Post- Approval Hintermann Series H® Study 1 (NCT06514196) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post- Approval Hintermann Series H® Study 1
Switzerland298 participantsStarted 2020-06-18
Plain-language summary
The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361).
This will be a Prospective, single-center, single arm 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:
* Skeletally mature
* Primary diagnosis of osteoarthritis, post-traumatic arthritis or rheumatoid arthritis
* Primary total ankle replacement
* Unilateral or the first ankle implanted if bilateral and the surgery dates for both sides are at least 6 months apart
* Implanted with the correct device without screws (for investigational arm),
* 3rd generation Hintermann Series H3 Total Ankle Replacement;
* Poor pre-operative American Orthopaedic Foot and Ankle Society Hindfoot Score (\< 60 points)
* Implanted in 2013 or earlier). Note that all subjects implanted in 2013 or earlier were included regardless of whether they were revised prior to the 2 year endpoint.
* Gave informed consent (unless IRB/Ethics Committee waived this requirement)
Exclusion Criteria:
* Prior TAR or arthrodesis at the involved ankle joint
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
AOFAS Score Measurement
Timeframe: 10 Years
2
Survivorship Measurement
Timeframe: 10 Years
3
Serious device-related adverse event Measurement
Timeframe: 10 Years
4
Reoperation, revisions or removals Measurement
Timeframe: 10 Years
5
Serious Device-Related Adverse Events Measurement
Timeframe: 10 Years
6
Device Explant Analysis Measurement
Timeframe: Through Study Completion an Average of 10 years