At a glance
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A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
In Brief
A clinical study evaluating BioD Restore and Kenalog for Knee Osteoarthritis. Completed, enrolled 90 participants across 1 site.
Detailed Summary
This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.
Study Details
Timeline
Interventions
Investigational product, BioD Restore, will be injected into the articular space of the knee.
Active comparator, Kenalog steroid, will be injected into the articular space of the knee.