Post-marketing surveillance of a femoral stem prosthesis for hip replacement

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 monitors the performance and outcomes of the SMS femoral stem prosthesis in patients undergoing total hip replacement. It aims to gather data on the effectiveness and safety of the prosthesis in individuals suffering from various hip joint conditions, including arthrosis and avascular necrosis. Participants will be followed for a period of 10 years to assess their progress and any potential complications associated with the implant. The study includes patients aged 18 to 75 who are scheduled for primary hip replacement surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
* In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
* Scheduled for a primary total hip replacement.

Exclusion Criteria:

* Active infection
* Pregnancy
* Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
* Grossly distorted anatomy (surgeon's discretion)
* Osteomalacia where uncemented implant fixation is contraindicated
* Active rheumatoid arthritis.
* Osteoporosis
* Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
* Muscular atrophy or neuromuscular disease
* Allergy to implant material
* Any patient who cannot or will not provide informed consent for participation in the study
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

Where it's running

• Herz-Jesu Krankenhaus
  Vienna, Austria Recruiting
• Istituto Ortopedico Galezzi
  Milan, Milan, Italy Recruiting
• Bürgerspital Solothurn
  Solothurn, Switzerland Recruiting
• The Elective Orthopaedic Centre (EOC)
  Epsom, Surrey, United Kingdom Recruiting

Study contacts

• Study coordinator: Mara Colombo, Eng
• Email: colombo@medacta.ch
• Phone: 0041 91 6966060

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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.