Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device (NCT04423120) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device
United States159 participantsStarted 2020-03-13
Plain-language summary
The PainTEQ study is a prospective, multi-site, prospective, single arm study intended to collect clinical data outcomes data associated with the treatment of sacroiliac disease with the LinQ fusion procedure. Data will be collected using self-report measures including the visual analog scale (VAS) for pain assessment where the participant is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Other self-report questionnaires will be administered including the Oswestry Disablity Index (ODI) to measure low-back pain and disability, and the Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) to measure physical, mental, and social health and well-being.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 21-70
* Patient has lower back pain for \>6 months inadequately responsive to conservative care
* Patient has at least 3 of 4 physical examination maneuvers specific for the SI joint (FABER, Gaenslen test, Stork/Gillete, and Yoman)
* Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) with confirmed arthrogram, within 30-60 min from injection
* Degenerative sacroiliitis as SIJ mediated in in the context of either radiographic evidence of SIJ degeneration, evident on computed tomography or Xrays or a history of prior lumbar fusion.
* SIJ disruption was defined in the study of as SIJ mediated pain in the context of asymmetric widening of SIJ on CT or Xrays or the presence of significant contrast leakage during diagnostic SIJ block
* Baseline Oswestry Disability Index (ODI) score of at least 30%
* Baseline Low back/buttock pain score of at least 50 on 0-100 mm visual analog scale
* Patient has signed study-specific informed consent form
* Patient has the necessary mental capacity to consent and participate and is physically able to comply with study protocol requirements
* Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.
* Patient's physician has decided that the best treatment for the patient's sacro-iliac disease is the LinQ system and the patient has agreed to the…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters
Timeframe: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
2
Absence of device related serious adverse events
Timeframe: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
3
Absence of neurological worsening related to the lumbosacral nerve roots
Timeframe: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
4
Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain
Timeframe: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.