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

Launched by GRUPPO BIOIMPIANTI S.R.L. · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term effectiveness of a specific hip replacement device called the Saphir stem, used in surgeries for patients with hip problems such as osteoarthritis or fractures. The main goal is to see how well this device works over time after surgery. The study is currently recruiting participants, and it is open to adults aged 18 and older who are planning to have a total hip replacement. This includes individuals with osteoarthritis aged 18 to 85, and those with a femoral neck fracture aged 18 to 90.

To be eligible, participants must be in good health and willing to commit to the study. They should not have had previous hip surgery on the same side, and individuals who are pregnant or have certain serious health conditions cannot take part. Those who join the study can expect to be monitored for their recovery and the performance of the Saphir stem over time. It's important for participants to understand the study and agree to take part willingly. This trial is a step toward ensuring that hip replacement surgeries provide lasting benefits for patients in the future.

Gender

ALL

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