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

NCT ID: NCT02000258

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Anterior Cruciate Ligament Rupture

Keywords

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Anterior cruciate ligament reconstruction Double-bundle MRI Graft location

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Double-bundle ACL reconstruction

Double-bundle ACL reconstruction

Group Type OTHER

Double-bundle ACL reconstruction

Intervention Type PROCEDURE

Magnetic resonance imaging (MRI)

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

Group Type OTHER

Magnetic resonance imaging (MRI)

Intervention Type 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.

Interventions

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Double-bundle ACL reconstruction

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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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)

Eligibility Criteria

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Inclusion Criteria

* primary ACL reconstruction, closed growth plates

Exclusion Criteria

* ligament injury to the opposite knee
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timo Järvelä, MD, PhD

Role: STUDY_CHAIR

Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland

Locations

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Tampere University hospital

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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R02071

Identifier Type: -

Identifier Source: org_study_id