The Medacta International SMS Post-Marketing Surveillance Study

M

Medacta

Status

Enrolling

Conditions

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

Treatments

Device: SMS femoral stem

Study type

Observational

Funder types

Industry

Identifiers

NCT02748408
P01.019.01

Details and patient eligibility

About

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

Enrollment

550 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

4

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Central trial contact

Mara Colombo, Eng

Data sourced from clinicaltrials.gov

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