A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

Smith & Nephew, Inc.11 sites in 2 countries132 target enrollmentAugust 24, 2017

ConditionsRheumatoid Arthritis Degenerative Arthritis Post Traumatic Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Smith & Nephew, Inc.
Enrollment: 132
Locations: 11
Primary Endpoint: Implant Survivorship
Status: Suspended
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 24, 2017

End Date

April 30, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Smith & Nephew, Inc.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Implant Survivorship

Time Frame: 2 years

Implant survival defined as absence of device removal or revision.

Secondary Outcomes

Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline(up to 10 Years)
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)(up to 10 Years)
Relative change of Pain compared to baseline(up to 10 Years)
Implant Survivorship(5 and 10 Years)
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline(up to 10 Years)
Relative change of Range Of Motion (ROM) compared to baseline(up to 10 Years)