Status:
RECRUITING
The Medacta International SMS Post-Marketing Surveillance Study
Lead Sponsor:
Medacta International SA
Conditions:
Arthrosis
Traumatic Arthritis
Eligibility:
All Genders
18-75 years
Brief Summary
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Eligibility Criteria
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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2032
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT02748408
Start Date
July 1 2015
End Date
July 1 2032
Last Update
September 29 2025
Active Locations (4)
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1
Herz-Jesu Krankenhaus
Vienna, Austria, 1030
2
Istituto Ortopedico Galezzi
Milan, Milan, Italy, 20161
3
Bürgerspital Solothurn
Solothurn, Switzerland, CH-4500
4
The Elective Orthopaedic Centre (EOC)
Epsom, Surrey, United Kingdom, KT18 7EG