NCT05649007 Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
| NCT ID | NCT05649007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gruppo Bioimpianti S.r.l. |
| Condition | Arthropathy of Hip |
| Study Type | OBSERVATIONAL |
| Enrollment | 630 participants |
| Start Date | 2022-09-30 |
| Primary Completion | 2035-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 630 participants in total. It began in 2022-09-30 with a primary completion date of 2035-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.
Eligibility Criteria
Inclusion Criteria: * patients\>18 years * Candidate for primary total hip replacement with femoral stem and acetabular cup * if ostheoarthritis patients aged 18 to 85 years * if femoral neck fracture patients aged 18 to 90 years * patients with social security scheme * patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation * patients who gavee consent to partecipare in the clinical investigation Exclusion Criteria: * \<18 years * if female, pregnant * patient who has already had primary hip surgery on the same side * local or disseminated neoplastic disease * inability to understand the study and agree to partecipate * patients cancelling partecipation before surgery * patients under guardianship or curatorship * patients without a social security scheme * patients refusing to partecipate
Contact & Investigator
Gerard Giordano, medicine
PRINCIPAL INVESTIGATOR
Hopital Ducuing
Frequently Asked Questions
Who can join the NCT05649007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arthropathy of Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05649007 currently recruiting?
Yes, NCT05649007 is actively recruiting participants. Contact the research team at regulatory@bioimpianti.it for enrollment information.
Where is the NCT05649007 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT05649007 clinical trial?
NCT05649007 is sponsored by Gruppo Bioimpianti S.r.l.. The principal investigator is Gerard Giordano, medicine at Hopital Ducuing. The trial plans to enroll 630 participants.