ArthrosisTraumatic ArthritisRheumatoid PolyarthritisCongenital Hip DysplasiaAvascular Necrosis of the Femoral Head
Investigational drug(s) / intervention(s)
SMS femoral stem
Study summary
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
survivorship of the Medacta SMS femoral stem — 10-year
Trial sites (4)
Facility
City
Region
Status
Herz-Jesu Krankenhaus
Vienna
Austria
Recruiting
Istituto Ortopedico Galezzi
Milan
Milan
Recruiting
Bürgerspital Solothurn
Solothurn
Switzerland
Recruiting
The Elective Orthopaedic Centre (EOC)
Epsom
Surrey
Recruiting
More Medacta International SA trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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