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Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique

Sponsor
National Police Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01513434
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
40
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transtibial technique
  • Procedure: Transportal technique
  • Procedure: anterior cruciate ligament reconstruction
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: transtibial technique

In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.

Procedure: transtibial technique
Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.

Procedure: anterior cruciate ligament reconstruction
femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw
Active Comparator: Transportal technique

In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.

Procedure: Transportal technique
Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.
Other Names:
  • anteromedial portal technique

    • Procedure: anterior cruciate ligament reconstruction
    femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw

    Outcome Measures

    Primary Outcome Measures

    1. Lysholm score [at least two years after surgery]

      Lysholm score was superior in transportal technique to transtibial technique.

    2. Position of femoral tunnel aperture [within one week after surgery]

      The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • diagnosis of anterior cruciate ligament rupture
    Exclusion Criteria:

    • female

    • over 45 years old

    • the subjects who had ACL reconstruction with graft other than Achilles allograft

    • the subjects who had concomitant other ligament injuries on the same knee needing surgical treatment

    • revision ACL reconstruction

    • double bundle ACL reconstruction

    • concomitant full thickness cartilage injury needing cartilage repairing surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Police Hospital Seoul Korea, Republic of 138-708

    Sponsors and Collaborators

    • National Police Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung Ho Noh, Principal investigator, National Police Hospital
    ClinicalTrials.gov Identifier:
    NCT01513434
    Other Study ID Numbers:
    • NPH2008-004
    First Posted:
    Jan 20, 2012
    Last Update Posted:
    Jan 20, 2012
    Last Verified:
    Jan 1, 2012
    Additional relevant MeSH terms:
    Rupture

    Study Results

    No Results Posted as of Jan 20, 2012