BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

This is a single-arm, single site, pilot study in patients with a ruptured ACL. A total of fifty (50) subjects will be enrolled in this trial. All patients will have been scheduled to undergo ACL reconstruction and will receive a BioCleanse Tibialis allograft as part of the normal standard of care practiced by the treating surgeon. Follow up is for 2 years. However, there is no assignment of graft, specific to donor age, to the patients. All treatment will follow standard of care and this study assumes that there will be a normal distribution of graft donor ages, from 18 to 65 years of age. Patient outcomes will be compared between the 2 groups of tendon donor ages. Neither the surgeon nor the patient will be aware of the age of the graft donor, per typical standard of care.