What this study is
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.
What's being tested
- Total Talus Replacement (TTR)
Intervention · DEVICE
The restor3d patient-specific TTR Implant and Instrumentation System is designed to replace a native talus bone that has been affected by a disease state or injury. The implant is an additively manufactured Cobalt Chromium alloy (ASTM F3213) construct produced by laser powder bed fusion. The data-driven design of the implant enables the patient to salvage their joint while maintaining ankle range of motion, reducing pain and improving physical function.
Study details
- Official title
- Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM): A Multicenter, Single Arm, Prospective, Post-approval Study for Patients Who Received the restor3d TTR Device to Evaluate Safety and Probable Benefit
- Sponsor
- Restor3D
- Conditions
- Avascular Necrosis of the Talus · Talar Osteochondral Defect of Ankle · Talar Dysfunction
- Enrolling
- 50 people
- Starts
- 2024-11-06
- Est. completion
- 2031-11
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Study team
Sponsor
Restor3D
Study ID restor3d-007
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.