Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (P… (NCT06311331) | Clinical Trial Compass
By InvitationNot Applicable
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
United States50 participantsStarted 2024-11-06
Plain-language summary
This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
*…
What they're measuring
1
Proportion of participants who pass a composite of safety and probable benefit outcomes