Sacroiliac Joint DysfunctionTRAQTIONNCT07547215
Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion
An observational study of Sacroiliac Joint Dysfunction and Sacroiliac Joint Pain, run by PainTEQ, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the real-world performance, safety and efficacy of the TRAQ System. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain
- What is being tested?
- Bone Allograft
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- BMI ≤ 40.
- 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.
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- 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
- 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
- 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).
- 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.
- Informed Consent and Compliance
- Is willing and capable of providing written informed consent; and
- Is willing and able to comply with all study related requirements, procedures, and follow up visits.
Who cannot join
- Subjects must meet none of the following criteria to be eligible for participation in this study, as determined by the Investigator:
- Pain Source Uncertainty
- Inability to confirm, in the Investigator's clinical judgment, that the subject's primary pain generator is the sacroiliac joint.
- Alternative Primary Spine Pathology
- 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.
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- Non SIJ Pain Syndromes
- History of coccydynia or prior coccygectomy, endometriosis, cluneal neuralgia, or pudendal neuralgia.
- Recent Sacral Interventions
- Prior sacral radiofrequency ablation performed within 6 months prior to enrollment.
- Recent Pelvic Trauma
- History of major pelvic trauma within 12 months prior to enrollment.
- Severe Osteoporosis
- 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.
- Medications Affecting Bone or Soft Tissue Healing
- Current use of medications known to adversely affect bone quality or soft tissue healing, as determined by the Investigator.
- Anatomic Constraints
- Anatomic anomalies or defects that, in the Investigator's opinion, would preclude safe or biomechanically appropriate device placement.
- Systemic Inflammatory or Rheumatologic Disease
- Presence of a chronic inflammatory rheumatologic condition, such as rheumatoid arthritis.
- Centralized Pain Syndromes
- Current diagnosis of fibromyalgia.
- Infection Risk
- Evidence of current local or systemic infection that would increase surgical risk.
- High-Dose Opioid Therapy (≥90 MME/day)
- 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.
- Current Nicotine Use (Self-Reported)
- 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.
- Secondary Gain or Litigation
- Currently receiving or actively seeking workers' compensation or disability benefits or involved in injury related litigation.
- Pregnancy
- Currently pregnant or planning to become pregnant within two (2) years following enrollment, as self reported.
- Vulnerable Populations
- Individuals who are prisoners or wards of the state.
- Substance Abuse
- Known or suspected active drug or alcohol abuse, including opioid misuse.
- Psychiatric Conditions
- Diagnosed psychiatric disorder (e.g., schizophrenia, major depressive disorder, personality disorder) that, in the Investigator's judgment, could interfere with study participation.
- Concurrent Interventional Research
- Current participation in another clinical trial.
- Neurologic Conditions Affecting Rehabilitation
- Presence of a significant neurologic disorder that would interfere with participation in physical therapy or post procedural rehabilitation.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pain Institute of Southern Arizona
Tucson, Arizona, 85712
Denise Riesgo, (520) 318-6035, driesgo@pisapain.com
About this study
Official title: 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.
- Being tested
- Bone Allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone AllograftOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (7)
Visual Analog Scale (VAS)
Change from baseline in VAS score (measured on 0-100 mm scale) and proportion achieving VAS MCID ≥ 20 mm.
Measured: Months 3, 6, 12, 18, 24.
Oswestry Disability Index (ODI)
Change from baseline in ODI and proportion achieving ODI MCID ≥ 15 points.
Measured: Months 3, 6, 12, 18, 24
Patient-Reported Outcomes Measurement Information System (PROMIS-29+2)
Change in T-scores from baseline
Measured: Months 3, 6, 12, 18, 24
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Change in EQ-5D-5L index scores from baseline
Measured: Months 3, 6, 12, 18, 24
Patient Global Impression of Change (PGIC)
PGIC categorical distribution
Measured: Months 3, 6, 12, 18, 24
Medication use
Medication use (including daily MME for opioids) per visit
Measured: 3, 6, 12, 18, 24
Healthcare Resource Utilization (HCRU)
HCRU per visit
Measured: Months 3, 6, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start27 May 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PainTEQ, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547215
- Sponsor's protocol ID
- PTQ-003
- Acronym
- TRAQTION
- Status last verified
- Jun 2026
- First submitted
- 6 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sponsored Study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Prospective, Multicenter, Single-Arm, Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion
- ClinicalTrials.gov ID
- NCT07547215
- Acronym / sponsor ID
- TRAQTION / PTQ-003
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PainTEQ, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 May 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the real-world performance, safety and efficacy of the TRAQ System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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)
- Chronic SIJ Related Pain
- Diagnosis of SIJ Dysfunction
- Baseline Disability and Pain Severity
Key exclusion criteria (43 listed)
- Subjects must meet none of the following criteria to be eligible for participation in this study, as determined by the Investigator:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone AllograftThe 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. | Other | – |
Primary outcome
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.
7 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Months 3, 6, 12, 18, 24.
Oswestry Disability Index (ODI)
Time frame: Months 3, 6, 12, 18, 24
Patient-Reported Outcomes Measurement Information System (PROMIS-29+2)
Time frame: Months 3, 6, 12, 18, 24
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Time frame: Months 3, 6, 12, 18, 24
Patient Global Impression of Change (PGIC)
Time frame: Months 3, 6, 12, 18, 24
Medication use
Time frame: 3, 6, 12, 18, 24
Healthcare Resource Utilization (HCRU)
Time frame: Months 3, 6, 12, 18, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. Sponsored Study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction and Sacroiliac Joint Pain, run by PainTEQ, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lalit Venkatesan, PhD (18552487246, lalit.venkatesan@painteq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite safety and efficacy endpoint (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.