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Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
anterior cruciate ligament reconstruction
Sponsored by
National Police Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring anterior cruciate ligament, Achilles, free tendon, bone-tendon, free tendon Achilles allograft, Achilles allograft with calcaneal bone block on its end

Eligibility Criteria

19 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Police Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

bone-tendon Achilles allograft group

free tendon Achilles allogarft group

Arm Description

the group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft

the group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft

Outcomes

Primary Outcome Measures

Lysholm score

Secondary Outcome Measures

side-to-side differences
the differences of anterior displacement of tibia under loading between normal knee and reconstructed knee

Full Information

First Posted
February 10, 2012
Last Updated
February 14, 2012
Sponsor
National Police Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01533025
Brief Title
Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men
Official Title
Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Police Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
anterior cruciate ligament, Achilles, free tendon, bone-tendon, free tendon Achilles allograft, Achilles allograft with calcaneal bone block on its end

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bone-tendon Achilles allograft group
Arm Type
Active Comparator
Arm Description
the group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft
Arm Title
free tendon Achilles allogarft group
Arm Type
Active Comparator
Arm Description
the group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft
Intervention Type
Procedure
Intervention Name(s)
anterior cruciate ligament reconstruction
Intervention Description
single bundle anterior cruciate ligament reconstruction with Achilles allograft
Primary Outcome Measure Information:
Title
Lysholm score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
side-to-side differences
Description
the differences of anterior displacement of tibia under loading between normal knee and reconstructed knee
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Ho Noh, M.D., Ph.D.
Organizational Affiliation
National Police Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Police Hospital
City
Seoul
ZIP/Postal Code
138-708
Country
Korea, Republic of

12. IPD Sharing Statement

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