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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT01148784

Collaborator

(none)

102

Enrollment

Location

Arms

46.1

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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	Phase
Anterior Cruciate Ligament Injury	Procedure: ACL reconstruction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

102 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 :

Jun 1, 2010

Actual Primary Completion Date :

Sep 17, 2012

Actual Study Completion Date :

Apr 5, 2014

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.

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

Knee outcome scores [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

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dennis Crawford, Principal Investigator, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01148784

Other Study ID Numbers:

OHSU-6158

First Posted:

Jun 22, 2010

Last Update Posted:

Jul 11, 2019

Last Verified:

Jul 1, 2019

Keywords provided by Dennis Crawford, Principal Investigator, Oregon Health and Science University

anterior cruciate ligament tear

Study Results

No Results Posted as of Jul 11, 2019