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Recruiting

NCT Number: NCT06640764

Multicentre SMS Study - FR

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 contraindicated.
  • 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 informed consent 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 investigational medical device.

Treatment and study plan

Total Hip Arthroplasty

Procedure

Total Hip Arthroplasty with SMS Femoral Stem (Medacta)

Primary outcomes

  1. Survival rate of SMS femoral stem

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

    Survival analysis accordin to the Kaplan-Meier method

Secondary outcomes

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

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

    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.

  2. Evaluation of the hip function

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

    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.

  3. Evaluation of the quality of life

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

    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

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

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

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

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Maisongrosse

CONTACT

[email protected]

0033 05 61 37 85 93

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS

Important dates

Study start
2024
Primary completion
2034
Study completion
2037
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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