RecruitingNCT02748408

The Medacta International SMS Post-Marketing Surveillance Study

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

Sponsor

Medacta International SA

Enrollment

550 participants

Start Date

Jul 1, 2015

Study Type

OBSERVATIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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 Criteria12

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

Interventions

DEVICESMS femoral stem

Locations(4)

Herz-Jesu Krankenhaus

Vienna, Austria

Istituto Ortopedico Galezzi

Milan, Milan, Italy

Bürgerspital Solothurn

Solothurn, Switzerland

The Elective Orthopaedic Centre (EOC)

Epsom, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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