Randomised Controlled Trial to Compare the Speed of Recovery and Functional Outcome Following Total Knee Replacement (TKR) Using a Quadriceps Sparing Approach to the Knee Against a Standard Medial Parapatellar Surgical Exposure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in Functional knee range of motion from pre surgery to 6 months post surgery
研究概览
简要总结
When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. And alternative and more recently introduced technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the muscle at the front of the leg. In this study we compare the two surgical techniques in a so-called randomized trial. This means that we put people randomly into two groups, one group will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the 'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus approach recover quicker and have a better short-term functional outcome than people who receive the 'Medial parapatellar approach'.
详细描述
This study is a prospective randomized controlled double blind trial in which both immediate post-operative recovery and functional outcome at 6 weeks, 3 and 6 months after total knee replacement surgery will be assessed for two different types of surgical approach; Medial Parapatellar and Mid-vastus.
Functional outcome will be assessed by recording the kinematics of the lower limb joints in addition to muscle activity (electromyography) during walking, stair ascending and descending and getting up from a chair through computerized 3D motion analysis. Outcome measures will be recorded immediate post surgery and at medium follow-up and will cover all areas of the World Health Organisation, International Components of Functioning, Disability and Health (ICF) components 'Body Structures and Functions/Impairments' ,'Activities and Participation' and 'Personal factors'. It is hypothesized that by minimizing the damage to the quadriceps, patients operated using the Mid-vastus approach will have better muscle function and will therefore have more normal knee range of motion, knee joint loading and muscle activity patterns compared to those with the Medial Parapatellar approach.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total knee arthroplasty
- •Osteoarthritis
- •Surgery at Royal Infirmary Edinburgh by participating surgeons
排除标准
- •A Body Mass Index of more than 40
- •Fixed valgus deformity of more than 15 degrees
- •Inflammatory polyarthritis
- •disorders of the feet, ankles or hips or spine causing abnormal gait or significant pain
- •severe visual impairment
- •neurological conditions affecting movement
- •inability to give informed consent
研究组 & 干预措施
Mid-vastus approach
干预措施: Mid-vastus approach (Procedure)
medial parapatellar approach
干预措施: medial parapatellar approach (Procedure)
结局指标
主要结局
change in Functional knee range of motion from pre surgery to 6 months post surgery
时间窗: 6 months after surgery
The knee range of motion during functional activities such as walking and stair ascending and descending is recorded using three dimensional motion analysis
次要结局
- change in WOMAC from pre surgery to 6 month after surgery(6 months after surgery)
- Change in Timed up and Go test from pre-surgery to 6 month post surgery(6 months after surgery)
- Change in range of motion of the knee in prone from pre surgery to post surgery(6 months after surgery)
- Change in Objective daily physical activity from pre to 6 month post surgery(6 month post surgery)
- Change in knee extensor strength from pre surgery to 6 months after surgery(6 months after surgery)
研究者
Marietta van der Linden
Research Fellow Physiotherapy
Queen Margaret University