NCT07547215
Not yet recruiting
Not Applicable
An Open Label, Prospective, Multicenter, Single-Arm, Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion
PainTEQ, LLC0 sites100 target enrollmentStarted: May 1, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- PainTEQ, LLC
- Enrollment
- 100
- Primary Endpoint
- Composite safety and efficacy endpoint
Overview
Brief Summary
The purpose of this study is to evaluate the real-world performance, safety and efficacy of the TRAQ System.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible to participate in this study, a subject must meet all the following criteria, as determined by the Investigator:
- •Age and Body Mass Index (BMI)
- •Adult patients aged ≥ 21 years at screening.
- •Chronic SIJ Related Pain
- •Has experienced low back and/or buttock pain for at least 6 months that has been inadequately responsive to non surgical management.
- •Has experienced nonradicular pain that is maximal below the L5 vertebrae, localized over the posterior SIJ, and consistent with SIJ pain.
- •Diagnosis of SIJ Dysfunction
- •a. Has a diagnosis of SIJ dysfunction (degenerative sacroiliitis or SIJ disruption) based on ALL of the following: i. A positive Fortin's finger test; and ii. Pain elicited on at least three (3) of five (5) SIJ specific physical examination maneuvers (FABER test, Gaenslen's test, Distraction, Thigh Thrust, Compression); and iii. At least 75% reduction in pain, with associated improvement in previously painful maneuvers, for the expected duration of action following two (2) image guided, contrast enhanced intra articular diagnostic SIJ injections, performed on separate visits using anesthetics with different durations of action; and iv. Completion of at least one (1) therapeutic intra articular SIJ injection (e.g., corticosteroid injection) within the past 12 months.
- •Baseline Disability and Pain Severity
- •a. Baseline Oswestry Disability Index (ODI) score ≥30%; and b. Baseline SI joint pain score of ≥60 mm on a 100 mm Visual Analog Scale (VAS).
Exclusion Criteria
- •Subjects must meet none of the following criteria to be eligible for participation in this study, as determined by the Investigator:
- •Pain Source Uncertainty
- •a. Inability to confirm, in the Investigator's clinical judgment, that the subject's primary pain generator is the sacroiliac joint.
- •Alternative Primary Spine Pathology
- •a. Presence of severe low back pain attributable to other spinal pathology, including but not limited to lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, or lumbar vertebral body fracture.
- •Other Sacroiliac Pathology a. Presence of known sacroiliac joint pathology other than degenerative SIJ dysfunction, including inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA associated spondyloarthropathies), tumor, infection, acute fracture, or crystal arthropathy.
- •Non SIJ Pain Syndromes
- •a. History of coccydynia or prior coccygectomy, endometriosis, cluneal neuralgia, or pudendal neuralgia.
- •Recent Sacral Interventions
- •a. Prior sacral radiofrequency ablation performed within 6 months prior to enrollment.
Outcomes
Primary Outcomes
Composite safety and efficacy endpoint
Time Frame: Month 6
Composite Success Responder Rate at Month 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: 1. Pain Improvement: Reduction in SIJ pain VAS score of ≥20 mm from baseline to Month 6 (VAS measured on 0-100 mm scale). 2. Safety: Absence of any device-related or procedure-related SAEs through Month 6 (Day 180). 3. 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.
Secondary Outcomes
- Patient-Reported Outcomes Measurement Information System (PROMIS-29+2)(Months 3, 6, 12, 18, 24)
- Visual Analog Scale (VAS)(Months 3, 6, 12, 18, 24.)
- Oswestry Disability Index (ODI)(Months 3, 6, 12, 18, 24)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire(Months 3, 6, 12, 18, 24)
- Patient Global Impression of Change (PGIC)(Months 3, 6, 12, 18, 24)
- Medication use(3, 6, 12, 18, 24)
- Healthcare Resource Utilization (HCRU)(Months 3, 6, 12, 18, 24)
Investigators
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