Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

February 14, 2012 updated by: Jung Ho Noh, National Police Hospital

Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lysholm score
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side-to-side differences
Time Frame: 2 years
the differences of anterior displacement of tibia under loading between normal knee and reconstructed knee
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Police Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (ESTIMATE)

February 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPH2008-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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