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Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

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ClinicalTrials.gov Identifier: NCT01440348
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : September 26, 2011
Sponsor:
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital

Brief Summary:
This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.

Condition or disease Intervention/treatment Phase
Rupture of Posterior Cruciate Ligament Rupture of Anterior Cruciate Ligament Procedure: cruciate ligament reconstruction Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Achilles allograft Procedure: cruciate ligament reconstruction
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 Measures :
  1. circumference and length of the Achilles allograft [ Time Frame: day 1 ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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): NCT01440348


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

Responsible Party: Jung Ho Noh, Orthopaedic surgeon, National Police Hospital
ClinicalTrials.gov Identifier: NCT01440348     History of Changes
Other Study ID Numbers: NPH2010-001
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011

Keywords provided by Jung Ho Noh, National Police Hospital:
Achilles allograft
cruciate ligament
reconstruction

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