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

NCT05649007 | Recruiting

• 1 other identifier: PRCS202201
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Hip

Outcome Measures

Primary Outcomes (1)

• stem survival rate

  Kaplan Meier survival analysis

  1 year, 3 years, 5 and 10 years

Interventions

hip arthroplasty with prosthesis DEVICE

Use of femoral stem and acetabular cup for hip arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

please see inclusion/exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Gruppo Bioimpianti S.r.l.: lead

Study Sites (1)

Hopital Ducuing

Toulouse, France

RECRUITING

MeSH Terms

Interventions

Prostheses and Implants

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Gerard Giordano, medicine

  Hopital Ducuing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio Vitale, Biotech

CONTACT

+390251650371; regulatory@bioimpianti.it

Fabio Stringhi, biomedic eng

CONTACT

patients under guardianship or; fabio.stringhi@bioimpianti.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 13, 2022
• Study Start: September 30, 2022
• Primary Completion (Estimated): September 30, 2035
• Study Completion (Estimated): September 30, 2036
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

FR (1)