Fusion and Patient-reported Outcomes of Minimally Invasive Sacroiliac Joint Fusion Surgery: A Meta-Analysis

Fusion and Patient-reported Outcomes of Minimally Invasive Sacroiliac Joint Fusion Surgery: A Meta-Analysis | 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 Fusion and Patient-reported Outcomes of Minimally Invasive Sacroiliac Joint Fusion Surgery: A Meta-Analysis Roxana Beladi, Gustavo Anton, Michael Lawless, Heather Lucke, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7402569/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 Purpose: We aimed to evaluate the fusion rate after minimally invasive (MIS) sacroiliac joint (SIJ) fusions and compare patient-reported outcomes (PRO) between MIS SIJF and conservative treatment. Additionally, we aimed to compare the SIJ fusion rate between devices. Methods Using PRISMA-P guidelines, we searched electronic databases using the standardized search strategies for publication dates 1/1/2000-7/17/2024. Our primary outcomes were fusion rates after MIS SIJ fusion as evaluated by CT. Our secondary outcomes included Visual analog score-back (VAS) and Oswestry disability index (ODI). We included randomized controlled trials (RCTs), prospective or retrospective comparative or single-cohort studies, and case series with > 10 subjects. We excluded pediatric studies, studies lacking our outcomes, non-degenerative pathology, non-English studies, and those with < 6-month follow-up. Two independent reviewers screened for eligibility and performed a risk of bias assessment using the Cochrane Collaboration Risk of Bias (RoB) tool and the Methodological Index for Non-Randomized Studies (MINORS) tool, and extracted data. A third reviewer arbitrated throughout all stages. Random or mixed-effects models and inverse variance were used for synthesis. Q and I 2 statistics were used to assess heterogeneity. GRADE was used to evaluate the quality of evidence used in our recommendation. We used Review Manager and Comprehensive Meta-Analysis. This protocol was registered at PROSPERO: 2021 CRD4202127348. Results One thousand and sixteen studies were identified. Thirty-eight were included after the screening. There were 4 RCTs, 32 single cohorts/case series, and 2 comparative cohort studies totaling 2,847 patients. Fusion outcomes demonstrated a pooled event rate of 0.86 (95% CI 0.78–0.91). Patient-reported outcomes demonstrated a significant improvement after SIJF in pooled mean VAS (-4.90, 95% CI -5.49 to -4.30, p = .00) and ODI (-22.01, 95% CI -27.90 to -16.12, p = .00). Among the comparative cohort studies, the SIJF group demonstrated a significantly improved pooled VAS (-3.71, 95% CI -4.74 to -2.68, p < .00001) and ODI (-19.30, 95% CI -23.87 to -14.4, p = .00001). There was no significant difference in fusion rate between devices and PROs between MINORS subgroups. I 2 indicated moderate to significant heterogeneity across all estimates. Per GRADE, the overall quality of the evidence of our recommendation is very low to moderate. Conclusion We demonstrated significant improvement of VAS after SIJF with moderate quality of evidence. We could not make a definitive conclusion regarding fusion rate, ODI, or comparative VAS (SIJF vs. conservative) due to the low quality of evidence. Further research is warranted to strengthen the evidence. Sacroiliac fusion minimally invasive fusion Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Introduction Background/rationale In the United States, back pain affects 15-45% of adults and causes significant morbidity. Sacroiliac joint (SIJ) dysfunction is the culprit in 15-30% of patients with low back pain [1, 2]. Multiple reports have demonstrated that motion or axial loading of the SIJ causes stress across the joint space, contributing to long-term arthrosis and pain [2]. SIJ fusions (SIJF) aim to stop motion by stabilizing the joint with implant fixation and allowing bony formation between the ilium and the sacrum [3]. The most common conservative treatments include pharmacologics, physical therapy, and intra-articular injections [1, 2]. Given the limited effectiveness of conservative management, with only 50% of symptomatic relief, surgical intervention was adopted [4]. The two primary surgical approaches are open and minimally invasive (MIS) SIJF [1]. While open SIJF was initially described in the 1920s, advances in technology and surgical technique have allowed MIS SIJF to evolve [5, 6]. MIS SIJF is linked to shorter hospital stays, reduced postoperative weight-bearing restrictions, decreased blood loss, minimized soft tissue damage, and enhanced patient-reported outcomes (PROs) [6, 7]. Moreover, Ballatori et al. has emphasized considerably higher costs associated with open SIJF when compared to MIS [7]. Consequently, MIS SIJ fusion has garnered increasing popularity. Many different MIS methods have been described in the literature, from triangular titanium implants to cylindrical implants to decortication of the joint [4, 8-12]. Tran et al. conducted a meta-analysis in 2019 evaluating the Visual Analog Scale (VAS), Short Form-12 (SF-12), Oswestry Disability Index (ODI), and quality of life (QoL) in twenty studies totaling 1,371 patients [13]. Abbas et al. conducted a meta-analysis in 2022 evaluating VAS and ODI across six studies totaling 564 patients [3]. Hermans et al. conducted a meta-analysis limited to randomized controlled trials and comparative cohort studies in 2022, evaluating 6 studies totaling 388 patients and evaluating VAS and ODI [14]. Chang et al. conducted a systematic review in 2022 analyzing sacroiliac pain after SI fusion in forty studies using VAS, ODI, QoL, and opioid use [15]. In 2023, Whang et al.’s meta-analysis analyzed VAS and ODI in 57 studies totaling 2,851 patients [16]. Most recently, Ghaddaf conducted a meta-analysis in 2024 solely on triangular titanium implants, evaluating VAS, ODI, QOL, and opioid use across 8 studies totaling 423 patients [17]. Despite the multiple recent meta-analyses, none assessed fusion rates, and most are based on a limited number of studies. Biomechanical studies using lumbar fixation models demonstrated that constant cyclic loading led to hardware loosening or failure. Similarly, SIJ fixation outcome studies demonstrated loosening of hardware in up to 45% of patients with poor sacral bone quality [18]. Thus, while patients have demonstrated symptomatic improvement with SI fixation alone, evidence has shown that SI fixation without fusion has resulted in a high rate of revision surgery of up to 30.8% [6]. A comprehensive review by Chang et al. in 2017 found that supplementing SI fixation with fusion led to a notably lower rate of revision surgery: 6.1% [15]. There is no standardized guideline for evaluating SIJ fusion [19]. Radiographic assessment using X-ray is inadequate due to difficulty in visualization, while computed tomography (CT) evaluation is not the standard of care, especially in asymptomatic patients. SIJF rate remains inconclusive, ranging from 13%-100%. Radiographic fusion, as defined by CT, is essential in answering the question of the long-term effectiveness of SI fixation [1]. Objective This meta-analysis evaluated fusion rates after MIS SIJF and compared PROs between MIS SIJF and conservative treatment. Additionally, we aimed to compare SIJ fusion rates between different implants. We assessed fusion rate by radiographic fusion on CT. Methods We conducted this review using the 2015 PRISMA for Systematic Review Protocols (PRISMA-P) [20]. This protocol has been registered on PROSPERO and is available as an open-access publication [21]. We prepared the manuscript using the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [20]. Eligibility Criteria We included randomized controlled trials (RCTs) comparing MIS fusion versus conservative treatment, prospective and retrospective observational comparative cohort studies with at least one cohort undergoing MIS SIJ fusion, and case series with more than 10 study subjects published from January 1, 2000, to July 17, 2024. We included adult populations with at least a 6-month follow-up postoperatively. For studies evaluating fusion rates, we included studies that used CT for fusion evaluation. Automated filters were applied to include specific periods, excluding non-human, cadaveric, and non-English studies. Additionally, we excluded pediatric populations (< 18 years of age), studies that did not report our primary or secondary outcomes, study populations with non-degenerative pathology, and studies with less than 6-month follow-up. Information Sources, Search Strategy We searched PubMed and Embase on 07/29/2021 and Cochrane Central Register of Controlled Trials (CENTRAL) on 07/31/2021. We conducted an updated search on PubMed, Embase, and CENTRAL on 7/17/2024. Keywords used included: Sacroiliac joint fusion, sacroiliac joint arthrodesis, minimally invasive sacroiliac joint fusion, minimally invasive sacroiliac joint arthrodesis, SIJ fusion OR SIJ arthrodesis, MIS SIJ fusion, MIS SIJ arthrodesis. Please refer to our full search strategy in our online supplemental materials. We conducted a hand search of the references, and we requested additional data from authors if needed. Selection process Studies from the search were imported into a reference management tool (Zotero version 6.0, Center for History and New Media at George Mason University: Fairfax, VA) to remove duplicates. Resulting articles were imported into Covidence (Veritas Health Innovation, Melbourne, Australia). Additional automated duplicate filters were applied. We manually verified the results of the eliminated duplicates. Using Covidence, two independent reviewers (G.A. and R.B.) screened for eligibility based on the abstract and title. Studies were then screened by full-text. A pilot screening was conducted at each screening stage to ensure consensus. An independent third reviewer (M.L.) arbitrated. Two independent reviewers (R.B. and H.L.) conducted the screening for the updated search, and an independent third reviewer (D.T.) arbitrated. Data collection process We did a pilot extraction. Two independent reviewers (G.A./R.B. or R.B./H.L.) extracted the data using a standardized template in Covidence. A third reviewer (M.L. or D.T.) arbitrated. The published outcomes for Polly et al. were incompatible with our definitions or planned analyses, and we successfully contacted the author to obtain further data [22]. We obtained Harvey et al’s data from their supplemental data [23]. We obtained Vanacochla et al.’s data from Herman’s meta-analysis [4, 14]. Data Items We extracted title, author(s), year of publication, study design, study period, sample size, intervention (fusion and/or conservative management), preoperative conservative treatment(s), age, sex, body mass index (BMI), smoking status, history of previous lumbar fusion, PROs (ODI, VAS-back), implant type, use of decortication, fusion rate as determined by CT, follow-up interval, and industry funding. The primary outcome is fusion rates as determined using postoperative CT scans. We defined fusion as the visualization of bridging trabecular bone across the joint. Our secondary outcomes are PRO, including VAS to assess low back pain, and ODI to evaluate global function. Study Risk of Bias Assessment Two reviewers assessed study bias (G.A./R.B. for search on 7/2023; R.B./H.L. for search on 7/2024). An independent third reviewer (D.T.) arbitrated. Risk of bias was assessed using the Cochrane Collaboration Risk of Bias (RoB) tool for RCTs and comparative cohorts [24]. Methodological Index for Non-Randomized Studies (MINORS) was used to assess non-randomized studies. Scores of 7 and below were deemed low quality for single-cohort studies. For comparative cohort studies, scores of 11 and below were deemed low quality [25]. Effect Measures Fusion rate, our primary outcome, was presented as the event rate. We presented our secondary outcome, PROs, in our synthesis of single and comparative cohorts as mean differences pre-/post-SIJF and pre-/post-conservative treatment, as all studies used the same measurement unit. Confidence intervals were presented for all outcome estimates. Minimal Clinically Important Difference (MCID) [26] was used to determine the PRO effect size in our Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessment. Synthesis Methods Our fusion synthesis included studies with at least one MIS SIJF cohort. Two sets of PRO syntheses, VAS and ODI, were carried out. The first set included single-cohort studies, while the second set included studies comparing SIJF and conservative treatment. Only MIS SIJF cohorts were included. Subgroup analyses were performed by synthesizing studies per device (iFuse Implant System (SI-BONE, Inc., Santa Clara, California, USA) vs. Rialto SI Fusion System (Medtronic, Minneapolis, Minnesota, USA) vs. SImmetry Sacroiliac Joint Fusion System (Surgalign Spine Technologies, Deerfield, IL)) and per MINORS (below vs. above cut-off). For studies that did not provide adequate information to calculate mean differences and standard deviations (SD) of the change, baseline SDs were used to substitute the SD of the change [27]. For studies that only provided median and interquartile ranges (IQR), we assumed no significant or relevant deviations from a normal distribution and converted the median/IQR to mean and SD [28, 29]. For studies that only provided confidence intervals or standard error of the mean, we calculated the standard deviations by standard formulae [30]. We considered a study an outlier if its confidence interval did not overlap with the pooled confidence interval. Sensitivity testing was performed using the leave-one-out method to ensure that the outlier study was not influential. Finally, before study removal, we reviewed the clinical or methodological basis of this deviation [31]. Fusion proportions and PRO mean differences were weighed using inverse variance and pooled using random effects models. Pooled estimates and 95% confidence intervals were determined for cohorts, subgroups, and combinations of subgroups. When I 2 was estimated at 0%, the upper 95% confidence interval was calculated to avoid underestimating heterogeneity [32]. Mixed effects models were used in subgroup analysis to determine the between-subgroup effect. Subgroup analyses were conducted on methodological quality scores and implant type. Heterogeneity was evaluated using Cochran’s Q and I 2 statistics. I 2 of ≥75% was considered substantial heterogeneity [33]. Significance was defined as p < 0.05. Data synthesis for RCT and observational cohort studies was performed using Review Manager (RevMan for Windows, Version 5.4.1, The Cochrane Collaboration, 2020) and Comprehensive Meta-Analysis (CMA©, v4.0), respectively. Reporting Bias Assessment Publication bias was evaluated using funnel plots to visualize relative symmetry within the plot and focal areas of study paucity. The mean difference in ODI was used as the effect estimate. Certainty Assessment The GRADE approach was used to evaluate the certainty or confidence of evidence for each outcome. Two independent reviewers, RB and HL, conducted independent assessments of GRADE. An independent third reviewer (D.T.) arbitrated. Randomized studies were given an initial rate of high quality, while non-randomized studies were given an initial rate of low quality. Using GRADE, we adjusted the score lower or higher according to the GRADE guidelines [34]. The final certainty of evidence for each outcome was rated as high, moderate, low, or very low [35]. Results Study Selection We identified 776 records in our initial search, and 240 additional studies published between 7/30/2021 and 7/17/2024 in our updated search on 7/17/2024. The searches totaled 1,016 studies with 442 duplicates. Using automation tools, 118 were excluded due to publication period and language. Fifteen records were removed as they were e-posters, letters to the editor, book sections, or videos. We screened 441 remaining records and excluded 368 during title and abstract review. We could not retrieve 8 for full-text review, leaving 65 full-text studies to be assessed for eligibility. During the full-text screening, 27 more records were removed, leaving 38 studies. We retrieved the summary data for Vanacochla et al. from Herman’s meta-analysis [14] (Figure 1). PRISMA flowchart for study selection. Bony trabeculation across an interspace is a standard criterion for lumbar fusion, according to Suk et al. and Duits et al. [36, 37]. As there are no standardized diagnostic criteria for SIJF, we defined SIJF criteria consistent with these established criteria. Duhon et al. were an outlier excluded from our fusion rate analyses as their primary assessment for successful fusion did not focus on trabecular bridging. Kasapovic et al. were an outlier and excluded because their data violated the normal distribution assumption required for IQR-to-SD conversion [38]. When assessing fusion rate, Sarkar et al. was removed due to the inability to ascertain how the fusion rate was evaluated. For both VAS and ODI, Patel et al. and Kucharzyk et al. were removed as they did not provide baseline and post-op standard deviations, respectively. For ODI, Kancherla et al. were removed as they did not provide a baseline mean. Twelve studies assessed fusion rate [12, 39-49]. Twenty-nine studies evaluated ODI [4, 6, 8, 11, 12, 22, 23, 38, 39, 41-46, 48, 50-62]and 31 evaluated VAS [4, 8, 9, 11, 12, 22, 23, 39, 40, 42-49, 52-59, 62-67]. Out of the 38 studies, 14 had industry funding [22, 23, 39, 40, 42, 44, 46, 48, 57-60, 62, 64]. Study Characteristics We included four RCT [22, 23, 39, 60], one retrospective comparative cohort study, [4], one prospective comparative cohort [51], and 32 single cohort or case series [5, 6, 9, 11, 12, 38, 40-50, 52-59, 61-67] (Table 1). Conservative treatments included medication, physical therapy, steroid injections, and nerve blocks. Twenty-seven studies were from USA [5, 6, 9, 11, 12, 22, 23, 40-44, 46, 48-50, 54-58, 62-67], three from United Kingdom [51, 52, 61], 4 from Germany [38, 39, 45, 53], two from Sweden [59, 60], one from India [47], and one from Spain [4]. Study periods spanned from 1994 to 2022. Mean patient age across included studies ranged from 44.3 to 69. The percentage of female patients among studies ranged from 21.1 to 97.0. Mean BMI ranged from 25.3 to 33.4. Risk of Biases in Studies We assessed the methodological quality of the randomized controlled trials using RoB and non-randomized studies using MINORS. Three RCTs demonstrated high or unclear bias in ≥3 out of the 7 RoB bias categories. For non-randomized studies, MINORS scores ranged from 4-18 (Figure 2). Comparative cohort studies with ≤11 MINORS scores and single cohort studies with ≤7 were considered low quality [25]. Ten out of 34 studies scored ≤7 for MINORS (Figure 2). Results of Individual Studies and Syntheses Fusion rates One RCT and 10 cohort studies totaling 852 patients were pooled for SIJ fusion. Random-effects model demonstrated a pooled event rate of 0.86 (95% CI 0.78 - 0.91). Heterogeneity between studies was significant (Q=50.20, df=10, p=.001, I 2 =80.08%) (Figure 3). In our subgroup analysis by device, eleven studies were grouped by implant type: IFuse, Rialto, and SImmetry. The Rialto group included SI-Lok and Integrity SI Fusion Systems, which employ comparable decortication techniques. The pooled event rate for iFuse was 0.89 (95% CI 0.82 - 0.94), Rialto/SI-Lok/Integrity SI Fusion was 0.86 (95% CI 0.71 - 0.94), and SImmetry was 0.75 (95% CI 0.61 - 0.85). The total combined heterogeneity among the studies was significant (Q= 50.20, df=10, p =.001, I 2 = 80.08%). There was no significant difference in event rate between subgroups (Q M = 5.14, df = 2, p =.077) (Figure 5A). Patient-reported outcomes In the SI fusion group, 31 single-cohort studies/case series totaling 1,911 patients demonstrated significant improvement in pooled mean VAS (-4.90, 95% CI -5.49 to -4.30, p=.00). Heterogeneity across these studies was minimal (Q=50.20, df=30, p=.95, I 2 =0%, 95% CI .00 - 5.86) (Figure 4A). Additionally, 27 single-cohort studies totaling 1,833 patients demonstrated significant improvement in pooled ODI (-22.01, 95% CI -27.90 to -16.12, p=.00). There was moderate heterogeneity across these studies (Q=48.68, df=26, p=.005, I 2 =46.59%) (Figure 4B). Four RCTs and one comparative cohort study compared fusion rate to conservative treatment, totaling 314 and 282 patients, respectively. The SIJF group demonstrated significantly improved pooled VAS (-3.71, 95% CI -4.74 to -2.68, p<.00001). There was significant heterogeneity across these studies (Q=37.21, df=4, p<.00001, I 2 =89%) (Figure 4C). Furthermore, the SIJF group demonstrated significantly improved pooled ODI (-19.30, 95% CI -23.87 to -14.4, p=.00001). These studies had moderate heterogeneity (Q=12.52, df=4, p=.01, I 2 =68%) (Figure 4D). We subsequently conducted subgroup analyses of VAS and ODI by MINORS quality scores. Cutoff scores of ≤7 for single-cohort studies and ≤11 for comparative cohort studies were used to divide the studies into two subgroups. For VAS, 8 studies scoring ≤7 demonstrated significant improvement in VAS (-5.08, 95% CI -6.13 – -4.03, p=.00); 19 studies scoring >8 demonstrated significant improvement in VAS (-4.89, 95% CI -5.68 – -4.10, p=.00). The total combined heterogeneity among the studies was low (Q= 17.17, df=26, p =.90, I 2 = 0%, 95% CI .00 - 16.65). There was no significant difference in VAS between MINORS subgroups (Q M = .084, df = 1, p =.77) (Figure 5B). For ODI, 4 studies scoring ≤7 demonstrated a significant improvement in ODI (-24.41, 95% CI -37.21– -19.61, p=.00); 19 studies scoring >8 demonstrated a significant improvement in ODI (-19.58, 95% CI -26.63 – -12.52, p=.00). The total combined heterogeneity among the studies was moderate (Q= 47.89, df=22, p =.001, I 2 = 54.06%). There was no significant difference in ODI between MINORS subgroups (Q M = 2.35, df = 1, p =.13) (Figure 5C). Complications Twenty-two case series, 2 single-cohort studies, and 4 RCTs reported complications totaling 27 cases of pseudoarthrosis, 57 cases of hematoma, and 20 instances of implant malposition. Additionally, 63 patients experienced increased pain in the postoperative period (exact timing was unspecified), 29 developed infections, and 34 required reoperation. Reporting Biases There was no missing data for fusion outcomes; however, several studies did not provide the data necessary to analyze VAS and ODI outcomes. We contacted Polly et al. to request clarification of the reported summary data [22]. The data for Harvey et al. were obtained from published supplemental material [23]. Furthermore, numerical data for Vanacochla 2018 were acquired from a meta-analysis by Herman et al. [14]. A funnel plot was created to assess publication bias, using the mean difference in the ODI as the effect estimate. The funnel plot illustrated in Figure 6 exhibits a relatively symmetrical distribution of the studies with minimal focal paucity, suggesting a low likelihood of publication bias. Certainty of Evidence We reported the quality of evidence for each outcome using GRADE. The fusion rate was downrated for risk of bias, publication bias, and inconsistency, making the overall quality of evidence very low. VAS in the SIJF group was downrated for risk of bias and publication bias and was rated up for a very large effect (2 x MCID), resulting in a moderate quality of evidence. ODI in the SIJF group was downrated for risk of bias, publication bias, and inconsistency, with a very low overall quality of evidence. Regarding our comparative studies, both VAS and ODI outcomes were downrated for risk of bias, publication bias, and inconsistency, with a very low overall quality of evidence. In our subgroup analysis of fusion rate by device, IFuse was downrated for risk of bias, publication bias, and inconsistency with a very low overall GRADE. Rialto/SI-Lok/Integrity group was downrated for risk of bias, publication bias, and very serious inconsistency with a very low overall GRADE. SImmetry was downrated for risk of bias and publication bias, yielding a very low overall rating. Studies were analyzed by MINORS for both VAS and ODI. Studies below the cutoff were rated down for risk of bias and publication bias, with a very low certainty of evidence overall. Studies above the cutoff were rated down for publication bias and rated up for significant effect (2xMCID for VAS) with an overall moderate GRADE assessment (Table 2). Discussion This meta-analysis systematically reviewed 38 MIS SIJF studies totaling 2,847 patients and demonstrated a significant improvement in VAS in SIJF single cohorts. A definitive conclusion on fusion rate, ODI, and comparative VAS between SIJF and conservative treatment cannot be made. Per GRADE, the quality of evidence for fusion rate, ODI, and comparative PROs between SIJF vs. conservation treatment was very low. Therefore, though our pooled analyses demonstrated that MIS SIJ fusion showed significant improvement for the outcomes described, we could not make a definitive conclusion. Conversely, the quality of evidence for VAS improvement in SIJF single cohorts was moderate. Subgroup analyses showed no difference in SIJF rate by device or PRO improvement by MINORS score. Per GRADE, the quality of evidence for the subgroup analyses is very low to moderate. Recent systematic reviews have investigated PROs of sacroiliac joint fusions, including Tran et al. with 20 studies, Abbas et al. with 6 studies, Hermans et al. limited to RCTs with 6 studies, Chang et al. with 40 studies, Whang et al. with 57 studies, and Ghaddaf et al. with 8 studies. These meta-analyses all demonstrated significant improvements in PROs, aligning with the VAS findings of our meta-analyses [ 3 , 13 – 16 ]. Our study is the most updated synthesis of the current evidence regarding SIJF. Compared to the previous systematic reviews and meta-analyses, our study used different inclusion criteria. Chang et al. included studies from 1987, which limits relevance compared to modern-day MIS surgical techniques. Whang et al. reported cohort numbers rather than study numbers and included studies with only a 3-month follow-up period, which we excluded as insufficient for accurate fusion evaluation. Despite these recent systematic reviews/meta-analyses, a significant gap remains: none assessed fusion rates, and notably, none evaluated fusion using CT. Addressing this gap is critical for advancing our understanding of surgical outcomes in SIJF. Our study not only evaluated the fusion rate as the primary outcome, but also offered subgroup analyses by fusion device and MINORS scores. Heterogeneity between studies for fusion rate is very high, likely due to a lack of granularity in fusion assessment data available in the studies. Even though CT evaluation is accepted as the gold standard for evaluating SIJF, there is a lack of standardized diagnostic criteria for SIJF. To standardize our analysis across studies, we defined fusion as the presence of trabecular bone bridging across the SIJ. However, the determination of trabecular volume, density, and follow-up interval for fusion assessment can be somewhat subjective. This subjectivity can influence the interpretation of fusion success and underscores the need for a standardized criterion for SIJ. For single-cohort VAS and VAS subgroup analyses by MINORS, I 2 and its 95% confidence intervals indicated low heterogeneity, while for ODI and ODI subgroup analyses by MINORS, I 2 and its 95% confidence intervals indicated moderate heterogeneity. The measurement of VAS and ODI is standardized as these are validated instruments. While VAS is a direct outcome measuring pain at the SI joint, ODI is a global measurement for QoL, which is an indirect outcome for SIJF efficacy. This may explain the presence of and degree of heterogeneity among studies measuring these outcomes. I 2 values for VAS and ODI in the comparative studies were moderate to high. This is likely due to Randers et al., a uniquely blinded RCT comparing SIJF to a sham operation. None of the other comparative studies shares this methodology, which could explain the high heterogeneity. Limitations The most important limitation of our study is heterogeneity in fusion rate assessment, which could preclude meaningful interpretation of the combined effect size. In our comparative cohort synthesis for PROs, Randers et al., the only RCT with blinded controls undergoing sham surgery, led to significant methodological heterogeneity [ 60 ]. Some studies reported a significant loss of follow-up of up to 50%, adversely impacting data validity. The absence of surgery dates in several studies introduces historical bias, as standards of care can vary over time. Without this crucial information, we cannot dismiss the possibility of historical bias. Industry-sponsored studies are more likely to publish data that favors their products and withhold data that does not support them, leading to publication bias. Other limitations included substantial risk of bias for individual studies and small sample sizes in a significant number of studies. During our review process, some studies’ data were missing or not collected in the format we needed. We obtained Vanacochla et al.’s data from a meta-analysis by Herman et al. [ 4 , 14 ]. Raw data from Polly et al. was obtained from the author [ 22 ]. Data for Harvey et al. was obtained from published supplemental data [ 23 ]. Many authors did not report standard deviations of the mean difference. To remedy this, we either converted the confidence interval or used the preoperative standard deviation. Due to the number of included studies, we could not run a meta-regression that included all study-level confounders. To conduct a meta-regression, the Cochrane Handbook recommends at least ten studies for each study-level variable to ensure reliable results [ 68 ]. Since we only had 11 studies included in the synthesis for fusion outcome, conducting a meta-regression for fusion outcome would yield low-power results. Instead, we conducted subgroup analyses for fusion by device and PRO by MINORS scores. When interpreting results, it should be noted that subgroup analyses and meta-regressions are observational in nature and subject to the limitations of any observational investigation, including bias through confounding by other study-level characteristics [ 69 ]. Conclusion This meta-analysis revealed a statistically significant improvement in VAS within a single SIJF, supported by moderate-quality evidence. However, due to the very low quality of evidence, a conclusive determination on fusion rate, ODI, and VAS improvement when comparing SIJF to conservative approaches is not possible. This indicates a need for further research to establish stronger conclusions regarding the efficacy of MIS SIJ fusion on fusion rates and patient-reported outcomes. Declarations Funding: This study received no funding from any funding agency in the public, commercial, or non-profit sectors. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have influenced the findings of this study. Author Contribution R.B., G.A., and D.T. conceptualized the study and conducted the methodology, while data curation was performed by R.B., G.A., M.L., and D.T. Formal analysis was performed by R.B., H.L., and D.T. Statistics were conducted by H.L. and D.T. The original draft was written by R.B., G.A., H.L., and D.T. The tables and figures were created by R.B., H.L., and D.T. Final manuscript editing and review were performed by R.B., H.L., D.T., and T.S. Supervision was performed by D.T. and T.S. 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Conducting Quantitative Synthesis When Comparing Medical Interventions: AHRQ and the Effective Health Care Program. In: Methods Guide for Effectiveness and Comparative Effectiveness Reviews . AHRQ Methods for Effective Health Care. Agency for Healthcare Research and Quality (US); 2008. Accessed November 6, 2024. http://www.ncbi.nlm.nih.gov/books/NBK49407/ Tables Tables 1 and 2 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.docx Table2.docx Supplementaryfile.docx 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. 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(MINORS).\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/c4ca283bcfc02ce55fe0b9c6.png"},{"id":91842676,"identity":"a5f8f3b5-4942-40a9-9231-9e835c4c672e","added_by":"auto","created_at":"2025-09-22 10:01:39","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":193806,"visible":true,"origin":"","legend":"\u003cp\u003eForest plot of fusion rate in the SI fusion group\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/958232d1e2a484a6c78a11a5.png"},{"id":91842678,"identity":"76e51a2f-fed7-4765-9085-b05d64e6e3ae","added_by":"auto","created_at":"2025-09-22 10:01:39","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":750196,"visible":true,"origin":"","legend":"\u003cp\u003eForest plots of patient-reported outcomes: \u003cstrong\u003eA:\u003c/strong\u003e Visual analog scale (VAS) among single-cohort studies. \u003cstrong\u003eB:\u003c/strong\u003e Oswestry disability index (ODI) for single-cohort studies. \u003cstrong\u003eC:\u003c/strong\u003e VAS for comparative cohort studies and randomized control trials. \u003cstrong\u003eD: \u003c/strong\u003eODI for comparative cohort and randomized control trials.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/f79629cac2709f3345276157.png"},{"id":91844667,"identity":"9074800a-2ec4-4d2c-92d2-7ef1217c605a","added_by":"auto","created_at":"2025-09-22 10:09:39","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":499601,"visible":true,"origin":"","legend":"\u003cp\u003eForest plots of subgroup analyses:\u003cstrong\u003e A:\u003c/strong\u003e Fusion rate by device.\u003cstrong\u003e B\u003c/strong\u003e: VAS is grouped by above and belowMINORS cutoff. \u003cstrong\u003eC:\u003c/strong\u003e ODI is grouped by above and below MINORS cutoff.\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/1e7beba5dcdc666ab024b10a.png"},{"id":91842671,"identity":"25895e57-6666-401f-9cff-42205baf6ff9","added_by":"auto","created_at":"2025-09-22 10:01:39","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":47127,"visible":true,"origin":"","legend":"\u003cp\u003eFunnel plot analysis for publication bias of ODI\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/84710994f3af398d97ecb7a1.png"},{"id":91848015,"identity":"8cb44eb7-dc0b-4cfd-9b7a-deeac3cea2c0","added_by":"auto","created_at":"2025-09-22 10:33:42","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2255890,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/505d7a2d-b054-4223-9c68-908e734f3026.pdf"},{"id":91842670,"identity":"d8d7cc11-bfb0-4ce0-b9ff-d4607f8c182f","added_by":"auto","created_at":"2025-09-22 10:01:39","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":38744,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/a282b60e7c0dc1780301fd17.docx"},{"id":91842667,"identity":"69b41e30-412d-4afd-881e-2b840199314c","added_by":"auto","created_at":"2025-09-22 10:01:39","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":17447,"visible":true,"origin":"","legend":"","description":"","filename":"Table2.docx","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/160bb698f29e5ff00efccda8.docx"},{"id":91844664,"identity":"c824ea6a-0753-4543-a591-0e9b31f2cce7","added_by":"auto","created_at":"2025-09-22 10:09:39","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":8754,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfile.docx","url":"https://assets-eu.researchsquare.com/files/rs-7402569/v1/b3774716d917aae35f4fdd07.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Fusion and Patient-reported Outcomes of Minimally Invasive Sacroiliac Joint Fusion Surgery: A Meta-Analysis","fulltext":[{"header":"Introduction","content":"\u003cp\u003e\u003cstrong\u003eBackground/rationale\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the United States, back pain affects 15-45% of adults and causes significant morbidity. Sacroiliac joint (SIJ) dysfunction is the culprit in 15-30% of patients with low back pain [1, 2]. Multiple reports have demonstrated that motion or axial loading of the SIJ causes stress across the joint space, contributing to long-term arthrosis and pain [2]. SIJ fusions (SIJF) aim to stop motion by stabilizing the joint with implant fixation and allowing bony formation between the ilium and the sacrum [3]. The most common conservative treatments include pharmacologics, physical therapy, and intra-articular injections [1, 2].\u003c/p\u003e\n\u003cp\u003eGiven the limited effectiveness of conservative management, with only 50% of symptomatic relief, surgical intervention was adopted [4]. The two primary surgical approaches are open and minimally invasive (MIS) SIJF [1]. While open SIJF was initially described in the 1920s, advances in technology and surgical technique have allowed MIS SIJF to evolve [5, 6]. MIS SIJF is linked to shorter hospital stays, reduced postoperative weight-bearing restrictions, decreased blood loss, minimized soft tissue damage, and enhanced patient-reported outcomes (PROs) [6, 7]. Moreover, Ballatori et al. has emphasized considerably higher costs associated with open SIJF when compared to MIS [7]. Consequently, MIS SIJ fusion has garnered increasing popularity. Many different MIS methods have been described in the literature, from triangular titanium implants to cylindrical implants to decortication of the joint [4, 8-12].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTran et al. conducted a meta-analysis in 2019 evaluating the Visual Analog Scale (VAS), Short Form-12 (SF-12), Oswestry Disability Index (ODI), and quality of life (QoL) in twenty studies totaling 1,371 patients [13]. Abbas et al. conducted a meta-analysis in 2022 evaluating VAS and ODI across six studies totaling 564 patients [3]. Hermans et al. conducted a meta-analysis limited to randomized controlled trials and comparative cohort studies in 2022, evaluating 6 studies totaling 388 patients and evaluating VAS and ODI [14]. \u0026nbsp;Chang et al. conducted a systematic review in 2022 analyzing sacroiliac pain after SI fusion in forty studies using VAS, ODI, QoL, and opioid use [15]. In 2023, Whang et al.’s meta-analysis analyzed VAS and ODI in 57 studies totaling 2,851 patients [16]. Most recently, Ghaddaf conducted a meta-analysis in 2024 solely on triangular titanium implants, evaluating VAS, ODI, QOL, and opioid use across 8 studies totaling 423 patients [17]. Despite the multiple recent meta-analyses, none assessed fusion rates, and most are based on a limited number of studies.\u003c/p\u003e\n\u003cp\u003eBiomechanical studies using lumbar fixation models demonstrated that constant cyclic loading led to hardware loosening or failure. Similarly, SIJ fixation outcome studies demonstrated loosening of hardware in up to 45% of patients with poor sacral bone quality [18]. Thus, while patients have demonstrated symptomatic improvement with SI fixation alone, evidence has shown that SI fixation without fusion has resulted in a high rate of revision surgery of up to 30.8% [6]. A comprehensive review by Chang et al. in 2017 found that supplementing SI fixation with fusion led to a notably lower rate of revision surgery: 6.1% [15]. There is no standardized guideline for evaluating SIJ fusion [19]. Radiographic assessment using X-ray is inadequate due to difficulty in visualization, while computed tomography (CT) evaluation is not the standard of care, especially in asymptomatic patients. SIJF rate remains inconclusive, ranging from 13%-100%. Radiographic fusion, as defined by CT, is essential in answering the question of the long-term effectiveness of SI fixation [1].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis meta-analysis evaluated fusion rates after MIS SIJF and compared PROs between MIS SIJF and conservative treatment. Additionally, we aimed to compare SIJ fusion rates between different implants. We assessed fusion rate by radiographic fusion on CT.\u0026nbsp;\u003c/p\u003e\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n"},{"header":"Methods","content":"\u003cp\u003eWe conducted this review using the 2015 PRISMA for Systematic Review Protocols (PRISMA-P) [20]. This protocol has been registered on PROSPERO and is available as an open-access publication [21]. We prepared the manuscript using the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [20].\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEligibility Criteria\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eWe included randomized controlled trials (RCTs) comparing MIS fusion versus conservative treatment, prospective and retrospective observational comparative cohort studies with at least one cohort undergoing MIS SIJ fusion, and case series with more than 10 study subjects published from January 1, 2000, to July 17, 2024. We included adult populations with at least a 6-month follow-up postoperatively. For studies evaluating fusion rates, we included studies that used CT for fusion evaluation. Automated filters were applied to include specific periods, excluding non-human, cadaveric, and non-English studies. Additionally, we excluded pediatric populations (\u0026lt; 18 years of age), studies that did not report our primary or secondary outcomes, study populations with non-degenerative pathology, and studies with less than 6-month follow-up.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eInformation Sources, Search Strategy\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eWe searched PubMed and Embase on 07/29/2021 and Cochrane Central Register of Controlled Trials (CENTRAL) on 07/31/2021. We conducted an updated search on PubMed, Embase, and CENTRAL on 7/17/2024. \u0026nbsp;Keywords used included: Sacroiliac joint fusion, sacroiliac joint arthrodesis, minimally invasive sacroiliac joint fusion, minimally invasive sacroiliac joint arthrodesis, SIJ fusion OR SIJ arthrodesis, MIS SIJ fusion, MIS SIJ arthrodesis. Please refer to our full search strategy in our online supplemental materials. We conducted a hand search of the references, and we requested additional data from authors if needed.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eSelection process\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eStudies from the search were imported into a reference management tool (Zotero version 6.0, Center for History and New Media at George Mason University: Fairfax, VA) to remove duplicates. Resulting articles were imported into Covidence (Veritas Health Innovation, Melbourne, Australia). Additional automated duplicate filters were applied. We manually verified the results of the eliminated duplicates. Using Covidence, two independent reviewers (G.A. and R.B.) screened for eligibility based on the abstract and title. Studies were then screened by full-text. A pilot screening was conducted at each screening stage to ensure consensus. An independent third reviewer (M.L.) arbitrated. Two independent reviewers (R.B. and H.L.) conducted the screening for the updated search, and an independent third reviewer (D.T.) arbitrated.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eData collection process\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eWe did a pilot extraction. Two independent reviewers (G.A./R.B. or R.B./H.L.) extracted the data using a standardized template in Covidence. A third reviewer (M.L. or D.T.) arbitrated. The published outcomes for Polly et al. were incompatible with our definitions or planned analyses, and we successfully contacted the author to obtain further data [22]. We obtained Harvey et al’s data from their supplemental data [23]. We obtained Vanacochla et al.’s data from Herman’s meta-analysis [4, 14].\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eData Items\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eWe extracted title, author(s), year of publication, study design, study period, sample size, intervention (fusion and/or conservative management), preoperative conservative treatment(s), age, sex, body mass index (BMI), smoking status, history of previous lumbar fusion, PROs (ODI, VAS-back), implant type, use of decortication, fusion rate as determined by CT, follow-up interval, and industry funding. The primary outcome is fusion rates as determined using postoperative CT scans. We defined fusion as the visualization of bridging trabecular bone across the joint. Our secondary outcomes are PRO, including VAS to assess low back pain, and ODI to evaluate global function.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eStudy Risk of Bias Assessment\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eTwo reviewers assessed study bias (G.A./R.B. for search on 7/2023; R.B./H.L. for search on 7/2024). An independent third reviewer (D.T.) arbitrated. Risk of bias was assessed using the Cochrane Collaboration Risk of Bias (RoB) tool for RCTs and comparative cohorts [24]. \u0026nbsp;Methodological Index for Non-Randomized Studies (MINORS) was used to assess non-randomized studies. Scores of 7 and below were deemed low quality for single-cohort studies. For comparative cohort studies, scores of 11 and below were deemed low quality [25].\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEffect Measures\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eFusion rate, our primary outcome, was presented as the event rate. We presented our secondary outcome, PROs, in our synthesis of single and comparative cohorts as mean differences pre-/post-SIJF and pre-/post-conservative treatment, as all studies used the same measurement unit. Confidence intervals were presented for all outcome estimates. Minimal Clinically Important Difference (MCID) [26] was used to determine the PRO effect size in our Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessment.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eSynthesis Methods\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eOur fusion synthesis included studies with at least one MIS SIJF cohort. Two sets of PRO syntheses, VAS and ODI, were carried out. The first set included single-cohort studies, while the second set included studies comparing SIJF and conservative treatment. \u0026nbsp; \u0026nbsp;Only MIS SIJF cohorts were included. Subgroup analyses were performed by synthesizing studies per device (iFuse Implant System (SI-BONE, Inc., Santa Clara, California, USA) vs. Rialto SI Fusion System (Medtronic, Minneapolis, Minnesota, USA) vs. SImmetry Sacroiliac Joint Fusion System (Surgalign Spine Technologies, Deerfield, IL)) and per MINORS (below vs. above cut-off).\u0026nbsp;\u003c/p\u003e\u003cp\u003eFor studies that did not provide adequate information to calculate mean differences and standard deviations (SD) of the change, baseline SDs were used to substitute the SD of the change [27]. For studies that only provided median and interquartile ranges (IQR), we assumed no significant or relevant deviations from a normal distribution and converted the median/IQR to mean and SD [28, 29]. For studies that only provided confidence intervals or standard error of the mean, we calculated the standard deviations by standard formulae [30].\u003c/p\u003e\u003cp\u003eWe considered a study an outlier if its confidence interval did not overlap with the pooled confidence interval. Sensitivity testing was performed using the leave-one-out method to ensure that the outlier study was not influential. Finally, before study removal, we reviewed the clinical or methodological basis of this deviation [31].\u003c/p\u003e\u003cp\u003eFusion proportions and PRO mean differences were weighed using inverse variance and pooled using random effects models. \u0026nbsp;Pooled estimates and 95% confidence intervals were determined for cohorts, subgroups, and combinations of subgroups. When I\u003csup\u003e2\u003c/sup\u003e was estimated at 0%, the upper 95% confidence interval was calculated to avoid underestimating heterogeneity [32]. Mixed effects models were used in subgroup analysis to determine the between-subgroup effect. Subgroup analyses were conducted on methodological quality scores and implant type. Heterogeneity was evaluated using Cochran’s Q and I\u003csup\u003e2\u003c/sup\u003e statistics. I\u003csup\u003e2\u003c/sup\u003e of ≥75% was considered substantial heterogeneity [33]. Significance was defined as p \u0026lt; 0.05.\u003c/p\u003e\u003cp\u003eData synthesis for RCT and observational cohort studies was performed using Review Manager (RevMan for Windows, Version \u0026nbsp;5.4.1, The Cochrane Collaboration, 2020) and Comprehensive Meta-Analysis (CMA©, v4.0), respectively. \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eReporting Bias Assessment\u003c/strong\u003e\u003c/p\u003e\u003cp\u003ePublication bias was evaluated using funnel plots to visualize relative symmetry within the plot and focal areas of study paucity. The mean difference in ODI was used as the effect estimate.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eCertainty Assessment\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eThe GRADE approach was used to evaluate the certainty or confidence of evidence for each outcome. Two independent reviewers, RB and HL, conducted independent assessments of GRADE. An independent third reviewer (D.T.) arbitrated. Randomized studies were given an initial rate of high quality, while non-randomized studies were given an initial rate of low quality. Using GRADE, we adjusted the score lower or higher according to the GRADE guidelines [34]. The final certainty of evidence for each outcome was rated as high, moderate, low, or very low [35].\u0026nbsp;\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eStudy Selection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe identified 776 records in our initial search, and 240 additional studies published between 7/30/2021 and 7/17/2024 in our updated search on 7/17/2024. The searches totaled 1,016 studies with 442 duplicates. Using automation tools, 118 were excluded due to publication period and language. Fifteen records were removed as they were e-posters, letters to the editor, book sections, or videos. We screened 441 remaining records and excluded 368 during title and abstract review. We could not retrieve 8 for full-text review, leaving 65 full-text studies to be assessed for eligibility. During the full-text screening, 27 more records were removed, leaving 38 studies. We retrieved the summary data for Vanacochla et al. from Herman\u0026rsquo;s meta-analysis [14] (Figure 1).\u003c/p\u003e\n\u003cp\u003ePRISMA flowchart for study selection.\u003c/p\u003e\n\u003cp\u003eBony trabeculation across an interspace is a standard criterion for lumbar fusion, according to Suk et al. and Duits et al. [36, 37]. As there are no standardized diagnostic criteria for SIJF, we defined SIJF criteria consistent with these established criteria. Duhon et al. were an outlier excluded from our fusion rate analyses as their primary assessment for successful fusion did not focus on trabecular bridging. Kasapovic et al. were an outlier and excluded because their data violated the normal distribution assumption required for IQR-to-SD conversion [38]. When assessing fusion rate, Sarkar et al. was removed due to the inability to ascertain how the fusion rate was evaluated. For both VAS and ODI, Patel et al. and Kucharzyk et al. were removed as they did not provide baseline and post-op standard deviations, respectively. For ODI, Kancherla et al. were removed as they did not provide a baseline mean. Twelve studies assessed fusion rate [12, 39-49]. Twenty-nine studies evaluated ODI [4, 6, 8, 11, 12, 22, 23, 38, 39, 41-46, 48, 50-62]and 31 evaluated VAS [4, 8, 9, 11, 12, 22, 23, 39, 40, 42-49, 52-59, 62-67]. Out of the 38 studies, 14 had industry funding [22, 23, 39, 40, 42, 44, 46, 48, 57-60, 62, 64].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe included four RCT [22, 23, 39, 60], one retrospective comparative cohort study, [4], one prospective comparative cohort [51], and 32 single cohort or case series [5, 6, 9, 11, 12, 38, 40-50, 52-59, 61-67] (Table 1). Conservative treatments included medication, physical therapy, steroid injections, and nerve blocks. Twenty-seven studies were from USA [5, 6, 9, 11, 12, 22, 23, 40-44, 46, 48-50, 54-58, 62-67], three from United Kingdom [51, 52, 61], 4 from Germany [38, 39, 45, 53], two from Sweden [59, 60], one from India [47], and one from Spain [4]. Study periods spanned from 1994 to 2022. Mean patient age across included studies ranged from 44.3 to 69. The percentage of female patients among studies ranged from 21.1 to 97.0. Mean BMI ranged from 25.3 to 33.4.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cbr\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRisk of Biases in Studies\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe assessed the methodological quality of the randomized controlled trials using RoB and non-randomized studies using MINORS. Three RCTs demonstrated high or unclear bias in \u0026ge;3 out of the 7 RoB bias categories. For non-randomized studies, MINORS scores ranged from 4-18 (Figure 2). Comparative cohort studies with \u0026le;11 MINORS scores and single cohort studies with \u0026le;7 were considered low quality [25]. Ten out of 34 studies scored \u0026le;7 for MINORS (Figure 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults of Individual Studies and Syntheses\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFusion rates\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOne RCT and 10 cohort studies totaling 852 patients were pooled for SIJ fusion. Random-effects model demonstrated a pooled event rate of 0.86 (95% CI 0.78 - 0.91). Heterogeneity between studies was significant (Q=50.20, df=10, p=.001, I\u003csup\u003e2\u003c/sup\u003e=80.08%) (Figure 3). In our subgroup analysis by device, eleven studies were grouped by implant type: IFuse, Rialto, and SImmetry. The Rialto group included SI-Lok and Integrity SI Fusion Systems, which employ comparable decortication techniques. The pooled event rate for iFuse was 0.89 (95% CI 0.82 - 0.94), Rialto/SI-Lok/Integrity SI Fusion was 0.86 (95% CI 0.71 - 0.94), and SImmetry was 0.75 (95% CI 0.61 - 0.85). The total combined heterogeneity among the studies was significant (Q= 50.20, df=10, p =.001, I\u003csup\u003e2\u003c/sup\u003e = 80.08%). There was no significant difference in event rate between subgroups (Q\u003csub\u003eM\u003c/sub\u003e= 5.14, df = 2, p =.077) (Figure 5A).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient-reported outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the SI fusion group, 31 single-cohort studies/case series totaling 1,911 patients demonstrated significant improvement in pooled mean VAS (-4.90, 95% CI -5.49 to -4.30, p=.00). Heterogeneity across these studies was minimal (Q=50.20, df=30, p=.95, I\u003csup\u003e2\u003c/sup\u003e=0%, 95% CI .00 - 5.86) (Figure 4A). Additionally, 27 single-cohort studies totaling 1,833 patients demonstrated significant improvement in pooled ODI (-22.01, 95% CI -27.90 to -16.12, p=.00). There was moderate heterogeneity across these studies (Q=48.68, df=26, p=.005, I\u003csup\u003e2\u003c/sup\u003e=46.59%) (Figure 4B). Four RCTs and one comparative cohort study compared fusion rate to conservative treatment, totaling 314 and 282 patients, respectively. The SIJF group demonstrated significantly improved pooled VAS (-3.71, 95% CI -4.74 to -2.68, p\u0026lt;.00001). There was significant heterogeneity across these studies (Q=37.21, df=4, p\u0026lt;.00001, I\u003csup\u003e2\u003c/sup\u003e=89%) (Figure 4C). Furthermore, the SIJF group demonstrated significantly improved pooled ODI (-19.30, 95% CI -23.87 to -14.4, p=.00001). These studies had moderate heterogeneity (Q=12.52, df=4, p=.01, I\u003csup\u003e2\u003c/sup\u003e=68%) (Figure 4D).\u003c/p\u003e\n\u003cp\u003eWe subsequently conducted subgroup analyses of VAS and ODI by MINORS quality scores. Cutoff scores of \u0026le;7 for single-cohort studies and \u0026le;11 for comparative cohort studies were used to divide the studies into two subgroups. For VAS, 8 studies scoring \u0026le;7 demonstrated significant improvement in VAS (-5.08, 95% CI -6.13 \u0026ndash; -4.03, p=.00); 19 studies scoring \u0026gt;8 demonstrated significant improvement in VAS (-4.89, 95% CI -5.68 \u0026ndash; -4.10, p=.00). The total combined heterogeneity among the studies was low (Q= 17.17, df=26, p =.90, I\u003csup\u003e2\u003c/sup\u003e = 0%, 95% CI .00 - 16.65). There was no significant difference in VAS between MINORS subgroups (Q\u003csub\u003eM\u003c/sub\u003e= .084, df = 1, p =.77) (Figure 5B).\u003c/p\u003e\n\u003cp\u003eFor ODI, 4 studies scoring \u0026le;7 demonstrated a significant improvement in ODI (-24.41, 95% CI -37.21\u0026ndash; -19.61, p=.00); 19 studies scoring \u0026gt;8 demonstrated a significant improvement in ODI (-19.58, 95% CI -26.63 \u0026ndash; -12.52, p=.00). The total combined heterogeneity among the studies was moderate (Q= 47.89, df=22, p =.001, I\u003csup\u003e2\u003c/sup\u003e= 54.06%). There was no significant difference in ODI between MINORS subgroups (Q\u003csub\u003eM\u003c/sub\u003e= 2.35, df = 1, p =.13) (Figure 5C).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComplications\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTwenty-two case series, 2 single-cohort studies, and 4 RCTs reported complications totaling 27 cases of pseudoarthrosis, 57 cases of hematoma, and 20 instances of implant malposition. Additionally, 63 patients experienced increased pain in the postoperative period (exact timing was unspecified), 29 developed infections, and 34 required reoperation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eReporting Biases\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere was no missing data for fusion outcomes; however, several studies did not provide the data necessary to analyze VAS and ODI outcomes. We contacted Polly et al. to request clarification of the reported summary data [22]. The data for Harvey et al. were obtained from published supplemental material [23]. Furthermore, numerical data for Vanacochla 2018 were acquired from a meta-analysis by Herman et al. [14]. A funnel plot was created to assess publication bias, using the mean difference in the ODI as the effect estimate. The funnel plot illustrated in Figure 6 exhibits a relatively symmetrical distribution of the studies with minimal focal paucity, suggesting a low likelihood of publication bias.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCertainty of Evidence\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe reported the quality of evidence for each outcome using GRADE. The fusion rate was downrated for risk of bias, publication bias, and inconsistency, making the overall quality of evidence very low. VAS in the SIJF group was downrated for risk of bias and publication bias and was rated up for a very large effect (2 x MCID), resulting in a moderate quality of evidence. ODI in the SIJF group was downrated for risk of bias, publication bias, and inconsistency, with a very low overall quality of evidence. Regarding our comparative studies, both VAS and ODI outcomes were downrated for risk of bias, publication bias, and inconsistency, with a very low overall quality of evidence.\u003c/p\u003e\n\u003cp\u003eIn our subgroup analysis of fusion rate by device, IFuse was downrated for risk of bias, publication bias, and inconsistency with a very low overall GRADE. Rialto/SI-Lok/Integrity group was downrated for risk of bias, publication bias, and very serious inconsistency with a very low overall GRADE. SImmetry was downrated for risk of bias and publication bias, yielding a very low overall rating. Studies were analyzed by MINORS for both VAS and ODI. Studies below the cutoff were rated down for risk of bias and publication bias, with a very low certainty of evidence overall. Studies above the cutoff were rated down for publication bias and rated up for significant effect (2xMCID for VAS) with an overall moderate GRADE assessment (Table 2).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis meta-analysis systematically reviewed 38 MIS SIJF studies totaling 2,847 patients and demonstrated a significant improvement in VAS in SIJF single cohorts. A definitive conclusion on fusion rate, ODI, and comparative VAS between SIJF and conservative treatment cannot be made.\u003c/p\u003e\u003cp\u003ePer GRADE, the quality of evidence for fusion rate, ODI, and comparative PROs between SIJF vs. conservation treatment was very low. Therefore, though our pooled analyses demonstrated that MIS SIJ fusion showed significant improvement for the outcomes described, we could not make a definitive conclusion. Conversely, the quality of evidence for VAS improvement in SIJF single cohorts was moderate.\u003c/p\u003e\u003cp\u003eSubgroup analyses showed no difference in SIJF rate by device or PRO improvement by MINORS score. Per GRADE, the quality of evidence for the subgroup analyses is very low to moderate.\u003c/p\u003e\u003cp\u003eRecent systematic reviews have investigated PROs of sacroiliac joint fusions, including Tran et al. with 20 studies, Abbas et al. with 6 studies, Hermans et al. limited to RCTs with 6 studies, Chang et al. with 40 studies, Whang et al. with 57 studies, and Ghaddaf et al. with 8 studies. These meta-analyses all demonstrated significant improvements in PROs, aligning with the VAS findings of our meta-analyses [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan additionalcitationids=\"CR14 CR15\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eOur study is the most updated synthesis of the current evidence regarding SIJF. Compared to the previous systematic reviews and meta-analyses, our study used different inclusion criteria. Chang et al. included studies from 1987, which limits relevance compared to modern-day MIS surgical techniques. Whang et al. reported cohort numbers rather than study numbers and included studies with only a 3-month follow-up period, which we excluded as insufficient for accurate fusion evaluation.\u003c/p\u003e\u003cp\u003eDespite these recent systematic reviews/meta-analyses, a significant gap remains: none assessed fusion rates, and notably, none evaluated fusion using CT. Addressing this gap is critical for advancing our understanding of surgical outcomes in SIJF. Our study not only evaluated the fusion rate as the primary outcome, but also offered subgroup analyses by fusion device and MINORS scores.\u003c/p\u003e\u003cp\u003eHeterogeneity between studies for fusion rate is very high, likely due to a lack of granularity in fusion assessment data available in the studies. Even though CT evaluation is accepted as the gold standard for evaluating SIJF, there is a lack of standardized diagnostic criteria for SIJF. To standardize our analysis across studies, we defined fusion as the presence of trabecular bone bridging across the SIJ. However, the determination of trabecular volume, density, and follow-up interval for fusion assessment can be somewhat subjective. This subjectivity can influence the interpretation of fusion success and underscores the need for a standardized criterion for SIJ.\u003c/p\u003e\u003cp\u003eFor single-cohort VAS and VAS subgroup analyses by MINORS, I\u003csup\u003e2\u003c/sup\u003e and its 95% confidence intervals indicated low heterogeneity, while for ODI and ODI subgroup analyses by MINORS, I\u003csup\u003e2\u003c/sup\u003e and its 95% confidence intervals indicated moderate heterogeneity. The measurement of VAS and ODI is standardized as these are validated instruments. While VAS is a direct outcome measuring pain at the SI joint, ODI is a global measurement for QoL, which is an indirect outcome for SIJF efficacy. This may explain the presence of and degree of heterogeneity among studies measuring these outcomes. I\u003csup\u003e2\u003c/sup\u003e values for VAS and ODI in the comparative studies were moderate to high. This is likely due to Randers et al., a uniquely blinded RCT comparing SIJF to a sham operation. None of the other comparative studies shares this methodology, which could explain the high heterogeneity.\u003c/p\u003e\n\u003ch3\u003eLimitations\u003c/h3\u003e\n\u003cp\u003eThe most important limitation of our study is heterogeneity in fusion rate assessment, which could preclude meaningful interpretation of the combined effect size. In our comparative cohort synthesis for PROs, Randers et al., the only RCT with blinded controls undergoing sham surgery, led to significant methodological heterogeneity [\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e]. Some studies reported a significant loss of follow-up of up to 50%, adversely impacting data validity. The absence of surgery dates in several studies introduces historical bias, as standards of care can vary over time. Without this crucial information, we cannot dismiss the possibility of historical bias. Industry-sponsored studies are more likely to publish data that favors their products and withhold data that does not support them, leading to publication bias. Other limitations included substantial risk of bias for individual studies and small sample sizes in a significant number of studies.\u003c/p\u003e\u003cp\u003e During our review process, some studies\u0026rsquo; data were missing or not collected in the format we needed. We obtained Vanacochla et al.\u0026rsquo;s data from a meta-analysis by Herman et al. [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Raw data from Polly et al. was obtained from the author [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Data for Harvey et al. was obtained from published supplemental data [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Many authors did not report standard deviations of the mean difference. To remedy this, we either converted the confidence interval or used the preoperative standard deviation.\u003c/p\u003e\u003cp\u003eDue to the number of included studies, we could not run a meta-regression that included all study-level confounders. To conduct a meta-regression, the Cochrane Handbook recommends at least ten studies for each study-level variable to ensure reliable results [\u003cspan citationid=\"CR68\" class=\"CitationRef\"\u003e68\u003c/span\u003e]. Since we only had 11 studies included in the synthesis for fusion outcome, conducting a meta-regression for fusion outcome would yield low-power results. Instead, we conducted subgroup analyses for fusion by device and PRO by MINORS scores. When interpreting results, it should be noted that subgroup analyses and meta-regressions are observational in nature and subject to the limitations of any observational investigation, including bias through confounding by other study-level characteristics [\u003cspan citationid=\"CR69\" class=\"CitationRef\"\u003e69\u003c/span\u003e].\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis meta-analysis revealed a statistically significant improvement in VAS within a single SIJF, supported by moderate-quality evidence. However, due to the very low quality of evidence, a conclusive determination on fusion rate, ODI, and VAS improvement when comparing SIJF to conservative approaches is not possible. This indicates a need for further research to establish stronger conclusions regarding the efficacy of MIS SIJ fusion on fusion rates and patient-reported outcomes.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eThis study received no funding from any funding agency in the public, commercial, or non-profit sectors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no known competing financial interests or personal relationships that could have influenced the findings of this study.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eR.B., G.A., and D.T. conceptualized the study and conducted the methodology, while data curation was performed by R.B., G.A., M.L., and D.T. Formal analysis was performed by R.B., H.L., and D.T. Statistics were conducted by H.L. and D.T. The original draft was written by R.B., G.A., H.L., and D.T. The tables and figures were created by R.B., H.L., and D.T. Final manuscript editing and review were performed by R.B., H.L., D.T., and T.S. Supervision was performed by D.T. and T.S.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eZaidi HA, Montoure AJ, Dickman CA. Surgical and clinical efficacy of sacroiliac joint fusion: a systematic review of the literature. \u003cem\u003eJ Neurosurg Spine\u003c/em\u003e. 2015;23(1):59-66. doi:10.3171/2014.10.SPINE14516\u003c/li\u003e\n\u003cli\u003eCohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. \u003cem\u003eExpert Rev Neurother\u003c/em\u003e. 2013;13(1):99-116. doi:10.1586/ern.12.148\u003c/li\u003e\n\u003cli\u003eAbbas A, Du JT, Toor J, Versteeg A, Finkelstein JA. 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A Prospective Outcome Study. \u003cem\u003eWorld Neurosurg\u003c/em\u003e. 2021;148:e164-e171. doi:10.1016/j.wneu.2020.12.104\u003c/li\u003e\n\u003cli\u003eCalodney A, Azeem N, Buchanan P, et al. Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant. \u003cem\u003eJ Pain Res\u003c/em\u003e. 2024;17:1209-1222. doi:10.2147/JPR.S458334\u003c/li\u003e\n\u003cli\u003eSmith A, Capobianco R, Cher D, et al. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes. \u003cem\u003eAnn Surg Innov Res\u003c/em\u003e. 2013;(1).\u003c/li\u003e\n\u003cli\u003eLynch PJ, Tubic G, Foster JM, Puri S, Burnette CA, Block JE. Minimally Invasive Inferior Intra-Articular Sacroiliac Joint Fusion: Successful Application of Osseous Stabilization Using Allograft Bone. \u003cem\u003eOrthop Res Rev\u003c/em\u003e. 2022;14:429-435. doi:10.2147/ORR.S387104\u003c/li\u003e\n\u003cli\u003eRaikar SV, Nilles-Melchert T, Patil AA, Crum W, Pandey D. Posterior Oblique Approach for Sacroiliac Joint Fusion. \u003cem\u003eCureus\u003c/em\u003e. 2023;15(1):e33502. doi:10.7759/cureus.33502\u003c/li\u003e\n\u003cli\u003eRudolf L. Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. \u003cem\u003eOpen Orthop J\u003c/em\u003e. 2012;6:495-502. doi:10.2174/1874325001206010495\u003c/li\u003e\n\u003cli\u003eSchmidt G, Bologna M, Schorr R. 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Accessed November 6, 2024. http://www.ncbi.nlm.nih.gov/books/NBK49407/\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 and 2 are available in the Supplementary Files section.\u003c/p\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":"Sacroiliac fusion, minimally invasive, fusion","lastPublishedDoi":"10.21203/rs.3.rs-7402569/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7402569/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose:\u003c/h2\u003e\u003cp\u003eWe aimed to evaluate the fusion rate after minimally invasive (MIS) sacroiliac joint (SIJ) fusions and compare patient-reported outcomes (PRO) between MIS SIJF and conservative treatment. Additionally, we aimed to compare the SIJ fusion rate between devices.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003e Using PRISMA-P guidelines, we searched electronic databases using the standardized search strategies for publication dates 1/1/2000-7/17/2024. Our primary outcomes were fusion rates after MIS SIJ fusion as evaluated by CT. Our secondary outcomes included Visual analog score-back (VAS) and Oswestry disability index (ODI). We included randomized controlled trials (RCTs), prospective or retrospective comparative or single-cohort studies, and case series with \u0026gt;\u0026thinsp;10 subjects. We excluded pediatric studies, studies lacking our outcomes, non-degenerative pathology, non-English studies, and those with \u0026lt;\u0026thinsp;6-month follow-up. Two independent reviewers screened for eligibility and performed a risk of bias assessment using the Cochrane Collaboration Risk of Bias (RoB) tool and the Methodological Index for Non-Randomized Studies (MINORS) tool, and extracted data. A third reviewer arbitrated throughout all stages. Random or mixed-effects models and inverse variance were used for synthesis. Q and I\u003csup\u003e2\u003c/sup\u003e statistics were used to assess heterogeneity. GRADE was used to evaluate the quality of evidence used in our recommendation. We used Review Manager and Comprehensive Meta-Analysis. This protocol was registered at PROSPERO: 2021 CRD4202127348.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eOne thousand and sixteen studies were identified. Thirty-eight were included after the screening. There were 4 RCTs, 32 single cohorts/case series, and 2 comparative cohort studies totaling 2,847 patients. Fusion outcomes demonstrated a pooled event rate of 0.86 (95% CI 0.78\u0026ndash;0.91). Patient-reported outcomes demonstrated a significant improvement after SIJF in pooled mean VAS (-4.90, 95% CI -5.49 to -4.30, p\u0026thinsp;=\u0026thinsp;.00) and ODI (-22.01, 95% CI -27.90 to -16.12, p\u0026thinsp;=\u0026thinsp;.00). Among the comparative cohort studies, the SIJF group demonstrated a significantly improved pooled VAS (-3.71, 95% CI -4.74 to -2.68, p\u0026thinsp;\u0026lt;\u0026thinsp;.00001) and ODI (-19.30, 95% CI -23.87 to -14.4, p\u0026thinsp;=\u0026thinsp;.00001). There was no significant difference in fusion rate between devices and PROs between MINORS subgroups. I\u003csup\u003e2\u003c/sup\u003e indicated moderate to significant heterogeneity across all estimates. Per GRADE, the overall quality of the evidence of our recommendation is very low to moderate.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eWe demonstrated significant improvement of VAS after SIJF with moderate quality of evidence. We could not make a definitive conclusion regarding fusion rate, ODI, or comparative VAS (SIJF vs. conservative) due to the low quality of evidence. Further research is warranted to strengthen the evidence.\u003c/p\u003e","manuscriptTitle":"Fusion and Patient-reported Outcomes of Minimally Invasive Sacroiliac Joint Fusion Surgery: A Meta-Analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-22 10:01:34","doi":"10.21203/rs.3.rs-7402569/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":"f2f40800-0d0b-471d-b4be-8960db057d62","owner":[],"postedDate":"September 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-09-22T10:01:37+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-22 10:01:34","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7402569","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7402569","identity":"rs-7402569","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}