ankle joint, aiming to improve the precise positioning of the tendon attachment point during the operation process through this technology and subsequently improve the surgical effect and clinical curative effect.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003epatients\u003c/h2\u003e \u003cp\u003eWe retrospectively analysed 48 patients in our hospital (The 985th Hospital People\u0026rsquo;s Liberation Army Joint Logistics Support Force) who underwent anatomic reconstruction of the anterior talofibular ligament and calcaneofibular ligament with lateral ankle instability treated with semitendinosus tendon autografts. The basic information of the patients is shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\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\u003ePatient demographic data\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTemplate group (n\u0026thinsp;=\u0026thinsp;24)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eConventional group (n\u0026thinsp;=\u0026thinsp;24)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSides\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eleft 17, right 7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eleft 11, right 13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.625\u003c/p\u003e \u003c/td\u003e \u003c/tr\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\u003e19\u0026ndash;34 (average 23)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21\u0026ndash;33(average 24)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.528\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean weight (SD) (kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e72.5 (SD, 5.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e70.2 (SD, 6.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.546\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClassification of CAI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLevel II 10, Level III14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLevel II 8, Level III 16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.746\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eA P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered to indicate statistical significance. The classification of CAI (American Medical Association, AMA) was as follows: Level I, ligament overstretching; Level II, partial ligament tear; and Level III, complete ligament tear. SD \u0026ndash; standard deviation. Values are presented as the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation, unless otherwise indicated.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eIn the template group (24 patients, 17 patients in the left ankle and 7 patients in the right ankle, aged 19\u0026ndash;34 years, with an average age of 23.0\u0026thinsp;\u0026plusmn;\u0026thinsp;7.3 years), 3D-printed templates were used to establish the talus end channel of the anterior talofibular ligament and the calcaneal end channel of the calcaneal fibular ligament. The conventional group (24 patients, 11 patients with left ankle involvement and 13 patients with right ankle involvement, aged 21\u0026ndash;33 years, average age 24.20\u0026thinsp;\u0026plusmn;\u0026thinsp;8.8 years) was treated with traditional intraoperative fluoroscopy-guided surgery.\u003c/p\u003e \u003cp\u003eThe inclusion criteria were as follows: (1) history of recurrent ankle sprains\u0026thinsp;\u0026gt;\u0026thinsp;6 months and ineffective conservative treatment; (2) chronic pain or tenderness of the lateral ankle; (3) MRI showing grade II or III injury of the lateral ankle ligament with or without calcaneofibular ligament injury; and (4) previous simple lateral ligament repair surgery failure[8\u0026ndash;9].\u003c/p\u003e \u003cp\u003eThe exclusion criteria were as follows: (1) ankle fracture; (2) ankle arthritis or multiple medial and lateral ligament injuries to the ankle joint; (3) open trauma or ankle infection; and (4) ankle and foot deformities.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eTemplate design and printing\u003c/h2\u003e \u003cp\u003eFrom March 2020 to March 2022, CT data for 24 patients (from the template group) with ankle joints were collected from the impact database, and the data were output in DICOM format. The data were imported into Mimics 19.0 software to reconstruct 3D models of the foot and ankle, including soft tissue. 3-Metric medical 13.0 software and materialize magics21.0 software were used to design and mark the talus attachment point of the anterior talofibular ligament and the calcaneal attachment point of the talofibular ligament, and a guide pin positioning channel was added. Positioning channel is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eA. The guide plate was made of polylactic acid at a ratio of 1:1. The preparation of the guide plate at the patient's ankle joint was verified before surgery, and the fit between the guide plate and the ankle joint was observed. Preoperative wearing photos is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eB. The guide plate was sterilized before surgery.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eSurgical technique and postoperative treatment\u003c/h2\u003e \u003cp\u003eAll patients were treated by the same senior surgeon. The operation was performed under epidural anaesthesia, and the patient was placed in the lateral position. After anaesthesia, the anterior posterior drawer test and varus stress test were performed to further confirm the diagnosis. The ipsilateral semitendinosus tendon was harvested, and a \"Y\" shape was used. A 1 cm incision was made at the anterior edge of the fibula to expose the fibular attachment point from the anterior fibular ligament (the lateral process of the talus), and the guide pin was inserted diagonally backwards and upwards. After C-arm fluoroscopy confirmed that the position of the guide pin was normal, holes were drilled with a 4.5 mm hollow drill trephine, and leads were inserted into the bone tunnels. Then, the \"Y\" shaped graft tendon connecting the single Endobutton plate was pulled into the fibular channel with the lead wire. The affected foot was placed in the neutral position, a 3D-printed guide plate was placed, a 2.0 mm guide pin was inserted along the talar and calcaneal positioning points of the guide plate, the bone tunnel was established with a 4.5 mm drill, and the transplanted tendon was guided subcutaneously. The foot was placed in a neutral position and slightly rotated outwards, and the ligaments of the talus and calcaneal bone tunnel were fixed with an interference screw. The wound was sutured layer-by-layer after rinsing. The ankle was held in place with plaster support of 90\u0026deg; dorsal flexion and 10\u0026deg; eversion. Practical operation during surgery is shown in Fig.\u0026nbsp;1C1, C2, C3.\u003c/p\u003e \u003cp\u003eIn the conventional group, a C-arm X-ray machine was used for fluoroscopic positioning before the operation. The location of the talus attachment point of the anterior fibular ligament and the calcaneus attachment point of the calcaneus fibular ligament was the same as that in the template group. A 2.0 mm guide pin was inserted into the talus and calcaneus on the body surface. It is necessary to conduct C-arm fluoroscopy again to confirm that the position and direction of the guide pin are normal. The remaining steps were the same as above.\u003c/p\u003e \u003cp\u003eRoutine prophylactic antibiotics were used for 2 days. After 2 weeks of non-weight-bearing gypsum use, the weight-bearing capacity gradually increased. Protective walking boots were used for 4 weeks. Rehabilitation started 4 weeks after surgery. Ankle activity, tibial strength, and varus resistance training gradually increased. Walking, jumping and running started 8 weeks after the operation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eIBM SPSS statistical software (version 19.0, IBM, Somers, NY, USA) was used for the statistical analysis. The mean and standard deviation (SD) were used for continuous variables, and numbers were used for categorical measurements. We performed an independent samples t test to compare the data between the template group and the conventional group. P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicated that the difference was statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eAll patients were followed up for 12–20 months. All participants achieved primary healing after the operation. All patients had no cases of iatrogenic fracture, incision infection, skin necrosis, internal fixator loosening or other complications.\u003c/p\u003e \u003cp\u003eThe average operation time was 38.6 ± 9.7 min, and the average number of radiation exposures was 1.2 ± 0.6 in the template group. The average operation time was 58.3 ± 12.6 min, and the average number of radiation exposures was 3.8 ± 2.2 in the conventional group (P \u0026lt; 0.05). The AOFAS score, FAOS score, anterior talar displacement, and talar tilt angle of the two groups before the operation and at the last follow-up after the operation were significantly greater than those before the operation (p \u0026lt; 0.05). There was no significant difference in the AOFAS score, FAOS score, anterior talar displacement, or talar tilt angle between the two groups at the last follow-up after the operation (p \u0026gt; 0.05). (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"±\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"±\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\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 between the 2 groups.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTemplate group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eConventional group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\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 (min)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c2\"\u003e \u003cp\u003e38.6 ± 9.7\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c3\"\u003e \u003cp\u003e58.3 ± 12.6\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt; 0.01\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExposure intraoperative (times)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c2\"\u003e \u003cp\u003e1.2 ± 0.6\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c3\"\u003e \u003cp\u003e3.8 ± 2.2\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt; 0.01\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAOFAS score\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c2\"\u003e \u003cp\u003e92.1 ± 5.3\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c3\"\u003e \u003cp\u003e91.0 ± 4.2\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFAOS score\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c2\"\u003e \u003cp\u003e36.5 ± 5.1\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c3\"\u003e \u003cp\u003e37.6 ± 4.8\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnterior drawer (stress radiography) (mm)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c2\"\u003e \u003cp\u003e4.6 ± 2.5\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c3\"\u003e \u003cp\u003e4.3 ± 1.5\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTalar tilt test (stress radiography) (degrees)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c2\"\u003e \u003cp\u003e8.5 ± 2.3\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\"±\" colname=\"c3\"\u003e \u003cp\u003e7.6 ± 2.6\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e \u003cp\u003e\u003c/p\u003e "},{"header":"Discussion","content":"\u003cp\u003e3D printing guide technology has significant advantages for ankle surgery. The preoperatively designed guide plate can provide precise localization of the bone tunnel and reduce surgical failure. This technology reduces the number of radiation exposures and operation time and provides safer and more effective surgical options for patients and doctors.\u003c/p\u003e\u003cp\u003eConservative treatment can improve functional recovery in patients with lateral ligament injury of the ankle joint. Patients who undergo conservative treatment have a long recovery time. The prevalence of habitual sprain of the ankle joint increases after ligament scar repair, and repeated sprains can lead to ligament injury. Therefore, surgical treatment provides another option for lateral ligament injury of the ankle joint. At present, there are two main surgical methods, anatomical repair and reconstructive surgery. Anatomic repair surgery is mostly based on the Broström operation with a support belt or periosteal reinforcement suture [10]. Numerous studies have reported that anatomical reconstruction of CLAI is superior to nonanatomical reconstruction[11–14]. Anatomical reconstruction can prevent anteversion and entropion of the talus without affecting the subtalar joint[15].\u003c/p\u003e\u003cp\u003eAt present, ankle ligament reconstruction surgery includes arthroscopic reconstruction of the ankle lateral ligament and percutaneous reconstruction of the ankle lateral ligament. Arthroscopic surgery has the advantages of less trauma, fast postoperative recovery, and the ability to treat intra-articular lesions, such as talus osteochondral injuries, ankle loosening and ankle synovial hyperplasia, but it has the disadvantages of high technical difficulty, a long operation time, and limited exposure of the arthroscopic field. Percutaneous reconstruction of the lateral ankle ligament reduces the technical difficulty and training time of surgery and is widely used. At the same time, some scholars have applied hybrid surgery involving ankle arthroscopy and percutaneous reconstruction[16].\u003c/p\u003e\u003cp\u003eOur hospital mainly performs percutaneous reconstruction surgery. During the operation, we found that the establishment of a bone tunnel is the key point of the operation. During the operation, the anterior single outlet peroneal ligament was used for reconstruction. We found that the talar and calcaneal tunnel designs of the anterior talofibular ligament and the calcaneal ligament were very different. Accurate anatomical reconstruction design can significantly reduce the problems caused by abnormal bone channel design, such as deviation of bone channels, iatrogenic fracture, and repeated puncture, which can lead to tendon fixation failure.\u003c/p\u003e\u003cp\u003eThe repeated establishment of a bone tunnel can cause many problems. The first is radiation exposure. Excessive radiation can cause many health risks to doctors and patients [17]. Computer-assisted surgery (CAS) allows surgeons to leave the operating room during image acquisition and reduces radiation exposure. However, expensive CAS equipment, preoperative preparation and increased patient radiation are also inevitable factors. In the past, several scholars have designed 3D guide plates to establish a ligament bone tunnel at the lateral malleolus and reduce the impact of radiation. The design of guide plates at the starting point of the fibula from the anterior fibular ligament and calcaneofibular ligament requires a larger incision, which can cause great trauma to patients due to the limitations of guide plate positioning. The second is deviation of the bone channel on bone tendon healing. In percutaneous reconstruction surgery, the design and positioning of the channel have a significant impact on the success of the operation. Inaccurate positioning of the channel will lead to the inability to complete anatomical reconstruction, resulting in movement disorders in patients after ankle surgery. The weak bone of the talus and calcaneus of the channels will have adverse effects on the healing of the transplanted tendon. Finally, repeated punctures can lead to iatrogenic injury, such as iatrogenic fracture and vascular injury.\u003c/p\u003e\u003cp\u003eThese problems can be avoided by individually designed guide plate technology while reducing the operation time. Compared with C-arm X-ray machine intraoperative auxiliary positioning, 3D-printed guide plate-assisted positioning has the same clinical efficacy. Its advantages are that it can significantly shorten the operation time, reduce the risk of tourniquet complications, and greatly reduce the number of intraoperative X-ray irradiations of patients. At the same time, the accuracy of talar tunnel positioning is greater, avoiding possible iatrogenic injury. However, we also found many problems when using the 3D-printed guide plate intraoperatively. For example, the patient's ankle joint may have inaccurate guide plate positioning due to insufficient detumescence of the ankle joint, which requires a short interval between the guide plate measurement and the operation time. Second, the starting points of the anterior talofibular ligament and calcaneofibular ligament were designed based on CT data and bone landmarks. It is not as accurate as the combination of CT and MRI, and even the location of the ligament starting point under arthroscopy in hybrid surgery. Finally, the number of patients included in this study was relatively small, and the follow-up time was relatively short.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn conclusion, template technology is a minimally invasive anatomic reconstruction technique for chronic instability of the ankle. Compared to those of conventional methods, the shorter operative time and less radiation exposure in the guide plate-assisted operation suggest that it is a better choice for the treatment of CLAI.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eContributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization: KL and YX; Data curation: ZD,JZ,WQ,YR and LS; Resources: KL and XT; Supervision: YX; Writing\u0026nbsp;\u0026ndash;\u0026nbsp;original draft: KL; Writing\u0026nbsp;\u0026ndash;\u0026nbsp;review \u0026amp; editing: KL and YX. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u003cbr\u003e\u003cstrong\u003eConflicts of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll raw data and code are available upon request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll procedures involving human participants in this study were in accordance with the Declaration of Helsinki (revised in 2013). This study was approved by the medical ethics committee of the 985th Hospital People\u0026rsquo;s Liberation Army Joint Logistics Support Force [(2020) ethics review No. 56]. All patients provided written consent.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGiuseppe, M., Ugo, F., Emanuela, F., Angelo, G., Luca, S., \u0026amp; Bruno, S. . (2005). Increased cancer risk among surgeons in an orthopaedic hospital. Occup Med(6), 498-500.\u003c/li\u003e\n\u003cli\u003eIwashita, K., Jujo, Y., Inokuchi, R., Glazebrook, M., \u0026amp; Perera, A. (2021). Hybrid ankle reconstruction of lateral ligaments. Arthroscopy Techniques, 10(3).\u003c/li\u003e\n\u003cli\u003eColville, M. R. . (1994). Instructional course lectures, the american academy of orthopaedic surgeons. reconstruction of the lateral ankle ligaments. The Journal of Bone and Joint Surgery, 76(7), 1092-1102.\u003c/li\u003e\n\u003cli\u003eVuurberg, G., Pereira, H., Blankevoort, L., \u0026amp; Van Dijk, C. N. . (2017). Anatomic stabilization techniques provide superior results in terms of functional outcome in patients suffering from chronic ankle instability compared to non-anatomic techniques. Knee Surgery Sports Traumatology Arthroscopy.\u003c/li\u003e\n\u003cli\u003eSong, B. , Li, C. , Chen, N. , Chen, Z. , Zhang, Y. , \u0026amp; Zhou, Y. , et al. (2017). All-arthroscopic anatomical reconstruction of anterior talofibular ligament using semitendinosus autografts. International Orthopaedics, 41(5), 975-982.\u003c/li\u003e\n\u003cli\u003eKrips, R. , Dijk, C. N. V. , Halasi, T. , Lehtonen, H. , Moyen, B. , \u0026amp; Lanzetta, A. , et al. (2000). Anatomical reconstruction versus tenodesis for the treatment of chronic anterolateral instability of the ankle joint: a 2- to 10-year follow-up, multicenter study. Knee Surgery Sports Traumatology Arthroscopy, 8(3), 173-179.\u003c/li\u003e\n\u003cli\u003eBoyer, D. S. , \u0026amp; Younger, A. S. E. . (2006). Anatomic reconstruction of the lateral ligament complex of the ankle using a gracilis autograft. Foot \u0026amp; Ankle Clinics, 11(3), 585-595.\u003c/li\u003e\n\u003cli\u003eTh\u0026egrave;s, Andr\u0026eacute;, Odagiri, H. , Elka\u0026iuml;m, Marc, Lopes, R. , Andrieu, M. , \u0026amp; Cordier, G. , et al. (2018). Arthroscopic classification of chronic anterior talo-fibular ligament lesions in chronic ankle instability. Orthopaedics \u0026amp; Traumatology Surgery \u0026amp; Research, 104.\u003c/li\u003e\n\u003cli\u003eGrambart, S. T. , \u0026amp; Brown, J. R. . (2020). Revision surgery for failed lateral ankle stabilization. Clinics in Podiatric Medicine and Surgery, 37(3).\u003c/li\u003e\n\u003cli\u003eLee, Keun-Bae, \u0026amp; He-Xing. (2016). Modified Brostrom procedure for chronic lateral ankle instability in patients with generalized joint laxity. American Journal of Sports Medicine, 44(12), 3152-3157.\u003c/li\u003e\n\u003cli\u003eBlackstone, E. H. . (2019). Precision medicine versus evidence-based medicine. Circulation, 140(15), 1236-1238.\u003c/li\u003e\n\u003cli\u003eK? Nig, I. R., Fuchs, O., Hansen, G., Von Mutius, E., \u0026amp; Kopp, M. V. . (2017). What is precision medicine?. European Respiratory Journal, 50(4), 1700391.\u003c/li\u003e\n\u003cli\u003eGuillo, S., Bauer, T., Lee, J. W., Takao, M., Kong, S. W., \u0026amp; Stone, J. W., et al. (2013). Consensus in chronic ankle instability: aetiology, assessment, surgical indications and place for arthroscopy. Orthopaedics \u0026amp; Traumatology Surgery \u0026amp; Research Otsr, 99(8), S411-S419.\u003c/li\u003e\n\u003cli\u003eChrisman, O. D. . (1969). Reconstruction of lateral ligament tears of the ankle. Journal of Bone \u0026amp; Joint Surgery-american Volume, 51.\u003c/li\u003e\n\u003cli\u003eAl-Mohrej, O. A., \u0026amp; Al-Kenani, N. S. . (2016). Chronic ankle instability: current perspectives. Avicenna Journal of Medicine, 6(4), 103-108.\u003c/li\u003e\n\u003cli\u003eSammarco, \u0026amp; V J. (2001). Complications of lateral ankle ligament reconstruction. Clinical Orthopaedics \u0026amp; Related Research(391), 123-32.\u003c/li\u003e\n\u003cli\u003eGerber, J. P., Williams, G. N., Scoville, C. R., Arciero, R. A., \u0026amp; Taylor, D. C. . (1998). Persistent disability associated with ankle sprains: a prospective examination of an athletic population. Foot \u0026amp; Ankle International, 19(10), 653.\u003c/li\u003e\n\u003c/ol\u003e\n"}],"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":"Ankle, Sprains and strains, Lateral ligament ankle, Reconstruction, 3D printing, Localization","lastPublishedDoi":"10.21203/rs.3.rs-4756719/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4756719/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e To investigate the positioning accuracy and clinical efficacy of 3D-printed, personalized guide plate assisted lateral ankle ligament reconstruction.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e We retrospectively studied 48 patients with chronic lateral ankle instability and divided them into two groups: the template group (24 patients) and the conventional group (24 patients). The operation time, intraoperative X-ray exposure time, American Orthopedic Foot and Ankle Society and Foot and Ankle Outcome Score (FAOS) were compared between the two groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e All patients were followed up for 12-20 months (14.5 ± 5.5). The operation time in the template group was 32-55 min (38.6 ± 9.7), the operation time in the conventional group was 48-73 min (58.3 ± 12.6), and there was a significant difference between the two groups (P\u0026lt;0.05). The number of X-ray exposures in the template group was 1-3 (1.2 ± 0.6), the number of X-ray exposures in the conventional group was 3-6 (3.8 ± 2.2), and there was a significant difference between the two groups (p\u0026lt;0.05). There was no significant difference in the AOFAS score or FAOS score between the two groups before the operation orat the last follow-up after the operation. There was no significant difference in the talar anteversion distance or talar varus angle between the two groups at the last follow-up after the operation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eComparedwith conventional surgery, 3D-printedtemplate surgery has a shorter operation time, higher positioning accuracy, and shorterradiation exposure time. 3D printing template surgery is a successful treatment option with the same satisfactory effect on patients with chronic lateral ankle instability.\u003c/p\u003e","manuscriptTitle":"Evaluation of Positioning Accuracy and Clinical Outcomes in 3D Printing- Assisted Ankle Ligament Surgery","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-09-09 09:35:56","doi":"10.21203/rs.3.rs-4756719/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","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}}],"origin":"","ownerIdentity":"8a0b7f80-4792-47b0-b898-6cbd3f19b2b5","owner":[],"postedDate":"September 9th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-10-18T09:08:51+00:00","versionOfRecord":[],"versionCreatedAt":"2024-09-09 09:35:56","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4756719","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4756719","identity":"rs-4756719","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}