Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery

Recruiting

• Conditions: Arthropathy of Hip

• Registration Number: NCT05649007
• Lead Sponsor: Gruppo Bioimpianti S.r.l.

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.

Detailed Description

The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)

Study Timeline

• Study Start: 2022-09-30
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-13
• Last Update Posted: 2022-12-13
• Primary Completion: 2035-09-30
• Study Completion: 2036-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 630

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stem survival rate	1 year, 3 years, 5 and 10 years	Kaplan Meier survival analysis

Trial Locations

Locations (1)

Hopital Ducuing; 🇫🇷 Toulouse, France