ArthrosisNCT02748408
The Medacta International SMS Post-Marketing Surveillance Study
An observational study of Arthrosis and Traumatic Arthritis, run by Medacta International SA at 4 sites in 4 countries.
Trial summary
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis
- What is being tested?
- SMS femoral stem
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2015to Jul 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals suitable for hip replacement using the Medacta SMS femoral stem
Who may be able to join
- 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 cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Austria1 site, 1 recruiting
- Recruiting
Herz-Jesu Krankenhaus
Vienna, 1030
Maximilian Walther, Dr
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Galezzi
Milan, Milan, 20161
Giuseppe Peretti, Prof.
Switzerland1 site, 1 recruiting
- Recruiting
Bürgerspital Solothurn
Solothurn, CH-4500
Näder Helmy, PD Dr.
United Kingdom1 site, 1 recruiting
- Recruiting
The Elective Orthopaedic Centre (EOC)
Epsom, Surrey, KT18 7EG
Richard Field, PhD FRCS, richardefield@aol.com
About this study
Official title: The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
- Conditions
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head
- Being tested
- SMS femoral stem
- Medical subject headings
- Osteoarthritis, Hip Dislocation, Congenital, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS femoral stemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
survivorship of the Medacta SMS femoral stem
Measured: 10-year
Secondary outcomes (7)
clinical performance
Harris Hip Score
Measured: 3, 5, 7 and 10 years
radiographic performance
presence of radiolucencies
Measured: 3, 5, 7 and 10 years
Evaluate the patient satisfaction
Oxford score
Measured: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
Evaluate the quality of life
EQ-5D
Measured: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
pattern of bone remodeling
Dual Energy X ray Absorptiometry (DEXA)
Measured: 6 weeks, 6 months, 1 year
stem migration
Radiostereometric Analysis (RSA)
Measured: 6 weeks, 6 months, 1 and 2 years
Adverse events
record of adverse event
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748408
- Sponsor's protocol ID
- P01.019.01
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2016
- Last updated
- 13 Oct 2026
- Results posted
- No