Multicentre SMS Study - FR

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorMedacta International SA

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participation in biomedical research.

Minor patient.

Protected adult patient.

Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Total Hip Arthroplasty

    Procedure/Surgery

    Total Hip Arthroplasty with SMS Femoral Stem (Medacta)

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

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