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

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.

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Key information

Conditions

Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Injury Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACL reconstruction

Procedure

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

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2014
First posted: Jun 22, 2010
Registry last updated: Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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