Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440348
• Other study ID #: NPH2010-001
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2011
• Last updated: September 23, 2011
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: National Police Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rupture
• Rupture of Anterior Cruciate Ligament
• Rupture of Posterior Cruciate Ligament

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	National Police Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Police Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 1	No