At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SMS femoral stem (device)
- How long the study runs
- Study runs about 204 months (dates as stated)
- About the drug or intervention
- SMS femoral stem (device)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Medacta International SA, is checking how well hip replacements perform in everyday use after the implant has been approved. It is for people aged 18 to 75 who are due to have their first total hip replacement because of a painful hip joint. Conditions listed include osteoarthritis (worn joints), traumatic arthritis (arthritis after injury), hip dysplasia present from birth, and avascular necrosis of the femoral head (loss of blood supply causing hip bone damage).
Who can take part
- Aged between 18 and 75 at the time of surgery
- Have a severely painful and/or disabling hip joint caused by osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head
- Are scheduled to have a first (primary) total hip replacement
Who may not be able to
- Have an active infection
- Are pregnant
- Have a mental illness that the study team thinks could affect your ability to give consent, judge your own progress, or complete the 10-year follow-up
- Have a hip shape that is very unusual, in the surgeon's view
- Have osteomalacia (soft bones) if an uncemented implant is not suitable
- Have active rheumatoid arthritis
- Have osteoporosis (thin or fragile bones)
- Have a metabolic disorder affecting bone formation if an uncemented implant is not suitable
- Have muscle wasting or a disease of the muscles or nerves
- Are allergic to the implant materials
- Cannot or will not give informed consent
- Have other medical problems that the study team believes would prevent recovery to independent mobility
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not fully stated — the study mentions follow-up appointments and reviews over a 10-year cycle; ask the trial team about how many visits and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 550
- Started
- 2015-07
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for arthrosis
- • Clinical study - 550 participants
- • This is a Post-Marketing Surveillance of SMS femoral stem prosthesis
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with arthrosis
Where?
- • Epsom - The Elective Orthopaedic Centre (EOC)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or...
- ✓In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at...
- ✓Scheduled for a primary total hip replacement.
Who cannot take part
- ✗Active infection
- ✗Pregnancy
- ✗Grossly distorted anatomy (surgeon's discretion)
- ✗Osteomalacia where uncemented implant fixation is not safe to use
- ✗Active rheumatoid arthritis.
See the full criteria
Where Is This Study? (1 UK site)
The Elective Orthopaedic Centre (EOC)
Epsom KT18 7EG, United Kingdom
How to Get in Touch
Mara Colombo, Eng
Sponsor contactCONTACT