Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)

Ki vehet részt

• ≥22 Years of Age
• Scheduled to receive TTR implant for one of the following indications:
• Avascular necrosis of the talus
• Avascular necrosis of the talus in addition to talar collapse, cysts or non-union
• Large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments
• Nonunion following talar fracture or talar extrusion, unresponsive to more conservative treatments
• Have not had a prior Total Talus Replacement device implanted
• Not planning to receive bilateral Total Talus Replacement devices
• Subject signs a written informed consent form (ICF) prior to the surgical procedure

Ki nem vehet részt

• Surgical procedures other than those listed in the indications for use
• Use of implant greater than 6 months from date of patient's preoperative CT scan
• Blood supply limitations and previous infections that may prevent healing
• Patients with foreign body sensitivity, suspected or documented material allergy or intolerance. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation
• Patients with an active local or systemic infection
• Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site
• Physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage
• Conditions which may limit the patient's ability or willingness to restrict activities or follow directions postoperatively during the healing period
• Degenerative changes in the tibiotalar, subtalar or talonavicular joints
• Gross deformity in sagittal or coronal planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane
• Osteonecrosis of the calcaneus, distal tibia or navicular
• Presence of neurological deficit which would prevent patient postoperative compliance