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

This study is currently recruiting participants.
Verified March 2011 by Oregon Health and Science University
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01148784
First received: June 21, 2010
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament
Injury
 Procedure: ACL reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Doubled Versus Quadrupled Allogenic Tissue Constructs for Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Knee outcome scores [ Time Frame: One year ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quadrupled Hamstring Allograft Procedure: ACL reconstruction
Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.
Active Comparator: Doubled Tibialis Anterior Allograft Procedure: ACL reconstruction
Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148784

Contacts
Contact: Michael Durkan, BS 503-494-5327 durkan@ohsu.edu
Contact: Samantha Quilici, PA-C 503-494-6400 quilicis@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Dennis C Crawford, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Dennis C. Crawford, MD, PhD; Assistant Professor, Department of Orthopaedics, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01148784     History of Changes
Other Study ID Numbers: OHSU-6158
Study First Received: June 21, 2010
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
anterior cruciate ligament tear
ACL
ligament
knee
allograft

ClinicalTrials.gov processed this record on May 22, 2013