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INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Sponsor
Stryker Trauma GmbH (Industry)
Overall Status
Terminated
CT.gov ID
NCT01366989
Collaborator
Duke University (Other)
24
Enrollment
1
Location
32.1
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.

Condition or Disease Intervention/Treatment Phase
  • Device: Radiographic evaluation of previously implanted patients

Detailed Description

The primary objective of this study is to determine the radiographic outcomes of patients who have received TAA with the calcaneal stem. Due to the fixation of the stem in the calcaneus, talar component position, osteolysis and bone quality are of interest to the FDA. Specifically, subsidence and/or migration of the talar component, osteolysis as a measure of wear, and bone quality of the talus, cuboid and navicular are to be evaluated in this study. Therefore, the radiographic outcomes of this study aim to assess these parameters

Study Design

Study Type:
Observational
Actual Enrollment :
24 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
Actual Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Jun 4, 2013
Actual Study Completion Date :
Jun 4, 2013

Arms and Interventions

Arm Intervention/Treatment
Total Ankle Arthroplasty with calcaneal stem

Patients received the TAA with calcaneal stem between 12/6/05 & 11/13/07 at approximately 28 sites.

Device: Radiographic evaluation of previously implanted patients
Radiographs of the ankle
Other Names:
  • Radiographs of previously implanted patients

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Radiographic Evaluation [Post operarative 1.2 -3.1 years]

      Bone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

    Exclusion Criteria:

    Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Michael Bolognesi, MD Durham North Carolina United States 27705

    Sponsors and Collaborators

    • Stryker Trauma GmbH
    • Duke University

    Investigators

    • Principal Investigator: Michael Bolognesi, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stryker Trauma GmbH
    ClinicalTrials.gov Identifier:
    NCT01366989
    Other Study ID Numbers:
    • 08-SJA-001
    First Posted:
    Jun 6, 2011
    Last Update Posted:
    Feb 17, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Stryker Trauma GmbH
    Total Ankle Arthroplasty
    Additional relevant MeSH terms:
    Arthritis
    Osteoarthritis

    Study Results

    No Results Posted as of Feb 17, 2017