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NCT01148784 Clinical Trial

Comparison of Doubled Quadrupled Versus Quadrupled Allograft Tissue Constructs for Anterior Cruciate Ligament (ACL) Reconstruction

Injury Clinical Trial

Official title:
A Prospective Randomized Comparison of Doubled Versus Quadrupled Allogenic Tissue Constructs for Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01148784
Other study ID # OHSU-6158
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2010
Est. completion date April 5, 2014

Study information
Verified date July 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two different soft tissue allografts, double bundle tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn anterior cruciate ligament (ACL) of the knee.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date April 5, 2014
Est. primary completion date September 17, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- ACL injury is the primary limitation to activities of daily living.

Exclusion Criteria:

- Multiple current ligamentous injuries to the knee.

- Revision reconstruction of the ACL.

- Uncorrected instability of the ACL on the opposite knee.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ACL reconstruction
Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.

Locations
Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knee outcome scores The change of physical function and pain as evaluated by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score). One year
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