Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Shoulder function by evaluation of Constant's Score
研究概览
简要总结
The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.
The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.
详细描述
This study is a prospective, national, multicenter, non-controlled, non-randomized study in order to evaluate outcomes of the MSS reverse prosthesis used for the management of primary osteoarthritis, cuff tear arthropathy, massive cuff tear, or post-instability arthroplasty.
Included patients, will have an oral and written information about the study, including the information note, during a preoperative visit. The surgeon will answer any questions that may arise and will collect their decision after sufficient time for the patient to reflect.
Patients participating in the research will be able to withdraw their consent and ask to stop the study at any time and for any reason. The investigator should document the reasons as fully as possible.
Patients will be followed according to the schedule below:
- V1 : Inclusion during a preoperative visit
- V2: Surgery maximum 4 months after inclusion
- V3: Follow-up visit at 3 months ± 1 month post-surgery
- V4: Follow-up visit at 12 months ± 2 months post-surgery
- V5: Follow-up visit between 24 months and 28 months post-surgery, marking the end of follow-up for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 aged 18 to 87 ;
- •Patient with one of the following diseases: primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy;
- •Patient in need of a total shoulder prosthesis;
- •Patient affiliated with or beneficiary of a social security scheme;
- •Patient who has given written informed consent for the study.
排除标准
- •Patient with malignant diseases;
- •Patient with known or suspected infections;
- •Patient with neurological deficits that may affect shoulder function;
- •Patient with known incompatibility or allergy to product materials;
- •Patient with previous open shoulder surgery (fracture sequelae, plate or nail, revision ...), treated for fractures, or suffering from rheumatoid arthritis (this does not concern patients treated by arthroscopy, or bone block);
- •Protected major patient;
- •Vulnerable person according to article L1121-6 of the Public Health Code;
- •Pregnant or breastfeeding woman or woman of childbearing age;
- •Impossibility to follow the consultation schedule planned in the study (planned move or mutation, etc...).
- •Exclusion criteria :
- •Patient with malignant diseases on the day of surgery;
- •Patient with known incompatibility or allergy to product materials on the day of surgery;
- •Patient with known or suspected infections on the day of surgery.
研究组 & 干预措施
Shoulder prothesis
Evaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis
干预措施: Medacta Shoulder System (Device)
结局指标
主要结局
Shoulder function by evaluation of Constant's Score
时间窗: 2 years post surgery
The main evaluation criteria is the rate of improvement of the Constant Score and preoperative and postoperative mobility (active external and internal rotation, elbow to body) at 2 years post surgery.
次要结局
- Survival implants(At 2 years post surgery)
- Position of the prosthesis(At 3 months, 1 year and 2 years post-surgery.)
- Bone behaviour(At 3 months, 1 year and 2 years post-surgery.)
- Oxford Shoulder Score(At 3 months, 1 year and 2 years post-surgery)
- Subjective Shoulder Value(At 3 months, 1 year and 2 years post-surgery)
- Complication rate(At 2 years post surgery)
- Shoulder function by evaluation of Constant's Score(At 3 months and 1 year post-surgery)