RECRUITINGOBSERVATIONAL
The Medacta International SMS Post-Marketing Surveillance Study
The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
About This Trial
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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 willing to sign a consent form for participation in the study
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
SMS 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