Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfun… (NCT04218838) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction
Stopped: Enrollment difficulties due to changes in control arm conventions
United States7 participantsStarted 2020-08-13
Plain-language summary
This study has been designed to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with refractory sacroiliac joint dysfunction.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
* Subject must provide written informed consent prior to any clinical study-related procedure.
* Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
* Subjects must meet criteria for sacroiliac joint dysfunction as determined below:
* History of persistent pain in the distribution of the sacroiliac joint despite adequate trial of physical therapy.
* NRS for pain ≥ 7 on a 0 -.10-point scale.
* 3 of 5 provocative tests with positive findings on physical examination (SI distraction, thigh thrust, FABER, lateral compression, Gaenslen's maneuver).
* Positive response (≥75% percent pain relief) to diagnostic sacroiliac joint injection on two occasions at least one week apart.
* Baseline pain with 30-day history and PROMIS-29
Exclusion Criteria:
* Patient will not be entered into the study if they meet one of the following criteria:
* Subject is unable to provide written informed consent
* Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investi…
What they're measuring
1
Efficacy of sacroiliac joint stabilization using the CornerLoc procedure in the treatment of sacroiliac joint pain by evaluating the efficacy responder rate versus an intra-articular steroid injection.