A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline Biodex isokinetic quadriceps strength at 6 months
研究概览
简要总结
RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.
详细描述
The purpose of the study is to compare rehabilitation after meniscal repair with or without the use of a knee orthosis. There is conflicting evidence regarding optimal postoperative rehabilitation following meniscal repair with ACLR. Many surgeons advocate the use of a knee orthosis which restricts flexion during the first 4-6 weeks following surgery. Some also avoid weight baring and crouching for various periods of time. This is due to the perceived risk that the healing meniscus is exposed to unnecessary strain, potentially compromising healing. There is however evidence that fewer postoperative restriction in the setting of meniscal repair in conjunction with ACLR does not compromise meniscal healing. There is also evidence that accelerated rehabilitation following isolated meniscal repair does not increase the risk of failure.
The study design is a prospective randomized study with equal groups.
A power analysis has been performed indicating that 57 patients in each group are required to detect a significant difference between groups, as such a cohort of 120 patients will be recruited. Randomisation will continue until 60 patients are allocated to both groups.
Randomization process and study design will be done according to the CONSORT guidelines.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures.
排除标准
- •Associated injury of the knee requiring surgical or non-surgical intervention that precludes the patient from completing accelerated rehabilitation- fracture, concomitant ligament or cartilage injury.
- •Previous meniscal repair in the affected meniscus
- •BMI over 30
研究组 & 干预措施
Standard rehab group
This group will follow the clinics standard rehab protocol, wherein they have a knee orthosis for six weeks, with flexion limited to 0-30 degress week 0-2, 0-60 degrees week 2-4 and 0-90 degrees week 4-6. Crouching is not permitted week 6-12.
干预措施: Standard rehab (Other)
Accelerated rehab group
accelerated rehab group, wherein they are permitted to perform range of motion training within their comfort zone. Running is permitted after 8 weeks, contact sports 4 months postoperatively
干预措施: accelerated rehab group (Other)
结局指标
主要结局
Change from baseline Biodex isokinetic quadriceps strength at 6 months
时间窗: six months
Patients will undergo Biodex Isokinetic measurement at 6 months
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS)(preoperative, six months, two years)
- Change from baseline Biodex isokinetic quadriceps strength at 24 months(2 years)
- Goniometric measurement: Knee flexion and extension(2 weeks, 6 weeks, 6 months, 2 years)
- IKDC(Pre-operative, 6 months, 2 years)
- Rates of failure(two years)
- Tegner activity score(Pre-operative, 6 months, 2 years)
- Measurement of circumference of the knee(Pre-operative, 6 weeks, 3 months, 6 months, 2 years)
- Lysholm score(Pre-operative, 6 months, 2 years)
- Functional knee tests(6 weeks, 6 months, 2 years)
研究者
Anders Stalman
Associate professor
Karolinska Institutet