NCT00586781

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Link America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Osteoarthritis
• Post-Traumatic Arthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Scandinavian Total Ankle Replacement (STAR)	The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-12-01
• First posted: 2008-01-04
• Last updated: 2008-01-04

Locations

5 sites across 1 country: United States