Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
NCT ID: NCT01245400
Last Updated: 2014-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2010-11-30
2017-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Z-Lig
Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure.
Z-Lig
ACL replacement
Allograft
Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure.
allograft
ACL replacement
Interventions
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Z-Lig
ACL replacement
allograft
ACL replacement
Eligibility Criteria
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Inclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Aperion Biologics, Inc.
INDUSTRY
Responsible Party
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Locations
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Contact Sponsor, , Belgium
Contact Sponsor, , Denmark
Bologna, , Italy
Contact Sponsor, , Netherlands
Contact Sponsor, , South Africa
Contact Sponsor, , Spain
Countries
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Related Links
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Click here for more information about this study: Z-Lig compared to Allograft
Other Identifiers
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ABI-ZLig-01-10-01
Identifier Type: -
Identifier Source: org_study_id
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