The Effect of the Unloader One® Knee Brace on Symptoms in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee osteoarthritis (OA) by comparing a functioning brace with a dummy.
详细描述
The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee OA by comparing a functioning brace with a dummy. The dummy will be manufactured by Össur and has the same look as the real brace, but lacks the fundamental tightening effect of the straps of the real brace (an insert of elastic bands assures this), thereby nullifying its unloading capabilities. In a recent trial by Dr. Ingvarsson, the brace seemed to lessen the pain from knee OA, but no randomised, controlled studies have been conducted. This is mandatory if the effect of the brace and its use as an accepted treatment for knee OA is to be advocated for general use.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients fulfilling all criteria listed below will be considered to eligible for participation in the study:
- •Patient, men and women, age 30 to 70 with knee OA not scheduled for surgery who understand the given information and are willing to participate in this study.
- •Signed informed patient consent
- •BMI < 35
- •Knee pain for more than 3 month
- •Patients with Knee OA Ahlbäck grade 1 and 2 and/or Kellgren-Lawrence 1 and 2
- •Patient with arthroscopic OA but do not have regular grade 1 OA
排除标准
- •Patient presenting with any of the following will not be included in the study:
- •prior major surgery to the same knee
- •patients with a history of stroke or neurological or psychiatric decease that potentially could affect the perception of pain
- •obesity (BMI > 35)
- •active or suspected infection
- •patients taking opioids or steroids
- •patients suffering from rheumatoid arthritis or have a immunological depression
- •patients with other severe medical problems that could affect the perioperative course
- •the patient had an intraarticular steroid injection in the actual knee during the last 3 months
- •Patient participating in a clinical trial
结局指标
主要结局
Knee Society Score (KSS)
时间窗: one year
Standardized outcome measure for knee problems presented in two subgroups of KSS Score and KSS Function, presented on a range from 0 (worst) to 100 (best)
Visual Analogue Scale (VAS)
时间窗: one year
VAS is presented as a range from 0 (no pain) to 100 (worst possible pain)
Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: one year
Standardized questionaire for knee problems, divided into 5 subscores of pain, symptoms, activity of daily living, sports/recreation and quality of life. Each subscore is presented from 0 (worst) to 100 (best).
EQ-5D
时间窗: one year
EQ-5D comprises two distinct self-report elements, providing three principal approaches to analysis(1) the EQ-5D profile: the patients' self reported health on the dimensions/levels of the descriptive system (2) the EQ-VAS: the patients' own global rating of their overall health, on a scale from 0 (worst possible health) to100 (best possible health)• Both types of data can be the focus of analysis, plus(3) Profiles can be summarized using 'value sets' (EQ-5DIndex) which reflect the preferences of the general public.
次要结局
未报告次要终点
研究者
Sören Toksvig-Larsen
Associate professor
Region Skane