NCT01440348

Brief Summary

This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

4 months

First QC Date

September 21, 2011

Last Update Submit

September 23, 2011

Conditions

Rupture of Posterior Cruciate LigamentRupture of Anterior Cruciate Ligament

Keywords

Achilles allograftcruciate ligamentreconstruction

Outcome Measures

Primary Outcomes (1)

  • circumference and length of the Achilles allograft

    After the fresh frozen Achilles allograft was thawed, circumference and length of the tendinous portion of the allograft were measured. According to the circumference and length of the allograft, it was divided into two or three grafts for cruciate ligament reconstruction.

    day 1

Study Arms (1)

Achilles allograft

EXPERIMENTAL
Procedure: cruciate ligament reconstruction

Interventions

cruciate ligament reconstructionPROCEDURE

Multiple cruciate ligament reconstructions with a single Achilles allograft with was divided into two or three strips according to the thickness and length of the allograft.

Achilles allograft

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • subjects who had any concomitant meniscus or cartilage injuries

You may not qualify if:

  • subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex
  • subject who wanted reconstruction with autograft
  • subject who denied participation in this study
  • subject who would meet the national reimbursement criteria

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

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Jung Ho Noh, M.D., Ph.D.

    National Police Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic surgeon

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 26, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations

KR(1)