NCT06311331
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Enrolling by Invitation
Not specifiedAges 22+ObservationalRestor3D
~50 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Total Talus Replacement (TTR)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who pass a composite of safety and probable benefit outcomes
Measured over At 5 years compared to baseline
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
≥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
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.
What this trial measures
- Proportion of participants who pass a composite of safety and probable benefit outcomesAt 5 years compared to baseline
The primary endpoint for this post approval study is a composite of safety and probable benefit. The safety endpoint is defined by the absence of device-related SAE and subsequent secondary surgical intervention (SSSI) on the affected joints. The probable benefit endpoint is defined as joint salvage with the restor3d device still in place. This composite endpoint will be evaluated by determining the proportion of patients who do not have a device-related SAE or SSSI, AND have the restor3d implant in place at 5 years.