Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 158
- 试验地点
- 4
- 主要终点
- Deviation in a mechanical axis of knees
研究概览
简要总结
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.
详细描述
Randomized, open and prospective clinical trial.
Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years old.
- •Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
- •Patient with a BMI equal to or greater than 30 Kg / m2
- •Patients with clinical and radiological criteria of knee osteoarthritis.
- •Patients with indication for primary TKA according to medical criteria.
排除标准
- •Pregnancy or lactation.
- •Inability to give informed consent in the absence of a legal representative.
- •Subjects that are participating in a study with medicines or other medical devices.
- •Those who show inability to follow the instructions or collaborate during the development of the study.
- •If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
- •Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment).
- •Need a simultaneous bilateral TKA.
- •Have a varus angle or valgus ≥ 15 °.
- •Total revision knee arthroplasty.
结局指标
主要结局
Deviation in a mechanical axis of knees
时间窗: 12 months
Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º
次要结局
- Surgical procedure time(Week 1)
- Number of Surgical complications (post-operative)(1-12 months)
- Radiological axes (femoral)(12 months)
- Radiological axes (tibial)(12 months)
- Admission (hospital) duration(Week 1)
- Number of Surgical complications (perioperative)(1 to 6 weeks)
- Number of Surgical complications (Intraoperative)(Week 1)
研究者
Pedro-José Torrijos-Garrido
Principal Investigator
Puerta de Hierro University Hospital