NCT03866642

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

March 5, 2019

Last Update Submit

March 5, 2019

Conditions

Ankle Arthritis

Outcome Measures

Primary Outcomes (1)

  • Implant Survivorship

    Two Years

Interventions

Cadence Total Ankle ReplacmentDEVICE

Cadence Total Ankle prosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end-stage ankle arthritis requiring surgical intervention.

You may qualify if:

  • Ankle arthritis treated with Cadence Total Ankle Replacement system

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 7, 2019

Study Start

September 1, 2018

Primary Completion

January 5, 2019

Study Completion

July 1, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

CA(1)