Clinical Trials in the UK / NCT02748408
Recruiting
Observational
The Medacta International SMS Post-Marketing Surveillance Study
NCT02748408 · tracked via the Priya Life Science UK tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Medacta International SA trials in the UK
The Medacta International GMK Sphere Post-Marketing Surveillance Study
Active, not recruiting
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Active, not recruiting
Other trials for the same condition
Persona Partial Knee Clinical Outcomes Study
Active, not recruiting
The Medacta International GMK Sphere Post-Marketing Surveillance Study
Active, not recruiting
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
Active, not 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