Ankle Arthropathy, Talus
Conditions
Keywords
Retrospective Study, Ankle Joint, Talus, Arthrodesis, Printing, Three-Dimensional, Joint Prosthesis, Prosthesis Design
Brief summary
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.
Interventions
PROCEDURETotal Talus Replacement (TTR)
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.
PROCEDURETotal Ankle Total Talus Replacement (TATTR)
Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.
PROCEDURETotal Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)
Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion.
PROCEDURETotal Talus Replacement + Subtalar Fusion (TTR + STJ)
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.
Sponsors
Restor3D
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in pain from pre-operative baseline | 12-months | Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Patient Reported Outcomes | 3 months | Secondary probably benefit endpoints will include patient reported functional outcome measures |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subsequent Surgical Intervention | Up to 3 years. | 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. |
| Adverse Events (AEs)/Serious Adverse Events (SAEs) | Up to 3 years. | Safety outcome measures by occurrence of adverse events (AEs), device- or procedure related AEs, and serious AEs. |
Countries
United States
Outcome results
None listed