Monitoring the Saphir Stem in Hip Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the long-term survival rate of the Saphir stem used in primary hip arthroplasty. It involves post-marketing surveillance to assess patient outcomes, including functional improvement, quality of life, and safety related to the prosthesis. Patients undergoing hip replacement surgery with the Saphir stem and associated systems will be monitored for adverse events and overall effectiveness over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Hopital Ducuing
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Gerard Giordano, medicine — Hopital Ducuing
• Study coordinator: Alessio Vitale, Biotech
• Email: regulatory@bioimpianti.it
• Phone: +390251650371

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two nerve-block approaches for pain after anterior-approach hip replacement

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• Breathing exercises before joint surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.