NCT03142958

Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.

Conditions

• Rheumatoid Arthritis
• Degenerative Arthritis
• Post Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Integra Cadence Total Ankle System	Primary or revision on total ankle replacement

Timeline

• Start date: 2017-08-24
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2017-05-08
• Last updated: 2024-11-12

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study