Arthrosis, Avascular Necrosis of the Femoral Head, Congenital Hip Dysplasia, Rheumatoid Polyarthritis, Traumatic Arthritis
Conditions
Brief summary
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Interventions
DEVICESMS femoral stem
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survivorship of the Medacta SMS femoral stem | 10-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radiographic performance | 3, 5, 7 and 10 years | presence of radiolucencies |
| Evaluate the patient satisfaction | 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years | Oxford score |
| Evaluate the quality of life | 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years | EQ-5D |
| clinical performance | 3, 5, 7 and 10 years | Harris Hip Score |
| stem migration | 6 weeks, 6 months, 1 and 2 years | Radiostereometric Analysis (RSA) |
| Adverse events | up to 10 years | record of adverse event |
| pattern of bone remodeling | 6 weeks, 6 months, 1 year | Dual Energy X ray Absorptiometry (DEXA) |
Countries
Austria, Italy, Switzerland, United Kingdom
Contacts
Primary ContactMara Colombo, Eng
Outcome results
None listed