Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
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.
| Condition(s) | Arthropathy of Hip |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 * patien |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Gruppo Bioimpianti S.r.l. |
| Locations | Toulouse, France |
| Start date | 2022-09-30 |
| NCT ID | NCT05649007 |
| Official listing | https://clinicaltrials.gov/study/NCT05649007 |