Treatment of Osteoarthritis With Autologous, Microfragmented Adipose Tissue. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- KOOS4
研究概览
简要总结
The study is a blinded, multicenter, randomized, controlled trial with participants individually randomized to one of two parallel groups:
- The intervention group: Participants receive one intra articular injection with autologous, microfragmented adipose tissue.
- The control group: Participants receive one intra articular injection with Saline (placebo).
The objective of the study is to investigate if intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system affects the patient reported outcome in patients with osteoarthritis of the knee.
The primary endpoint is KOOS4 evaluated at 6 months after the intervention. Secondary endpoints are the KOOS including all five subscales evaluated after 6months, 1 and 2 years.
详细描述
2 Study Objective To investigate if intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system affects the patient reported outcome in patients with osteoarthritis of the knee.
Hypothesis Treatment with autologous, microfragmented adipose tissue has the potential to reverse degenerative changes in knees with osteoarthritis. The patient will experience a better patient reported health in comparison with placebo treatment.
Null hypothesis There is no difference in patient reported outcome when treatment with autologous, microfragmented adipose tissue is compared to placebo treatment.
3 Background Osteoarthritis (OA) of the knee is a destructive joint disease, causing degeneration of cartilage, damage to the underlying bone and morphological changes to the joint1. It is a major public health concern due to the increased life expectancy of the ageing population2,3. No approved medical treatment that reverses the morphological changes currently exists. Conventional treatment includes physiotherapy, pain killers, braces and in end-stage OA surgical knee replacement4.
During the past decade researchers have started to explore the regenerative potential of mesenchymal stem cells (MSC) in OA5. MSCs are multipotent progenitor cells able to give rise to osteocytes, adipocytes, chondrocytes, myoblasts and tenocytes6. MSCs were first used to treat Chondral defects in 19987 and to treat OA in 20028. Since then, a number of case reports and prospective series have been published showing significant short term and long term effect on pain and cartilage thickness5. Latest a prospective case-series of 1128 patients involving 1856 joints showed an improvement of at least 50% in 86% of patients at 3 months and 91% of patients at 12 months using a modified Knee/Hip Osteoarthritis Outcome Score (KOOS/HOOS) questionnaire9. Only 0.9% of patients did not show improvement after treatment. However, when interpreting these studies one should bear in mind that they are all level four evidence and as such prone to bias.
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)
盲法说明
4.4.1 Randomization Randomization is computer based, performed in blocks of twelve.
4.4.2 Blinding Blinding of the patient is secured as follows: The liposuction and microfragmentation of the fatty tissue is performed in the operating theatre. When the graft is ready for use the randomization envelope is opened by the project nurse; if the patient is allocated to active treatment syringes containing the microfragmented fatty tissue are prepared; if the patient is allocated to placebo syringes containing saline are prepared. The 10ml syringe is placed in the hand of the treating surgeon. Injection is performed with a 21G cannula. Due to the difference in viscosity of the graft and saline, the surgeon cannot be blinded.
In order to investigate if the blinding is working the patients will be asked at 6 months follow up which group he/she believe he/she was assigned to.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
KOOS4
时间窗: 6 months
The Knee injury and Osteoarthritis Outcome Score. The KOOS questionnaire was developed in the 1990s as an instrument to assess the patient's opinion about their knee and associated problems. Since the first publication in 1998, the psychometric properties of the KOOS have been assessed in more than twenty individual studies from all over the world. Furthermore, KOOS has been evaluated and compared to other instruments in several reviews measured after one year19,20 ,21,22. KOOS4 constructs an average score for four out of the five KOOS subscale scores. It was first used by Frobell et al in 201023. The reason for not including all five subscale scores is that in active patients, very few difficulties with activities of daily living (ADL) exists. Including the subscale ADL would then add unwanted 'noise' to the constructed outcome22.
次要结局
- Failure(24 months)
- KOOS(24 months)
研究者
Kristoffer Barfod
Associate Professor, MD PhD
Hvidovre University Hospital