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Clinical Trials/NCT02000258
NCT02000258
Completed
Not Applicable

Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique

Tampere University Hospital1 site in 1 country75 target enrollmentMarch 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Rupture
Sponsor
Tampere University Hospital
Enrollment
75
Locations
1
Primary Endpoint
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee.

Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • primary ACL reconstruction, closed growth plates

Exclusion Criteria

  • ligament injury to the opposite knee

Outcomes

Primary Outcomes

The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages

Time Frame: 2 years after surgery

The measurements of the graft location from the MRI were made by two musculoskeletal radiologists separately and the means of these measurements were used. In brief, first the centers of the tunnels were measured from sagittal images referring to the Blumensaat's line and to the posterior femoral condyle. Then these were divided with the maximum diameters of the femoral condyle parallel to and perpendicular to the Blumensaat's line. In the tibial side, the centers of the tunnels were measured from the anterior edge of the tibial plateau and then divided with the maximum diameter of the plateau, which was measured from the sagittal view.

The visibility of the ACL grafts measured from the MRI

Time Frame: 2 years after surgery

Two musculoskeletal radiologists made the interpretation of the images separately and the means of these measurements were used. A graft was considered visible when intact graft fibers were seen. The graft was considered partially visible when only few graft fibers were seen. The graft was considered invisible when no graft fibers were seen.

Secondary Outcomes

  • KT-1000 measurement (mm) of the knees of 61 patients(2 years after surgery)
  • Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form(2 years after surgery)
  • International Knee Documentation Committee (IKDC) functional score(2 years after surgery)
  • Lysholm knee evaluation score(2 years after surgery)

Study Sites (1)

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