Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem (NCT05560022) | Clinical Trial Compass
WithdrawnNot Applicable
Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem
Stopped: This record is a duplicate. The study is already registered on ClinicalTrials.gov under another NCT number. No participants were enrolled in this duplicate record.
France0Started 2017-12-05
Plain-language summary
The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .
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:
* Man or women
* Degenerative or inflammatory hip pathology requiring a total hip replacement
* Primary or secondary osteoarthritis
* Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
* Fracture or avascular necrosis
* Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY
* Traumatic joint destruction
* Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty
Exclusion Criteria:
* People with diminished mental faculties
* Known current pregnancy
* Breast-feeding
* Neurological disorders or other pathologies that may influence locomotion
* Septic antecedent on hip to operate
* Patient requiring a bone graft
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
Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements
Timeframe: per operative period to 10 years
Trial details
NCT IDNCT05560022
SponsorSociete dEtude, de Recherche et de Fabrication