INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Stryker Trauma and Extremities24 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Arthrodesis Degenerative Arthritis Rheumatoid Arthritis Complications; Arthroplasty, Mechanical

Interventions

Radiographic evaluation of previously implanted patientsDEVICE

Radiographs of the ankle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Michael Bolognesi, MD

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Radiographic Evaluation

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

Time frame: Post operarative 1.2 -3.1 years

Data from ClinicalTrials.gov

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