Dataset Information

Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System.

ABSTRACT:

Background

Sacroiliac joint (SIJ) degeneration is a common source of low back pain (LBP). Minimally invasive (MI) SIJ fusion procedures have demonstrated meaningful clinical improvement. A recently developed MI SIJ fusion system incorporates decortication, placement of bone graft and fixation with threaded implants (DC/BG/TF).

Patients and methods

Nineteen patients who had MI SIJ fusion with DC/BG/TF were enrolled at three centers. Fusion was assessed in CT images obtained 12 and 24 months postoperatively by an independent radiographic core laboratory. LBP was assessed using a 0-10 numerical pain scale (NPS) preoperatively and at 12 and 24 months postoperatively.

Results

At 12 months, 15/19 patients (79%) had bridging bone across the SIJ, and at 24 months 17/18 patients (94%) available for follow-up had SIJ fusion. Of the patients with bridging bone 88% had fusion within the decorticated area, with solid fusion in 83%. A significant reduction in NPS scores was demonstrated, representing a 73% reduction in average low back pain.

Conclusion

The patients in this series demonstrated significant improvement in LBP. Fusion rates at 24 months demonstrate promise for this system, which utilizes the established orthopedic principles of DC/BG/TF to achieve arthrodesis. Further study is warranted to demonstrate comparative fusion rates for different implant systems.

SUBMITTER: Cross WW

PROVIDER: S-EPMC5791206 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System.

Cross William W WW Delbridge Arnold A Hales Donald D Fielding Louis C LC

The open orthopaedics journal 20180117

<h4>Background</h4>Sacroiliac joint (SIJ) degeneration is a common source of low back pain (LBP). Minimally invasive (MI) SIJ fusion procedures have demonstrated meaningful clinical improvement. A recently developed MI SIJ fusion system incorporates decortication, placement of bone graft and fixation with threaded implants (DC/BG/TF).<h4>Patients and methods</h4>Nineteen patients who had MI SIJ fusion with DC/BG/TF were enrolled at three centers. Fusion was assessed in CT images obtained 12 and ...[more]

PMID: 29430266

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Project description:BackgroundThis report documents 1-year results of 250 patients enrolled in a prospective, multicenter study of a minimally invasive (MI) sacroiliac joint fusion (SIJF) system that uses decortication, graft placement, and joint fixation.MethodsThe cohort includes all patients enrolled in the EVoluSIon (EVSI) clinical study who had MI SIJF surgery and completed 1-year follow-up. Average age at baseline was 60.5 years, and 70.8% were female. Sacroiliac (SI) joint-related pain duration was ≥2 years in 56% of patients. Visual analog scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life, and opioid use were assessed preoperatively and at 1 year.ResultsAt 1 year, the mean VAS pain demonstrated a significant reduction of more than 43 points, from 76.4 at baseline to 33.0 (P < 0.0001), with 72.2% of patients attaining the minimal clinically important difference (MCID, ≥20-point improvement). Mean ODI scores also significantly improved from 54.4 at baseline to 30.5 at 1 year (P < 0.0001), with 62.5% of patients achieving the MCID (≥15-point improvement). Prior to surgery, 62.7% (126/201) of patients were taking opioids or other narcotics, but by 1 year postsurgery, only 26.9% (54/201) of patients reported using these medications, representing a significant 57.1% decrease in narcotic/opioid use (P < 0.0001). Fusion of the SI joint was seen in 68.7% of patients. Few procedural complications were reported. In all, there were 8 (8/250) serious procedure-related events, including 1 device malposition observed on the day of surgery that required replacing the superior screw with a shorter screw.ConclusionsAnalysis of patients treated with MI SIJF in the EVSI study demonstrated that the procedure can be performed safely and results in significant improvements in pain, quality of life, and opioid use at 1 year as well as causing fusion in the majority of patients.Level of evidence: 2Clinical relevanceMI SIJF differs from most procedures currently being performed in that it applies true orthopedic principles with decorticating, bone grafting, fusion, and placement of implants perpendicular to the joint for greatest stability. The 12-month data show improvement in functionality, reduction in pain, and, most notably, a reduction in narcotic usage, which is important considering the ongoing opioid epidemic.

Project description:BackgroundMinimally 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.ObjectiveThe 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.MethodsA 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.ResultsMean (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.ConclusionIn 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 evidenceLevel II.Clinical relevanceSIJF with TTI.

Dataset Information

Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System.

Background

Patients and methods

Results

Conclusion

Publications

Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System.

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