Prospective Clinical Trial Regarding the Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty in Rio Hortega University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Oxford Knee Score pre op and post op
研究概览
简要总结
Patients undergoing total knee arthroplasty will follow two different rehabilitation protocols. In one of them, they will start walking the day of surgery and discharged on a 48 hours basis. On the other one, start walking 3 days after surgery and discharged on a 96 hours basis. Outcomes will be satisfaction, pain, range of movement, incidence of DVT and overall complications.
详细描述
Randomization will be performed concealed the day before surgery. Tranexamic acid will be used in both groups. Rapid recovery group will not be using a drain, whereas the standard protocol group will have one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis willing to undergo total knee arthroplasty
- •Age 55-79
排除标准
- •Hipersensibility to any of the components used
- •Pulmonary embolism
结局指标
主要结局
Oxford Knee Score pre op and post op
时间窗: 6 months
Difference in Oxford Knee Scores postoperatively and preoperatively
Range of Motion
时间窗: 6 months
Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)
Pain: Morphine clorhydrate shots requested by the patient
时间窗: 24 hours
Number of shots requested and administered to the patient after surgery
Overall score given by the patient to the knee replacement process
时间窗: 6 months
Satisfaction with the protocol. Subjective measure by the patient from 0 (bad) to 10 (best) with the surgery process.
Blood loss
时间窗: 48 hours
Haemoglobin drop
Infection
时间窗: 1 year
Incidence of infection
Ultrasonography incidence of deep vein thrombosis
时间窗: 4 weeks-8 weeks
Incidence of deep vein thrombosis measured by ultrasound
次要结局
未报告次要终点
研究者
Ignacio Aguado Maestro
Principal Investigator
Hospital del Río Hortega