Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hip arthroplasty with prosthesis.
- Who it may be relevant to
- Registry conditions: Arthropathy of Hip. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
Interventions
- Device hip arthroplasty with prosthesis
Use of femoral stem and acetabular cup for hip arthroplasty
Primary outcome measures
- stem survival rate [Time frame: 1 year, 3 years, 5 and 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Hopital Ducuing — Toulouse
Identifiers
NCT: NCT05649007 · PRCS202201