Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

Conditions
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Talus, Ankle Arthropathy

Intervention / Treatment
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* Procedure: Total Talus Replacement (TTR)
* Procedure: Total Ankle Total Talus Replacement (TATTR)
* Procedure: Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)
* Procedure: Total Talus Replacement + Subtalar Fusion (TTR + STJ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 Years of Age Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022. Exclusion Criteria: No available postoperative data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total Talus Replacement<br> | Procedure: Total Talus Replacement (TTR)<br>* Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.<br>|
| Total Ankle Total Talus Replacement<br> | Procedure: Total Ankle Total Talus Replacement (TATTR)<br>* Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.<br>|
| Total Ankle Total Talus Replacement + Subtalar Fusion<br> | Procedure: Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)<br>* Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion.<br>|
| Total Talus Replacement + Subtalar Fusion<br> | Procedure: Total Talus Replacement + Subtalar Fusion (TTR + STJ)<br>* Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retrospective Study, Ankle Joint, Talus, Arthrodesis, Printing, Three-Dimensional, Joint Prosthesis, Prosthesis Design