NCT01533025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

3.4 years

First QC Date

February 10, 2012

Last Update Submit

February 14, 2012

Conditions

Anterior Cruciate Ligament Rupture

Keywords

anterior cruciate ligamentAchillesfree tendonbone-tendonfree tendon Achilles allograftAchilles allograft with calcaneal bone block on its end

Outcome Measures

Primary Outcomes (1)

  • Lysholm score

    2 years

Secondary Outcomes (1)

  • side-to-side differences

    2 years

Study Arms (2)

bone-tendon Achilles allograft group

ACTIVE COMPARATOR

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

Procedure: anterior cruciate ligament reconstruction

free tendon Achilles allogarft group

ACTIVE COMPARATOR

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

Procedure: anterior cruciate ligament reconstruction

Interventions

anterior cruciate ligament reconstructionPROCEDURE

single bundle anterior cruciate ligament reconstruction with Achilles allograft

bone-tendon Achilles allograft groupfree tendon Achilles allogarft group

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Police Hospital

Seoul, 138-708, South Korea

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Jung Ho Noh, M.D., Ph.D.

    National Police Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 15, 2012

Study Start

August 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

KR(1)