Pain Relief Salvage with a Novel Minimally Invasive Posterior Sacroiliac Joint Fusion Device in Patients with Previously Implanted Pain Devices and Therapies

Deer, Timothy R; Rupp, Adam; Budwany, Ryan; Bovinet, Christopher; Chatas, John W; Pyles, Stephen; Azeem, Nomen; Li, Sean; Naidu, Ramana; Antony, Ajay; Hagedorn, Jonathan M; Sayed, Dawood

doi:10.2147/jpr.s325059

Cited by 10 publications

(13 citation statements)

References 22 publications

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“…This multi-institutional review demonstrates that patients with persistent sacroiliitis despite usual medical management review of patients with a history of previously implanted pain devices and therapies receiving a posterior MI SIJ fusion device as a salvage therapy resulted in a mean patient reported pain relief of 67.6%. 19 Similar to these studies, our cohort reported an overall patient reported pain relief of 66.5% and NRS reduction of at least 3, over a year out from initial implant. Notably, patients in this review reported relief that was sustained on average 612 days after implant.…”

Section: Discussionsupporting

confidence: 81%

“… 18 A recent publication by Deer et al detailed a retrospective chart review of patients with a history of previously implanted pain devices and therapies receiving a posterior MI SIJ fusion device as a salvage therapy resulted in a mean patient reported pain relief of 67.6%. 19 Similar to these studies, our cohort reported an overall patient reported pain relief of 66.5% and NRS reduction of at least 3, over a year out from initial implant.…”

Section: Discussionsupporting

confidence: 81%

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A Multicenter Retrospective Analysis of the Long-Term Efficacy and Safety of a Novel Posterior Sacroiliac Fusion Device

Sayed¹,

Balter²,

Pyles³

et al. 2021

JPR

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Background: Sacroiliac joint (SIJ) pathology is a cause of low back pain that may be difficult to diagnose and challenging to treat. Open and minimally invasive (MI) lateral approach fusions have been used to treat sacroiliitis over the past two decades. A novel MI posterior approach SIJ fusion technique utilizes a posteriorly placed transfixing device with single point S1/S2 level or mid-segment SIJ fixation (LinQ procedure). Current efficacy and safety data for this novel procedure are lacking. Objective: To review multicenter retrospective 12 months or greater outcomes data in patients receiving the LinQ procedure, with sub-analysis of patients with prior lumbar fusions. Methods: Patients with sacroiliitis refractory to conservative care with short-term benefit from diagnostic local anesthetic SIJ injections receiving MI posterior approach SIJ fusion with allograft were included from different centers including both academic and private practice. Numeric rating scale (NRS) scores at baseline (pre-procedural) and most recent follow-up were reviewed across three institutions. Results: Of 110 patients who received MI SIJ fusion, 50 patients had sufficient data for evaluation of outcomes at least 12 months post-implant. The average time out from implant at follow-up was 612.2 days for all unique patients. The average NRS was 6.98 pre-fusion and 3.06 at last follow-up. Twenty-four patients had prior lumbar surgery of which 17 had prior lumbar fusions. Average NRS for this subset was 6.85 at baseline and 2.86 at last follow-up with an average follow-up of 613.2 days out from implant. No major adverse events or complications were associated with any of the 50 implants. Conclusion: Real-world evidence suggests that MI posterior SIJ fusion with the LinQ procedure is a viable approach for medically refractory sacroiliitis management with long-term efficacy and safety. Further prospective studies are needed to fully evaluate this technique.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionsupporting

confidence: 81%

A Multicenter Retrospective Analysis of the Long-Term Efficacy and Safety of a Novel Posterior Sacroiliac Fusion Device

Sayed¹,

Balter²,

Pyles³

et al. 2021

JPR

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“…This subset of patients reported 76.5% pain relief with an average follow-up duration of 394.4 days. 17 There were no device related major adverse events or complications in either study.…”

Section: Introductionmentioning

confidence: 79%

“…Deer et al published a case series on the utilization of posterior SIJ fusion as a salvage technique in patients who had previously undergone advanced interventional pain therapies. 17 A total of 111 patients with history and physical exam consistent with SIJ pathology who had previously undergone spinal cord stimulation, interspinous spacer, intrathecal drug delivery, or minimally invasive lumbar decompression and had persistent LBP were studied. The mean patient reported pain relief following SI joint fusion was 67.5% following implant at last follow-up, which was on average 290 days from the date of implant for the index area of pain.…”

Section: Introductionmentioning

confidence: 99%

Salvage of Failed Lateral Sacroiliac Joint Fusion with a Novel Posterior Sacroiliac Fusion Device: Diagnostic Approach, Surgical Technique, and Multicenter Case Series

Sayed¹,

Khatri²,

Rupp³

et al. 2022

JPR

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Background Studies have found that up to one-third of patients with LBP have sacroiliac joint (SIJ) dysfunction as a contributing cause. Historically, the management of SIJ dysfunction has been plagued by ineffectiveness or significant morbidity. In 2008, minimally invasive lateral SIJ fusion was developed. While this procedure is a safe and effective treatment, there is still a significant proportion of patients who will not experience therapeutic success. There is a paucity of data in the literature regarding the management of these patients. Recently, a novel posterior sacroiliac joint fusion device has been developed which minimizes complications compared to lateral approaches and may serve to salvage therapeutic failures in this patient population. Objective Determine the efficacy and feasibility of a posterior SIJ fusion device as a salvage technique in patients who have not experienced therapeutic success following lateral SIJ fusion. Design Multi-center retrospective observational study. Methods Patients who had previously undergone lateral SIJ fusion and had persistent LBP were evaluated and diagnosed to have persistent primary SIJ pathology. All patients underwent posterior SIJ fusion utilizing a machined allograft transfixing sacroiliac fusion device. Demographic data and patient reported pain scores were collected. Results A total of 7 patients who had undergone lateral SIJ fusion were included in the study and underwent posterior SIJ fusion. The mean patient reported pain improvement following posterior fusion was 80% with an average follow-up time of 10 months. Median morphine milliequivalents were 20 pre-procedure and 0 post-procedure. Conclusion We were able to show significant reductions in pain scores and opioid consumption, which suggests that minimally invasive posterior SIJ utilizing a novel implant and technique may be a viable treatment option to salvage pain relief in this patient population. Further, the favorable safety profile of this posterior technique uniquely positions it to be an appropriate first-line surgical therapy.

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“…While previous investigators have reported efficacy of 66.5% to 76.5% in pain reported outcomes for this approach, there are currently no studies that clinically examine the consistency of the allograft placement. 39 , 41 …”

Section: Discussionmentioning

confidence: 99%

A Cadaver-Based Biomechanical Evaluation of a Novel Posterior Approach to Sacroiliac Joint Fusion: Analysis of the Fixation and Center of the Instantaneous Axis of Rotation

Sayed¹,

Amirdelfan²,

Naidu³

et al. 2021

MDER

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Purpose The purpose of this study was to assess the stabilizing effect of a posterior joint fixation technique using a novel cortical allograft implant in unilateral and bilateral fixation constructs. We hypothesize that fixation would reduce the joint’s range of motion during flexion-extension, axial rotation, and lateral bending loads. We also hypothesize that fixation would shift the center of the instantaneous axis of rotation during the predominant flexion-extension motions towards the implant’s location, and that this shift would be correlated with the reduction in flexion-extension range of motion. Materials and Methods Six cadaveric sacroiliac joint specimens were tested under intact, unilateral fixation, and bilateral fixation conditions. The total range of motion (ROM) of the sacroiliac joint in flexion–extension, lateral bending, and axial rotation were evaluated by an optical tracking system, in a multidirectional flexibility pure moment model, between ± 7.5 Nm applied moment loads. The centers of the instantaneous axis of rotation (cIAR) of the sacroiliac joint were evaluated during flexion-extension loading. A correlation analysis was performed between the ROM reduction in flexion-extension upon implantation and shift of the cIAR to the graft implantation site. Results Unilateral and bilateral fixations generated sacroiliac joint ROM reductions in flexion-extension, lateral bending, and axial rotation motions. Fixation shifted the cIAR to the graft implantation site. Reduction in the total range of motion had a moderate correlation with the shift of the cIAR. Conclusion Our novel posterior approach presents a multifaceted mechanism for stabilizing the joint: first, by the reduction of the total range of motion in all planes of motion; second, by shifting the centers of the instantaneous axis of rotation towards the implant’s location in the predominant plane of motion, ensuring little to no motion at the implantation site, thus promoting fusion in this region.

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Pain Relief Salvage with a Novel Minimally Invasive Posterior Sacroiliac Joint Fusion Device in Patients with Previously Implanted Pain Devices and Therapies

Cited by 10 publications

References 22 publications

A Multicenter Retrospective Analysis of the Long-Term Efficacy and Safety of a Novel Posterior Sacroiliac Fusion Device

A Multicenter Retrospective Analysis of the Long-Term Efficacy and Safety of a Novel Posterior Sacroiliac Fusion Device

Salvage of Failed Lateral Sacroiliac Joint Fusion with a Novel Posterior Sacroiliac Fusion Device: Diagnostic Approach, Surgical Technique, and Multicenter Case Series

A Cadaver-Based Biomechanical Evaluation of a Novel Posterior Approach to Sacroiliac Joint Fusion: Analysis of the Fixation and Center of the Instantaneous Axis of Rotation

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