Actively Recruiting
Multicentre SMS Study - FR
Led by Medacta International SA · Updated on 2024-10-15
260
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
CONDITIONS
Official Title
Multicentre SMS Study - FR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.
- Patient who will receive a Medacta SMS femoral stem.
- Patient agrees to comply with the study requirements.
- Patient has signed the consent form.
- Patient is affiliated with a social security system.
- Patient aged 18 to 75 years
You will not qualify if you...
- Participation in other biomedical research.
- Minor patient.
- Protected adult patient.
- Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.
- Pregnant or breastfeeding women.
- Patient unable to express their non-opposition.
- Patient refusing the collection of personal data.
- Acute, systemic, or chronic infection.
- Skeletal immaturity.
- Grossly deformed anatomy as determined by the surgeon.
- Osteomalacia contraindicating uncemented implant fixation.
- Active rheumatoid arthritis or osteoporosis.
- Metabolic disorders impairing bone formation contraindicating uncemented implant fixation.
- Muscle atrophy or neuromuscular disease.
- Allergy to implant material.
- Patient unable or unwilling to give informed consent.
- Medical problems compromising prospects of regaining independent mobility.
- Any contraindication listed in the investigational device's instructions for use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinique de l'Union
Saint-Jean, France, 31240
Actively Recruiting
Research Team
P
Paul Maisongrosse
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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