Zimmer Trabecular Metal Total Ankle

The study design is a prospective, multicenter, study of the commercially available Zimmer
Trabecular Metal Ankle semiconstrained implants. The study will require each site to obtain
Institutional Review Board approval prior to study enrollment. All potential study subjects
will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their primary or
revision total ankle arthroplasty. The post-operative clinical and radiographic evaluations
will be conducted at 6 weeks, 6 month, 1 year, 2, 3, 5, 7, and 10 years. Follow-up surveys
will occur at 4, 6, 8, and 9 years.

Inclusion Criteria:

- The patient is > 18 years of age

- The patient is skeletally mature

- The patient qualifies for primary or revision total ankle replacement based on
physical exam and medical history including the following: degenerative arthritis,
rheumatoid arthritis, post-traumatic arthritis.

- The patient is willing and able to provide written informed consent

- Patient is willing and able to cooperate in the required post-operative therapy

- The patient is willing and able to complete scheduled follow-up evaluations
questionnaires as described in the Informed Consent

- The patient has participated in the Informed Consent process and has signed the
Institutional Review Board/European Commission approved Informed Consent

Exclusion Criteria:

- The patient is: a prisoner, mentally incompetent or unable to understand what
participation in the study entails, a known alcohol or drug abuser, anticipated to be
non-compliant.

- The patient has one of the following compromising the affected limb: ankle arthrodesis
with malleolar exeresis, severe neurological or vascular disease, loss of musculature
or neuromuscular compromise, severe instability, maltracking or misalignment of the
tibia and talus uncorrectable by surgery.

- The patient has a local/systemic infection that may affect the prosthetic joint

- The patient has a previous history of infection in the affected joint

- The patient is known to be pregnant

- The patient has insufficient bone stock or bone quality to fix the components (i.e.
osteoporosis, Charcot's disease)

- The patient has a known sensitivity or allergic reaction to one or more of the
implanted materials

- The patient is unwilling or unable to give consent or to comply with the follow-up
program