Ankle ArthritisNCT03866642
Two Year Follow up of Cadence Total Ankle Replacement
An observational study of Ankle Arthritis, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Arthritis
- What is being tested?
- Cadence Total Ankle Replacment
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage ankle arthritis requiring surgical intervention.
Who may be able to join
- Ankle arthritis treated with Cadence Total Ankle Replacement system
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ankle Arthritis
- Being tested
- Cadence Total Ankle Replacment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadence Total Ankle ReplacmentDevice
Cadence Total Ankle prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Sep 2018
- Primary completion5 Jan 2019
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ArthritisStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866642
- Sponsor's protocol ID
- Cadence-2019
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Year Follow up of Cadence Total Ankle Replacement
- ClinicalTrials.gov ID
- NCT03866642
- Acronym / sponsor ID
- Cadence-2019
- Conditions
- Ankle Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 5 Jan 2019 (actual)
- Study completion
- Jul 2019 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage ankle arthritis requiring surgical intervention.
Key inclusion criteria (1 listed)
- Ankle arthritis treated with Cadence Total Ankle Replacement system
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadence Total Ankle ReplacmentCadence Total Ankle prosthesis | Device | – |
Primary outcome
Implant Survivorship
Time frame: Two Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Ankle Arthritis
Not yet recruitingPhase 2
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Ankle Arthritis, Wound Complication
RecruitingObservational study
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Rheumatoid Arthritis, Arthritis of Ankle
RecruitingObservational study
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
Ankle Rheumatoid Arthritis, Arthritis of Ankle
Active, not recruitingObservational study
Longitudinal Changes in Lower Extremity Alignment and Mechanical Axis Parameters After Bariatric Surgery in Patients With Morbid Obesity: A Prospective Observational Study
Obese, Limb Deformities
Not yet recruitingObservational study
Diagnostic Accuracy of Triphasic Bone Scan and SPECT/CT in Foot and Ankle Osteoarthritis
Osteoarthritis, Foot Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Arthritis, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survivorship (time frame: Two Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.