Biomet subsidiary Biomet Biologics has completed the required patient enrolment of 230 subjects for a clinical trial to evaluate the use of the Recover Kit for the treatment of chronic tennis elbow.
The Recover Kit works by producing autologous platelet-rich plasma to treat the injury.
The multicentre, prospective, randomised, controlled and double-blind clinical trial is being performed under a US Food and Drug Administration (FDA)-approved investigational device exemption to evaluate the safety and efficacy of the Recover Kit.
Study subjects will receive either the investigational platelet-rich plasma treatment or an active control (bupivacaine), and the study will compare adverse event profiles and clinical assessments of pain and function in the two groups.
The trial will be completed when the last subject enrolled will reach 24 weeks follow up in mid-2011.