Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: anterior cruciate ligament reconstruction

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-708
    • National Police Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lysholm score	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side-to-side differences	the differences of anterior displacement of tibia under loading between normal knee and reconstructed knee	2 years

Collaborators and Investigators

• Sponsor: National Police Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (ESTIMATE): February 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 15, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Achilles; anterior cruciate ligament; free tendon; bone-tendon; free tendon Achilles allograft; Achilles allograft with calcaneal bone block on its end
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: NPH2008-007