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

Apeiron Biologics

Status: Unknown

Conditions: Ruptured Anterior Cruciate Ligaments

Treatments: Device: allograft; Device: Z-Lig

Study type: Interventional

Funder types: Industry

Identifiers

NCT01245400

ABI-ZLig-01-10-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Contact Sponsor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Z-Lig

Experimental group

Description:

Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure.

Treatment:

Device: Z-Lig

Allograft

Active Comparator group

Description:

Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure.

Treatment:

Device: allograft