NCT01284283

2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use

2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Encore Medical, L.P. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.

Detailed description

This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.

Conditions

• Primary Arthrosis
• Post Traumatic Arthritis
• Rheumatoid Arthritis
• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Scandinavian Total Ankle Replacement System (STAR Ankle)	For total ankle replacement

Timeline

• Start date: 2009-11-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2011-01-26
• Last updated: 2022-07-29

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study