Trials / Recruiting
RecruitingNCT05649007
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 630 (estimated)
- Sponsor
- Gruppo Bioimpianti S.r.l. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | hip arthroplasty with prosthesis | Use of femoral stem and acetabular cup for hip arthroplasty |
Timeline
- Start date
- 2022-09-30
- Primary completion
- 2035-09-30
- Completion
- 2036-09-30
- First posted
- 2022-12-13
- Last updated
- 2022-12-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05649007. Inclusion in this directory is not an endorsement.