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

Completed · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02034032

Run by

Regenexx, LLC

People needed

48

Starts

2014-01-01

Expected to finish

2018-12-01

Last updated by the study team

2019-01-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary signature of the IRB approved Informed Consent
• Ages 18 to 70
• Diagnosis of Knee osteoarthritis
• Kellgren-Lawrence Grade 2 or 3 on X-Ray
• BMI of <30
• Minimum flexion to 110 degrees
• Varus under 12 degrees/Valgus under 15 degrees
• Instability in any plane less than 2 mm translation
• ACL intact and no history of ACL reconstruction
• Knee Society 100 point score > 65
• If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
• Candidate is able to follow Regenexx medication guidelines
• Patient agrees to return for periodic assessment protocol
• Patient must execute all required documents
• Patient must be appraised of Clinical Trial

You may not qualify if…

• History of infection of the joint in the last five years
• Intra-articular PRP, steroid or viscosupplementation in the last three months
• Previous knee surgery within the last 6 months
• Flexion contracture over 15 degrees
• Low back pain with radiculopathy or with "significant" radiographic changes
• History of immunosuppressive or chemotherapy in the last five years
• Systemic neurological disease
• HIV positive or chronic hepatitis
• Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study

Where it is running

• Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute — Des Plaines, Illinois, United States

Full record on ClinicalTrials.gov

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