Single- vs. Double-Bundle ACL Reconstruction

Summary

The purpose of this double-blind, randomized clinical trial to compare outcomes of single-bundle (SB) to anatomic double-bundle (DB) ACL reconstruction. We hypothesize that anatomically reconstructing both bundles of the ACL will lead to better restoration of healthy knee mechanics and clinical outcomes. In addition to standard clinical outcome measures, we will utilize a unique combination of high-speed biplane radiography (for highly accurate assessment of knee kinematics) and 3D imaging (MRI and CT, to define joint and cartilage morphology) to characterize joint kinematics and cartilage surface interactions during functional tasks.

The specific aims of this study are to:

Specific Aim 1: Determine if anatomic double-bundle ACL reconstruction restores normal dynamic knee function better than single-bundle ACL reconstruction.

Hypothesis 1.1 Knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 and 24 months after surgery.

Hypothesis 1.2 Graft elongation from 6 to 24 months after surgery is reduced with anatomic double-bundle ACL reconstruction in comparison to single-bundle ACL reconstruction, as measured with dynamic stereoradiography.

Specific Aim 2: Determine if anatomic double-bundle ACL reconstruction results in better clinical outcomes than single-bundle ACL reconstruction.

Hypothesis 2.1 Anatomic double-bundle ACL reconstruction will result in more symmetrical laxity and better range of motion and hop test scores in comparison to single-bundle ACL reconstruction.

Hypothesis 2.2 In comparison to single-bundle ACL reconstruction, anatomic double-bundle ACL reconstruction will result in better patient-oriented outcomes, indicating fewer symptoms, a higher level of activity and more complete return to sport.

Successful completion of these aims will provide quantitative evidence of the efficacy of anatomic double-bundle ACL reconstruction for restoring normal knee mechanics. Should the results show a clear benefit for this procedure, it would provide support for wider adaptation of anatomic DB reconstruction. By completing the proposed aims, we will also establish a sound basis for additional studies with longer follow-up (including the subjects in this cohort), to assess the benefits of anatomic DB ACL reconstruction for improving long-term clinical outcomes and maintaining joint and cartilage health.

Conditions

• Anterior Cruciate Ligament Injury

Interventions

PROCEDURE

Anatomic Double-Bundle ACL Reconstruction

Surgical reconstruction of the posterolateral (PL) and anteromedial (AM) bundles of the ACL using an autograft quadriceps tendon with a bone block that is split into 2 free arms to recreate the AM and PL bundles. The bone block is placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The free ends of the graft are be placed in 2 separate tunnels located in the centers of the tibial insertions for the PL and AM bundles. The PL bundle is fixed with the knee in full extension and the AM bundle is fixed with the knee at 45 degrees of flexion.

PROCEDURE

Anatomic Single-Bundle ACL Reconstruction

Surgical reconstruction of the ACL using a single autograft quadriceps tendon with a bone block. The free end of the graft is not split. The bone block is placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The single free end of the graft is placed in a single tibial tunnel located in the center of the tibial ACL insertion site. The graft is fixed with the knee in 10 to 20 degrees of flexion.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• James J Irrgang, PT PhD ATC · University of Pittsburgh

• Freddie H Fu, MD · University of Pittsburgh

• Scott Tashman, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States

Study Locations