Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- KOOS (The Knee injury and Osteoarthritis Outcome Score)
研究概览
简要总结
The goal of this randomized clinical trial is to compare treatment for osteoarthritis in the knee using platelet rich plasma (PRP) or adipose stem cells (ADS). The main questions it aims to answer are:
- Will the patients clinically benefit from the treatment, and if so, which treatment is better?
- Will there be radiological findings to support this? Participants will be randomized into one of four groups: PRP, ADS, PRP + ADS or placebo treatment (saline) and will be examined and get an X-ray and MRI of the knee taken at inclusion and after 1 and 2 years.
详细描述
Patients will be randomized into one of four treatment groups and then be followed up at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after intervention. They will fill out scores and be clinically evaluated, as well as radiologically examined at inclusion and at the final check up (x-ray and MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic osteoarthritis in the knee grade I-III using the Kellgren-Lawrance Grading Scale
- •Age 40-70 years
- •Minimum VAS 3
- •No use of NSAIDs or steroids the last 14 days
- •No injections of hyaluronic acid the last three months
- •Varus/valgus deformity <5 degrees as evaluated on x-ray imaging
排除标准
- •Pregnant or breastfeeding women
- •Other etiologies of knee pain (refered pain, pain from the back, dislocated meniscus on MRI, osteoarthritis grade IV using the Kellgren-Lawrance Grading Scale)
- •Previous knee surgery on the affected knee
- •Secondary osteoarthritis in the knee
- •Previous infection in the knee
- •Other diseases (rheumatoid arthritis, diabetes, systemic diseases or corticosteroid-demaning disease)
- •Patients with a high risk of deep vein thrombosis
- •Patients who cannot cooperate/are low compliance (psychiatric disease) or has contraindications for MRI
研究组 & 干预措施
Platelet rich plasma (PRP)
Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee.
干预措施: PRP injection (Biological)
Adipose tissue stem cells
Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee.
干预措施: ADSTEM Inj. (Adult human mesenchymal stem cells) (Biological)
Platelet rich plasma + adipose tissue stem cells
A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee.
干预措施: Injection (Biological)
Placebo (saline)
Saline (NaCl) is injected into the patients knee.
干预措施: Saline (NaCl 0,9 %) (placebo) (Biological)
结局指标
主要结局
KOOS (The Knee injury and Osteoarthritis Outcome Score)
时间窗: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
KOOS score filled out by the patient, from 0-100 where a higher score indicates worse outcomes.
WOMAC score (Western Ontario og McMaster Universities Osteoarthritis Index)
时间窗: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
Clinical outcome scores (WOMAC) filled out by the patient. Scale from 0-96 in total (0-4 on each question, added together). A higher score indicates a worse score.
VAS (Visual analogue scale)
时间窗: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
Pain score (VAS) from 0-10 where a higher score indicates worse outcomes.
次要结局
- Radiological findings after treatment(At inclusion and 2 years after intervention.)