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Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device

CompletedNCT04423120
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Single Arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device
Conditions
Sponsor
PainTEQ, LLC
Collaborators
Pacific Research Institute
Start date
2020-03-13
Primary completion
2023-04-30
Sex
All
Age range
from 21 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 treatment. Exclusion Criteria: * Inability to confirm that the pain is arising from the sacroiliac joint * Current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture * SIJ pain secondary to inflammatory conditions, Other known sacroiliac pathology such as: Sacral dysplasia, Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), Tumor, Infection, Acute fracture, and Crystal arthropathy. * Radicular pain extending beyond the buttock ≥ 30mm on VAS * Has complete resolution of pain from the diagnostic SIJ injection lasting 30 days or more * Has had an injection with corticosteroid into the index SIJ within the last 90 days * Has had any neuraxial injection with corticosteroid within the last 90 days * Has greater than 50% pain relief from diagnostic medial branch bl…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04423120