Recruiting NCT02748408
The Medacta International SMS Post-Marketing Surveillance Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SMS femoral stem.
- Who it may be relevant to
- Registry conditions: Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Italy, Switzerland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
Overview
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Interventions
- Device SMS femoral stem
Primary outcome measures
- survivorship of the Medacta SMS femoral stem [Time frame: 10-year]
Secondary outcome measures (7)
- clinical performance [Time frame: 3, 5, 7 and 10 years]
- radiographic performance [Time frame: 3, 5, 7 and 10 years]
- Evaluate the patient satisfaction [Time frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years]
- Evaluate the quality of life [Time frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years]
- pattern of bone remodeling [Time frame: 6 weeks, 6 months, 1 year]
- stem migration [Time frame: 6 weeks, 6 months, 1 and 2 years]
- Adverse events [Time frame: up to 10 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Herz-Jesu Krankenhaus — Vienna
Italy · 1 center
- Istituto Ortopedico Galezzi — Milan
Switzerland · 1 center
- Bürgerspital Solothurn — Solothurn
United Kingdom · 1 center
- The Elective Orthopaedic Centre (EOC) — Epsom
Identifiers
NCT: NCT02748408 · P01.019.01