Analysis of Complications in Sacroiliac Joint Fusions Using FDA 510(k) Cleared Devices.

STUDY DESIGN: This was a level III-retrospective cohort study. OBJECTIVE: The objective of this study was to present an unbiased report of the current rate of severe complications for Federal Drug Administration (FDA) 510(k) cleared sacroiliac joint (SIJ) fusions and investigate the underlying cause of these complications. SUMMARY OF BACKGROUND DATA: The number of yearly SIJ fusions is on an upward trend. Currently, the most utilized implants to fuse the SIJ have been FDA 510(k) cleared devices. Studies reporting on complications following SIJ fusions are mostly industry-sponsored. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was searched for all reported FDA 510(k) cleared SIJ fusion device complications. Several data points were obtained from each report and recorded. The Hospital Inpatient National Statistics and the Center for Medicare and Medicaid Services (CMS) was also searched for the number of SIJ fusions performed each year. RESULTS: A search of the MAUDE database returned 1115 reports, with the first report on June 30, 2011, and the last report on July 28, 2020. Patient injury was the most common type of event reported at 97.5% (1080/1107). Death was reported in 3 patients (0.3%). Malposition was the most common device problem at 49.5% (548/1107). The root cause of these events was primarily user error at 58.2% (644/1107). Revision surgery or reoperation occurred in 92.8% (1028/1107) of reports. Data for SIJ fusions through CMS showed an overall trend of increasing yearly SIJ fusions. CONCLUSIONS: The majority of complications reported to MAUDE for FDA 510(k) cleared SIJ fusion devices are user error due to improper placement of implants. These complications are likely underreported, and there is currently no formal tracking system of total SIJ fusions performed to calculate accurate complication and revision rates. Patient injury and health care costs can potentially be reduced with improved education, training, and oversight, which is currently lacking.

Biomechanical analysis of motion following sacroiliac joint fusion using lateral sacroiliac screws with or without lumbosacral instrumented fusion.

BACKGROUND: Sacroiliac joint hypermobility or aberrant mechanics may be a source of pain. The purpose of this study was to assess sacroiliac joint range of motion after simulated adjacent lumbosacral instrumented fusion, with or without sacroiliac joint fusion, with lateral sacroiliac screws. METHODS: In this in vitro biomechanical study, seven cadaveric specimens were tested on a six-degrees-of-freedom machine under load control. Left posterior sacroiliac joint ligaments were severed to maximize joint range of motion. Influence of lumbosacral instrumentation on sacroiliac joint motion, with or without fixation, was studied. FINDINGS: During flexion-extension in the setting of posterior sacroiliac joint injury and L5-S1 fixation, sacroiliac joint range of motion increased to 195% of intact. After fixation with lateral sacroiliac screws, average range of motion reduced to 144% of intact motion. Sacroiliac joint screws thus partially stabilized the joint and reduced motion. Use of 6 bilateral sacroiliac joint screws with L5-S1 screw and rod fixation in lateral bending and axial rotation yielded the greatest reduction in range of motion. Without lumbosacral fixation, baseline motion of the sacroiliac joint was reduced, and sacroiliac joint screw alone, using either 2, 3, or 6 screws, was able to restore motion at or below the level of an intact joint. INTERPRETATION: Sacroiliac joint ligament injury with existing lumbosacral fixation doubled sacroiliac joint range of motion, but thereafter, fixation with lateral sacroiliac screws decreased range of motion of the injured sacroiliac joint. Screw configuration played a minor role, but generally, 6 sacroiliac joint screws had the greatest motion reduction.

Outcomes of bilateral sacroiliac joint fusions and the importance of understanding potential coexisting lumbosacral pathology that might also require surgical treatment.

Only one study in the literature describes performing a bilateral sacroiliac joint fusion, and the results were poor. Many patients needing a bilateral sacroiliac joint fusion frequently have had previous lumbosacral surgeries and present with lumbosacral pain as well. This study reviews our results in consecutive patients having had a bilateral sacroiliac joint fusion over a five-year period. Fifteen patients had bilateral sacroiliac joint fusions with 13 having concurrent lumbosacral fusions. The modified posterior midline fascial splitting approach, first described by Belanger was utilized. Patients were followed for an average of 30.3 months. There were no infections, neurovascular injuries, lasting morbidity or deaths. One non-union of a sacroiliac joint (7%) occurred, which after revision was satisfactory. There was a statistically significant drop in pain (p=0.01488) using the VAS, and patient satisfaction rates were 86%. With all those patients saying they would have the surgery again for the same result. There was no significant increase in functionality. Patients needing bilateral sacroiliac joint fusions frequently fall into the "failed back" category, and it is important to evaluate both the sacroiliac joints and the lumbosacral spine for potential pain generators. This study shows that by treating all the pain generators in both areas there were significant decreases in pain, low complications, low re-operation rates, and high patient satisfaction scores. Overall functionality, however, was not positively affected.

Minimally invasive sacroiliac arthrodesis: outcomes of a new technique.

STUDY DESIGN: Prospective cohort. OBJECTIVE: Comparing efficacy and outcomes of a new technique for sacroiliac arthrodesis. BACKGROUND: The sacroiliac joint has been described as a possible source of chronic low back pain. However, surgical treatment of sacroiliac pain and dysfunction is controversial. Arthrodesis is normally reserved as a salvage procedure when all others have failed to relieve pain and involves an extensive surgical exposure. We have developed a novel technique of sacroiliac arthrodesis using percutaneously inserted fusion cages filled with bone morphogenic protein. This study describes the radiographic and clinical outcomes of this procedure. METHODS: Thirteen consecutive patients underwent minimally invasive sacroiliac arthrodesis between February and December 2004 at a single teaching hospital and were prospectively followed. Six patients had bilateral fusions for a total of 19 joints. The average age was 53.1 (range 45 to 62). Average body mass index was 31.2 (range 21.9 to 46.9). Mean follow-up was 29.5 months (range 24 to 35). Diagnosis was confirmed using fluoroscopically guided intra-articular injections of local anesthetic and corticosteroid when their pain was relieved 2 or more hours. Arthrodesis was only performed on patients with positive injections who subsequently had their symptoms recur. Outcome measurements included radiographic assessment for fusion and improvement in visual analog pain scale for low back pain, leg pain, and dyspareunia. Computed tomography scan to evaluate implant placement was performed postoperatively and again at 6 months to assess fusion. RESULTS: The overall fusion rate was 89% (17/19 joints). Significant improvements were seen in final low back pain score on a visual analog scale (0 to 10) (average improvement 4.9, P< or =0.001). Leg pain improved an average of 2.4 (P=0.013). Dyspareunia improved an average of 2.6 (P=0.0028). One patient was revised to an open arthrodesis secondary to nonunion and persistent pain. There were no infections or neurovascular complications. CONCLUSIONS: Minimally invasive sacroiliac arthrodesis via a percutaneous posterior approach is a safe and efficacious procedure, leading to a high fusion rate and significant improvement in low back, leg pain, and dyspareunia.