Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Joint Injuries
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is indicated for total ankle arthroplasty
Patient is at least 21 years of age
Patient is likely to be available for follow-up out to 10 years
Patient is willing to participate by complying with pre- and postoperative visitrequirements
Patient is willing and able to read and sign a study informed consent form
Exclusion
Exclusion Criteria:
Patient with excessive bone loss at the ankle joint site
Patient with severe osteoporosis
Patient with complete talar avascular necrosis
Patient with active osteomyelitis
Patient with infection at the ankle site or infection at distant sites that couldmigrate to the ankle
Patient with sepsis
Patient with vascular deficiency in the involved limb
Pateint with neuropathic joints
Patient with neurological or musculoskeletal disease or loss of function that mayadversely affect movement of the lower limb, gait, or weight bearing
Patient with poor soft tissue coverage around the ankle
Patient with Charcot arthropathy
Previsous ankle arthrodesis with excision of the malleoli
Excessive loads as cuased by activity or patient weight - per investigatordiscretion
Skeletally immature patients (patient is less than 21 years if age at time ofsurgery)
Patient with dementia
Patient with known metal allergies
Patients who are unwilling to provide informed consent
Patients who are unlikely to be available for follow-up out to 10 years
Patients who are not deemed suitable candidates for the subject device
Patient is pregnant
Study Design
Connect with a study center
Hospital Universitario de Canarias
Santa Cruz De Tenerife, 38320
SpainActive - Recruiting
SWISS ORTHO CENTER Pain Clinic Basel
Basel, CH-4010
SwitzerlandActive - Recruiting
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