INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Terminated

• Conditions: Arthrodesis; Complications; Arthroplasty, Mechanical; Degenerative Arthritis; Rheumatoid Arthritis
• Interventions: Device: Radiographic evaluation of previously implanted patients

• Registration Number: NCT01366989
• Lead Sponsor: Stryker Trauma and Extremities

Brief 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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Primary Completion: 2013-06-04
• Study Completion: 2013-06-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Ankle Arthroplasty with calcaneal stem	Radiographic evaluation of previously implanted patients	Patients received the TAA with calcaneal stem between 12/6/05 \& 11/13/07 at approximately 28 sites.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Michael Bolognesi, MD; 🇺🇸 Durham, North Carolina, United States