Clinical trial NCT03142958: Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)
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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Rheumatoid Arthritis
Degenerative Arthritis
Post Traumatic Arthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Implant Survivorship
timeFrame: 2 years
Secondary outcomes:
measure: Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline
timeFrame: up to 10 Years
measure: Relative change of Range Of Motion (ROM) compared to baseline
timeFrame: up to 10 Years
measure: Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline
timeFrame: up to 10 Years
measure: Relative change of Pain compared to baseline
timeFrame: up to 10 Years
measure: Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)
timeFrame: up to 10 Years
measure: Implant Survivorship
timeFrame: 5 and 10 Years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Sarasota
country: United States
facility: Florida Orthopedic Foot and Ankle Center
state: Florida
city: Buffalo
country: United States
facility: State University of Ney York - Buffalo
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Westerville
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Catholic Health Initiatives
state: Washington
city: Calgary
country: Canada
facility: Calgary - South Health Campus
state: Alberta
city: Toronto
country: Canada
facility: Providence St. Joseph's and St. Michael's Healthcare
state: Ontario
Study officials:
affiliation: University of Toronto
name: Timothy Daniels, MD
role: PRINCIPAL_INVESTIGATOR
References: