Two Year Follow up of Cadence Total Ankle Replacement | NCT03866642

Studies
Two Year Follow up of Cadence Total Ankle Replacement

NCT03866642

Sponsor

Unity Health Toronto

Status

Unknown status

Last Update Posted

Mar 7, 2019Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Ankle Arthritis

Interventions

Cadence Total Ankle Replacment

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Jan 5, 2019Actual

Completion Date

Jul 2019Estimated

First Submitted Date

Mar 5, 2019

First Submission Date that Met QC Criteria

Mar 5, 2019

First Posted Date

Mar 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2019

Last Update Posted Date

Mar 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cadence Total Ankle Replacment	Device	Cadence Total Ankle prosthesis

Measure	Description	Time Frame
Implant Survivorship		Two Years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ankle arthritis treated with Cadence Total Ankle Replacement system

Exclusion Criteria:

Under 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with end-stage ankle arthritis requiring surgical intervention.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Michael's Hospital		Toronto	Ontario	M5B 1W8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided