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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aperion Biologics, Inc.
ClinicalTrials.gov Identifier:
NCT01245400
First received: November 1, 2010
Last updated: March 11, 2014
Last verified: March 2014
  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: April 2017
Estimated Primary Completion Date: April 2014 (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
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, see Learn About Clinical Studies.

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: March 11, 2014
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: Federal Agency for Medicines and Health Products, FAMHP
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 October 01, 2014