NCT05364606 · Paragon 28
Patient Specific Talus Spacer Post Approval Study
What this study is about
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
View original scientific description
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
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
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.
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.
A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Santa Rosa, California
- Fort Wayne, Indiana
- Baltimore, Maryland
- Morrisville, North Carolina
- Charleston, South Carolina
- Pearland, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 7, 2024 · Source of record for eligibility and locations