LINQT: An Open Label Randomized, Controlled, Multicenter, Prospective, Long Term Clinical Study on the Minimally Invasive Posterior Sacroiliac Fusion Device LINQ® System
PainTEQ, LLC
Summary
The objective of this clinical evaluation is to assess the safety and effectiveness of LINQ fusion procedure for treatment of sacroiliac joint (SIJ) dysfunction compared to Conservative Medical Management (CMM).
Description
Prospective, multi-center, open-label, randomized, clinical study. Subjects who meet the eligibility criteria and are enrolled will be randomized 2:1 to LINQ or CMM. After their 6 Month evaluations are complete, subjects in the Control Group can elect to stay in the CMM Arm or crossover to receive the LINQ procedure. Each subject will undergo a Screening Visit, Randomization, Baseline Procedure or CMM Initiation Visit, and Follow-Up Visits through 24 Months. The primary endpoint is evaluated at the 6 Month Follow Up Visit. Subjects that elect to crossover from the Control Group to the Treatm…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * To be eligible to participate in this study, a subject must meet ALL of the following criteria, as determined by the Investigator: 1. Age and Body Mass Index (BMI) 1. Adult subjects aged ≥ 21 years at screening. 2. BMI ≤ 40. 2. Chronic SIJ-Related Pain 1. Has experienced low back and/or buttock pain for at least 6 months that has been inadequately responsive to non-surgical management. 2. Has experienced nonradicular pain that is maximal below the L5 vertebrae, localized over the posterior SIJ, and consistent with SIJ pain. 3. Diagnosis of SI…
Interventions
- ProcedureBone Allograft
The LINQ system is intended for use in patients with SIJ disease by implantation of compatible implants to prepare the SIJ for allograft fusion.
- OtherConventional Medical Management (CMM)
CMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain.
Location
- Procura Pain and SpineShenandoah, Texas