Ruptured Anterior Cruciate Ligaments Clinical Trial
Official title:
A Prospective, Randomized, Double-Blind, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Z-Lig Medical Device Compared to Allograft for the Reconstruction of Ruptured Anterior Cruciate Ligaments
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.
Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or
allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e.,
autologous tissue exposes patients to increased morbidity and allograft tissue use is
limited by global availability and quality).
There are currently no effective artificial materials or xenograft tissue substitutes widely
available. The purpose of this multicenter clinical trial is to evaluate the safety and
efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior
cruciate ligaments and compare those results to allograft.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment