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

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Injury; Anterior Cruciate Ligament

Treatments: Procedure: ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01148784

OHSU-6158

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Quadrupled Hamstring Allograft

Active Comparator group

Treatment:

Procedure: ACL reconstruction

Doubled Tibialis Anterior Allograft

Active Comparator group

Treatment:

Procedure: ACL reconstruction