Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

Smith & Nephew

Status: Suspended

Conditions: Post Traumatic Arthritis; Degenerative Arthritis; Rheumatoid Arthritis

Treatments: Device: Integra Cadence Total Ankle System

Study type: Observational

Funder types: Industry

Identifiers

NCT03142958

T-CTAS-001

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

132 participants in 1 patient group

Integra® Cadence™ Total Ankle System

Treatment:

Device: Integra Cadence Total Ankle System