scholarly journals Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption

Author(s):  
Jon Block ◽  
Miller ◽  
Reckling
2013 ◽  
Vol 37 (8) ◽  
pp. 1547-1554 ◽  
Author(s):  
Xiaowei Yu ◽  
Mingjie Tang ◽  
Zubin Zhou ◽  
Xiaochun Peng ◽  
Tianyi Wu ◽  
...  

2019 ◽  
Vol 1 (22;1) ◽  
pp. 29-40
Author(s):  
Zung Vu Tran

Background: Sacroiliac (SI) joint fusion represents a unique area of orthopedic surgery with procedural literature dating to the early 1920s, showing limited innovation in either technique or hardware over the last 90 years. Recent improvements in the diagnosis and treatment of SI joint dysfunction warrant comparisons to older surgical techniques. Objective: To evaluate treatment efficacies and patient outcomes associated with minimally invasive joint fusion in comparison to screw-type surgeries. Study Design: Systematic review and meta-analysis. Setting: Electronic databases, EMBASE, Pubmed (Medline), manual bibliography cross-referencing for published works until Dec. 31, 2017. Methods: A thorough literature search was performed in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. Data repositories accessed included Pubmed and EMBASE, until Dec. 31, 2017. All studies evaluating sacroiliac joint fusion and reporting quantifiable outcome data were included. Exclusion criteria included nonhuman studies, qualitative reviews, and meta-analyses. Data compilation, coding, and extraction were performed using MedAware Systems proprietary software. Data from each study were extracted by 2 analysts, using software that allowed automatic comparisons of all data fields. The standardized mean difference (SMD) was used as a summary statistic for pooling outcomes data across studies. Multiple outcome measures were grouped into 3 categories, according to similarity of measurements - Pain, Disability/Physical Function, and Global/QOL. Results: A total of 20 studies had adequate data to calculate a SMD, and were included in the meta-analysis. Results of iFuse trials were compared to screw type trials, pooled in 3 categories of outcomes - Pain, Disability/Physical Function, and Global/QOL. The Pain category showed a statistically significant (P = 0.03) difference in outcomes for patients receiving the iFuse implant compared to screw types (SMD = 2.04 [95%CI: 1.76 to 2.33] vs. 1.28 [95%CI: 0.47 to 2.09]), with iFuse showing significantly better outcomes. The Disability category also showed a statistically significant (P = 0.01) difference in outcomes for patients receiving the iFuse implant compared to screw types (SMD = 1.68 [95%CI: 1.43 to 1.94] vs. 0.26 [95%CI: -1.90 to 2.41]), with iFuse showing significantly better outcomes. For Global/Quality of Life (QOL) outcomes, there was a significant difference (P = 0.04) between iFuse and screw-type procedures (SMD = 0.99 [95%CI: 0.75 to 1.24] vs. 0.60 [95%CI: 0.33 to 0.88]), with iFuse showing significantly better outcomes. There was a statistically significant correlation between lower baseline Oswestry Disability Index (ODI) and Short Form 36 Health Survey (SF-36) values and better post treatment outcomes (r2 = 0.47, P < 0.01, and r2 = 0.30, P < 0.01, respectively). An association was found between pain at baseline and better outcomes (r2 = 0.21, P < 0.01), where worse baseline pain was associated with better outcomes. Limitations: There was a limited number of studies in this meta-analysis with treatments that could be properly classified as screw-type. Conclusion: In this analysis, compared to screw-type surgeries, the iFuse system showed statistically superior outcomes. This was the case when outcome measures were classified into 3 main categories - Pain, Disability/Physical Function, and Global/QOL. Key words: Meta-analysis, systematic review, sacroiliac joint, sacroiliac joint fusion


2012 ◽  
Vol 6 (1) ◽  
pp. 495-502 ◽  
Author(s):  
Leonard Rudolf

This retrospective study of 50 consecutive patients treated by a single orthopedic spine surgeon in private practice was conducted to evaluate the safety and efficacy of minimally invasive sacroiliac joint fusion using a series of triangular, porous plasma spray coated titanium implants.Medical charts were reviewed for perioperative metrics, complications, pain, quality of life and satisfaction with surgery. All patients were contacted at a 24 months post-op to assess SI joint pain, satisfaction with surgery and work status.An early and sustained statistically significant improvement in pain function was identified at all post-operative time points (ANOVA, p<0.000). A clinically significant improvement (>2 point change from baseline) was observed in 7 out of 9 domains of daily living. The complication rate was low and more than 80% of patients would have the same surgery again.MIS SI joint fusion appears to be a safe and effective procedure for the treatment of sacroiliac joint disruption or degenerative sacroiliitis.


2014 ◽  
Vol 8 (1) ◽  
pp. 375-383 ◽  
Author(s):  
Leonard Rudolf ◽  
Robyn Capobianco

Object : Previous reports of minimally invasive (MIS) sacroiliac (SI) joint fusion for low back, SI joint, and buttock pain secondary to SI joint disorders have shown favorable short- and mid-term outcomes. Herein we present 5-year clinical and radiographic outcomes after MIS SI joint fusion using a series of triangular porous titanium plasma spray (TPS) coated implants. Methods : Consecutive patients treated with MIS SI joint fusion for degenerative sacroiliitis and/or sacroiliac joint disruptions between October 2007 and March 2009 were evaluated. Pain on VAS, an SI joint specific survey and Oswestry Disability Index (ODI) were administered. X-ray and CT scans were obtained to assess the implants. Results : Of 21 patients treated, 17 were available for the study. Mean age was 58 years (range 36-85), 77% were female and 47% had prior lumbar spinal fusion. Pain on VAS improved from 8.3 at baseline to 2.4 at 5 years; 88% of patients reached Substantial Clinical Benefit. Mean ODI score at 5 years was 21.5 (SD 22.7). Patient satisfaction achieved at 12 months was maintained for 5 years (82%). A qualitative review of x-ray and CT imaging showed increased bone density immediately adjacent to all implants, intra-articular osseous bridging in 87% of patients and no evidence of implant loosening or migration. Conclusion : Long-term clinical and radiographic outcomes after MIS SIJ fusion are favorable. Clinical improvements observed at 12 months postoperatively were maintained at 5 years. There was no evidence of long-term complications, implant loosening or migration. Patients who did not achieve large improvements were affected by multiple severe concomitant degenerative conditions of the lumbar spine, pelvis, and/or hip.


2016 ◽  
Vol 10 (1) ◽  
pp. 679-689 ◽  
Author(s):  
Richard A. Kube ◽  
Jeffrey M. Muir

Background:Recalcitrant sacroiliac joint pain responds well to minimally-invasive surgical (MIS) techniques, although long-term radiographic and fusion data are limited.Objective:To evaluate the one-year clinical results from a cohort of patients with chronic sacroiliac (SI) joint pain unresponsive to conservative therapies who have undergone minimally invasive SI joint fusion.Methods:SI joint fusion was performed between May 2011 and January 2014. Outcomes included radiographic assessment of fusion status, leg and back pain severityviavisual analog scale (VAS), disabilityviaOswestry Disability Index (ODI) and complication rate. Outcomes were measured at baseline and at follow-up appointments 6 months and 12 months post-procedure.Results:Twenty minimally invasive SI joint fusion procedures were performed on 18 patients (mean age: 47.2 (14.2), mean BMI: 29.4 (5.3), 56% female). At 12 months, the overall fusion rate was 88%. Back and leg pain improved from 81.7 to 44.1 points (p<0.001) and from 63.6 to 27.7 points (p=0.001), respectively. Disability scores improved from 61.0 to 40.5 (p=0.009). Despite a cohort containing patients with multiple comorbidities and work-related injuries, eight patients (50%) achieved the minimal clinically important difference (MCID) in back pain at 12 months, with 9 (69%) patients realizing this improvement in leg pain and 8 (57%) realizing the MCID in ODI scores at 12 months. No major complications were reported.Conclusion:Minimally invasive SI joint surgery is a safe and effective procedure, with a high fusion rate, a satisfactory safety profile and significant improvements in pain severity and disability reported through 12 months post-procedure.


2021 ◽  
pp. 1-10
Author(s):  
Dmitry Enikeev ◽  
Vincent Misrai ◽  
Enrique Rijo ◽  
Roman Sukhanov ◽  
Denis Chinenov ◽  
...  

<b><i>Objective:</i></b> To critically appraise the methodological rigour of the clinical practice guidelines (CPGs) vis-à-vis BPH surgery as used by specialist research associations in the US, Europe and UK, and to compare whether the guidelines cover all or only some of the available treatments. <b><i>Methods:</i></b> The current guidelines issued by the EUA, AUA and NICE associations have been analyzed by 4 appraisers using the AGREE-II instrument. We also compared the recommendations given in the guidelines for surgical and minimally invasive treatment to find out which of these CPGs include most of the available treatment options. <b><i>Results:</i></b> According to the AGREE II tool, the median scores of domains were: domain 1 scope and purpose 66.7%, domain 2 stakeholder involvement 50.0%, domain 3 rigor of development 65.1%, domain 4 clarity of presentation 80.6%, domain 5 applicability 33.3%, domain 6 editorial independence 72.9%. The overall assessment according to AGREE II is 83.3%. The NICE guideline scored highest on 5 out of 6 domains and the highest overall assessment score (91.6%). The EAU guideline scored lowest on 4 out of 6 domains and has the lowest overall assessment score (79.1%). <b><i>Conclusions:</i></b> The analyzed CPGs comprehensively highlight the minimally invasive and surgical treatment options for BPH. According to the AGREE II tool, the domains for clarity of presentation and editorial independence received the highest scores. The stakeholder involvement and applicability domains were ranked as the lowest. Improving the CPG in these domains may help to improve the clinical utility and applicability of CPGs.


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