Degenerative Arthritis, Post Traumatic Arthritis, Rheumatoid Arthritis
Conditions
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.
Interventions
DEVICEIntegra Cadence Total Ankle System
Primary or revision on total ankle replacement
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship | 2 years | Implant survival defined as absence of device removal or revision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change of Range Of Motion (ROM) compared to baseline | up to 10 Years | Relative change of ROM compared to baseline |
| Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline | up to 10 Years | Relative change of FAAM compared to baseline |
| Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline | up to 10 Years | Relative change of PROMIS PF - Mobility compared to baseline |
| Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) | up to 10 Years | Relative change of SF-36v2 compared to baseline |
| Implant Survivorship | 5 and 10 Years | Implant survival defined as absence of device removal or revision. |
| Relative change of Pain compared to baseline | up to 10 Years | Relative change of Visual Analogue Scale Pain compared to baseline |
Countries
Canada, United States
Outcome results
None listed