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Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital
ClinicalTrials.gov Identifier:
NCT01533025
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  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 Blind (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:

U.S. FDA Resources

Further study details as provided by National Police Hospital:

Primary Outcome Measures:
  • Lysholm score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • side-to-side differences [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   19 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jung Ho Noh, Principal Investigator, National Police Hospital
ClinicalTrials.gov Identifier: NCT01533025     History of Changes
Other Study ID Numbers: NPH2008-007
Study First Received: February 10, 2012
Last Updated: February 14, 2012
Health Authority: United States: Federal Government
Korea: Institutional Review Board

Keywords provided by 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
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013