Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain
Conditions
Brief summary
The purpose of this study is to evaluate the real-world performance, safety and efficacy of the TRAQ System.
Interventions
OTHERBone Allograft
The 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.
Sponsors
PainTEQ, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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: 1. Age and Body Mass Index (BMI) 1. Adult patients 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 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. 4. 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). 5. Treatment Decision a. The treating physician has independently determined that the TRAQ procedure is an appropriate treatment option for the subject's SIJ dysfunction in the course of routine clinical care, and the subject has agreed to undergo this treatment. 6. Informed Consent and Compliance 1. Is willing and capable of providing written informed consent; and 2. Is willing and able to comply with all study related requirements, procedures, and follow up visits.
Exclusion criteria
Subjects must meet none of the following criteria to be eligible for participation in this study, as determined by the Investigator: 1. Pain Source Uncertainty a. Inability to confirm, in the Investigator's clinical judgment, that the subject's primary pain generator is the sacroiliac joint. 2. 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. 3. 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. 4. Non SIJ Pain Syndromes a. History of coccydynia or prior coccygectomy, endometriosis, cluneal neuralgia, or pudendal neuralgia. 5. Recent Sacral Interventions a. Prior sacral radiofrequency ablation performed within 6 months prior to enrollment. 6. Recent Pelvic Trauma a. History of major pelvic trauma within 12 months prior to enrollment. 7. Severe Osteoporosis a. Prior diagnosis or suspicion of severe osteoporosis, defined as a prior bone mineral density T score of \< -2.5 or a history of osteoporotic fracture. 8. Medications Affecting Bone or Soft Tissue Healing a. Current use of medications known to adversely affect bone quality or soft tissue healing, as determined by the Investigator. 9. Anatomic Constraints a. Anatomic anomalies or defects that, in the Investigator's opinion, would preclude safe or biomechanically appropriate device placement. 10. Systemic Inflammatory or Rheumatologic Disease a. Presence of a chronic inflammatory rheumatologic condition, such as rheumatoid arthritis. 11. Centralized Pain Syndromes a. Current diagnosis of fibromyalgia. 12. Infection Risk a. Evidence of current local or systemic infection that would increase surgical risk. 13. High-Dose Opioid Therapy (≥90 MME/day) a. Current use of systemic opioid analgesics at Screening/Baseline with an average daily dose ≥90 morphine milligram equivalents (MME/day), based on medication reconciliation (prescription records and subject report) and standard MME conversion factors. 14. Current Nicotine Use (Self-Reported) a. Self-reported use of any nicotine-containing products (including smoking, vaping/e-cigarettes, cigars, pipes, smokeless tobacco, nicotine pouches, and nicotine replacement products) within 6 weeks prior to Screening/Baseline. 15. Secondary Gain or Litigation a. Currently receiving or actively seeking workers' compensation or disability benefits or involved in injury related litigation. 16. Pregnancy a. Currently pregnant or planning to become pregnant within two (2) years following enrollment, as self reported. 17. Vulnerable Populations a. Individuals who are prisoners or wards of the state. 18. Substance Abuse a. Known or suspected active drug or alcohol abuse, including opioid misuse. 19. Psychiatric Conditions a. Diagnosed psychiatric disorder (e.g., schizophrenia, major depressive disorder, personality disorder) that, in the Investigator's judgment, could interfere with study participation. 20. Concurrent Interventional Research a. Current participation in another clinical trial. 21. Neurologic Conditions Affecting Rehabilitation a. Presence of a significant neurologic disorder that would interfere with participation in physical therapy or post procedural rehabilitation. 22. Other Confounding Medical Conditions a. Any other medical condition or pain condition not intended to be treated in this study that, in the Investigator's judgment, could interfere with study procedures, accurate pain reporting, or interpretation of study endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite safety and efficacy endpoint | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Months 3, 6, 12, 18, 24. | Change from baseline in VAS score (measured on 0-100 mm scale) and proportion achieving VAS MCID ≥ 20 mm. |
| Oswestry Disability Index (ODI) | Months 3, 6, 12, 18, 24 | Change from baseline in ODI and proportion achieving ODI MCID ≥ 15 points. |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29+2) | Months 3, 6, 12, 18, 24 | Change in T-scores from baseline |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire | Months 3, 6, 12, 18, 24 | Change in EQ-5D-5L index scores from baseline |
| Patient Global Impression of Change (PGIC) | Months 3, 6, 12, 18, 24 | PGIC categorical distribution |
| Medication use | 3, 6, 12, 18, 24 | Medication use (including daily MME for opioids) per visit |
| Healthcare Resource Utilization (HCRU) | Months 3, 6, 12, 18, 24 | HCRU per visit |
Contacts
CONTACTLalit Venkatesan, PhD
Outcome results
None listed