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

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.