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Recruiting
NCT05649007
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Conditions: Arthropathy of Hip
Sex: All
Ages: 18 Years – N/A
Enrollment: 630
Sponsor: Gruppo Bioimpianti S.r.l.
Location: France
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 yearsCandidate for primary total hip replacement with femoral stem and acetabular cupif ostheoarthritis patients aged 18 to 85 yearsif femoral neck fracture patients aged 18 to 90 yearspatients with social security schemepatients understands the condition of the study and is willing to partecipate for the duration of the clinical investigationpatients who gavee consent to partecipare in the clinical investigationExclusion Criteria:<18 yearsif female, pregnantpatient who has already had primary hip surgery on the same sidelocal or disseminated neoplastic diseaseinability to understand the study and agree to partecipatepatients cancelling partecipation before surgerypatients under guardianship or curatorshippatients without a social security schemepatients refusing to partecipate
Source: ClinicalTrials.gov (NCT05649007). StuddyBuddy aggregates publicly available trial information.