Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

NCT ID: NCT05231304

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-05

Study Completion Date

2024-02-19

Brief Summary

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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

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Conditions

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Talus Ankle Arthropathy

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Total Talus Replacement

Total Talus Replacement (TTR)

Intervention Type PROCEDURE

Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.

Total Ankle Total Talus Replacement

Total Ankle Total Talus Replacement (TATTR)

Intervention Type PROCEDURE

Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.

Total Ankle Total Talus Replacement + Subtalar Fusion

Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)

Intervention Type PROCEDURE

Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion.

Total Talus Replacement + Subtalar Fusion

Total Talus Replacement + Subtalar Fusion (TTR + STJ)

Intervention Type PROCEDURE

Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.

Interventions

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Total Talus Replacement (TTR)

Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.

Intervention Type PROCEDURE

Total Ankle Total Talus Replacement (TATTR)

Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Restor3D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, United States

Site Status

The Bellevue Hospital

Bellevue, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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restor3d-002

Identifier Type: -

Identifier Source: org_study_id

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