Zimmer Trabecular Metal Total Ankle PMCF

Korábbi kezelés

• 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 a previous history of infection in the affected joint

Más betegség

• 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 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

Egyéb

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

• 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