Active — Not RecruitingNot Applicable

Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

France180 participantsStarted 2017-12-05

Plain-language summary

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring 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: * Male or female * Degenerative or inflammatory hip disease requiring total hip replacement * Primary or secondary osteoarthritis, * Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin, * Avascular fracture or necrosis, * Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects. * Joint destruction of traumatic origin * Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty). Exclusion Criteria: * Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up * Known pregnancy in progress * Breastfeeding * Patient requiring a bone graft * Neurological disorders or other pathology that may influence locomotion * History of sepsis in the hip to be operated on * Short-term vital prognosis

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

Survival rate

Timeframe: Per operative period to 10 years

Trial details

NCT IDNCT05524350

SponsorSociete dEtude, de Recherche et de Fabrication

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-01-20

View on ClinicalTrials.gov More Hip Arthropathy trials