3D-Printed ankle bone implant tested in new study
NCT ID NCT06311331
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a custom 3D-printed device that replaces the talus bone in the ankle. The device is designed for people with severe bone damage from conditions like avascular necrosis or large cartilage defects. Researchers will follow 50 participants for 5 years to see if the implant stays in place and reduces pain without serious complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Total Talus Replacement (TTR) device
- What this could lead to
- If successful, this device could offer a way to replace a damaged ankle bone, reducing pain and helping people avoid ankle fusion or amputation.
- What could go wrong
- This is a small, single-arm study with only 50 participants, so results may not apply to everyone. There is a risk of device-related complications or the need for further surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults (≥22 years of age) who will receive a restor3d Total Talus Replacement device under an approved HDE for one of the indications listed on the Instructions for Use (IFU) and who do not have a contraindication (see Inclusion and Exclusion Criteria)
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.