Patient Specific Talus Spacer Post Approval Study (NCT05364606) | Clinical Trial Compass
RecruitingNot Applicable
Patient Specific Talus Spacer Post Approval Study
United States50 participantsStarted 2022-07-08
Plain-language summary
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)
Timeframe: At 5 years compared to Baseline
2
A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits
Timeframe: 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.