Using a special hip implant with vitamin E for active young patients
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
This study is testing if a special hip implant with vitamin E can help young and active people recover better and have longer-lasting results compared to a standard implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05175300 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty for young and active individuals. It is a single-centre, prospective, randomised, single-blind comparative study involving two groups: one receiving a ceramic-on-highly cross-linked polyethylene prosthesis and the other receiving a ceramic-on-ceramic prosthesis. The aim is to evaluate the performance and outcomes of these two types of implants in improving hip function and longevity.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 65 who require total hip arthroplasty and can provide informed consent.
Not a fit: Patients with a history of hip surgery, hip dysplasia, or other significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and longer-lasting hip implants for young and active patients.
How similar studies have performed: Other studies have shown promise with ceramic and polyethylene combinations in hip arthroplasty, but the specific use of vitamin E in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 to 65 years, * Who have signed their consent to participate in the study, * For whom an indication for total hip arthroplasty has been given Exclusion Criteria: * History of hip surgery * Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly) * Hip dysplasia * Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis * Sequelae of neurological disease or stroke * Pregnant or breastfeeding women * Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol * Patient likely not to return for follow-up visits * Patient already included in another therapeutic study protocol * Patient under court protection, guardianship or curatorship.
Where this trial is running
Lyon
- Hôpital Privé Jean Mermoz — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Jean LANGLOIS, MD
- Email: jeangast@gmail.com
- Phone: 0603294533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.