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Recruiting NCT05364606

Patient Specific Talus Spacer Post Approval Study

— Observational Avascular Necrosis of the Talus

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Specific Talus Spacer.
Who it may be relevant to
Registry conditions: Avascular Necrosis of the Talus. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Device Patient Specific Talus Spacer
    Patient Specific Talus Spacer is a solid polished replica of the patient's bone.

Primary outcome measures

  • Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) [Time frame: At 5 years compared to Baseline]
  • A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits [Time frame: A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study.]
Secondary outcome measures (1)
  • Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle. [Time frame: 5 Years Post Procedure compared to baseline.]

Eligibility criteria

Inclusion criteria

  • Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular 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 criteria

  • Presence of any contraindication identified in the device Instructions for Use;
  • Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
  • Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus 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 that could impact the validity of results;
  • 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.
  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 6 centers
  • Redwood Orthopaedics — Santa Rosa
  • Fort Wayne Orthopedics — Fort Wayne
  • Mercy Institute for Foot & Ankle Reconstruction — Baltimore
  • Duke Orthopeadics Arringdon — Morrisville
  • Medical University of South Carolina — Charleston
  • UT Physicians Orthopedics - Pearland — Pearland

Identifiers

NCT: NCT05364606 · AOPSTSPAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗