Back to resultsSimultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
Primary Purpose
Rupture of Posterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cruciate ligament reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Rupture of Posterior Cruciate Ligament focused on measuring Achilles allograft, cruciate ligament, reconstruction
Eligibility Criteria
Inclusion Criteria:
- subjects who had any concomitant meniscus or cartilage injuries
Exclusion Criteria:
- subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex
- subject who wanted reconstruction with autograft
- subject who denied participation in this study
- subject who would meet the national reimbursement criteria
Sites / Locations
- National Police Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Achilles allograft
Arm Description
Outcomes
Primary Outcome Measures
circumference and length of the Achilles allograft
After the fresh frozen Achilles allograft was thawed, circumference and length of the tendinous portion of the allograft were measured. According to the circumference and length of the allograft, it was divided into two or three grafts for cruciate ligament reconstruction.
Secondary Outcome Measures
Full Information
NCT ID
NCT01440348
First Posted
September 21, 2011
Last Updated
September 23, 2011
Sponsor
National Police Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01440348
Brief Title
Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
Official Title
Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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
This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Posterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament
Keywords
Achilles allograft, cruciate ligament, reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Achilles allograft
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
cruciate ligament reconstruction
Intervention Description
Multiple cruciate ligament reconstructions with a single Achilles allograft with was divided into two or three strips according to the thickness and length of the allograft.
Primary Outcome Measure Information:
Title
circumference and length of the Achilles allograft
Description
After the fresh frozen Achilles allograft was thawed, circumference and length of the tendinous portion of the allograft were measured. According to the circumference and length of the allograft, it was divided into two or three grafts for cruciate ligament reconstruction.
Time Frame
day 1
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects who had any concomitant meniscus or cartilage injuries
Exclusion Criteria:
subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex
subject who wanted reconstruction with autograft
subject who denied participation in this study
subject who would meet the national reimbursement criteria
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
Learn more about this trial
Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
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