A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.
研究概览
简要总结
This research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.
详细描述
The intention of this research project is to study a new treatment for severe ankle sprains.This new treatment is called Platelet Rich Plasma (PRP) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. Platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. PRP therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. The investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe ankle sprain
- •X-ray completed
排除标准
- •Pregnancy/breastfeeding
- •Police custody
- •active infection
- •metastatic disease/tumors
- •History of thrombocytopenia
- •Allergy to ester or amine anesthetics
- •On anticoagulant medication
- •Peripheral vascular disease
- •Known coagulopathy
研究组 & 干预措施
Platelet Rich Plasma
Patients receive Platelet rich plasma injection + standard of care therapy(bandaging or boot and crutches) + non-NSAID pain medicine
干预措施: Platelet rich plasma injection (Procedure)
Placebo/Standard of Care
Patient receives Placebo Comparator: Placebo/Standard of Care [saline injection + standard of care (bandaging or boot and crutches)] + non-NSAID pain medicine
干预措施: Placebo Comparator: Placebo/Standard of Care (Procedure)
结局指标
主要结局
Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.
时间窗: Day 0; Day2-3; Day 8-10; Day30
The primary outcome of this investigation is change from baseline in LEFS score, a previous validated 80-point scale used to quantify lower extremity function. A difference of 9 points is considered clinically significant.
次要结局
- Change in pain from baseline(Day 0; Day 2-3, Day 8-10, Day 30)
研究者
James Gardner, MD
MD
Albert Einstein Healthcare Network