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INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01366989
Enrollment
24
Registered
2011-06-06
Start date
2010-10-31
Completion date
2013-06-04
Last updated
2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Total Ankle Arthroplasty

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

Interventions

DEVICERadiographic evaluation of previously implanted patients

Radiographs of the ankle

Sponsors

Duke University
CollaboratorOTHER
Stryker Trauma and Extremities
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic EvaluationPost operarative 1.2 -3.1 yearsBone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026