Patient Specific Talus Spacer Post Approval Study

Last updated: November 5, 2024
Sponsor: Paragon 28
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Patient Specific Talus Spacer

Clinical Study ID

NCT05364606
AOPSTSPAS
  • Ages > 21
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject plans to undergo implantation of the Patient Specific Talus Spacer foravascular 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.

Exclusion

Exclusion Criteria:

  1. Presence of any contraindication identified in the device Instructions for Use;

  2. Surgeon determines that the patient is not appropriate for the Talus Spacerprocedure based on the device IFU (including the enumerated Warnings andPrecautions);

  3. Based on the medical opinion of the surgeon, the patient is not appropriate for theTalus 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 thatcould impact the validity of results;

  9. 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.

  10. 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.

  11. 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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Patient Specific Talus Spacer
Phase:
Study Start date:
July 08, 2022
Estimated Completion Date:
November 30, 2029

Study Description

This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.

Connect with a study center

  • Redwood Orthopaedics

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Fort Wayne Orthopedics

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Mercy Institute for Foot & Ankle Reconstruction

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Duke Orthopeadics Arringdon

    Morrisville, North Carolina 27560
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • UT Physicians Orthopedics - Pearland

    Pearland, Texas 77584
    United States

    Active - Recruiting

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