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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05649007
Study type Observational
Source Gruppo Bioimpianti S.r.l.
Contact Alessio Vitale, Biotech
Phone +390251650371
Email regulatory@bioimpianti.it
Status Recruiting
Phase
Start date September 30, 2022
Completion date September 30, 2036
View Details
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