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

NCT02000258 | Completed DMC

• 1 other identifier: R02071
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior cruciate ligament reconstruction; Double-bundle; MRI; Graft location

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• KT-1000 measurement (mm) of the knees of 61 patients

  2 years after surgery

• International Knee Documentation Committee (IKDC) functional score

  2 years after surgery

• Lysholm knee evaluation score

  2 years after surgery

• Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form

  2 years after surgery

Study Arms (2)

Double-bundle ACL reconstruction

OTHER

Double-bundle ACL reconstruction

Procedure: Double-bundle ACL reconstruction

Magnetic resonance imaging (MRI)

OTHER

MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery.

Device: Magnetic resonance imaging (MRI)

Interventions

Double-bundle ACL reconstruction PROCEDURE

Double-bundle ACL reconstruction

Magnetic resonance imaging (MRI) DEVICE

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.

Also known as: 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)

Magnetic resonance imaging (MRI)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• primary ACL reconstruction, closed growth plates

You may not qualify if:

• ligament injury to the opposite knee

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University hospital

Tampere, Pirkanmaa, 33521, Finland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Timo Järvelä, MD, PhD

  Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 4, 2013
• Study Start: March 1, 2003
• Primary Completion: September 1, 2010
• Study Completion: August 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-11

Locations

FI (1)