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

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.

Study Overview

• Status: Completed
• Conditions: Talus; Ankle Arthropathy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Orthopaedic Institute of Western Kentucky
  • Ohio
    • Bellevue, Ohio, United States, 44811
      • The Bellevue Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in pain from pre-operative baseline	Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	3 months
Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	6 months
Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	12 months
Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	24 months
Improvement in Patient Reported Outcomes	Secondary probably benefit endpoints will include patient reported functional outcome measures	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Restor3D

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): February 19, 2024

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Talus; Retrospective Study; Ankle Joint; Arthrodesis; Printing, Three-Dimensional; Joint Prosthesis; Prosthesis Design
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: restor3d-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No