OrthoPure™ XT Pilot Clinical Study

The OrthoPure™ XT device is a decellularized, sterile, single use biological scaffold for use in the treatment of patients with a partial or complete tear of the Anterior Cruciate Ligament (ACL) who require surgical reconstruction of the ACL. This is a Pilot Safety Study. The primary objective of this study is to evaluate the clinical safety of the OrthoPure™ XT device in a small group of patients that require reconstruction of the Anterior Cruciate Ligament (ACL) due to partial or complete tear of the ACL. Clinical safety will be analyzed through measurement of immune response (alpha-Gal IgG), blood and urine analysis, incidence of secondary surgical interventions with the treated knee, and the incidence of individual adverse events. The second objectives of this study are to assess the efficacy endpoints, specifically: improvement in knee stability, function and pain; improvement in patient quality of life and radiographic analysis.