Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) - A Randomized Controlled Trial of Meniscal Tear Treatment in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 7
- 主要终点
- the Knee Injury and Osteoarthritis Outcome Score (KOOS4)
研究概览
简要总结
There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can be caused by either a smaller or larger trauma or be a degenerative age-related tear. Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40 years or younger) in comparison to non-surgical treatments.
The purpose of this study is to determine if a strategy of early arthroscopic meniscal surgery (repair or resection) is superior to a strategy of initial individualized supervised exercise therapy including patient education with the option of later surgery if needed in improving pain, function and quality of life in young patients (18-40 years) with meniscal tears.
The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve more than patients treated with exercise and education.
详细描述
Arthroscopic meniscal surgery is the most common orthopedic procedure. In Denmark, meniscal surgeries have doubled from around 9.000 yearly procedures in 2000 to more than 17.000 in 2011, with the total number of meniscal surgeries exceeding 150.000 in this period. Similar trends have been observed in the US, where more than 700.000 orthopedic procedures are carried out annually. Numerous randomized controlled trials (RCT) have investigated the efficacy of meniscal surgery compared with placebo surgery, in addition to non-surgical treatment and in direct comparison to exercise in middle-aged and older patients.
However, no RCTs have investigated the efficacy of meniscal surgery for younger patients (i.e. 40 years or younger) in comparison to non-surgical treatments. In contrast to middle-aged and older adults with degenerative meniscal tears of unknown origin, most tears in younger adults (18-40 years) are of traumatic origin (i.e. such as a sports related trauma), which highlights the need for a high-quality trial in the younger population.
The aim of this RCT is to investigate if early arthroscopic meniscal surgery (repair or resection) is superior to individualized supervised exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in young patients (18-40 years) with meniscal tears. The study hypothesis is that patients randomized to surgery will improve significantly more in pain, function and quality of life after 12 months than those randomized to exercise and education.
Patients fulfilling eligibility criteria and willing to participate in the study will be randomized to one of the two groups after the baseline assessment with follow-up after 3, 6 and 12 months (Subsequently, a 24-month follow-up has been added):
- Arthroscopic meniscal surgery: Arthroscopic meniscal repair or resection will be conducted at the discretion of the operating surgeon (this cannot be determined before the surgeon has visual confirmation about the exact knee pathology and extend of the meniscal tear by scope).
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 40 years with knee pain
- •Clinical history and symptoms consistent with meniscal tear and meniscal tear verified on magnetic resonance imaging (MRI)
- •Deemed eligible for meniscal surgery (i.e. repair or resection) by the examining orthopedic surgeon
- •Willing to participate in 12 weeks of supervised exercise twice a week or undergo surgery for the meniscal tear as soon as possible
排除标准
- •Previous knee surgery on the affected knee
- •Clinical suspicion (acute locking of knee AND/OR extension deficit) of displaced bucket-handle tear confirmed by MRI
- •Fracture of the affected extremity within the previous 12 months
- •Complete rupture of one or more knee ligaments.
- •Participation in supervised systematic exercise for knee problems within the last 3 months prior to recruitment
- •Other reasons for exclusion (Unable to understand Danish, mentally unable to participate, etc.)
结局指标
主要结局
the Knee Injury and Osteoarthritis Outcome Score (KOOS4)
时间窗: Primary endpoint: Change from baseline to 12 months.
The mean score for the KOOS subscales Pain, Symptoms, Function in sports and recreational activities, and Quality of life. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
次要结局
- The five KOOS subscales(Primary endpoint: Change from baseline to 12 months.)
- The one-leg hop for distance(Primary endpoint: 12 months.)
- Western Ontario Meniscal Evaluation Tool (WOMET)(Primary endpoint: Change from baseline to 12 months.)
- Isometric muscle strength(Primary endpoint: Change from baseline to 3 months.)
- Structural knee joint changes(Baseline to 24 months)
- The maximum number of knee-bends in 30s(Primary endpoint: Change from baseline to 12 months.)
- The 6 m timed hop(Primary endpoint: 12 months.)
- Adverse events(Primary endpoint: 12 months.)
研究者
Søren Thorgaard Skou
PT, PhD, Professor
University of Southern Denmark