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INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

This study has been terminated.
(The retrospective data review did not provide adequate information to continue the investigation.)
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Wright Medical Technology
ClinicalTrials.gov Identifier:
NCT01366989
First received: June 2, 2011
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Arthrodesis
Degenerative Arthritis
Rheumatoid Arthritis
Complications; Arthroplasty, Mechanical
 Device: Radiographic evaluation of previously implanted patients

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wright Medical Technology:

Primary Outcome Measures:
  • Radiographic Evaluation [ Time Frame: Post operarative 1.2 -3.1 years ] [ Designated as safety issue: Yes ]
    Bone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs


Enrollment: 24
Study Start Date: October 2010
Groups/Cohorts Assigned Interventions
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 Name: Radiographs 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366989

Locations
United States, North Carolina
Michael Bolognesi, MD
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Wright Medical Technology
Duke University
Investigators
Principal Investigator: Michael Bolognesi, MD Duke University
  More Information

No publications provided

Responsible Party: Wright Medical Technology
ClinicalTrials.gov Identifier: NCT01366989     History of Changes
Other Study ID Numbers: 08-SJA-001
Study First Received: June 2, 2011
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wright Medical Technology:
Total Ankle Arthroplasty

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013