ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01245400
Recruitment Status : Unknown
Verified March 2014 by Aperion Biologics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ruptured Anterior Cruciate Ligaments Device: Z-Lig Device: allograft Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2010
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Z-Lig
Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure.
Device: Z-Lig
ACL replacement

Active Comparator: Allograft
Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure.
Device: allograft
ACL replacement




Primary Outcome Measures :
  1. KT-1000 [ Time Frame: baseline, 3,6, 12 & 24 monhts ]
    Contact Sponsor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Contact Sponsor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245400


Locations
Belgium
Contact Sponsor, Belgium
Denmark
Contact Sponsor, Denmark
Italy
Bologna, Italy
Netherlands
Contact Sponsor, Netherlands
South Africa
Contact Sponsor, South Africa
Spain
Contact Sponsor, Spain
Sponsors and Collaborators
Aperion Biologics, Inc.

Responsible Party: Aperion Biologics, Inc.
ClinicalTrials.gov Identifier: NCT01245400     History of Changes
Other Study ID Numbers: ABI-ZLig-01-10-01
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Aperion Biologics, Inc.:
Z-Lig
allograft
ACL
Anterior Cruciate Ligament
ACLR
Anterior Cruciate Ligament Reconstruction
EU
European Union
S. Africa
Reconstruction of ruptured anterior cruciate ligaments

Additional relevant MeSH terms:
Rupture
Wounds and Injuries