Single- vs. Double-Bundle ACL Reconstruction

Completed · Phase 2

Conditions studied: Anterior Cruciate Ligament Injury

In brief

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.

Key facts

Study ID
NCT01319409
Run by
University of Pittsburgh
People needed
57
Starts
2011-03-01
Expected to finish
2015-01-01
Last updated by the study team
2016-01-05

Who can join

Age: 14 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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