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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Medacta International SAThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
- ClinicalTrials.gov ID
- NCT02748408
- Acronym / sponsor ID
- P01.019.01
- Conditions
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals suitable for hip replacement using the Medacta SMS femoral stem
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS femoral stem | Device | – |
Primary outcome
survivorship of the Medacta SMS femoral stem
Time frame: 10-year
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrosis and Traumatic Arthritis, run by Medacta International SA at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Italy, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mara Colombo, Eng (0041 91 6966060, colombo@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survivorship of the Medacta SMS femoral stem (time frame: 10-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.