Effect of Tunnel Placements on Clinical and MRI Findings Two Years After ACL Reconstruction With DB Technique

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Procedure: Double-bundle ACL reconstruction; Device: Magnetic resonance imaging (MRI)

• Registration Number: NCT02000258
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2010-09
• Study Completion: 2013-08
• Study First Submitted: 2013-10-30
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-26
• Last Update Submitted: 2013-11-26
• Study First Posted: 2013-12-04
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• primary ACL reconstruction, closed growth plates

Exclusion Criteria

• ligament injury to the opposite knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double-bundle ACL reconstruction	Double-bundle ACL reconstruction	Double-bundle ACL reconstruction
Magnetic resonance imaging (MRI)	Magnetic resonance imaging (MRI)	MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery.

Primary Outcome Measures

Name	Time	Method
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages	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	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 Outcome Measures

Name	Time	Method
Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form	2 years after surgery	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.
KT-1000 measurement (mm) of the knees of 61 patients	2 years after surgery	KT-1000 measurements were reported as millimeters.
International Knee Documentation Committee (IKDC) functional score	2 years after surgery	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.
Lysholm knee evaluation score	2 years after surgery	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.

Trial Locations

Locations (1)

Tampere University hospital; 🇫🇮 Tampere, Finland