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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthropathy of Hip
• Intervention / Treatment: Device: hip arthroplasty with prosthesis

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 Type: Observational
• Enrollment (Anticipated): 630

Contacts and Locations

• Study Contact: Name: Alessio Vitale, Biotech; Phone Number: +390251650371; Email: regulatory@bioimpianti.it
• Study Contact Backup: Name: Fabio Stringhi, biomedic eng; Phone Number: patients under guardianship or; Email: fabio.stringhi@bioimpianti.it

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • Hopital Ducuing
    • Contact: Gerard Giordano; Email: ortho.giordano@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

please see inclusion/exclusion criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gruppo Bioimpianti S.r.l.
• Investigators: Principal Investigator: Gerard Giordano, medicine, Hopital Ducuing

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Anticipated): September 30, 2035
• Study Completion (Anticipated): September 30, 2036

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: PRCS202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No