Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

Completed

• Conditions: Ankle Arthropathy; Talus
• Interventions: Procedure: Total Talus Replacement (TTR); Procedure: Total Ankle Total Talus Replacement (TATTR); Procedure: Total Talus Replacement + Subtalar Fusion (TTR + STJ); Procedure: Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)

• Registration Number: NCT05231304
• Lead Sponsor: Restor3D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Study Start: 2022-04-05
• Primary Completion: 2023-01-06
• Status Verified: 2024-02
• Study Completion: 2024-02-19
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Talus Replacement	Total Talus Replacement (TTR)	-
Total Ankle Total Talus Replacement	Total Ankle Total Talus Replacement (TATTR)	-
Total Talus Replacement + Subtalar Fusion	Total Talus Replacement + Subtalar Fusion (TTR + STJ)	-
Total Ankle Total Talus Replacement + Subtalar Fusion	Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)	-

Primary Outcome Measures

Name	Time	Method
Improvement in pain from pre-operative baseline	12-months	Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.

Secondary Outcome Measures

Name	Time	Method
Improvement in Patient Reported Outcomes	36 months	Secondary probably benefit endpoints will include patient reported functional outcome measures

Trial Locations

Locations (2)

Orthopaedic Institute of Western Kentucky; 🇺🇸 Paducah, Kentucky, United States

The Bellevue Hospital; 🇺🇸 Bellevue, Ohio, United States