Anterior Cruciate Ligament Rupture Clinical Trial
Official title:
Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique
Verified date | November 2013 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | August 2013 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - primary ACL reconstruction, closed growth plates Exclusion Criteria: - ligament injury to the opposite knee |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages | 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. | 2 years after surgery | Yes |
Primary | The visibility of the ACL grafts measured from the MRI | 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. | 2 years after surgery | Yes |
Secondary | KT-1000 measurement (mm) of the knees of 61 patients | KT-1000 measurements were reported as millimeters. | 2 years after surgery | Yes |
Secondary | International Knee Documentation Committee (IKDC) functional score | IKDC functional score was used to evaluate knee functions (IKDC scale: 0-10). Full function without any limitations was scored as 10, while zero indicated that those patients were unable to perform their daily activities. | 2 years after surgery | Yes |
Secondary | Lysholm knee evaluation score | Patients completed the Lysholm knee score, which measures subjective functions e.g. squatting and running. The scale is 0-100, 100 being perfect functioning of the knee. | 2 years after surgery | Yes |
Secondary | Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form | The clinical evaluation was performed on the basis of IKDC knee examination form, which gives the final score A-D. A being normal, B nearly normal, C abnormal and D severely abnormal. | 2 years after surgery | Yes |
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