Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorPainTEQ, LLC
About this trial
The purpose of this study is to evaluate the real-world performance, safety and efficacy of the TRAQ System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age and Body Mass Index (BMI)
Adult patients aged ≥ 21 years at screening.
BMI ≤ 40.
Chronic SIJ Related Pain
Disqualifiers
Pain Source Uncertainty
Alternative Primary Spine Pathology
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
Trial population
Subjects with chronic, SIJ pain will be screened for participation in this study. Subjects who provide informed consent and meet the study eligibility criteria will be enrolled and will undergo an implant procedure. Subjects will be followed up at 3-, 6-, 12-, 18-, and 24-months following the implant.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bone Allograft
Other interventionThe PainTEQ TRAQ™ Posterior SI Joint Implant is processed human bone tissue that has been precision milled from cortical and cancellous bone. The allograft pierces the SI joint cortices and provides a scaffold around which new bone can grow.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Composite safety and efficacy endpoint
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.
Time frame
Month 6Secondary outcomes
1
Visual Analog Scale (VAS)
Change from baseline in VAS score (measured on 0-100 mm scale) and proportion achieving VAS MCID ≥ 20 mm.
Time frame
Months 3, 6, 12, 18, 24.2
Oswestry Disability Index (ODI)
Change from baseline in ODI and proportion achieving ODI MCID ≥ 15 points.
Time frame
Months 3, 6, 12, 18, 243
Patient-Reported Outcomes Measurement Information System (PROMIS-29+2)
Change in T-scores from baseline
Time frame
Months 3, 6, 12, 18, 244
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Change in EQ-5D-5L index scores from baseline
Time frame
Months 3, 6, 12, 18, 24Sponsors and contacts
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Source ClinicalTrials.gov