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

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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: Double-bundle ACL reconstruction; Device: Magnetic resonance imaging (MRI)

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary ACL reconstruction, closed growth plates

Exclusion Criteria:

• ligament injury to the opposite knee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Double-bundle ACL reconstruction	Procedure: Double-bundle ACL reconstruction
Other: Magnetic resonance imaging (MRI); MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery.	Device: Magnetic resonance imaging (MRI); MRI sequences were as follows: sagittal T1-weighted, proton density (PD)-weighted and T2-weighted fast spin echo (FSE) images with 4 mm slice and 1 mm gap, coronal T1-weighted and fat-saturated T2-weighted FSE images with 4 mm slice and 1 mm gap, axial fat saturated PD FSE images with 4 mm slice and 1 mm gap and oblique sagittal and oblique coronal T1 FSE images along AM graft plane with 3 mm slice and 0.3 mm gap.; Other Names: MRI evaluations were made with a 1.5-T Signa Excite HD imager (GE Healthcare, Milwaukee, WI) by use of an eight-channel receiver/transmitter extremity coil.; The interpretation of the images was made with the Impax DS 3000 workstation (Agfa HealthCare, Mortsel, Belgium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KT-1000 measurement (mm) of the knees of 61 patients	KT-1000 measurements were reported as millimeters.	2 years after surgery
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
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
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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Study Chair: Timo Järvelä, MD, PhD, Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 4, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: MRI; Anterior cruciate ligament reconstruction; Double-bundle; Graft location
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: R02071