Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

Ankle Arthropathy Clinical Trial

— RECLAIM  

Official title:

Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231304
• Other study ID #: restor3d-002
• Status: Completed
• Start date: April 5, 2022
• Est. completion date: February 19, 2024

Study information

• Verified date: February 2024
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 19, 2024
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Arthropathy
• Joint Diseases

Intervention

Procedure:
• Total Talus Replacement (TTR)
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.
• Total Ankle Total Talus Replacement (TATTR)
Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.
• Total 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.
• Total Talus Replacement + Subtalar Fusion (TTR + STJ)
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.

Locations

Country	Name	City	State
United States	The Bellevue Hospital	Bellevue	Ohio
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 3 years.
Other	Adverse Events (AEs)/Serious Adverse Events (SAEs)	Safety outcome measures by occurrence of adverse events (AEs), device- or procedure related AEs, and serious AEs.	Up to 3 years.
Primary	Improvement in pain from pre-operative baseline	Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.	12-months
Secondary	Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	3 months
Secondary	Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	6 months
Secondary	Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	12 months
Secondary	Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	24 months
Secondary	Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	36 months