RecruitingNCT05649007
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Sponsor
Gruppo Bioimpianti S.r.l.
Enrollment
630 participants
Start Date
Sep 30, 2022
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria9
- \<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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEhip arthroplasty with prosthesis
Use of femoral stem and acetabular cup for hip arthroplasty
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05649007
Related Trials
Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
NCT072846151 location
Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
NCT053818181 location