LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction

Part of paid clinical trials in Shenandoah, Texas.

Sponsor
PainTEQ, LLC
Study ID
NCT07558278
Phase
PHASE4
Status
Recruiting

Conditions

  • Sacroiliac Joint Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bone Allograft — PROCEDURE
    The LINQ system is intended for use in patients with SIJ disease by implantation of compatible implants to prepare the SIJ for allograft fusion.
  • Conventional Medical Management (CMM) — OTHER
    CMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain.

Study Details

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).

Key Dates

First listed
Apr 30, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2027
Completion
Jul 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment Arm (LINQ Procedure)
    Subjects randomized to the Treatment Arm will undergo the LINQ Procedure.
  • Active Comparator: Conventional Medical Management (CMM)
    Subjects randomized to the CMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain.

Primary Outcome Measure

Composite Success Responder Rate at Month 6 [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Procura Pain and SpineShenandoahTexas77384
Courtney Harvey
(713) 714-1399

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