Rheumatoid ArthritisCadenceNCT03142958
Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)
An observational study of Rheumatoid Arthritis and Degenerative Arthritis, run by Smith & Nephew, Inc. at 11 sites in 2 countries.
Trial summary
A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Degenerative Arthritis, Post Traumatic Arthritis
- What is being tested?
- Integra Cadence Total Ankle System
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 24 Aug 2017to 30 Apr 2025
- 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 enrolled in this study will have will have at least one of the indications listed below and meet all of the inclusion criteria. Patients meeting any of the exclusion criteria are not eligible for this study. The Integra® Cadence™ Total Ankle System (CTAS) is indicated for use to treat: * Primary arthritis (e.g. degenerative disease) * Secondary arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved) * Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis). The CTAS is also indicated for revision surgeries following failed total ankle replacement (TAR) and non-union/mal-union of ankle arthrodesis, provided sufficient bone stock is present.
Who may be able to join
- The patient is skeletally mature.
- The patient qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a diagnosis of one of the following: Primary Arthritis (e.g. Degenerative Disease), Secondary Arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved), or Systemic Arthritis of the ankle (e.g. Rheumatoid Arthritis, Hemochromatosis).
- The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent.
- The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent.
Who cannot join
- The patient is Morbidly Obese (defined by Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
- The patient has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise.
- The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
- The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
- The patient is pregnant or plans to become pregnant during the follow up period.
- The patient has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors.
- The patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
- The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
State University of Ney York - Buffalo
Buffalo, New York, 14215
University of Virginia
Charlottesville, Virginia, 22908
Duke University
Durham, North Carolina, 27703
Rothman Institute
Philadelphia, Pennsylvania, 49525
Kaiser Permanente
San Francisco, California, 94118
Florida Orthopedic Foot and Ankle Center
Sarasota, Florida, 34239
Harborview Medical Center
Seattle, Washington, 98104
Catholic Health Initiatives
Seattle, Washington, 98402
OhioHealth Research Institute
Westerville, Ohio, 43082
Canada2 sites
Calgary - South Health Campus
Calgary, Alberta, T3M 1M4
Providence St. Joseph's and St. Michael's Healthcare
Toronto, Ontario, M5B 1W8
About this study
Official title: A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.
- Being tested
- Integra Cadence Total Ankle System
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integra Cadence Total Ankle SystemDevice
Also called Primary Ankle Arthroplasty
Primary or revision on total ankle replacement
| Study group | Role | What they receive |
|---|---|---|
| Integra® Cadence™ Total Ankle System | Not described Receives: Device: Integra Cadence Total Ankle System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Implant survival defined as absence of device removal or revision.
Measured: 2 years
Secondary outcomes (6)
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline
Relative change of PROMIS PF - Mobility compared to baseline
Measured: up to 10 Years
Relative change of Range Of Motion (ROM) compared to baseline
Relative change of ROM compared to baseline
Measured: up to 10 Years
Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline
Relative change of FAAM compared to baseline
Measured: up to 10 Years
Relative change of Pain compared to baseline
Relative change of Visual Analogue Scale Pain compared to baseline
Measured: up to 10 Years
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)
Relative change of SF-36v2 compared to baseline
Measured: up to 10 Years
Implant Survivorship
Implant survival defined as absence of device removal or revision.
Measured: 5 and 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start24 Aug 2017
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Why it stopped: Prematurely terminated -Sponsor decision not due to adverse events, complications, or device issues. Final data collection underway.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Daniels, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142958
- Sponsor's protocol ID
- T-CTAS-001
- Acronym
- Cadence
- Status last verified
- Nov 2024
- First submitted
- 2 May 2017
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
- ClinicalTrials.gov ID
- NCT03142958
- Acronym / sponsor ID
- Cadence / T-CTAS-001
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Prematurely terminated -Sponsor decision not due to adverse events, complications, or device issues. Final data collection underway.
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 8 May 2017 (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.
A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integra® Cadence™ Total Ankle System | – | Device: Integra Cadence Total Ankle System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in this study will have will have at least one of the indications listed below and meet all of the inclusion criteria. Patients meeting any of the exclusion criteria are not eligible for this study. The Integra® Cadence™ Total Ankle System (CTAS) is indicated for use to treat: * Primary arthritis (e.g. degenerative disease) * Secondary arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved) * Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis). The CTAS is also indicated for revision surgeries following failed total ankle replacement (TAR) and non-union/mal-union of ankle arthrodesis, provided sufficient bone stock is present.
Key inclusion criteria (4 listed)
- The patient is skeletally mature.
- The patient qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a diagnosis of one of the following: Primary Arthritis (e.g. Degenerative Disease), Secondary Arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved), or Systemic Arthritis of the ankle (e.g. Rheumatoid Arthritis, Hemochromatosis).
- The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent.
- The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent.
Key exclusion criteria (8 listed)
- The patient is Morbidly Obese (defined by Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
- The patient has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise.
- The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
- The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
- The patient is pregnant or plans to become pregnant during the follow up period.
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 |
|---|---|---|
| Integra Cadence Total Ankle SystemAlso: Primary Ankle ArthroplastyPrimary or revision on total ankle replacement | Device | Integra® Cadence™ Total Ankle System |
Primary outcome
Implant Survivorship
Time frame: 2 years
Implant survival defined as absence of device removal or revision.
6 secondary outcomes
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline
Time frame: up to 10 Years
Relative change of Range Of Motion (ROM) compared to baseline
Time frame: up to 10 Years
Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline
Time frame: up to 10 Years
Relative change of Pain compared to baseline
Time frame: up to 10 Years
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)
Time frame: up to 10 Years
Implant Survivorship
Time frame: 5 and 10 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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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.
Timothy Daniels, MD principal investigator
University of Toronto
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Degenerative Arthritis, run by Smith & Nephew, Inc. at 11 sites in 2 countries.
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 4 inclusion and 8 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: paused, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, 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: 2 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 12 Nov 2024.