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

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Double-bundle ACL reconstruction
Magnetic resonance imaging (MRI)
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring Anterior cruciate ligament reconstruction, Double-bundle, MRI, Graft location

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • primary ACL reconstruction, closed growth plates

Exclusion Criteria:

  • ligament injury to the opposite knee

Sites / Locations

  • Tampere University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Double-bundle ACL reconstruction

Magnetic resonance imaging (MRI)

Arm Description

Double-bundle ACL reconstruction

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

KT-1000 measurement (mm) of the knees of 61 patients
KT-1000 measurements were reported as millimeters.
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.
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.
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.

Full Information

First Posted
October 30, 2013
Last Updated
November 26, 2013
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02000258
Brief Title
Effect of Tunnel Placements on Clinical and MRI Findings Two Years After ACL Reconstruction With DB Technique
Official Title
Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
Anterior cruciate ligament reconstruction, Double-bundle, MRI, Graft location

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double-bundle ACL reconstruction
Arm Type
Other
Arm Description
Double-bundle ACL reconstruction
Arm Title
Magnetic resonance imaging (MRI)
Arm Type
Other
Arm Description
MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery.
Intervention Type
Procedure
Intervention Name(s)
Double-bundle ACL reconstruction
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imaging (MRI)
Other Intervention Name(s)
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)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages
Description
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.
Time Frame
2 years after surgery
Title
The visibility of the ACL grafts measured from the MRI
Description
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.
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
KT-1000 measurement (mm) of the knees of 61 patients
Description
KT-1000 measurements were reported as millimeters.
Time Frame
2 years after surgery
Title
International Knee Documentation Committee (IKDC) functional score
Description
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.
Time Frame
2 years after surgery
Title
Lysholm knee evaluation score
Description
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.
Time Frame
2 years after surgery
Title
Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form
Description
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.
Time Frame
2 years after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: primary ACL reconstruction, closed growth plates Exclusion Criteria: ligament injury to the opposite knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timo Järvelä, MD, PhD
Organizational Affiliation
Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland
Official's Role
Study Chair
Facility Information:
Facility Name
Tampere University hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

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

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