The Medacta International SMS Post-Marketing Surveillance Study

Recruiting · NCT02748408 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medacta International SA

Interventions studied

SMS femoral stem

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

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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
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

4 locations listed.