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Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533025
First Posted: February 15, 2012
Last Update Posted: February 15, 2012
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.
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital
  Purpose
The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles allograft are comparable to those using Achilles allograft with bone block on its end.

Condition Intervention
Anterior Cruciate Ligament Rupture Procedure: anterior cruciate ligament reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft

Resource links provided by NLM:


Further study details as provided by Jung Ho Noh, National Police Hospital:

Primary Outcome Measures:
  • Lysholm score [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • side-to-side differences [ Time Frame: 2 years ]
    the differences of anterior displacement of tibia under loading between normal knee and reconstructed knee


Enrollment: 72
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bone-tendon Achilles allograft group
the group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft
Procedure: anterior cruciate ligament reconstruction
single bundle anterior cruciate ligament reconstruction with Achilles allograft
Active Comparator: free tendon Achilles allogarft group
the group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft
Procedure: anterior cruciate ligament reconstruction
single bundle anterior cruciate ligament reconstruction with Achilles allograft

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male subjects
  • subjects who had concomitant medial collateral ligament injury which was managed conservatively
  • subjects who had meniscus tear which was managed by partial meniscectomy

Exclusion Criteria:

  • subjects who underwent a subtotal or total meniscectomy, meniscal repair, or meniscal transplantation due to meniscus injury
  • subjects who underwent an operation due to any concomitant ipsilateral ligament injuries
  • subjects who underwent microfracture or cartilage transplantation due to full thickness cartilage injury
  • female
  • subjects who were older than 45
  • subjects who had histories of injuries on either knee
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533025


Locations
Korea, Republic of
National Police Hospital
Seoul, Korea, Republic of, 138-708
Sponsors and Collaborators
National Police Hospital
Investigators
Principal Investigator: Jung Ho Noh, M.D., Ph.D. National Police Hospital
  More Information

Responsible Party: Jung Ho Noh, Principal Investigator, National Police Hospital
ClinicalTrials.gov Identifier: NCT01533025     History of Changes
Other Study ID Numbers: NPH2008-007
First Submitted: February 10, 2012
First Posted: February 15, 2012
Last Update Posted: February 15, 2012
Last Verified: February 2012

Keywords provided by Jung Ho Noh, National Police Hospital:
anterior cruciate ligament
Achilles
free tendon
bone-tendon
free tendon Achilles allograft
Achilles allograft with calcaneal bone block on its end

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries