An observational study in Talus and Ankle Arthropathy, sponsored by Restor3D. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Restor3D · Observational
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.
83 studies on the registry are indexed under Ankylosis; 18 are open to participants now.
This study's enrollment of 80 is below the median of 103 across 46 observational studies indexed under Ankylosis.
Browse Ankylosis studies →Restor3D is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
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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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Exclusion Criteria:
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)
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.
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.
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
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.
Time frame: Up to 3 years.
Adverse Events (AEs)/Serious Adverse Events (SAEs)
Safety outcome measures by occurrence of adverse events (AEs), device- or procedure related AEs, and serious AEs.
Time frame: Up to 3 years.
Ran from Apr 2022 to primary completion in Jan 2023, 9 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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