Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants.

BACKGROUND: Accumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction. OBJECTIVE: To report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI). METHODS: One hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist. RESULTS: Compared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0-1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%). CONCLUSION: A 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion. LEVEL OF EVIDENCE: Level II.

Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants.

BACKGROUND: Minimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain. OBJECTIVE: The objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3 years postoperatively. METHODS: A total of 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203). Subjects were evaluated in study clinics at study start and again at 3, 4, and 5 years. RESULTS: Mean (SD) preoperative SIJ pain score was 81.5, and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3 years, mean pain SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p<0.0001). At 3 years, mean ODI was 28.2 (a 28-point improvement from baseline, p<0.0001). In all, 82% of subjects were very satisfied with the procedure at 3 years. EuroQol-5D (EQ-5D) time trade-off index improved by 0.30 points (p<0.0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom four underwent contralateral SIJF. The proportion of subjects who were employed outside the home full- or part-time at 3 years decreased somewhat from baseline (p=0.1814), and the proportion of subjects who would have the procedure again was lower at 3 years compared to earlier time points. CONCLUSION: In long-term (3-year) follow-up, minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability, and quality of life with relatively high satisfaction rates. LEVEL OF EVIDENCE: Level II. CLINICAL RELEVANCE: SIJF with TTI.

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.

Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction.

BACKGROUND: Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. OBJECTIVE: To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. METHODS: One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared. RESULTS: In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<.0001 for superiority). By month 24, 83.1% and 82.0% received either clinical improvement or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10% with non-surgical treatment only. Parallel changes were seen for EQ-5D and SF-36, with larger changes in the surgery group at 6 months compared to NSM. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period. CONCLUSIONS: In this Level 1 multicenter prospective randomized controlled trial, minimally invasive SIJF with triangular titanium implants provided larger improvements in pain, disability and quality of life compared to NSM. Improvements after SIJF persisted to 24 months. This study was approved by a local or central IRB before any subjects were enrolled. All patients provided study-specific informed consent prior to participation.

Work intensity in sacroiliac joint fusion and lumbar microdiscectomy.

BACKGROUND: The evidence base supporting minimally invasive sacroiliac (SI) joint fusion (SIJF) surgery is increasing. The work relative value units (RVUs) associated with minimally invasive SIJF are seemingly low. To date, only one published study describes the relative work intensity associated with minimally invasive SIJF. No study has compared work intensity vs other commonly performed spine surgery procedures. METHODS: Charts of 192 patients at five sites who underwent either minimally invasive SIJF (American Medical Association [AMA] CPT® code 27279) or lumbar microdiscectomy (AMA CPT® code 63030) were reviewed. Abstracted were preoperative times associated with diagnosis and patient care, intraoperative parameters including operating room (OR) in/out times and procedure start/stop times, and postoperative care requirements. Additionally, using a visual analog scale, surgeons estimated the intensity of intraoperative care, including mental, temporal, and physical demands and effort and frustration. Work was defined as operative time multiplied by task intensity. RESULTS: Patients who underwent minimally invasive SIJF were more likely female. Mean procedure times were lower in SIJF by about 27.8 minutes (P<0.0001) and mean total OR times were lower by 27.9 minutes (P<0.0001), but there was substantial overlap across procedures. Mean preservice and post-service total labor times were longer in minimally invasive SIJF (preservice times longer by 63.5 minutes [P<0.0001] and post-service labor times longer by 20.2 minutes [P<0.0001]). The number of postoperative visits was higher in minimally invasive SIJF. Mean total service time (preoperative + OR time + postoperative) was higher in the minimally invasive SIJF group (261.5 vs 211.9 minutes, P<0.0001). Intraoperative intensity levels were higher for mental, physical, effort, and frustration domains (P<0.0001 each). After taking into account intensity, intraoperative workloads showed substantial overlap. CONCLUSION: Compared to a commonly performed lumbar spine surgical procedure, lumbar microdiscectomy, that currently has a higher work RVU, preoperative, intraoperative, and postoperative workload for minimally invasive SIJF is higher. The work RVU for minimally invasive SIJF should be adjusted upward as the relative amount of work is comparable.

Does Level of Response to SI Joint Block Predict Response to SI Joint Fusion?

BACKGROUND: The degree of pain relief required to diagnose sacroiliac joint (SIJ) dysfunction following a diagnostic SIJ block (SIJB) is not known. No gold standard exists. Response to definitive (i.e., accepted as effective) treatment might be a reference standard. METHODS: Subgroup analysis of 320 subjects enrolled in two prospective multicenter trials evaluating SIJ fusion (SIJF) in patients with SIJ dysfunction diagnosed by history, physical exam and standardized diagnostic SIJB. A 50% reduction in pain at 30 or 60 minutes following SIJB was considered confirmatory. The absolute and percentage improvements in Visual Analog Scale (VAS) SIJ pain and Oswestry Disability Index (ODI) scores at 6 and 12 months after SIJF were correlated with the average acute improvement in SIJ pain with SIJB. RESULTS: The average pain reduction during the first hour after SIJB was 79.3%. Six months after SIJF, the overall mean VAS SIJ pain reduction was 50.9 points (0-100 scale) and the mean ODI reduction was 24.6 points. Reductions at 12 months after SIJF were similar. Examined in multiple ways, improvements in SIJ pain and ODI at 6 and 12 months did not correlate with SIJB findings. CONCLUSIONS: The degree of pain improvement during SIJB did not predict improvements in pain or ODI scores after SIJF. A 50% SIJB threshold resulted in excellent post-SIJF responses. Using overly stringent selection criteria (i.e. 75%) to qualify patients for SIJF has no basis in evidence and would withhold a beneficial procedure from a substantial number of patients with SIJ dysfunction. LEVEL OF EVIDENCE: Level 1. CLINICAL RELEVANCE: The degree of pain improvement during an SIJ block does not predict the degree of pain improvement after SIJ fusion.

Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes.

BACKGROUND: Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE: To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS: A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS: Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). CONCLUSION: This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.

Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial.

BACKGROUND: Sacroiliac (SI) joint pain is a prevalent, underdiagnosed cause of lower back pain. SI joint fusion can relieve pain and improve quality of life in patients who have failed nonoperative care. To date, no study has concurrently compared surgical and non-surgical treatments for chronic SI joint dysfunction. METHODS: We conducted a prospective randomized controlled trial of 148 subjects with SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions who were assigned to either minimally invasive SI joint fusion with triangular titanium implants (N=102) or non-surgical management (NSM, n=46). SI joint pain scores, Oswestry Disability Index (ODI), Short-Form 36 (SF-36) and EuroQol-5D (EQ-5D) were collected at baseline and at 1, 3 and 6 months after treatment commencement. Six-month success rates, defined as the proportion of treated subjects with a 20-mm improvement in SI joint pain in the absence of severe device-related or neurologic SI joint-related adverse events or surgical revision, were compared using Bayesian methods. RESULTS: Subjects (mean age 51, 70% women) were highly debilitated at baseline (mean SI joint VAS pain score 82, mean ODI score 62). Six-month follow-up was obtained in 97.3%. By 6 months, success rates were 81.4% in the surgical group vs. 23.9% in the NSM group (difference of 56.6%, 95% posterior credible interval 41.4-70.0%, posterior probability of superiority >0.999). Clinically important (≥15 point) ODI improvement at 6 months occurred in 75% of surgery subjects vs. 27.3% of NSM subjects. At six months, quality of life improved more in the surgery group and satisfaction rates were high. The mean number of adverse events in the first six months was slightly higher in the surgical group compared to the non-surgical group (1.3 vs. 1.0 events per subject, p=0.1857). CONCLUSIONS: Six-month follow-up from this level 1 study showed that minimally invasive SI joint fusion using triangular titanium implants was more effective than non-surgical management in relieving pain, improving function and improving quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruptions. CLINICAL RELEVANCE: Minimally invasive SI joint fusion is an acceptable option for patients with chronic SI joint dysfunction due to degenerative sacroiliitis and sacroiliac joint disruptions unresponsive to non-surgical treatments.