Evaluation of Preoperative Education and Mini-invasive Total Hip Replacement in Regard to the Attainment of Functional Independency and Reduction of Hospital Stay
试验速览
- 阶段
- 3 期
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Time to reach functional independence at hospital discharge
研究概览
简要总结
We propose to evaluate a preoperative education of the patient and a new surgical technique (the mini-invasive THR) that could reduce the time to achieve functional independence.
The primary objective of the trial is to assess the time to reach functional independence after total hip replacement depending on the treatment groups: preoperative education versus no preoperative education and mini-invasive procedure versus standard procedure. The study hypothesis is that education and mini-invasive procedure will reduce the time to reach functional independence.
This is a prospective trial with a double randomization.
详细描述
We propose to evaluate a preoperative education of the patient and a new surgical technique (the mini-invasive THR) that could reduce the time to achieve functional independence. Preoperative education is compared to no education and the mini-invasive surgery is compared to the standard group.
The education is based on explaining to the patient what will the postoperative rehabilitation be like.
The mini-invasive THR is based on the minimisation of soft tissue trauma. It requires a specific instrumentation to allow dissection and implantation of the prosthesis. Only few studies have evaluated such a technique. However, these studies were retrospective or non-randomised and results are contradictory. Therefore, a randomised controlled clinical trial is necessary to evaluate the possible benefits and feasibility of this technique.
The primary outcome is the time to reach functional independence. Secondary outcomes evaluate the duration of hospital stay, the quality of implantation of the prosthesis, the postoperative morbidity, the functional benefits and the quality of life.
Methods: this monocentric randomised controlled clinical trial compares the preoperative education versus no preoperative education (first randomization) and the conventional THR to the mini-invasive THR (second randomization). One hundred and forty patients will be included in each group.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis of the hip
- •avascular necrosis of the hip
- •patient between 40 and 90 years old (included)
排除标准
- •history of previous hip operation (bone)
- •patient >90 or < 40
- •inflammatory arthritis
- •important proximal femur or acetabular deformity
- •complete functional independence not possible
- •BMI > 30
结局指标
主要结局
Time to reach functional independence at hospital discharge
时间窗: during de study
Time to reach functional independence at hospital discharge
次要结局
- Perioperative criteria :(during the study)
- estimated blood loss(during the study)
- duration of operation(during the study)
- implant position(during the study)
- implant fixation(during th study)
- perioperative technical errors(during the study)
- Postoperative during hospital stay:(during the study)
- number of patients and number of units transfused before hospital discharge(during the study)
- total estimated blood loss(during the study)
- postoperative pain(during the study)
- skin problems(during the study)
- duration of hospital stay(during the study)
- Postoperative (3, 6 and 12 months):(during the study)
- Harris hip score, SF-36, evaluation of satisfaction and expectation(during the study)
- Abduction strength, balance and gate(during the study)
- Scar assessment(during the study)
- complications(during the study)