Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

Sponsor
Rothman Institute Orthopaedics (Other)
Overall Status
Completed
CT.gov ID
NCT01156558
Collaborator
DePuy Orthopaedics (Industry)
30

Study Details

Study Description

Brief Summary

Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
    Study Start Date :
    Jun 1, 2010
    Actual Primary Completion Date :
    Jul 1, 2010
    Actual Study Completion Date :
    Jul 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Implant survivorship 2 years following revision TKA []

    Secondary Outcome Measures

    1. Knee Society Score []

    2. KOOS score []

    3. Radiographic assessment 1 and 2 years following revision surgery []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used

    2. Cases with at least 2 year follow-up

    3. Cases with regular follow-up visits completed

    Exclusion Criteria:
    1. Cemented sleeves

    2. Patients with less than two year follow-up completed

    3. Cases lost to follow-up

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rothman Institute Orthopaedics
    • DePuy Orthopaedics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01156558
    Other Study ID Numbers:
    • 10FA01
    First Posted:
    Jul 5, 2010
    Last Update Posted:
    Mar 31, 2011
    Last Verified:
    Mar 1, 2011

    Study Results

    No Results Posted as of Mar 31, 2011