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

NCT01245400 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-13

No results posted yet for this study

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.

Conditions

  • Ruptured Anterior Cruciate Ligaments

Interventions

DEVICE

Z-Lig

ACL replacement

DEVICE

allograft

ACL replacement

Sponsors & Collaborators

  • Aperion Biologics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-04-30
Completion
2017-04-30

Countries

  • Belgium
  • Denmark
  • Italy
  • Netherlands
  • South Africa
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245400 on ClinicalTrials.gov