Two Year Follow up of Cadence Total Ankle Replacement

Ankle Arthritis Clinical Trial

Official title:

Two Year Follow up of Cadence Total Ankle Replacement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03866642
• Other study ID #: Cadence-2019
• Status: Active, not recruiting
• Start date: September 1, 2018
• Est. completion date: July 2019

Study information

• Verified date: March 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Over the last decades, total ankle replacement (TAR) emerged as a reliable treatment option in end-stage ankle osteoarthritis (OA) while preserving motion and physiological load. The Cadence™ is a fourth-generation, two-component, fixed-bearing implant with minimal tibial and talar resection. It has been in clinical use since July 2016, the purpose of this study was to compare the clinical outcome and radiological outcomes of total ankle arthroplasty with use of the Cadence™ prosthesis at St. Michael's Hospital.

Description:

Over the last decades, total ankle replacement (TAR) emerged as a reliable treatment option in end-stage ankle osteoarthritis (OA) while preserving motion and physiological load. The Cadence™ is a fourth-generation, two-component, fixed-bearing implant with minimal tibial and talar resection. It has been in clinical use since July 2016, the purpose of this study was to compare the clinical outcome and radiological outcomes of total ankle arthroplasty with use of the Cadence™ prosthesis at St. Michael's Hospital.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2019
• Est. primary completion date: January 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ankle arthritis treated with Cadence Total Ankle Replacement system

Exclusion Criteria:

• Under 18 years of age

Related Conditions & MeSH terms

• Ankle Arthritis

Intervention

Device:
• Cadence Total Ankle Replacment
Cadence Total Ankle prosthesis

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship		Two Years