NCT01366989

INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Arthrodesis
• Degenerative Arthritis
• Rheumatoid Arthritis
• Complications; Arthroplasty, Mechanical

Interventions

Type	Name	Description
DEVICE	Radiographic evaluation of previously implanted patients	Radiographs of the ankle

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-06-04
• Completion: 2013-06-04
• First posted: 2011-06-06
• Last updated: 2017-02-17

Locations

1 site across 1 country: United States