Monitoring the Saphir Stem in Hip Surgery
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
This study looks at how well the Saphir stem used in hip replacement surgery works for patients over time, focusing on their recovery and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 630 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Bioimpianti S.r.l. Industry-sponsored |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05649007 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term survival rate of the Saphir stem used in primary hip arthroplasty. It involves post-marketing surveillance to assess patient outcomes, including functional improvement, quality of life, and safety related to the prosthesis. Patients undergoing hip replacement surgery with the Saphir stem and associated systems will be monitored for adverse events and overall effectiveness over time.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are scheduled for primary total hip replacement due to osteoarthritis or femoral neck fractures.
Not a fit: Patients under 18, those who are pregnant, or individuals with prior hip surgery on the same side will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the durability and effectiveness of the Saphir stem, potentially improving patient outcomes in hip arthroplasty.
How similar studies have performed: While this study focuses on post-marketing surveillance, similar studies have shown success in evaluating the long-term outcomes of hip prostheses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse
- Hopital Ducuing — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Gerard Giordano, medicine — Hopital Ducuing
- Study coordinator: Alessio Vitale, Biotech
- Email: regulatory@bioimpianti.it
- Phone: +390251650371
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.