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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Total Hip Arthroplasty
Procedure/SurgeryTotal Hip Arthroplasty with SMS Femoral Stem (Medacta)
Treatment groups
Trial outcomes
Primary outcomes
Survival rate of SMS femoral stem
Survival analysis accordin to the Kaplan-Meier method
Secondary outcomes
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.
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.
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
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
Sponsors and contacts
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