LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction
This study is looking at two ways to treat sacroiliac joint (SIJ) pain, which is pain in the joint connecting your spine and pelvis. It compares the LINQ® procedure, which involves implanting a bone allograft (a type of bone graft) to help fuse the joint, with Conventional Medical Management (CMM). CMM includes standard, non-surgical treatments for SIJ pain. The study wants to see how safe and effective the LINQ procedure is compared to CMM. You might be able to join if you are at least 21 years old, have chronic SIJ-related pain, and a BMI (Body Mass Index) of 40 or less. The main goal is to see how many people show improvement after 6 months. The current recruitment status is unclear.
- Study design
- This is a randomized study where participants are assigned to either the LINQ procedure or Conventional Medical Management. About 200 people are expected to join.
- What's involved
- You will have a screening visit, a randomization visit, and then either the LINQ procedure or start CMM. You will have follow-up visits for up to 24 months, with the main check-up at 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for up to 24 months, with the primary endpoint measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Composite Success Responder Rate at Month 6Month 6
Unit of Measure: Percentage of participants Description: The primary endpoint is a single binary (Yes/No) composite responder classification per subject at Month 6. A subject is classified as a composite success responder ONLY if ALL three of the following criteria are met: Pain Improvement: Reduction in SIJ pain VAS score of ≥20 mm from baseline to Month 6 (VAS measured on 0-100 mm scale). Safety: Absence of any device-related or procedure-related SAEs through Month 6 (Day 180). Surgical Reintervention: No surgical reintervention for SIJ fusion through Month 6 (Day 180), including device removal (complete or partial), device revision or replacement, or reoperation at the index SIJ. Subjects meeting all three components are classified as responders; the outcome is reported as the percentage (%) of participants classified as responders.