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| Name | Class |
|---|---|
| OrthoCarolina Research Institute, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Talus Replacement | 50 subjects receiving the Total Talus Replacement device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 5 years compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 5 years compared to baseline |
| Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | 28207 | United States |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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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. |
| At 5 years compared to baseline |
| Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline | At 5 years compared to baseline |
| Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline | At 5 years compared to baseline |
| Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline | At 5 years compared to baseline |
| Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline | At 5 years compared to baseline |
| Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline | 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 | 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. | 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. | At 5 years compared to baseline |
| D013568 |
| Pathological Conditions, Signs and Symptoms |