The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study

Medacta International SA4 sites in 4 countries550 target enrollmentJuly 1, 2015

Overview

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

Registry

clinicaltrials.gov

Start Date

July 1, 2015

End Date

July 1, 2032

Last Updated

7 months ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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

survivorship of the Medacta SMS femoral stem

Time Frame: 10-year

clinical performance(3, 5, 7 and 10 years)
radiographic performance(3, 5, 7 and 10 years)
Adverse events(up to 10 years)
Evaluate the patient satisfaction(6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years)
Evaluate the quality of life(6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years)
pattern of bone remodeling(6 weeks, 6 months, 1 year)
stem migration(6 weeks, 6 months, 1 and 2 years)