This trial is active, not recruiting.

Condition ruptured anterior cruciate ligaments
Treatments z-lig, allograft
Sponsor Aperion Biologics, Inc.
Start date November 2010
End date April 2014
Trial size 60 participants
Trial identifier NCT01245400, ABI-ZLig-01-10-01


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.

United States No locations recruiting
Other countries No locations recruiting

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
Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure.
ACL replacement
(Active Comparator)
Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure.
ACL replacement

Primary Outcomes

time frame: baseline, 3,6, 12 & 24 monhts

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Contact Sponsor

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Aperion Biologics, Inc..