Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain (Visual Analogue Scale)
研究概览
简要总结
Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only.
Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo SVF injection and splinting vs. splinting only.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. The primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (PRWE).
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-70 years
- •Eaton-Glickel II thumb CMC osteoarthrosis
- •Symptom duration > 3 months
- •Pain visual analogue score > 30 mm
- •< 3 months of treatment with thumb splinting
- •American Society of Anaesthesiologists physical status (ASA) I-III
- •Fluent in written and spoken Finnish
排除标准
- •Age <40 or >70 years
- •Eaton-Glickel I, III-IV
- •Symptom duration < 3 months
- •Pain VAS < 30 mm
- •Post-traumatic osteoarthrosis of thumb CMC I
- •Rheumatoid arthritis or other inflammatory joint disease
- •The use of per oral corticosteroids or other immunomodulatory drugs
- •Less than 6 months after another operation of the same upper limb
- •Other condition of the same upper limb requiring surgery
- •Malnutrition
- •Neurological condition affecting upper limb function
- •Heavy smoking (> 20 cigarettes per day)
- •Alcohol or drug abuse
- •Previous history or active cancer
- •Previous history of allergic reaction to local anaesthetic
结局指标
主要结局
Pain (Visual Analogue Scale)
时间窗: 6 months
The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
Patient-Rated Wrist Evaluation (PRWE)
时间窗: 6 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
次要结局
- Grip strength(6 months)
- Key pinch strength(6 months)
- Global improvement(6 months)
- Michigan Hand Outcomes Questionnaire (MHQ)(6 months)
- Complications(6 months)
研究者
Samuli Aspinen
Principal investigator
Töölö Hospital