Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
- Conditions
- Ruptured Anterior Cruciate Ligaments
- Interventions
- Device: Z-LigDevice: allograft
- Registration Number
- NCT01245400
- Lead Sponsor
- Aperion Biologics, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Z-Lig Z-Lig Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure. Allograft allograft Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure.
- Primary Outcome Measures
Name Time Method KT-1000 baseline, 3,6, 12 & 24 monhts Contact Sponsor
- Secondary Outcome Measures
Name Time Method