Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion (TRAQTION)

An Open Label, Prospective, Multicenter, Single-Arm, Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion

The purpose of this study is to evaluate the real-world performance, safety and efficacy of the TRAQ System.

Study Overview

• Status: Not yet recruiting
• Conditions: Sacroiliac Joint Pain; Sacroiliac Joint Dysfunction
• Intervention / Treatment: Other: Bone Allograft

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Lalit Venkatesan, PhD; Phone Number: 18552487246; Email: lalit.venkatesan@painteq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Change from baseline in VAS score (measured on 0-100 mm scale) and proportion achieving VAS MCID ≥ 20 mm.	Months 3, 6, 12, 18, 24.
Oswestry Disability Index (ODI)	Change from baseline in ODI and proportion achieving ODI MCID ≥ 15 points.	Months 3, 6, 12, 18, 24
Patient-Reported Outcomes Measurement Information System (PROMIS-29+2)	Change in T-scores from baseline	Months 3, 6, 12, 18, 24
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire	Change in EQ-5D-5L index scores from baseline	Months 3, 6, 12, 18, 24
Patient Global Impression of Change (PGIC)	PGIC categorical distribution	Months 3, 6, 12, 18, 24
Medication use	Medication use (including daily MME for opioids) per visit	3, 6, 12, 18, 24
Healthcare Resource Utilization (HCRU)	HCRU per visit	Months 3, 6, 12, 18, 24

Collaborators and Investigators

• Sponsor: PainTEQ, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PTQ-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sponsored Study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No