Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft

Not Applicable

• Conditions: Ruptured Anterior Cruciate Ligaments

• 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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-13
• Primary Completion: 2014-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
KT-1000	baseline, 3,6, 12 & 24 monhts	Contact Sponsor