Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

NCT ID: NCT01533025

Last Updated: 2012-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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bone-tendon Achilles allograft group

the group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft

Group Type ACTIVE_COMPARATOR

anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

single bundle anterior cruciate ligament reconstruction with Achilles allograft

free tendon Achilles allogarft group

the group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft

Group Type ACTIVE_COMPARATOR

anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

single bundle anterior cruciate ligament reconstruction with Achilles allograft

Interventions

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anterior cruciate ligament reconstruction

single bundle anterior cruciate ligament reconstruction with Achilles allograft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Police Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jung Ho Noh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Ho Noh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Police Hospital

Locations

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National Police Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NPH2008-007

Identifier Type: -

Identifier Source: org_study_id

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