RECRUITING

Patient Specific Talus Spacer Post Approval Study

Conditions

Avascular Necrosis of the Talus Avascular Necrosis Talus Ankle

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.

Official Title

Patient Specific Talus Spacer Post Approval Study

Quick Facts

Study Start:2022-07-08

Study Completion:2029-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05364606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol; 2. Avascular necrosis of the ankle joint; 3. Age 21 years old or older; 4. Subject has good general health; and 5. Subject signs a written informed consent form (ICF) prior to the surgical procedure.	1. Presence of any contraindication identified in the device Instructions for Use; 2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions); 3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure; 4. For female subjects, pregnancy; 5. Active systemic disease, such as AIDS, HIV, or active infection; 6. Active infection or the skin is compromised at the surgical site; and 7. Systemic disease that would affect the subject's welfare; 8. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results; 9. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up. 10. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient. 11. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.

Inclusion Criteria

Exclusion Criteria

1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
2. Avascular necrosis of the ankle joint;
3. Age 21 years old or older;
4. Subject has good general health; and
5. Subject signs a written informed consent form (ICF) prior to the surgical procedure.

1. Presence of any contraindication identified in the device Instructions for Use;
2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
4. For female subjects, pregnancy;
5. Active systemic disease, such as AIDS, HIV, or active infection;
6. Active infection or the skin is compromised at the surgical site; and
7. Systemic disease that would affect the subject's welfare;
8. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
9. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up.
10. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient.
11. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.

Contacts and Locations

Study Contact

Jacy Legue

CONTACT

720-399-3400

jlegue@paragon28.com

Caleigh Bates

CONTACT

720-399-3400

cbates@paragon28.com

Study Locations (Sites)

Redwood Orthopaedics

Santa Rosa, California, 95403

United States

Fort Wayne Orthopedics

Fort Wayne, Indiana, 46804

United States

Mercy Institute for Foot & Ankle Reconstruction

Baltimore, Maryland, 21202

United States

Duke Orthopeadics Arringdon

Morrisville, North Carolina, 27560

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

UT Physicians Orthopedics - Pearland

Pearland, Texas, 77584

United States

Collaborators and Investigators

Sponsor: Paragon 28

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-08

Study Completion Date2029-11-30

Study Record Updates

Study Start Date2022-07-08

Study Completion Date2029-11-30

Terms related to this study

Keywords Provided by Researchers

Avascular Necrosis
Talus
Ankle

Additional Relevant MeSH Terms

Avascular Necrosis of the Talus