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Recruiting Observational

The Medacta International SMS Post-Marketing Surveillance Study

NCT02748408 · tracked via the Priya Life Science UK tracker
Phase
Observational
Started
2015-07
Last updated
2026-10-13

Condition(s) studied

ArthrosisTraumatic ArthritisRheumatoid PolyarthritisCongenital Hip DysplasiaAvascular Necrosis of the Femoral Head

Investigational drug(s) / intervention(s)

SMS femoral stem

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • survivorship of the Medacta SMS femoral stem — 10-year

Trial sites (4)

FacilityCityRegionStatus
Herz-Jesu Krankenhaus Vienna Austria Recruiting
Istituto Ortopedico Galezzi Milan Milan Recruiting
Bürgerspital Solothurn Solothurn Switzerland Recruiting
The Elective Orthopaedic Centre (EOC) Epsom Surrey Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02748408 on ClinicalTrials.gov ↗ ← All trials in the UK