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

Launched by RESTOR3D · Mar 13, 2024

Keywords

ClinConnect Summary

This study is watching how safe and helpful the restor3d Total Talus Replacement (TTR) device is for people who have already received it under a humanitarian device exemption. It is an ongoing, multi-center, prospective (looking forward) study that follows about 50 adults who are getting the TTR implant to treat problems like avascular necrosis (dead bone) of the talus or large talar defects. The device is a cobalt-chromium implant designed to replace the talus bone while helping the ankle keep its movement. The study focuses on the long-term safety and “probable benefit” of the implant in real-world use.

Who can participate? Adults aged 22 and older who are about to receive the TTR implant for one of the approved talus conditions, have not had a TTR implant before, and are not planning to have implants in both ankles, and who sign informed consent. People with certain issues such as other surgeries, infection, or serious degeneration in nearby ankle joints, or conditions that could affect healing, may not be eligible. What to expect if you join: you’ll be followed for up to about 5 years after the surgery, with visits to measure pain levels, overall foot-and-ankle function, daily activities, ankle movement, and any safety problems. The main goal is to see what proportion of participants have no device-related serious problems or additional surgeries and still have the implant in place at 5 years. The study is sponsored by Restor3D, with collaboration from OrthoCarolina Research Institute in Charlotte, NC, and is currently enrolling by invitation, with results expected around 2031.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥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
• Exclusion Criteria:
• • 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.
• • 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
• • Patients with an active local or systemic infection.
• • Osteonecrosis of the calcaneus, distal tibia or navicular.
• • Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site.
• • Blood supply limitations and previous infections that may prevent healing.
• • 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.
• • Presence of neurological deficit which would prevent patient postoperative compliance.
• • 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.