Clinique de l'Union
Saint-Jean, 31240, France
Location status: Recruiting
NCT Number: NCT06640764
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Saint-Jean, 31240, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total Hip Arthroplasty with SMS Femoral Stem (Medacta)
Time frame: From enrollment to the end of treatment at 10 years
Survival analysis accordin to the Kaplan-Meier method
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.
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.
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
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
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.
Contact information is provided by the study sponsor or research team.
Medacta International SA
Industry
Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
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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