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Clinical Trials/NCT01533025
NCT01533025CompletedNot Applicable

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

National Police Hospital1 site in 1 country72 target enrollmentStarted: August 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
72
Locations
1
Primary Endpoint
Lysholm score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
19 Years to 45 Years (Adult)
Sex
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
  • •subjects who were older than 45
  • •subjects who had histories of injuries on either knee

Arms & Interventions

bone-tendon Achilles allograft group

Active Comparator

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

Intervention: anterior cruciate ligament reconstruction (Procedure)

free tendon Achilles allogarft group

Active Comparator

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

Intervention: anterior cruciate ligament reconstruction (Procedure)

Outcomes

Primary Outcomes

Lysholm score

Time Frame: 2 years

Secondary Outcomes

  • side-to-side differences(2 years)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Jung Ho Noh

Principal Investigator

National Police Hospital

Study Sites (1)

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Single Bundle Anterior Cruciate Ligament... | Clinical Trial