Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

• Sponsor: National Police Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01533025
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Rupture	Procedure: anterior cruciate ligament reconstruction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bone-tendon Achilles allograft group the group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft	Procedure: anterior cruciate ligament reconstruction; single bundle anterior cruciate ligament reconstruction with Achilles allograft
Active Comparator: free tendon Achilles allogarft group the group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft	Procedure: anterior cruciate ligament reconstruction; single bundle anterior cruciate ligament reconstruction with Achilles allograft

Outcome Measures

Primary Outcome Measures

1. Lysholm score [2 years]

Secondary Outcome Measures

1. side-to-side differences [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jung Ho Noh, Principal Investigator, National Police Hospital
• ClinicalTrials.gov Identifier: NCT01533025
• Other Study ID Numbers: NPH2008-007
• First Posted: Feb 15, 2012
• Last Update Posted: Feb 15, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Jung Ho Noh, Principal Investigator, National Police Hospital: anterior cruciate ligament; Achilles; free tendon; bone-tendon; free tendon Achilles allograft; Achilles allograft with calcaneal bone block on its end
• Additional relevant MeSH terms: Rupture

Study Results

No Results Posted as of Feb 15, 2012