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.
Study Type
OBSERVATIONAL
Enrollment
80
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.
Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.
Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion.
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
The Bellevue Hospital
Bellevue, Ohio, United States
Improvement in pain from pre-operative baseline
Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.
Time frame: 12-months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Time frame: 3 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Time frame: 6 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Time frame: 12 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Time frame: 24 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Time frame: 36 months
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Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.