Steroid Injection vs. BioDRestore for Patients With Knee OA

A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis

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.

Inclusion Criteria:

• Male or female, aged 18 to 80 years.
• Willing and able to give voluntary informed consent to participate in this investigation.
• Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
• Candidate for intra-articular knee injection.
• BMI < 40

Exclusion Criteria:

• Patients who have received intra-articular injection(s) in the last 3 months.
• Patients who have undergone arthroscopic surgery on the study knee in the past year.
• Patients who have undergone arthroplasty on the study knee.
• Ligament instability
• Diabetes (Type 1 or II)
• Inflammatory arthropathies.
• Fibromyalgia or chronic fatigue syndrome.
• Female patient who is pregnant or nursing.
• Chronic use of narcotics.
• Any other reason (in the judgment of the investigator).