INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Rheumatoid Arthritis Clinical Trial

Official title:

INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01366989
• Other study ID #: 08-SJA-001
• Status: Terminated
• Phase: N/A
• First received: June 2, 2011
• Last updated: February 15, 2017
• Start date: October 2010
• Est. completion date: June 4, 2013

Study information

• Verified date: February 2017
• Source: Wright Medical Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: June 4, 2013
• Est. primary completion date: June 4, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Radiographic evaluation of previously implanted patients
Radiographs of the ankle

Locations

Country	Name	City	State
United States	Michael Bolognesi, MD	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wright Medical Technology	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post operarative 1.2 -3.1 years