Single Injection of Platelet-rich Plasma (PRP) to m. Gluteus Medius During Total Hip Arthroplasty Using Direct Lateral (Hardinge) Approach
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The decrease of T2 weighted signaling between PRP and placebo group
研究概览
简要总结
Study purpose is to evaluate perioperative usefulness of Platelet-rich Plasma (PRP) in total hip arthroplasty (THA) surgery. The study is designed as a randomized double blinded study using saline as placebo. The measurement outcomes includes objective variables (MRI, dynamometer) as well as subjective measurements (Oxford Hip Score, Harris Hip Score).
Patients are assigned to two different groups, according to a randomization list. PRP (approximately 9ml from which 1ml is delivered to in-house laboratory for the measurement of platelet count) is obtained from venous blood and applied to m. gluteus medius during the closure of modified lateral approach (Hardinge).
Study participants are evaluated preoperatively by trained physiotherapist. After surgery, participants undergo clinical evaluation and imaged (MRI) at 3 and 12 months post-operative. In the same time points, strength, Harris Hip Score and Oxford Hip Score. At the end of the study, the nature of the injected substance is revealed to the patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically and radiology confirmed arthritis which treatment is total hip arthroplasty.
排除标准
- •Revision surgery, insulin dependent diabetes and other endocrinology disease, smoking, use of per os cortisone, malignancy, rheumatoid arthritis, any autoimmune disease, alcoholist, previous fracture to hip, patients with diagnosed mental illness, absolute contraindications for MRI study
结局指标
主要结局
The decrease of T2 weighted signaling between PRP and placebo group
时间窗: Change from 3 months at 12 months
Quantitative method of tissue healing
次要结局
- Differences in Harris Hip Score points between PRP and placebo group(Change from 3 months at 12 months)
- Comparison of hip abduction strengths between PRP and placebo group using dynamometer(Change from 3 months at 12 months)
研究者
Jussi Kosola
Resident, researcher
Satakunta Central Hospital