Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft (Z-Lig)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Ruptured Anterior Cruciate Ligaments||Device: Z-Lig Device: allograft||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- KT-1000 [ Time Frame: baseline, 3,6, 12 & 24 monhts ]Contact Sponsor
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
|Contact Sponsor, Belgium|
|Contact Sponsor, Denmark|
|Contact Sponsor, Netherlands|
|Contact Sponsor, South Africa|
|Contact Sponsor, Spain|