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Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction — COVI  

Sacroiliac Joint Somatic Dysfunction Clinical Trial

Official title:
A Prospective, Multi-Center, Bi-Phasic Randomized Design to Compare Outcomes of the CornerLoc™ SI Joint Stabilization System and Intra-Articular Sacroiliac Joint Steroid Injection in Patients With Refractory Sacroiliac Joint Dysfunction

Clinical Trial 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.

Clinical Trial Description

Randomized, multicenter, open-label, randomized design to compare CornerLoc Allograft-based Sacroiliac Joint Stabilization System to Intra-articular Sacroiliac Joint Steroid Injection. Within the initial phase, referred to as the Randomized Phase, the primary determination of efficacy and safety will be 6-months following the study procedure. The analysis will be based on the randomization assignment. In the second phase of the study, referred to as the Cross-over Phase, patients who fail to respond to the randomized treatment assignment will be permitted to receive the non-randomized treatment. The basis of the sample size and hypothesis testing for this clinical investigation will be based on the Randomization Phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04218838
Study type Interventional
Source CornerLoc
Contact
Status Terminated
Phase N/A
Start date August 13, 2020
Completion date January 1, 2022
View Details
See also
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