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

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ClinicalTrials.gov Identifier: NCT01148784
Recruitment Status : Unknown
Verified March 2011 by Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : June 22, 2010
Last Update Posted : April 1, 2011
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Anterior Cruciate Ligament Injury Procedure: ACL reconstruction

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Doubled Versus Quadrupled Allogenic Tissue Constructs for Anterior Cruciate Ligament Reconstruction
Study Start Date : June 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Knee outcome scores [ Time Frame: One year ]
    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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011

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