Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA

Overview

The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.

The study is single center, prospective, randomized, controlled trial to include 50 subjects, 25 treated with Regenexx SD and 25 treated with Exercise Therapy for treatment of knee osteoarthritis. Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of Exercise Therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection. Subjects in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at or after the 3 month visit and then continue to be followed through 24 months. Subjects will complete the study following the 2 year follow-up visit. They will be withdrawn from the study prematurely if a revision occurs. The study subjects will be compared to a historical total knee arthroplasty group. Data of the TKA group subjects will be reviewed retrospectively after it is retrieved from the clinical database. The TKA group will consist of patients who underwent TKA for knee osteoarthritis. The inclusion criteria of age and BMI will be applied to these subjects.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes