Two Year Follow up of Cadence Total Ankle Replacement

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03866642
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Arthritis	Device: Cadence Total Ankle Replacment

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Two Year Follow up of Cadence Total Ankle Replacement
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Jan 5, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Outcome Measures

Primary Outcome Measures

1. Implant Survivorship [Two Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ankle arthritis treated with Cadence Total Ankle Replacement system

Exclusion Criteria:

• Under 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8

Sponsors and Collaborators

• Unity Health Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT03866642
• Other Study ID Numbers: Cadence-2019
• First Posted: Mar 7, 2019
• Last Update Posted: Mar 7, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Arthritis

Study Results

No Results Posted as of Mar 7, 2019