Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device (NCT05361317) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
France86 participantsStarted 2022-06-13
Plain-language summary
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.
The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.
Who can participate
Age range
18 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:
* Patient with a hallux valgus foot pathology requiring correction
* First line operation
* Use of the medical device concerned PECA Bunion
* Unilateral operation
* Patient aged 18 or over
* Isolated hallux valgus correction, without associated surgical procedures
* Patient able to respect the prescriptions and recommendations of his surgeon
* Patient able to read and understand the information note on the objectives of the study and the collection of their data
* Patient able to sign a consent form
Exclusion Criteria:
* Patient with a contraindication to the device under investigation,
* Simultaneous participation in another clinical investigation protocol,
* Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors.
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
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of patient's foot determined thanks to the "general sub-score" of the European Foot and Ankle Society scale