Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management.

PURPOSE: To compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain. METHODS: 103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (N = 52) or CM (N = 51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025. RESULTS: At 6 months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, p < 0.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (p < 0.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group. CONCLUSIONS: In patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life.

Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial.

BACKGROUND: The first results from the randomized, controlled iFuse Implant System Minimally Invasive Arthrodesis (iMIA) trial showed that minimally invasive surgical management (MISM) of low back pain originating from the sacroiliac joint (SIJ) by placing transarticular triangular titanium implants reduced pain more effectively than conservative management (CM). We now conducted a separate analysis of the iMIA data to assess whether the referred leg pain (RLP) component of SIJ-associated pain may also be affected by MISM or CM. METHODS: Data from 101 patients, recruited between June 2013 and May 2015 at nine European spine care centers, were included. Forty-nine patients were randomized to CM and 51 patients to MISM. RLP was defined as pain below the gluteal fold and assessed using the visual analogue scale (VAS). Changes in RLP over 6 months were the primary endpoint. RESULTS: The prevalence of clinically significant RLP was 76.2 %. Over 6 months of follow-up, CM produced no significant change in RLP, which was 51.0 VAS points (interquartile range (IQR) 17.0-75.0) at baseline. In contrast, in the MISM cohort, we found a significant decrease in RLP from VAS 58.0 (IQR 24.5-80.0) at baseline to VAS 13.5 (IQR 0.0-39.3) after 6 months (p < 0.01). Improvement of RLP was associated only with the type of treatment (OR 5.04, p < 0.01), but not with patient age, sex, or different patterns of pain referral. CONCLUSIONS: Our analysis shows that RLP is a frequent phenomenon in patients with SIJ-associated pain. At 6 months of follow-up, MISM helped relieve RLP more effectively than CM. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01741025.

Minimally Invasive SI Joint Fusion Procedures for Chronic SI Joint Pain: Systematic Review and Meta-Analysis of Safety and Efficacy.

BACKGROUND: Sacroiliac (SI) joint fusion is increasingly used to treat chronic SI joint pain. Multiple surgical approaches are now available. METHODS: Data abstraction and random effects meta-analysis of safety and efficacy outcomes from published patient cohorts. Patient-reported outcomes (PROs) and safety measures were stratified by surgical technique: transiliac, including lateral transiliac (LTI) and posterolateral transiliac (PLTI), and posterior interpositional (PI) procedures. RESULTS: Fifty-seven cohorts of 2851 patients were identified, including 43 cohorts (2126 patients) for LTI, 6 cohorts (228 patients) for PLTI, and 8 cohorts (497 patients) for PI procedures. Randomized trials were only available for LTI. PROs were available for pain (numeric rating scale) in 57 cohorts (2851 patients) and disability (Oswestry Disability Index [ODI]) in 37 cohorts (1978 patients).All studies with PROs showed improvement from baseline after surgery. Meta-analytic improvements in pain scores were highest for LTI (4.8 points [0-10 scale]), slightly lower for PLTI (4.2 points), and lowest for PI procedures (3.8 points, P = 0.1533). Mean improvements in ODI scores were highest for LTI (25.9 points), lowest for PLTI procedures (6.8 points), and intermediate for PI (16.3 points, P = 0.0095).For safety outcomes, acute symptomatic implant malposition was 0.43% for LTI, 0% for PLTI, and 0.2% for PI procedures. Wound infection was reported in 0.15% of LTI, 0% of PLTI, and 0% of PI procedures. Bleeding requiring surgical intervention was reported in 0.04% of LTI procedures and not reported for PLTI or PI. Breakage and migration were not reported for any device. Radiographic imaging evaluation reporting implant placement accuracy and fusion was only available for LTI. DISCUSSION: Literature support for SI joint fusion is growing. The LTI procedure contains the largest body of available evidence and shows the largest improvements in pain and ODI. Only LTI procedures have independent radiographic evidence of fusion and implant placement. The adverse event rate for all procedures was low.

Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint.

BACKGROUND: Sacroiliac joint pain is increasingly recognized as a cause of low back pain. We compared the safety and effectiveness of minimally invasive sacroiliac joint arthrodesis using triangular titanium implants and conservative management in patients with chronic sacroiliac joint pain. METHODS: This study was a prospective, multicenter randomized controlled trial of adults with chronic sacroiliac joint pain assigned to either conservative management or sacroiliac joint arthrodesis with triangular titanium implants. The study end points included self-rated low back pain (visual analog scale [VAS]), back dysfunction (Oswestry Disability Index [ODI]), and quality of life. Ninety percent of subjects in both groups completed the study. RESULTS: Between June 6, 2013, and May 15, 2015, 103 subjects were randomly assigned to conservative management (n = 51) or sacroiliac joint arthrodesis (n = 52). At 2 years, the mean low back pain improved by 45 points (95% confidence interval [CI], 37 to 54 points) after sacroiliac joint arthrodesis and 11 points (95% CI, 2 to 20 points) after conservative management, with a mean difference between groups of 34 points (p < 0.0001). The mean ODI improved by 26 points (95% CI, 21 to 32 points) after sacroiliac joint arthrodesis and 8 points (95% CI, 2 to 14 points) after conservative management, with a mean difference between groups of 18 points (p < 0.0001). Parallel improvements were seen in quality of life. In the sacroiliac joint arthrodesis group, the prevalence of opioid use decreased from 56% at baseline to 33% at 2 years (p = 0.009), and no significant change was observed in the conservative management group (47.1% at baseline and 45.7% at 2 years). Subjects in the conservative management group, after crossover to the surgical procedure, showed improvements in all measures similar to those originally assigned to sacroiliac joint arthrodesis. In the first 6 months, the frequency of adverse events did not differ between groups (p = 0.664). By month 24, we observed 39 severe adverse events after sacroiliac joint arthrodesis, including 2 cases of sacroiliac joint pain, 1 case of a postoperative gluteal hematoma, and 1 case of postoperative nerve impingement. The analysis of computed tomographic (CT) imaging at 12 months after sacroiliac joint arthrodesis showed radiolucencies adjacent to 8 implants (4.0% of all implants). CONCLUSIONS: For patients with chronic sacroiliac joint pain due to joint degeneration or disruption, minimally invasive sacroiliac joint arthrodesis with triangular titanium implants was safe and more effective throughout 2 years in improving pain, disability, and quality of life compared with conservative management. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Building a Collaborative Model of Sacroiliac Joint Dysfunction and Pelvic Girdle Pain to Understand the Diverse Perspectives of Experts.

BACKGROUND: Pelvic girdle pain (PGP) and sacroiliac joint (SIJ) dysfunction/pain are considered frequent contributors to low back pain (LBP). Like other persistent pain conditions, PGP is increasingly recognized as a multifactorial problem involving biological, psychological, and social factors. Perspectives differ between experts and a diversity of treatments (with variable degrees of evidence) have been utilized. OBJECTIVE: To develop a collaborative model of PGP that represents the collective view of a group of experts. Specific goals were to analyze structure and composition of conceptual models contributed by participants, to aggregate them into a metamodel, to analyze the metamodel's composition, and to consider predicted efficacy of treatments. DESIGN: To develop a collaborative model of PGP, models were generated by invited individuals to represent their understanding of PGP using fuzzy cognitive mapping (FCM). FCMs involved proposal of components related to causes, outcomes, and treatments for pain, disability, and quality of life, and their connections. Components were classified into thematic categories. Weighting of connections was summed for components to judge their relative importance. FCMs were aggregated into a metamodel for analysis of the collective opinion it represented and to evaluate expected efficacy of treatments. RESULTS: From 21 potential contributors, 14 (67%) agreed to participate (representing six disciplines and seven countries). Participants' models included a mean (SD) of 22 (5) components each. FCMs were refined to combine similar terms, leaving 89 components in 10 categories. Biomechanical factors were the most important in individual FCMs. The collective opinion from the metamodel predicted greatest efficacy for injection, exercise therapy, and surgery for pain relief. CONCLUSIONS: The collaborative model of PGP showed a bias toward biomechanical factors. Most efficacious treatments predicted by the model have modest to no evidence from clinical trials, suggesting a mismatch between opinion and evidence. The model enables integration and communication of the collection of opinions on PGP.

European guidelines for the diagnosis and treatment of pelvic girdle pain.

A guideline on pelvic girdle pain (PGP) was developed by "Working Group 4" within the framework of the COST ACTION B13 "Low back pain: guidelines for its management", issued by the European Commission, Research Directorate-General, Department of Policy, Coordination and Strategy. To ensure an evidence-based approach, three subgroups were formed to explore: (a) basic information, (b) diagnostics and epidemiology, and (c) therapeutical interventions. The progress of the subgroups was discussed at each meeting and the final report is based on group consensus. A grading system was used to denote the strength of the evidence, based on the AHCPR Guidelines (1994) and levels of evidence recommended in the method guidelines of the Cochrane Back Review group. It is concluded that PGP is a specific form of low back pain (LBP) that can occur separately or in conjunction with LBP. PGP generally arises in relation to pregnancy, trauma, arthritis and/or osteoarthritis. Uniform definitions are proposed for PGP as well as for joint stability. The point prevalence of pregnant women suffering from PGP is about 20%. Risk factors for developing PGP during pregnancy are most probably a history of previous LBP, and previous trauma to the pelvis. There is agreement that non risk factors are: contraceptive pills, time interval since last pregnancy, height, weight, smoking, and most probably age. PGP can be diagnosed by pain provocation tests (P4/thigh thrust, Patrick's Faber, Gaenslen's test, and modified Trendelenburg's test) and pain palpation tests (long dorsal ligament test and palpation of the symphysis). As a functional test, the active straight leg raise (ASLR) test is recommended. Mobility (palpation) tests, X-rays, CT, scintigraphy, diagnostic injections and diagnostic external pelvic fixation are not recommended. MRI may be used to exclude ankylosing spondylitis and in the case of positive red flags. The recommended treatment includes adequate information and reassurance of the patient, individualized exercises for pregnant women and an individualized multifactorial treatment program for other patients. We recommend medication (excluding pregnant women), if necessary, for pain relief. Recommendations are made for future research on PGP.

Risk Factors for Continued Opioid Use in Conservative Versus Surgical Management of Low Back Pain Originating From the Sacroiliac Joint.

STUDY DESIGN: Secondary analysis of data from a randomized controlled trial. OBJECTIVES: To identify risk factors for continued opioid use after conservative management (CM) or minimally invasive surgical management (MISM) of low back pain (LBP) originating from the sacroiliac joint. METHODS: Patients were randomized either to CM (n = 49) or MISM (n = 52). We documented opioid use, pain intensity (visual analogue scale [VAS]), Oswestry Disability Index (ODI), and the Zung depression score (Zung Self-Rating Depression Scale) at baseline and at months 3 and 6 after treatment initiation. RESULTS: Compared with opioid nonusers, opioid users at baseline had higher mean levels of disability (ODI 61.5, standard deviation [SD] 13.3 vs ODI 51.5, SD 12.8; P < .01) and higher depression scores (Zung 48.5, SD 8.5, vs Zung 42.2, SD 7.2; P < .01). At 6 months, opioid users had higher 6-month pain levels (VAS 60.4, SD 24.0, vs VAS 42.4, SD 28.2; P < .01), higher disability scores (ODI 50.5, SD 16.2, vs ODI 32.7, SD 19.3; P < .01) and higher depression scores (Zung 47.6, SD 8.0, vs Zung 38.8, SD 8.9; P < .01). Risk factors for continued opioid use at 6 months were patient age (odds ratio [OR] for age = 0.91; P = .02) and an increase in LBP (OR 1.08; P = .02) in the CM group and a lack of improvement in depression scores (OR 1.12; P = .03) in the MISM group. CONCLUSIONS: In our patient cohort, the risk of continued opioid use in the treatment of LBP increased not only with pain intensity but also with levels of depression during the course of treatment.

Movement of the sacroiliac joint during the Active Straight Leg Raise test in patients with long-lasting severe sacroiliac joint pain.

BACKGROUND: The Active Straight Leg Raise is a functional test used in the assessment of pelvic girdle pain, and has shown to have good validity, reliability and responsiveness. The Active Straight Leg Raise is considered to examine the patients' ability to transfer load through the pelvis. It has been hypothesized that patients with pelvic girdle pain lack the ability to stabilize the pelvic girdle, probably due to instability or increased movement of the sacroiliac joint. This study examines the movement of the sacroiliac joints during the Active Straight Leg Raise in patients with pelvic girdle pain. METHODS: Tantalum markers were inserted in the dorsal sacrum and ilium of 12 patients with long-lasting pelvic girdle pain scheduled for sacroiliac joint fusion surgery. Two to three weeks later movement of the sacroiliac joints during the Active Straight Leg Raise was measured with radiostereometric analysis. FINDINGS: Small movements were detected. There was larger movement of the sacroiliac joint of the rested leg's sacroiliac joint compared to the lifted leg's side. A mean backward rotation of 0.8° and inward tilt of 0.3° were seen in the rested leg's sacroiliac joint. INTERPRETATION: The movements of the sacroiliac joints during the Active Straight Leg Raise are small. There was a small backward rotation of the innominate bone relative to sacrum on the rested leg's side. Our findings contradict an earlier understanding that a forward rotation of the lifted leg's innominate occur while performing the Active Straight Leg Raise.

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

STUDY DESIGN: A pooled patient-level analysis of two multicenter randomized controlled trials and one multicenter single-arm prospective trial. OBJECTIVE: 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). SUMMARY OF BACKGROUND DATA: 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. METHODS: 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). RESULTS: 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 < 0.0001] in the SIJF group than in the NSM group. Similarly, the improvement in ODI was 18.3 points larger (95% CI 14.3-22.4), P < 0.0001). In NSM, we found no predictors of outcome. In SIJF, a reduced improvement in outcome was predicted by smoking (P = 0.030), opioid use (P = 0.017), lower patient age (P = 0.008), and lower duration of SIJ pain (P = 0.028). CONCLUSIONS: Our results support the view that SIJF leads to better treatment outcome than conservative management of SIJ pain and that a higher margin of improvement can be predicted in nonsmokers, nonopioid users, and patients of increased age and with longer pain duration. LEVEL OF EVIDENCE: 1.

1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain.

BACKGROUND: Low back pain (LBP) emanating from the sacroiliac joint (SIJ) is a common finding. Devices to fuse the SIJ are now commercially available, but high-quality evidence supporting their effectiveness is limited. OBJECTIVES: To compare the safety and effectiveness of conservative management (CM) to minimally invasive sacroiliac joint fusion (SIJF) in patients with chronic LBP originating from the SIJ. STUDY DESIGN: Prospective, multicenter randomized controlled trial. SETTING: One hundred three adults in spine clinics with chronic LBP originating from the SIJ. METHODS: Patients were randomly assigned to CM (n = 51) or SIJF using triangular titanium implants (n = 52). CM consisted of optimization of medical therapy, individualized physiotherapy, and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated LBP at 6 months using a 0 - 100 visual analog scale (VAS). Other effectiveness and safety endpoints, including leg pain, disability using Oswestry Disability Index (ODI), quality of life using EQ-5D, and SIJ function using active straight leg raise test (ASLR), were assessed up to 12 months. RESULTS: At 12 months, mean LBP improved by 41.6 VAS points in the SIJF group vs. 14.0 points in the CM group (treatment difference of 27.6 points, P < 0.0001). Mean ODI improved by 25.0 points in the SIJF group vs. 8.7 points in the CM group (P < 0.0001). Mean improvements in leg pain and EQ-5D scores were large after SIJF and superior to those after CM. CM patients were allowed to crossover to SIJF after 6 months. Patients who crossed to surgical treatment had no pre-crossover improvement in pain and ODI scores; after crossover, improvements were as large as those originally assigned to SIJF. One case of postoperative nerve impingement occurred in the surgical group. Two SIJF patients had recurrent pain attributed to possible device loosening and one had postoperative hematoma. In the CM group, one crossover surgery patient had recurrent pain requiring a revision surgery. LIMITATIONS: The primary limitation was lack of blinding and the subjective nature of self-assessed outcomes. CONCLUSIONS: For patients with chronic LBP originating from the SIJ, minimally invasive SIJF with triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, and improving patient function and quality of life. Our findings will help to inform decisions regarding its use as a treatment option in this patient population.Key words: Sacroiliac joint dysfunction, pelvic girdle pain, randomized controlled trial, quality of life, spine implants.

Radiosteriometric analysis of movement in the sacroiliac joint during a single-leg stance in patients with long-lasting pelvic girdle pain.

BACKGROUND: Chamberlain's projections (anterior-posterior X-ray of the pubic symphysis) have been used to diagnose sacroiliac joint mobility during the single-leg stance test. This study examined the movement in the sacroiliac joint during the single-leg stance test with precise radiostereometric analysis. METHODS: Under general anesthesia, tantalum markers were inserted into the dorsal sacrum and the ilium of 11 patients with long-lasting and severe pelvic girdle pain. After two to three weeks, a radiostereometric analysis was conducted while the subjects performed a single-leg stance. FINDINGS: Small movements were detected in the sacroiliac joint during the single-leg stance. In both the standing- and hanging-leg sacroiliac join, a total of 0.5 degree rotation was observed; however, no translations were detected. There were no differences in total movement between the standing- and hanging-leg sacroiliac joint. INTERPRETATION: The movement in the sacroiliac joint during the single-leg stance is small and almost undetectable by the precise radiostereometric analysis. A complex movement pattern was seen during the test, with a combination of movements in the two joints. The interpretation of the results of this study is that, the Chamberlain examination likely is inadequate in the examination of sacroiliac joint movement in patients with pelvic girdle pain.