INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-04

Brief Summary

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

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Detailed Description

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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

Conditions

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Arthrodesis Degenerative Arthritis Rheumatoid Arthritis Complications; Arthroplasty, Mechanical

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Total Ankle Arthroplasty with calcaneal stem

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

Radiographic evaluation of previously implanted patients

Intervention Type DEVICE

Radiographs of the ankle

Interventions

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Radiographic evaluation of previously implanted patients

Radiographs of the ankle

Intervention Type DEVICE

Other Intervention Names

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Radiographs of previously implanted patients

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No