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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02000258
Enrollment
75
Registered
2013-12-04
Start date
2003-03-31
Completion date
2013-08-31
Last updated
2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture

Keywords

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

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.

Interventions

PROCEDUREDouble-bundle ACL reconstruction
DEVICEMagnetic 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.

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* primary ACL reconstruction, closed growth plates

Exclusion criteria

* ligament injury to the opposite knee

Design outcomes

Primary

MeasureTime frameDescription
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages2 years after surgeryThe 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 MRI2 years after surgeryTwo 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

MeasureTime frameDescription
KT-1000 measurement (mm) of the knees of 61 patients2 years after surgeryKT-1000 measurements were reported as millimeters.
International Knee Documentation Committee (IKDC) functional score2 years after surgeryIKDC 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 score2 years after surgeryPatients 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 form2 years after surgeryThe 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026