Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
This study is ongoing, but not recruiting participants.
Sponsor:
Aperion Biologics, Inc.
Information provided by (Responsible Party):
Aperion Biologics, Inc.
ClinicalTrials.gov Identifier:
NCT01245400
First received: November 1, 2010
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
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 | Intervention |
|---|---|
|
Ruptured Anterior Cruciate Ligaments |
Device: Z-Lig Device: allograft |
| Study Type: | Interventional |
| 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 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Aperion Biologics, Inc.:
Primary Outcome Measures:
- KT-1000 [ Time Frame: baseline, 3,6, 12 & 24 monhts ] [ Designated as safety issue: No ]Contact Sponsor
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Contact Sponsor
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
More Information
Additional Information:
No publications provided
| Responsible Party: | Aperion Biologics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01245400 History of Changes |
| Other Study ID Numbers: | ABI-ZLig-01-10-01 |
| Study First Received: | November 1, 2010 |
| Last Updated: | October 10, 2012 |
| Health Authority: | European Union: European Medicines Agency South Africa: Department of Health South Africa: Human Research Ethics Committee South Africa: Medicines Control Council South Africa: National Health Research Ethics Council Italy: Ethics Committee Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Belgium: Directorate general for the protection of Public health: Medicines Belgium: Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Belgium: Ministry of Social Affairs, Public Health and the Environment Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: Ethics Committee Denmark: National Board of Health Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: The Ministry of the Interior and Health Denmark: The Regional Committee on Biomedical Research Ethics Netherlands: Independent Ethics Committee Netherlands: De Voedsel en Waren Autoriteit Netherlands: Dutch Health Care Inspectorate Netherlands: Medical Ethics Review Committee (METC) Netherlands: Medicines Evaluation Board (MEB) Netherlands: Ministry of Health, Welfare and Sport Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: ZonMw, Netherlands Organisation for Health Research and Development Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica Spain: Departament de Salut de la Generalitat de Catalunya Spain: Ethics Committee Spain: Ministry of Health Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicines |
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 |
ClinicalTrials.gov processed this record on May 23, 2013