Biomet, Inc., announced that its subsidiary, Biomet Biologics, LLC, has completed the required 230-subject enrollment for a study on the use of the Recover Kit device which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis). This multicenter, prospective, randomized, controlled, double-blind clinical trial will be completed when the last subject enrolled reaches 24 weeks follow-up in mid-2011. Enrollment was completed by 12 investigational sites in the United States, according to a press release.
The clinical trial is being performed under an FDA-approved Investigational Device Exemption (IDE) to evaluate the safety and efficacy of the company’s Recover Kit to treat chronic tennis elbow. Study subjects received either the investigational PRP treatment or an active control (bupivacaine). Adverse event profiles and clinical assessments of pain and function will be compared in the two treatment groups. The clinical data from this pivotal study will support a submission to the FDA requesting approval to market the kit to treat chronic tennis elbow, the company said.
“We are excited to complete the required enrollment for this study, as it addresses a very problematic issue for the patient and surgeon alike,” Stuart Kleopfer, president of Biomet Biologics, stated in the release. “We believe this is an important step forward in advancing the use of autologous, point-of-care therapies to treat chronic tendinopathies.”