Dataset Information

Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating From the Sacroiliac Joint: A Pooled Analysis.

ABSTRACT: A pooled patient-level analysis of two multicenter randomized controlled trials and one multicenter single-arm prospective trial.The aim of this study was to identify predictors of outcome of conservative and minimally invasive surgical management of pain originating from the sacroiliac joint (SIJ).Three recently published prospective trials have shown that minimally invasive SIJ fusion (SIJF) using triangular titanium implants produces better outcomes than conservative management for patients with pain originating from the SIJ. Due to limitations in individual trial sample size, analyses of predictors of treatment outcome were not conducted.We pooled individual patient data from the three trials and used random effects models with multivariate regression analysis to identify predictors for treatment outcome separately for conservative and minimally invasive surgical treatment. Outcome was measured using visual analogue scale (VAS), Oswestry Disability Index (ODI), and EuroQOL-5D (EQ-5D).We included 423 patients assigned to either nonsurgical management (NSM, n?=?97) or SIJF (n?=?326) between 2013 and 2015. The reduction in SIJ pain was 37.9 points larger [95% confidence interval (95% CI) 32.5-43.4, P?

SUBMITTER: Dengler J

PROVIDER: S-EPMC5636200 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating From the Sacroiliac Joint: A Pooled Analysis.

Dengler Julius J Duhon Bradley B Whang Peter P Frank Clay C Glaser John J Sturesson Bengt B Garfin Steven S Cher Daniel D Rendahl Aaron A Polly David D

Spine 20171101 21

<h4>Study design</h4>A pooled patient-level analysis of two multicenter randomized controlled trials and one multicenter single-arm prospective trial.<h4>Objective</h4>The aim of this study was to identify predictors of outcome of conservative and minimally invasive surgical management of pain originating from the sacroiliac joint (SIJ).<h4>Summary of background data</h4>Three recently published prospective trials have shown that minimally invasive SIJ fusion (SIJF) using triangular titanium imp ...[more]

PMID: 28350586

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Project description:BackgroundSacroiliac (SI) joint pain is an often overlooked cause of low back pain. SI joint arthrodesis has been reported to relieve pain and improve quality of life in patients suffering from degeneration or disruption of the SI joint who have failed non-surgical care. We report herein early results of a multicenter prospective single-arm cohort of patients with SI joint degeneration or disruption who underwent minimally invasive fusion using the iFuse Implant System®.MethodsThe safety cohort includes 94 subjects at 23 sites with chronic SI joint pain who met study eligibility criteria and underwent minimally invasive SI joint fusion with the iFuse Implant System® between August 2012 and September 2013. Subjects underwent structured assessments preoperatively, immediately postoperatively, and at 1, 3, and 6 months postoperatively, including SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQoL-5D (EQ-5D). Patient satisfaction with surgery was assessed at 6 months. The effectiveness cohort includes the 32 subjects who have had 6-month follow-up to date.ResultsMean subject age was 51 years (n=94, safety cohort) and 66% of patients were women. Subjects were highly debilitated at baseline (mean VAS pain score 78, mean ODI score 54). Three implants were used in 80% of patients; two patients underwent staged bilateral implants. Twenty-three adverse events occurred within 1 month of surgery and 29 additional events occurred between 30 days and latest follow-up. Six adverse events were severe but none were device-related. Complete 6-month postoperative follow-up was available in 26 subjects. In the effectiveness cohort, mean (± standard deviation) SI joint pain improved from a baseline score of 76 (±16.2) to a 6-month score of 29.3 (±23.3, an improvement of 49 points, P<0.0001), mean ODI improved from 55.3 (±10.7) to 38.9 (±18.5, an improvement of 15.8 points, P<0.0001) and SF-36 PCS improved from 30.7 (±4.3) to 37.0 (±10.7, an improvement of 6.7 points, P=0.003). Ninety percent of subjects who were ambulatory at baseline regained full ambulation by month 6; median time to full ambulation was 30 days. Satisfaction with the procedure was high at 85%.ConclusionMinimally invasive SI joint fusion using the iFuse Implant System® is safe. Mid-term follow-up indicates a high rate of improvement in pain and function with high rates of patient satisfaction.

Dataset Information

Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating From the Sacroiliac Joint: A Pooled Analysis.

Publications

Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating From the Sacroiliac Joint: A Pooled Analysis.

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