Patient Specific Talus Spacer Post Approval Study
1 other identifier
observational
50
1 country
6
Brief Summary
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedStudy Start
First participant enrolled
July 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2029
November 7, 2024
November 1, 2024
7.2 years
February 4, 2022
November 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain.
At 5 years compared to Baseline
A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits
A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative
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 Outcomes (1)
Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.
5 Years Post Procedure compared to baseline.
Other Outcomes (1)
Additional Analyses at 5 Years Post Operative compared to Baseline for Foot and Outcome Score FAOS
5 Years Post Procedure compared to baseline
Study Arms (1)
50 Subjects
50 Subjects Receiving the Patient Specific Talus Spacer.
Interventions
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
Eligibility Criteria
Patients with Avascular Necrosis of the Ankle Joint.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paragon 28lead
Study Sites (6)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2022
First Posted
May 6, 2022
Study Start
July 8, 2022
Primary Completion (Estimated)
August 30, 2029
Study Completion (Estimated)
November 30, 2029
Last Updated
November 7, 2024
Record last verified: 2024-11