ClinicalTrials.gg
RecruitingNCT02748408Updated Oct 13, 2026

The Medacta International SMS Post-Marketing Surveillance Study

An observational study in Arthrosis, Traumatic Arthritis and Rheumatoid Polyarthritis, sponsored by Medacta International SA. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Medacta International SA · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
550
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.

02

Conditions studied

  • Arthrosis
  • Traumatic Arthritis
  • Rheumatoid Polyarthritis
  • Congenital Hip Dysplasia
  • Avascular Necrosis of the Femoral Head
03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's planned enrollment of 550 is above the median of 100 across 601 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Individuals suitable for hip replacement using the Medacta SMS femoral stem

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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 for participation in the study
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
550 participants (estimated)
Patient registry
No

Interventions

  • DeviceSMS femoral stem
06

What researchers measure

Primary outcomes

  1. survivorship of the Medacta SMS femoral stem

    Time frame: 10-year

Secondary outcomes

  1. clinical performance

    Harris Hip Score

    Time frame: 3, 5, 7 and 10 years

  2. radiographic performance

    presence of radiolucencies

    Time frame: 3, 5, 7 and 10 years

  3. Evaluate the patient satisfaction

    Oxford score

    Time frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years

  4. Evaluate the quality of life

    EQ-5D

    Time frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years

  5. pattern of bone remodeling

    Dual Energy X ray Absorptiometry (DEXA)

    Time frame: 6 weeks, 6 months, 1 year

  6. stem migration

    Radiostereometric Analysis (RSA)

    Time frame: 6 weeks, 6 months, 1 and 2 years

  7. Adverse events

    record of adverse event

    Time frame: up to 10 years

07

Study locations

4 of 4 sites recruiting
  • Herz-Jesu Krankenhaus
    Vienna, 1030, Austria
    Recruiting
    • Maximilian Walther, Dr · Contact
  • Istituto Ortopedico Galezzi
    Milan, Milan 20161, Italy
    Recruiting
    • Giuseppe Peretti, Prof. · Contact
  • Bürgerspital Solothurn
    Solothurn, CH-4500, Switzerland
    Recruiting
    • Näder Helmy, PD Dr. · Contact
  • The Elective Orthopaedic Centre (EOC)
    Epsom, Surrey KT18 7EG, United Kingdom
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date, oversight details and data sharing statement
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 3 other changes: verification date, oversight details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT02748408
Responsible party
Sponsor
First posted
Apr 22, 2016
Start date
Jul 2015
Primary completion
Jul 2032 (estimated)
Completion
Jul 2032 (estimated)
Last update
Oct 13, 2026

Study contacts

Mara Colombo, Eng
Contact
colombo@medacta.ch
0041 91 6966060
View the source record on ClinicalTrials.gov ↗

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