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

Arthropathy of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649007
• Other study ID #: PRCS202201
• Status: Recruiting
• Start date: September 30, 2022
• Est. completion date: September 30, 2036

Study information

• Verified date: December 2022
• Source: Gruppo Bioimpianti S.r.l.
• Contact: Alessio Vitale, Biotech
• Phone: +390251650371
• Email: regulatory[@]bioimpianti.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. completion date: September 30, 2036
• Est. primary completion date: September 30, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Joint Diseases

Intervention

Device:
• hip arthroplasty with prosthesis
Use of femoral stem and acetabular cup for hip arthroplasty

Locations

Country	Name	City	State
France	Hopital Ducuing	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Bioimpianti S.r.l.

Country where clinical trial is conducted

France, 

Outcome

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