LinQ Clinical Evidence
| Publication Title | Date of Publication | Number of Patients | Adverse Events | Conclusion | Article Link |
|---|---|---|---|---|---|
| SECURE Study 12-month Results: A Single Arm, Multicenter, Prospective Clinical Study | March 2024 | 83 | 5 (no implant-related SAEs) | Pain and functional scores were significantly improved at 12 months with an improved safety profile vs. lateral SI fusion.
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| Posterior intra-articular fixation stabilizes both primary and secondary sacroiliac joints: a cadaveric study and comparison to lateral trans-articular fixation literature | June 2023 | n/a | n/a | During flexion–extension, the posterior approach to SIJ fusion is equivalent to the lateral approach, while producing superior stabilization during lateral bend and axial rotation. | VIEW |
| SECURE 6-month Interim Results: A Single Arm, Multicenter, Prospective Clinical Study | June 2022 | 69 | 2 (no implant-related SAEs) | The posterior single point transfixation is safe and efficacious for the treatment of sacroiliac joint dysfunction with statistical improvements in pain and function. | VIEW |
| Best Practices for Postoperative Management of Posterior Sacroiliac Joint Fusion | May 2022 | n/a | n/a | SIJ fusion is a rapidly growing and evolving therapy with developing evidence to support its safety and efficacy. In the setting of a desired surgical outcome, safety and efficacy can be adversely impacted by poor post-operative care. The American Society of Pain and Neuroscience has created this best practice document in an effort to improve and standardize care in this critical time of patient recovery. | VIEW |
| Lateral Salvage | May 2022 | 7 | O | A total of 7 patients were included in this retrospective review. The mean age was 66.5, ranging from 50 to 81. 4 patients were female, and 3 were male. The mean BMI was 29, with a range from 21 to 36. All of the patients had right-sided pain. 100% of patients had a positive result from a diagnostic SIJ injection on the affected side. The average duration of time in months between lateral SIJ fusion and salvage with posterior SIJ fusion was 19.7 but ranged from 6 to 26. | VIEW |
| LinQ Biomechanics | December 2021 | n/a | n/a | 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. | VIEW |
| Successful Diagnosis of Sacroiliac Joint Dysfunction | October 2021 | n/a | n/a | The diagnosis of SIJ pain is a multifaceted process that involves a careful assessment, including differentiating other pain generators in the region. This involves careful history taking and appropriate physical examination, including provocative maneuvers and diagnostic injections. Once the diagnosis is confirmed, long-term solutions may be considered, including recent advances in sacral lateral branch denervation and sacroiliac joint fusion. | VIEW |
| Real World Study | October 2021 | 50 | O | 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. | VIEW |
| LinQ Salvage | September 2021 | 111 | O | In this retrospective case, a series of patients with continued intolerable pain following SCS, ISS, IDDS, or MILD, a novel posterior SIJ fusion device provided significant pain relief in a salvage manner. These early results suggest that this intervention may be a therapeutic option to consider in these patients. | VIEW |
| A Review and Algorithm in the Diagnosis and Treatment of Sacroiliac Joint Pain | December 2020 | 156 | O | SIJ pain is felt to be an underdiagnosed and undertreated element of LBP. There is an emerging disconnect between the growing incidence of diagnosed SI pathology and the underwhelming treatment efficacy of current therapies. This has led to an increase in SI joint fixation. We have created a clearer diagnostic and treatment pathway to establish an algorithm for patients that can include conservative measures and interventional techniques once the diagnosis is identified. | VIEW |
Additional Supporting Evidence
| Publication Title | Date of Publication | Number of Patients | Adverse Events | Conclusion | Article Link |
|---|---|---|---|---|---|
| Trends in Diagnosis and Treatment of Sacroiliac Joint Pathology Over the Past 10 Years: Review of Scientific Evidence for New Devices for Sacroiliac Joint Fusion | June 2021 | 1,411 | Six total adverse events related to the device were reported, including one requiring a revision procedure for nerve impingement. | Minimally invasive sacroiliac joint fusion is an increasingly popular procedure for treatment of chronic refractory low back pain isolated to the SI joint. Many novel and different devices have been developed for this indication over the past 10 years. While the triangular titanium implants and cylindrical threaded implants have the most robust literature backing their efficacy, the majority of novel implants are varieties of a cannulated screw. Further randomized comparative trials that investigate different aspects of each novel device is warranted to evaluate novel devices and elucidate unique features that may be of clinical benefit. | VIEW |
| Minimally Invasive and Conservative Interventions for the Treatment of Sacroiliac Joint Pain: A Review of Recent Literature | April 2022 | >1000 | Adverse outcomes encountered after MIS include new-onset facet joint pain, trochanteric bursitis, deep wound infections, new onset of low-back or leg pain, and superficial cellulitis.68 Other complications faced involved radiculopathy, vascular necrosis of the hip, piriformis syndrome, implant penetration into the sacral neural foramen, peripheral neuropathy, a nondisplaced fracture, and pulmonary emboli/deep vein thrombosis.68 Fourteen studies of 720 patients (499 females/221 males) with a mean follow-up of 22 months reported ninety-nine patients (13.75%) underwent bilateral SI joint arthrodesis resulting in a total of 819 SI joints fused.69 There were 91 reported procedural-related complications (11.11%) with the most common adverse event being surgical wound infection/drainage (n = 17) .69 Twenty-five adverse events were attributed to placement of the implant (3.05%) with nerve root impingement (n = 13) being the most common and the revision rate was 2.56%.69 | Sacroiliac joint pain is a considerable contributor to the common affliction of persistent lower back pain that diminishes the quality of life for patients by limiting daily activity and work capacity. Though conservative management through multi-modal pain control and physical therapy have their role as first line therapies, an increasing body of evidence supports the use of minimally invasive procedures, both as adjuvant treatments to conservative management and as second line therapies for patient’s that fail first line treatment. Given the novelty of minimally invasive procedures in the SI joint pain space, there is a need for more clinical studies and comprehensive reviews to further elucidate their role in treatment pathways. | VIEW |
| Pain Relief Salvage with a Novel Minimally Invasive Posterior Sacroiliac Joint Fusion Device in Patients with Previously Implanted Pain Devices and Therapies | September 2021 | 111 | n/a |
In this retrospective case series of patients with continued intolerable pain following SCS, ISS, IDDS, or MILD, a novel posterior SIJ fusion device provided significant pain relief in a salvage manner. These early results suggest this intervention may be a therapeutic option to consider in these patients.
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| Review of the Current Evidence for Minimally Invasive Posterior Sacroiliac Joint Fusion | June 2021 | 363 | O | SIJ dysfunction accounts for a substantial amount of reported lower back pain. Surgical stabilization and/or fusion of the SIJ may be considered when a patient has persistent moderate to severe pain, functional impairment, and failed intensive nonoperative care. While the lateral or transiliac approach has been well published, the posterior and posterior oblique approach has been recently introduced as an alternative means of stabilization of the SIJ. Preliminary case series presented reveal consistent decreases in pain scores and low complication rates. Formal meta-analysis was not possible given the preliminary data; however, it will be imperative as further studies begin to emerge on this developing therapy. | VIEW |
| A Multicenter Retrospective Analysis of the Long-Term Efficacy and Safety of a Novel Posterior Sacroiliac Fusion Device | June 2021 | 110 | O | 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. | VIEW |
