Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
RECLAIM
1 other identifier
observational
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 9, 2022
CompletedStudy Start
First participant enrolled
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2024
CompletedFebruary 21, 2024
February 1, 2024
9 months
January 27, 2022
February 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in pain from pre-operative baseline
Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.
12-months
Secondary Outcomes (5)
Improvement in Patient Reported Outcomes
3 months
Improvement in Patient Reported Outcomes
6 months
Improvement in Patient Reported Outcomes
12 months
Improvement in Patient Reported Outcomes
24 months
Improvement in Patient Reported Outcomes
36 months
Other Outcomes (2)
Subsequent Surgical Intervention
Up to 3 years.
Adverse Events (AEs)/Serious Adverse Events (SAEs)
Up to 3 years.
Study Arms (4)
Total Talus Replacement
Total Ankle Total Talus Replacement
Total Ankle Total Talus Replacement + Subtalar Fusion
Total Talus Replacement + Subtalar Fusion
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- \>18 Years of Age
- Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.
You may not qualify if:
- No available postoperative data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Restor3Dlead
Study Sites (2)
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001, United States
The Bellevue Hospital
Bellevue, Ohio, 44811, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 9, 2022
Study Start
April 5, 2022
Primary Completion
January 6, 2023
Study Completion
February 19, 2024
Last Updated
February 21, 2024
Record last verified: 2024-02