An observational study in Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle and Talar Dysfunction, sponsored by Restor3D. Enrolling by invitation at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Restor3D · Observational
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 50 is below the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Restor3D is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 subjects receiving the Total Talus Replacement device
Device: 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.
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.
Time frame: At 5 years compared to baseline
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
Time frame: 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.
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
Ankle ROM will be evaluated using a goniometer to determine the change in degrees of plantarflexion and dorsiflexion
Time frame: 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.
Time frame: 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.
Time frame: At 5 years compared to baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Nov 2031, 84 months after the start.
Of 59 observational studies under Osteonecrosis, half reached primary completion within 141 months of starting (the median), counting those still running; a quarter within 93 and three quarters within 184. This study's planned 84 months is below that.
How these figures are worked out, and which studies are left out of them.
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