ClinicalTrials.gg
RecruitingNCT06640764Updated Oct 8, 2026

Multicentre SMS Study - FR

An observational study in Dysplasia of Hip Joint, Hip Osteoarthritis and Traumatic Arthritis of Hip, sponsored by Medacta International SA. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Medacta International SA · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem

02

Conditions studied

  • Dysplasia of Hip Joint
  • Hip Osteoarthritis
  • Traumatic Arthritis of Hip
  • Avascular Necrosis of Femur Head
03

In context

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

This study's planned enrollment of 260 is above the median of 135 across 158 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip 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 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients suffering from a severely painful and/or disabling hip joint (osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, avascular necrosis of the femoral head) requiring a total hip prosthesis and who will receive a Medacta SMS femoral stem.

Patients will be able to participate in other non-interventional research for the duration of the study.

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

  • Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.
  • Patient who will receive a Medacta SMS femoral stem.
  • Patient agrees to comply with the study requirements.
  • Patient has signed the consent form.
  • Patient is affiliated with a social security system.
  • Patient aged 18 to 75 years

Exclusion criteria

Exclusion Criteria:

  • Participation in biomedical research.
  • Minor patient.
  • Protected adult patient.
  • Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.
  • Pregnant or breastfeeding women.
  • Patient unable to express their non-opposition.
  • Patient refusing the collection of their personal data.
  • Acute, systemic, or chronic infection. Skeletal immaturity.
  • Grossly deformed anatomy (at the surgeon's discretion).
  • Osteomalacia for which the fixation of an uncemented implant is .
  • Patient suffering from active rheumatoid arthritis or osteoporosis.
  • Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated.
  • Patient suffering from muscle atrophy or neuromuscular disease.
  • Patient with an allergy to the implant material.
  • Any patient who cannot or does not wish to give their to participate in the study.
  • Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems.
  • Any contraindication mentioned in the instructions for use of the medical device.
Terms in these criteria, in plain language(3)

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

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

Interventions

  • ProcedureTotal Hip Arthroplasty

    Total Hip Arthroplasty with SMS Femoral Stem (Medacta)

06

What researchers measure

Primary outcomes

  1. Survival rate of SMS femoral stem

    Survival analysis accordin to the Kaplan-Meier method

    Time frame: From enrollment to the end of treatment at 10 years

Secondary outcomes

  1. Evaluation of the clinical performance of the SMS femoral stem

    Clinical performance of the SMS femoral stem evaluated through the Harris Hip Score. The Harris Hip Score is a standardized measure used to assess the severity of hip pain and functional limitations in individuals with hip conditions. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

    Time frame: From enrollment to the end of treatment at 10 years

  2. Evaluation of the hip function

    Hip function evaluated through the Oxford Hip Score. The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability.

    Time frame: From enrollment to the end of treatment at 10 years

  3. Evaluation of the quality of life

    Quality of life evaluated through the EuroQol Score (EQ-5D-5L). The EQ-5D family of instruments has been developed to describe and value health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking only a few minutes to complete. The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of their own overall current health

    Time frame: From enrollment to the end of treatment at 10 years

  4. Evaluation of the safety (adverse events) of the SMS femoral stem

    Safety of the SMS femoral stem evaluated through the collection of the intraoperative and postoperative complications

    Time frame: From enrollment to the end of treatment at 10 years

  5. Evaluation of the stability and the fixation of the SMS femoral stem

    Stability and fixation of the SMS femoral stem evaluated through the radiographic anaysis, assessing the position of the implant (subsidence and migration), the presence of radiolucent lines, the implant breakage.

    Time frame: From enrollment to the end of treatment at 10 years

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: index terms, verification date and site details
1 update, last Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Minor edits only
    + 3 other changes: index terms, verification date and site details

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
NCT06640764
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Sep 1, 2024
Primary completion
Sep 1, 2034 (estimated)
Completion
Sep 1, 2037 (estimated)
Last update
Oct 8, 2026

Study contacts

Paul Maisongrosse
Contact
paul.maisongrosse@hotmail.fr
0033 05 61 37 85 93
View the source record on ClinicalTrials.gov ↗

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