Steroid Injection vs. BioDRestore for Patients With Knee OA

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.

Timeline

Start

2017-01

Primary completion

2020-01

Completion

2020-01

Publications

• Pill SG, Ahearn B, Tokish JM, Cook C, Siffri PJ, Mercuri JJ, Burnikel B, Cassas KJ, Wyland DJ, Sawvell E, Wright N, Hutchinson J, Bynarowicz T, Adams KJ, Kissenberth MJ. Amniotic Tissue Injections Are an Effective Alternative to Corticosteroid Injections for Pain Relief and Function in Patients With Severe Knee Osteoarthritis: A Double-Blind, Randomized, Prospective Study. J Am Acad Orthop Surg Glob Res Rev. 2025 Jan 9;9(1):e23.00276. doi: 10.5435/JAAOSGlobal-D-23-00276. eCollection 2025 Jan 1.

Drugs

Indications