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

Gruppo Bioimpianti

Status: Enrolling

Conditions: Arthropathy of Hip

Treatments: Device: hip arthroplasty with prosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT05649007

PRCS202201

Details and patient eligibility

About

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.

Full 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)

Enrollment: 630 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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