Biomet Biologics, a subsidiary of orthopedic and biotechnology products manufacturer Biomet, has completed the required 230 subject enrollment for its Recover Kit clinical trial by 12 investigational sites in the US.
The clinical trial studies the use of the Recover Kit device, which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis).
Biomet said the multicenter, prospective, randomized, controlled, double-blind clinical trial will be completed when the last subject enrolled reaches 24 weeks follow-up in mid-2011.
The clinical trial is being performed under a US Food and Drug Administration (FDA) approved investigational device exemption (IDE) to evaluate the safety and efficacy of the company’s Recover Kit to treat chronic tennis elbow and the study subjects received either the investigational PRP treatment or an active control (bupivacaine).
Biomet Biologics president Stuart Kleopfer said they are excited to complete the required enrollment for this study, as it addresses a problematic issue for the patient and surgeon alike.
"We believe this is an important step forward in advancing the use of autologous, point-of-care therapies to treat chronic tendinopathies," Kleopfer said.