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

Ruptured Anterior Cruciate Ligaments Clinical Trial

— Z-Lig  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01245400
• Other study ID #: ABI-ZLig-01-10-01
• Status: Active, not recruiting
• Phase: N/A
• First received: November 1, 2010
• Last updated: March 11, 2014
• Start date: November 2010
• Est. completion date: April 2017

Study information

• Verified date: March 2014
• Source: Aperion Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencySouth Africa: Department of HealthSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics CouncilItaly: Ethics CommitteeItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: National Board of HealthDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Ministry of HealthDenmark: The Regional Committee on Biomedical Research EthicsNetherlands: Independent Ethics CommitteeNetherlands: De Voedsel en Waren AutoriteitNetherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)Netherlands: Medicines Evaluation Board (MEB)Netherlands: Ministry of Health, Welfare and SportNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: ZonMw, Netherlands Organisation for Health Research and DevelopmentSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación ClínicaSpain: Departament de Salut de la Generalitat de CatalunyaSpain: Ethics CommitteeSpain: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years
• Eligibility: Contact Sponsor

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

Related Conditions & MeSH terms

• Rupture
• Ruptured Anterior Cruciate Ligaments

Intervention

Device:
• Z-Lig
ACL replacement
• allograft
ACL replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aperion Biologics, Inc.

Countries where clinical trial is conducted

Belgium,  Denmark,  Italy,  Netherlands,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KT-1000	Contact Sponsor	baseline, 3,6, 12 & 24 monhts	No

External Links

•   Click here for more information about this study: Z-Lig compared to Allograft