Phase
Condition
N/ATreatment
Patient Specific Talus Spacer
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject plans to undergo implantation of the Patient Specific Talus Spacer foravascular necrosis of the ankle joint independent of this research protocol;
Avascular necrosis of the ankle joint;
Age 21 years old or older;
Subject has good general health; and
Subject signs a written informed consent form (ICF) prior to the surgical procedure.
Exclusion
Exclusion Criteria:
Presence of any contraindication identified in the device Instructions for Use;
Surgeon determines that the patient is not appropriate for the Talus Spacerprocedure based on the device IFU (including the enumerated Warnings andPrecautions);
Based on the medical opinion of the surgeon, the patient is not appropriate for theTalus Spacer procedure;
For female subjects, pregnancy;
Active systemic disease, such as AIDS, HIV, or active infection;
Active infection or the skin is compromised at the surgical site; and
Systemic disease that would affect the subject's welfare;
Is a prisoner, incarcerated, or has been coerced to participate in the study thatcould impact the validity of results;
Is currently participating in an investigational therapy (device and/orpharmaceutical) within 30 days prior to entering the study or such treatment isplanned during the time course of follow-up.
If the Sponsor has notified the site that 30 subjects have been enrolled in thestudy with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believesthat a Cobalt Chromium Patient Specific Talus Spacer is the best option for thepatient.
If the Sponsor has notified the site that 30 subjects have been enrolled in thestudy with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient SpecificTalus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with TitaniumNitride (TiN) coating Patient Specific Talus Spacer is the best option for thepatient.
Study Design
Study Description
Connect with a study center
Redwood Orthopaedics
Santa Rosa, California 95403
United StatesActive - Recruiting
Fort Wayne Orthopedics
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Mercy Institute for Foot & Ankle Reconstruction
Baltimore, Maryland 21202
United StatesActive - Recruiting
Duke Orthopeadics Arringdon
Morrisville, North Carolina 27560
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
UT Physicians Orthopedics - Pearland
Pearland, Texas 77584
United StatesActive - Recruiting
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