Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- KT-1000 [ Time Frame: baseline, 3,6, 12 & 24 monhts ] [ Designated as safety issue: No ]Contact Sponsor
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure.
Active Comparator: Allograft
Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure.
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.
|Contact Sponsor, Belgium|
|Contact Sponsor, Denmark|
|Contact Sponsor, Netherlands|
|Contact Sponsor, South Africa|
|Contact Sponsor, Spain|