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RecruitingNCT02748408Updated Sep 29, 2025

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 2025-09-29.

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

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

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 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
04

Study design

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

Interventions

  • DeviceSMS femoral stem
05

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

06

Study locations

4 of 4 sites recruiting
  • Herz-Jesu Krankenhaus
    Vienna, 1030, Austria
    • Maximilian Walther, Dr · Contact
    Recruiting
  • Istituto Ortopedico Galezzi
    Milan, Milan 20161, Italy
    • Giuseppe Peretti, Prof. · Contact
    Recruiting
  • Bürgerspital Solothurn
    Solothurn, CH-4500, Switzerland
    • Näder Helmy, PD Dr. · Contact
    Recruiting
  • The Elective Orthopaedic Centre (EOC)
    Epsom, Surrey KT18 7EG, United Kingdom
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02748408
Lead sponsor
Medacta International SA
Responsible party
Sponsor
First posted
Apr 22, 2016
Start date
Jul 2015
Primary completion
Jul 2032 (estimated)
Completion
Jul 2032 (estimated)
Last update
Sep 29, 2025

Study contacts

Mara Colombo, Eng
Contact
colombo@medacta.ch
0041 91 6966060

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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