INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Stryker Trauma and Extremities

Status: Terminated

Conditions: Complications; Arthroplasty, Mechanical; Arthrodesis; Degenerative Arthritis; Rheumatoid Arthritis

Treatments: Device: Radiographic evaluation of previously implanted patients

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01366989

08-SJA-001

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

Total Ankle Arthroplasty with calcaneal stem

Description:

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

Treatment:

Device: Radiographic evaluation of previously implanted patients