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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05649007

Enrollment

630

Registered

2022-12-13

Start date

2022-09-30

Completion date

2036-09-30

Last updated

2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Hip

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)

Interventions

DEVICEhip arthroplasty with prosthesis

Use of femoral stem and acetabular cup for hip arthroplasty

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
stem survival rate	1 year, 3 years, 5 and 10 years	Kaplan Meier survival analysis

Countries

France

Contacts

Primary ContactAlessio Vitale, Biotech

regulatory@bioimpianti.it+390251650371

Backup ContactFabio Stringhi, biomedic eng

fabio.stringhi@bioimpianti.itpatients under guardianship or

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026