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Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease

Rheumatoid Arthritis Clinical Trial

Official title:
Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm

Clinical Trial Summary

The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.

Clinical Trial Description

The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00586781
Study type Interventional
Source Link America, Inc.
Contact
Status Completed
Phase Phase 3
Start date September 2001
View Details
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