NCT06640764招募中不适用
Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Survival rate of SMS femoral stem
研究概览
简要总结
Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Survival rate of SMS femoral stem
时间窗: From enrollment to the end of treatment at 10 years
Survival analysis accordin to the Kaplan-Meier method
次要结局
- Evaluation of the clinical performance of the SMS femoral stem(From enrollment to the end of treatment at 10 years)
- Evaluation of the hip function(From enrollment to the end of treatment at 10 years)
- Evaluation of the quality of life(From enrollment to the end of treatment at 10 years)
- Evaluation of the safety (adverse events) of the SMS femoral stem(From enrollment to the end of treatment at 10 years)
- Evaluation of the stability and the fixation of the SMS femoral stem(From enrollment to the end of treatment at 10 years)
研究者
研究点 (1)
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