RECLAIM: Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

Sponsor

Restor3D (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05231304

Collaborator

(none)

175

Enrollment

Locations

8.9

Anticipated Duration (Months)

58.3

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Talus Ankle Arthropathy	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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

175 participants

Observational Model:

Case-Crossover

Time Perspective:

Retrospective

Official Title:

Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

Actual Study Start Date :

Apr 5, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Improvement in Patient Reported Outcomes [3 months]
Secondary probably benefit endpoints will include patient reported functional outcome measures
Improvement in Patient Reported Outcomes [6 months]
Secondary probably benefit endpoints will include patient reported functional outcome measures
Improvement in Patient Reported Outcomes [12 months]
Secondary probably benefit endpoints will include patient reported functional outcome measures
Improvement in Patient Reported Outcomes [24 months]
Secondary probably benefit endpoints will include patient reported functional outcome measures
Improvement in Patient Reported Outcomes [36 months]
Secondary probably benefit endpoints will include patient reported functional outcome measures

Other Outcome Measures

Subsequent Surgical Intervention [Up to 3 years.]
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.
Adverse Events (AEs)/Serious Adverse Events (SAEs) [Up to 3 years.]
Safety outcome measures by occurrence of adverse events (AEs), device- or procedure related AEs, and serious AEs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Foot and Ankle Institute	Phoenix	Arizona	United States	85251
2	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky	United States	42001
3	The Bellevue Hospital	Bellevue	Ohio	United States	44811