Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital
ClinicalTrials.gov Identifier:
NCT01440348
First received: September 21, 2011
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Rupture of Posterior Cruciate Ligament
Rupture of Anterior Cruciate Ligament
Procedure: cruciate ligament reconstruction
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

Resource links provided by NLM:


Further study details as provided by National Police Hospital:

Primary Outcome Measures:
  • circumference and length of the Achilles allograft [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jung Ho Noh, Orthopaedic surgeon, National Police Hospital
ClinicalTrials.gov Identifier: NCT01440348     History of Changes
Other Study ID Numbers: NPH2010-001
Study First Received: September 21, 2011
Last Updated: September 23, 2011
Health Authority: Korea: Institutional Review Board
United States: Federal Government

Keywords provided by National Police Hospital:
Achilles allograft
cruciate ligament
reconstruction

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on July 09, 2014