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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital
ClinicalTrials.gov Identifier:
NCT01513434
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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 Intervention
Anterior Cruciate Ligament Rupture
Procedure: transtibial technique
Procedure: Transportal technique
Procedure: anterior cruciate ligament reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Police Hospital:

Primary Outcome Measures:
  • Lysholm score [ Time Frame: at least two years after surgery ] [ Designated as safety issue: No ]
    Lysholm score was superior in transportal technique to transtibial technique.

  • Position of femoral tunnel aperture [ Time Frame: within one week after surgery ] [ Designated as safety issue: No ]
    The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.


Enrollment: 64
Study Start Date: July 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01513434

Locations
Korea, Republic of
National Police Hospital
Seoul, Korea, Republic of, 138-708
Sponsors and Collaborators
National Police Hospital
  More Information

No publications provided

Responsible Party: Jung Ho Noh, Principal investigator, National Police Hospital
ClinicalTrials.gov Identifier: NCT01513434     History of Changes
Other Study ID Numbers: NPH2008-004
Study First Received: January 16, 2012
Last Updated: January 19, 2012
Health Authority: Korea: Institutional Review Board
United States: Federal Government

ClinicalTrials.gov processed this record on October 19, 2014