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This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion. This study seeks to analyze the clinical and radiographic outcomes of TTR implant recipients and generate additional data on the safety and benefit of the TTR implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Talus Replacement |
| ||
| Total Ankle Total Talus Replacement |
| ||
| Total Ankle Total Talus Replacement + Subtalar Fusion |
| ||
| Total Talus Replacement + Subtalar Fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Talus Replacement (TTR) | Procedure | Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pain from pre-operative baseline | Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline. | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Patient Reported Outcomes | Secondary probably benefit endpoints will include patient reported functional outcome measures | 3 months |
| Improvement in Patient Reported Outcomes | Secondary probably benefit endpoints will include patient reported functional outcome measures |
| Measure | Description | Time Frame |
|---|---|---|
| Subsequent Surgical Intervention | The primary safety outcome measure is rate of subsequent surgical intervention (SSI), as defined as any surgical procedure or service required after the initial implant of the TTR device. | Up to 3 years. |
| Adverse Events (AEs)/Serious Adverse Events (SAEs) |
Inclusion Criteria:
Exclusion Criteria:
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All adult patients who underwent surgery involving a TTR implant with or without total ankle replacement and/or subtalar fusion between 1/1/2019 and 01/28/2022 will be will be included in this retrospective review. Patients with at least one postoperative follow-up visit will be included in this study. Only data in existence as of 01/28/2022 will be collected.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | United States | ||
| The Bellevue Hospital |
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| Total Ankle Total Talus Replacement (TATTR) | Procedure | Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device. |
|
| Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ) | Procedure | Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion. |
|
| Total Talus Replacement + Subtalar Fusion (TTR + STJ) | Procedure | Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion. |
|
| 6 months |
| Improvement in Patient Reported Outcomes | Secondary probably benefit endpoints will include patient reported functional outcome measures | 12 months |
| Improvement in Patient Reported Outcomes | Secondary probably benefit endpoints will include patient reported functional outcome measures | 24 months |
| Improvement in Patient Reported Outcomes | Secondary probably benefit endpoints will include patient reported functional outcome measures | 36 months |
Safety outcome measures by occurrence of adverse events (AEs), device- or procedure related AEs, and serious AEs. |
| Up to 3 years. |
| Bellevue |
| Ohio |
| 44811 |
| United States |
| ID | Term |
|---|---|
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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