Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System (NCT04770870) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
United States94 participantsStarted 2022-02-01
Plain-language summary
The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.
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:
* Each potential subject must be an appropriate candidate for mobile bearing TAR by having: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease, as determined by the Principle Investigator.
* Willingness to participate in the study and follow-up visits
* Written informed consent, including authorization to release collected health data
Exclusion Criteria:
* Skeletal immaturity
* Bone stock inadequate to support the device including:
* Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality
* Avascular necrosis of the talus
* Active or prior deep infection in the ankle joint or adjacent bones
* Malalignment or severe deformity of involved or adjacent anatomic structures including:
* Hindfoot or forefoot malalignment precluding plantigrade foot
* Significant malalignment of the knee joint
* Insufficient ligament support that cannot be repaired with soft tissue stabilization (syndesmosis disruption)
* Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle
* Neuromuscular disease resulting in lack of normal muscle function about the affected ankle
* Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
* Poor skin and soft tissue quality about the surgical site
* Immunosupressive therapy
* Prior ankle fusion or revision of total ankle replacement
* High demanding sport activities (e.g., contac…
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.