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The Medacta International SMS Post-Marketing Surveillance Study

RecruitingN/A

Sponsor: Medacta International SA

Conditions: Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head

Interventions: SMS femoral stem

Countries: Austria, Italy, Switzerland, United Kingdom

This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (4)

Vienna, Austria
Milan, Milan, Italy
Solothurn, Switzerland
Epsom, Surrey, United Kingdom