Removal of infected bone in-growth pelvic fixation implants and microcomputed tomography analysis of osseous integration: illustrative case.

BACKGROUND: A novel pelvic fixation screw fusion device (iFuse Bedrock Granite implant) was designed to promote bony fusion through self-harvesting fenestrations throughout the outer screw shank. Bone on-growth and in-growth using this design have been demonstrated in a sheep model, but data from human subjects have not been reported. A 66-year-old medically complex female with 2 prior spine fusions developed spondylodiscitis cephalad to a prior fusion, requiring the removal of instrumentation, which included screw fusion devices. OBSERVATIONS: Within this case report, the authors present a novel bone-preserving technique for the removal of well-fixed screw fusion devices. One screw backed out with a driver, and the other 3 had to be trephined out. One screw sheared off the T30 torque driver, implying a removal torque greater than 270 inch-lbs (30.5 Nm). In addition, the removed implants were analyzed using microcomputed tomography (micro-CT) and demonstrated bone on-growth, in-growth, and through-growth in all 4 screws. LESSONS: Micro-CT clearly demonstrated osseous integration of the screw fusion devices and provided significant support for the use of these implants for lumbopelvic fixation. The authors' hope is that the novel bone-preserving technique will help other surgeons when faced with the difficult removal of well-fixed screw fusion devices. https://thejns.org/doi/10.3171/CASE24274.

Evaluation of a New Treatment Strategy for Geriatric Fragility Fractures of the Posterior Pelvic Ring Using Sensor-Supported Insoles: A Proof-of-Concept Study.

The incidence of fragility fractures of the pelvis (FFPs) is currently rising. Surgical treatment, which is performed using sacroiliac screws, is complicated by compromised bone quality, oftentimes resulting in implant failure. The iFuse implant system aims to improve attachment and durability with promising results for sacroiliac dysfunction, though data for its feasibility on FFPs are rare. Consequently, this study aims to evaluate the feasibility of the iFuse for FFPs. A total of 10 patients with FFPs were treated with the iFuse in this study. Pre- and postoperatively, both mobility using an established insole force sensor for an inpatient gait analysis and general well-being and pain using questionnaires were evaluated. When comparing pre- and postoperative findings, this study demonstrated a significant increase in the average (8.14%) and maximum (9.4%) loading (p < 0.001), a reduction in pain, as measured by the visual analog scale (VAS), from 4.60 to 2.80 at rest (p = 0.011) and from 7.00 to 4.40 during movement (p = 0.008), an increase in the Barthel Index by 20 points (p < 0.001) and an increase in the Parker Mobility Score by 2.00 points (p = 0.011). All this contributes to the possibility of early postoperative mobilization and improved general well-being, ultimately preventing the late consequences of postoperative immobilization and maintaining patients autonomy and contentment.

Minimally invasive sacroiliac fusion, a case series, and a literature review.

INTRODUCTION: Non-autoimmune sacroiliac joint pain contributes to nearly a quarter of low back pain patients. Non-surgical management fails to satisfy patients. A new minimally invasive technique for sacroiliac stabilization has been introduced, defying the traditional rules of fusion. The results outside explanatory trials and in day-to-day practice have not been reported. MATERIALS AND METHODS: This case series includes 20 patients diagnosed with chronic sacroiliac pain resistant to conservative management for at least 6 months. The diagnosis was confirmed with a positive sacroiliac injection. Patients underwent stabilization using the iFuse® implant. Patients were followed up for a minimum of one year. The primary outcome was the functional outcomes, assessed using VAS, ODI, and SF36. Secondary procedure rates, complication rates, and radiological assessments of fusion were collected as secondary outcomes. RESULTS: At one year, the mean VAS score improved from 81.25 ± 10.7 SD preoperatively to 52.5 ± 26.8, p-value 0.0013. The mean ODI improved from 54.8 ± 11.21 SD preoperatively to 41.315 ± 15.34, P value = 0.0079. The mean PCS and MCS of SF36 improved by 17 and 20 points, respectively. Only 55% of patients achieved the MCID for the VAS score. 35% of the cohort had secondary procedures. DISCUSSION: Minimally invasive sacroiliac fusion resulted in an improvement in mean functional scores with a wide dispersion. Patients not achieving MCID are patients with either a malpositioned implant, an associated lumbar pathology, or an inaccurate diagnosis. Our results are underwhelming compared to similar work but are still better than conservative cohorts in comparative studies. CONCLUSION: Minimally invasive sacroiliac fusion can be used successfully in select patients. Attention to diagnosis and surgical technique can improve the reproducibility of results.

One-year results of minimally invasive fusion surgery of the sacroiliac joint as an alternative treatment after failed endoscopic thermal coagulation.

BACKGROUND: While pain in the severe sacroiliac joint (SIJ) is a common cause of lower back pain, SIJ disease is often overlooked as a diagnosis. OBJECTIVE: This study examines the extent of sufficient long-term pain relief and functional improvement in patients with SIJ syndrome that are treated with thermocoagulation. Some patients treated with thermocoagulation noted initial improvement, but the functionality and pain relief had limited duration and efficacy. Patients with insufficient improvement were recommended to undergo fusion surgery as an option for better and longer lasting results. METHOD: Patients with a long history of back or pelvic problems were selected for the study. Endoscopic thermal coagulation of the SIJ was carried out. The follow-up examinations took place after 1, 3, 6, 12 months. In patients with insufficient pain relief and functionality after thermocoagulation, a fusion surgery was performed. The results of the fusion surgery were documented over a 12-month follow-up period. To carry out the statistical evaluation visual analog scale (VAS), Oswestry-Disability-Index (ODI) and the consumption of opioids were recorded. RESULTS: Forty-eight patients were included. The mean VAS values 12 months after thermocoagulation were 68.9. The ODI after 12 months was very near or somewhat higher than their baseline prior to the thermocoagulation. Thus, a fusion surgery was recommended. Thirty-three patients agreed to the fusion operation. The VAS values 12 months after fusion surgery decreased to 53.1. Analogous to the VAS values, the Oswestry index (ODI) showed a significant improvement after the fusion operation. CONCLUSION: The success of surgical intervention in 88% of the SIJ syndrome patients with inadequate results 12 months after thermocoagulation proves the superiority of SIJ fusion surgery. This study showed long-lasting pain relief by an average of 65% and a median improvement in functional impairments of 60%. In view of these results, fusion surgery should be considered for patients without sufficient success of thermocoagulation.

Biomechanics of a laterally placed sacroiliac joint fusion device supplemental to S2 alar-iliac fixation in a long-segment adult spinal deformity construct: a cadaveric study of stability and strain distribution.

OBJECTIVE: S2 alar-iliac (S2AI) screw fixation effectively enhances stability in long-segment constructs. Although S2AI fixation provides a single transarticular sacroiliac joint fixation (SIJF) point, additional fixation points may provide greater stability and attenuate screw and rod strain. The objectives of this study were to evaluate changes in stability and pedicle screw and rod strain with extended distal S2AI fixation and with supplemental bilateral integration of two sacroiliac joint fusion devices implanted using a traditional minimally invasive surgical approach. METHODS: Eight L1-pelvis human cadaveric specimens underwent pure moment (7.5 Nm) and compression (400 N) tests under 4 conditions: 1) intact (pure moment loading only); 2) L2-S1 pedicle screw and rod with L5-S1 interbody fusion; 3) added S2AI screws; and 4) added bilateral laterally placed SIJF. Range of motion (ROM), rod strain, and screw-bending moment (S1 and S2AI) were analyzed. RESULTS: Compared with S1 fixation, S2AI fixation significantly reduced L5-S1 ROM in right lateral bending by 50% (0.11°, p = 0.049) and in compression by 39% (0.22°, p = 0.003). Compared with fixation ending at S1, extending fixation with S2AI significantly decreased sacroiliac joint ROM by 52% (0.28°, p = 0.02) in flexion, by 65% (0.48°, p = 0.04) in extension, by 59% (0.76°, p = 0.02) in combined flexion-extension, and by 36% (0.09°, p = 0.02) in left axial rotation. The addition of S2AI screws reduced S1 screw-bending moment during flexion (0.106 Nm [43%], p = 0.046). With S2AI fixation, posterior L5-S1 primary rod strain increased by 124% (159 µE, p = 0.002) in flexion, by 149% (285 µE, p = 0.02) in left axial rotation, and by 99% (254 µE, p = 0.04) in right axial rotation. Compared with S2AI fixation, the addition of SIJF reduced L5-S1 strain during right axial rotation by 6% (28 µE, p = 0.04) and increased L5-S1 strain in extension by 6% (28 µE, p = 0.02). CONCLUSIONS: Long-segment constructs ending with S2AI screws created a more stable construct than those ending with S1 screws, reducing lumbosacral and sacroiliac joint motion and S1 screw-bending moment in flexion. These benefits, however, were paired with increased rod strain at the lumbosacral junction. The addition of SIJF to constructs ending at S2AI did not significantly change SI joint ROM or S1 screw bending and reduced S2AI screw bending in compression. SIJF further decreased L5-S1 rod strain in axial rotation and increased it in extension.

Novel Interventional Techniques for Chronic Pain with Minimally Invasive Arthrodesis of the Sacroiliac Joint: (INSITE, iFuse, Tricor, Rialto, and others).

Acute and chronic pain are public health issues that clinicians have been battling for years. Opioid medications have been a treatment option for both chronic and acute pain; however, they can cause unwanted complications and are a major contributor to our present opioid epidemic. The sacroiliac (SI) joint is a common cause of both acute and chronic low back pain. It affects about 15-25% of patients with axial low back pain, and up to 40% of patients with ongoing pain following lumbar fusion. Recent advances in the treatment of SI joint pain have led to the development of a wide variety of SI joint fusion devices. These fusion devices seek to stabilize the joints themselves in order that they become immobile and, in theory, can no longer be a source for pain. This is a minimally invasive procedure aimed to address chronic pain without subjecting patients to lengthy surgery or medications, including opioids with the potential for addiction and abuse. Minimally invasive SI fusion can be performed by a lateral approach (i.e., iFuse, Tricor) or posterior approach (i.e., CornerLoc, LinQ, Rialto). The posterior approach requires the patient to be in the prone position but allows for less disruption of muscles with entry. More data are necessary to determine which fusion system may be best for a particular patient. SI fusion devices are a promising way of treating chronic lower back pain related to the SI joint. This narrative review will discuss various types of SI fusion devices, and their potential use in terms of their safety and efficacy.

Biomechanical effects of a novel posteriorly placed sacroiliac joint fusion device integrated with traditional lumbopelvic long-construct instrumentation.

OBJECTIVE: S2-alar-iliac (S2AI) screw fixation effectively ensures stability and enhances fusion in long-segment constructs. Nevertheless, pelvic fixation is associated with a high rate of mechanical failure. Because of the transarticular nature of the S2AI screw, adding a second point of fixation may provide additional stability and attenuate strains. The objective of the study was to evaluate changes in stability and strain with the integration of a sacroiliac (SI) joint fusion device, implanted through a novel posterior SI approach, supplemental to posterior long-segment fusion. METHODS: L1-pelvis human cadaveric specimens underwent pure moment (7.5 Nm) and compression (400 N) tests in the following conditions: 1) intact, 2) L2-S1 pedicle screw and rod fixation with L5-S1 interbody fusion, 3) added S2AI screws, and 4) added bilateral SI joint fixation (SIJF). The range of motion (ROM), rod strain, and screw bending moments (S1 and S2AI) were analyzed. RESULTS: S2AI fixation decreased L2-S1 ROM in flexion-extension (p ≤ 0.04), L5-S1 ROM in flexion-extension and compression (p ≤ 0.004), and SI joint ROM during flexion-extension and lateral bending (p ≤ 0.03) compared with S1 fixation. SI joint ROM was significantly less with SIJF in place than with the intact joint, S1, and S2AI fixation in flexion-extension and lateral bending (p ≤ 0.01). The S1 screw bending moment decreased following S2AI fixation by as much as 78% in extension, but with statistical significance only in right axial rotation (p = 0.03). Extending fixation to S2AI significantly increased the rod strain at L5-S1 during flexion, axial rotation, and compression (p ≤ 0.048). SIJF was associated with a slight increase in rod strain versus S2AI fixation alone at L5-S1 during left lateral bending (p = 0.048). Compared with the S1 condition, fixation to S2AI increased the mean rod strain at L5-S1 during compression (p = 0.048). The rod strain at L5-S1 was not statistically different with SIJF compared with S2AI fixation (p ≥ 0.12). CONCLUSIONS: Constructs ending with an S2AI screw versus an S1 screw tended to be more stable, with reduced SI joint motion. S2AI fixation decreased the S1 screw bending moments compared with fixation ending at S1. These benefits were paired with increased rod strain at L5-S1. Supplementation of S2AI fixation with SIJF implants provided further reductions (approximately 30%) in the sagittal plane and lateral bending SI joint motion compared with fixation ending at the S2AI position. This stability was not paired with significant changes in rod or screw strains.

Radiculopathy with concomitant sacroiliac dysfunction and lumbosacral degenerative disease: illustrative case.

BACKGROUND: The sacroiliac joint (SIJ) is an important cause of low back pain and referred leg pain (RLP). Pain from SIJ dysfunction may occur in isolation or may result from a combination with lumbosacral area-mediated pain. SIJ fusion is one treatment modality for medically refractory symptoms and may also have a role in the treatment of RLP. OBSERVATIONS: The authors present a challenging case of concomitant lumbosacral degenerative disease and SIJ dysfunction in a patient with radiculopathy. They provide clinical characteristics and imaging findings and discuss difficulties in dealing with the intersection of these two distinct diagnoses. In addition, the authors offer a review of the relevant literature, elucidating the role of SIJ dysfunction in causing radicular lower extremity pain, the relationship to concomitant lumbosacral degenerative disease, and outcome data for SIJ fusion as it relates to RLP. LESSONS: With increasing numbers of patients undergoing spinal instrumentation in the setting of degenerative lumbosacral arthritis, as well as randomized controlled trial data demonstrating the efficacy of SIJ fusion for medically refractory SIJ dysfunction, it is important to recognize the challenges in understanding how both of these patient groups may present with radiculopathy. Failure to do so may result in incorrect patient selection, poor outcomes, and increased morbidity for at-risk patients.

Sacroiliac joint fusion in patients with Ehlers Danlos Syndrome: A case series.

BACKGROUND: Sacroiliac joint dysfunction (SJD) is a known cause of lower back pain. SJD might be due to hypermobility in the Sacroiliac joint (SIJ) in patients with Ehlers Danlos Syndrome (EDS). Stabilization of the SIJ can be a highly successful treatment for lower back pain. No previous literature about EDS and SIJ fusion is available. The purpose of this study was to assess our mid-term results of SIJ fusion surgery in EDS patients suffering from SIJ dysfunction. METHODS: A case series of patients who underwent SIJ fusion for SIJ dysfunction due to EDS between January 2012 and December 2018 were analyzed in retrospect. Patients underwent surgery and the SIJ was stabilized with triangular implants bridging the joint. Pain and functional outcomes were assessed in nine agree/disagree questions and a satisfaction performance scale. Clinical data has been extracted from the patient files and in addition, we reassessed the position of the implants on the CT scans. RESULTS: A total of 16 patients with EDS completed the questionnaire and were available for analysis. The mean satisfaction score is 78.1 out of 100 and seven patients reported a 100% satisfaction score. CONCLUSION: SIJ fusion is a safe and useful procedure to reduce pain and function levels in EDS patients with lower back pain due to SIJ dysfunction.

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.

Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System(®).

INTRODUCTION: Surgical revision rate is a key outcome with all permanent implants. The iFuse Implant System(®) is a permanent implant used to perform minimally invasive sacroiliac joint fusion. The purpose of this study is to determine the surgical revision rate after sacroiliac joint fusion surgery with this system. METHODS: Using two internal sources of information, revision surgeries were identified and linked to index surgeries. The likelihood of revision surgery was calculated using the Kaplan-Meier life table approach. Predictors of revision were explored. RESULTS: Four-year survivorship free from implant revision was 96.46%. Revision rate did not differ by sex and was lower for age >65. In all, 24% of revisions occurred within the first 30 days after surgery; 63.5% occurred within year 1. Implant survivorship has improved annually since the device was introduced in 2009. CONCLUSION: The survivorship rate with this implant is high and improving; the rate is somewhat higher than total hip replacement but lower than that of lumbar spine procedures.

Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States commercial payer population: potential economic implications of a new minimally invasive technology.

INTRODUCTION: Low back pain is common and treatment costly with substantial lost productivity and lost wages in the working-age population. Chronic low back pain originating in the sacroiliac (SI) joint (15%-30% of cases) is commonly treated with nonoperative care, but new minimally invasive surgery (MIS) options are also effective in treating SI joint disruption. We assessed whether the higher initial MIS SI joint fusion procedure costs were offset by decreased nonoperative care costs from a US commercial payer perspective. METHODS: An economic model compared the costs of treating SI joint disruption with either MIS SI joint fusion or continued nonoperative care. Nonoperative care costs (diagnostic testing, treatment, follow-up, and retail pharmacy pain medication) were from a retrospective study of Truven Health MarketScan(®) data. MIS fusion costs were based on the Premier's Perspective™ Comparative Database and professional fees on 2012 Medicare payment for Current Procedural Terminology code 27280. RESULTS: The cumulative 3-year (base-case analysis) and 5-year (sensitivity analysis) differentials in commercial insurance payments (cost of nonoperative care minus cost of MIS) were $14,545 and $6,137 per patient, respectively (2012 US dollars). Cost neutrality was achieved at 6 years; MIS costs accrued largely in year 1 whereas nonoperative care costs accrued over time with 92% of up front MIS procedure costs offset by year 5. For patients with lumbar spinal fusion, cost neutrality was achieved in year 1. CONCLUSION: Cost offsets from new interventions for chronic conditions such as MIS SI joint fusion accrue over time. Higher initial procedure costs for MIS were largely offset by decreased nonoperative care costs over a 5-year time horizon. Optimizing effective resource use in both nonoperative and operative patients will facilitate cost-effective health care delivery. The impact of SI joint disruption on direct and indirect costs to commercial insurers, health plan beneficiaries, and employers warrants further consideration.

Early results of sacro-iliac joint fixation following long fusion to the sacrum in adult spine deformity.

BACKGROUND: The sacro-iliac joint (SIJ) is the largest joint in the human body. When the lumbar spine is fused to the sacrum, motion across the SIJ is increased, leading to increased degeneration of the SIJ. Degeneration can become symptomatic in up to 75% of the cases when a long lumbar fusion ends with a sacral fixation. If medical treatments fail, patients can undergo surgical fixation of the SIJ. QUESTIONS/PURPOSES: This study reports the results of short-term complications, length of stay, and clinical as well as radiographic outcomes of patients undergoing percutaneous SIJ fixation for SIJ pain following long fusions to the sacrum for adult scoliosis. METHODS: A retrospective review of all the patients who underwent a percutaneous fixation of the SIJ after corrective scoliosis surgery was performed in a single specialized scoliosis center between the years 2011-2013. Ten SIJ fusions were performed in six patients who failed conservative care for SIJ arthritis. Average age was 50 (range 25-60 years). The patients were 15.3 years in average after the original surgical procedure (range 4-25 years). Average post-operative follow-up was 10.25 months (range 15-4 months). The medical charts of the patients were reviewed for hospital stay, complications, pre- and post-operative pain, quality of life, and satisfaction with surgery using the visual analogues score (VAS), Scoliosis Research Society (SRS)22 and Oswestry Disability Index (ODI) questionnaires. Images were reviewed for fixation of the SIJ, fusion, and deviation of the implants from the SIJ. RESULTS: There were no complications in surgery or post-operatively. Discharge was on post-operative day 2 (range 1-4 days). Leg VAS score improved from 6.5 to 2.0 (P < 0.005; minimal clinically important difference (MCID) 1.6). Back VAS score decreased from 7.83 to 2.67 mm (P < 0.005; MCID 1.2). ODI scores dropped from 22.2 to 10.5 (P = 0.0005; MCID 12.4). SRS22 scores increased from 2.93 to 3.65 (P = 0.035; MCID 0.2) with the largest increases in the pain, function, and satisfaction domains of the questionnaires. CONCLUSION: Fixation of the SIJ in patients that fail conservative care for SIJ arthritis after long fusions ending in the sacrum provides a reduction in back pain and improved quality of life in the short and medium range follow-up period.

Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States Medicare population: potential economic implications of a new minimally-invasive technology.

INTRODUCTION: The economic burden associated with the treatment of low back pain (LBP) in the United States is significant. LBP caused by sacroiliac (SI) joint disruption/degenerative sacroiliitis is most commonly treated with nonoperative care and/or open SI joint surgery. New and effective minimally invasive surgery (MIS) options may offer potential cost savings to Medicare. METHODS: An economic model was developed to compare the costs of MIS treatment to nonoperative care for the treatment of SI joint disruption in the hospital inpatient setting in the US Medicare population. Lifetime cost savings (2012 US dollars) were estimated from the published literature and claims data. Costs included treatment, follow-up, diagnostic testing, and retail pharmacy pain medication. Costs of SI joint disruption patients managed with nonoperative care were estimated from the 2005-2010 Medicare 5% Standard Analytic Files using primary International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes 720.2, 724.6, 739.4, 846.9, or 847.3. MIS fusion hospitalization cost was based on Diagnosis Related Group (DRG) payments of $46,700 (with major complications - DRG 459) and $27,800 (without major complications - DRG 460), weighted assuming 3.8% of patients have complications. MIS fusion professional fee was determined from the 2012 Medicare payment for Current Procedural Terminology code 27280, with an 82% fusion success rate and 1.8% revision rate. Outcomes were discounted by 3.0% per annum. RESULTS: The extrapolated lifetime cost of treating Medicare patients with MIS fusion was $48,185/patient compared to $51,543/patient for nonoperative care, resulting in a $660 million savings to Medicare (196,452 beneficiaries at $3,358 in savings/patient). Including those with ICD-9-CM code 721.3 (lumbosacral spondylosis) increased lifetime cost estimates (up to 478,764 beneficiaries at $8,692 in savings/patient). CONCLUSION: Treating Medicare beneficiaries with MIS fusion in the hospital inpatient setting could save Medicare $660 million over patients' lifetimes.

Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption.

BACKGROUND: The sacroiliac joint is a common but under-recognized source of low back and gluteal pain. Patients with degenerative sacroiliitis or sacroiliac joint disruption resistant to nonsurgical treatments may undergo open surgery with sacroiliac joint arthrodesis, although outcomes are mixed and risks are significant. Minimally invasive sacroiliac joint arthrodesis was developed to minimize the risk of iatrogenic injury and to improve patient outcomes compared with open surgery. METHODS: Between April 2009 and January 2013, 5319 patients were treated with the iFuse SI Joint Fusion System® for conditions including sacroiliac joint disruption and degenerative sacroiliitis. A database was prospectively developed to record all complaints reported to the manufacturer in patients treated with the iFuse device. Complaints were collected through spontaneous reporting mechanisms in support of ongoing mandatory postmarket surveillance efforts. RESULTS: Complaints were reported in 204 (3.8%) patients treated with the iFuse system. Pain was the most commonly reported clinical complaint (n = 119, 2.2%), with nerve impingement (n = 48, 0.9%) and recurrent sacroiliac joint pain (n = 43, 0.8%) most frequently cited. All other clinical complaints were rare (≤0.2%). Ninety-six revision surgeries were performed in 94 (1.8%) patients at a median follow-up of four (range 0-30) months. Revisions were typically performed in the early postoperative period for treatment of a symptomatic malpositioned implant (n = 46, 0.9%) or to correct an improperly sized implant in an asymptomatic patient (n = 10, 0.2%). Revisions in the late postoperative period were performed to treat symptom recurrence (n = 34, 0.6%) or for continued pain of undetermined etiology (n = 6, 0.1%). CONCLUSION: Analysis of a postmarket product complaints database demonstrates an overall low risk of complaints with the iFuse SI Joint Fusion System in patients with degenerative sacroiliitis or sacroiliac joint disruption.