Avascular Necrosis of the TalusNCT06311331
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
An observational study of Avascular Necrosis of the Talus and Talar Osteochondral Defect of Ankle, run by Restor3D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle, Talar Dysfunction
- What is being tested?
- Total Talus Replacement (TTR)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- ≥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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
About this study
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
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.
- Being tested
- Total Talus Replacement (TTR)
- Keywords
- Avascular necrosis, Talus, Ankle joint
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Talus Replacement (TTR)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 group | Role | What they receive |
|---|---|---|
| Total Talus Replacement | 50 subjects receiving the Total Talus Replacement device Receives: Device: Total Talus Replacement (TTR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who pass a composite of safety and probable benefit outcomes
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.
Measured: At 5 years compared to baseline
Secondary outcomes (10)
Change in perceived pain from baseline
Scores on the 11-point Pain Numeric Rating Scale (NRS) rated from 0-10 where higher scores indicate worse pain
Measured: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline
Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire with 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (ADL) (17 items), sports/recreation (5 items), and quality of life (4 items). Each question is graded from 0 to 4 on a 5-point Likert scale (none, mild, moderate, severe, and extreme problems). Composite FAOS scores include all 42-items across the 5 subscales, scored together to provide one comprehensive value. The FAOS composite score ranges from 0 to 100 where a score of 0 indicates the worst possible symptoms, and a score of 100 indicates no symptoms.
Measured: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline
Measured: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline
Measured: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline
Measured: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline
Measured: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline
Measured: At 5 years compared to baseline
Change in ankle range of motion (ROM) from baseline
Ankle ROM will be evaluated using a goniometer to determine the change in degrees of plantarflexion and dorsiflexion
Measured: At 5 years compared to baseline
Proportion of procedure-related Serious Adverse Events
Procedure-related Serious Adverse Event will be defined as the number of patients who have a procedure-related event including: death, life-threatening condition, hospital admission (initial or prolonged), disability or permanent damage, or required intervention to prevent permanent impairment or damage.
Measured: At 5 years compared to baseline
Proportion of Adverse Events
Adverse Event will be defined as the number of patients who have a non-serious, unexpected procedure- or device-related event before 5 years post-implantation.
Measured: At 5 years compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start6 Nov 2024
- Primary completionNov 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of the TalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OrthoCarolina Research Institute, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311331
- Sponsor's protocol ID
- restor3d-007
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06311331
- Acronym / sponsor ID
- restor3d-007
- Keywords
- Avascular necrosis, Talus, Ankle joint
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Collaborators
- OrthoCarolina Research Institute, Inc.
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Talus Replacement | – | Device: Total Talus Replacement (TTR)50 subjects receiving the Total Talus Replacement device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (9 listed)
- ≥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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Talus Replacement (TTR)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. | Device | Total Talus Replacement |
Primary outcome
Proportion of participants who pass a composite of safety and probable benefit outcomes
Time frame: At 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.
10 secondary outcomes
Change in perceived pain from baseline
Time frame: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline
Time frame: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline
Time frame: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline
Time frame: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline
Time frame: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline
Time frame: At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline
Time frame: At 5 years compared to baseline
Change in ankle range of motion (ROM) from baseline
Time frame: At 5 years compared to baseline
Proportion of procedure-related Serious Adverse Events
Time frame: At 5 years compared to baseline
Proportion of Adverse Events
Time frame: At 5 years compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Avascular Necrosis of the Talus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis of the Talus and Talar Osteochondral Defect of Ankle, run by Restor3D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who pass a composite of safety and probable benefit outcomes (time frame: At 5 years compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.