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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01513434
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Sponsor:
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital

Tracking Information
First Submitted Date  ICMJE January 16, 2012
First Posted Date  ICMJE January 20, 2012
Last Update Posted Date January 20, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Lysholm score [ Time Frame: at least two years after surgery ]
    Lysholm score was superior in transportal technique to transtibial technique.
  • Position of femoral tunnel aperture [ Time Frame: within one week after surgery ]
    The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Rupture
Intervention  ICMJE
  • Procedure: transtibial technique
    Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.
  • 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
Study Arms  ICMJE
  • Active Comparator: transtibial technique
    In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.
    Interventions:
    • Procedure: transtibial technique
    • Procedure: anterior cruciate ligament reconstruction
  • Active Comparator: Transportal technique
    In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.
    Interventions:
    • Procedure: Transportal technique
    • Procedure: anterior cruciate ligament reconstruction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2012)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 17 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01513434
Other Study ID Numbers  ICMJE NPH2008-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jung Ho Noh, National Police Hospital
Study Sponsor  ICMJE National Police Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Police Hospital
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP