Multicenter Double Blind, With Evaluator Blinding, Parallel, Randomized Clinical Trial, to Assess the Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Time to complete recover of muscular lesions
研究概览
简要总结
This is a multicenter, simple blind, masking of outcomes assessors, parallel, randomised clinical trial in patient with muscle rupture and with hematoma production. The main hypothesis is that infiltration in the area of muscle injury in autologous platelet-rich plasma (PRP)improves muscle regeneration and repair by shortening the time to complete recovery.
The main objective is to evaluate the PRP for healing muscular lesions 'tennis leg' type or distal rectus femoral. The secondary objectives are: to evaluate the risk of lesion recurrence; to evaluate the quality of lesion recovery process and evaluate intervention's safety.
Experimental treatment will be the administration of PRP autologous (4-8 cc in a unique dose) by muscular infiltration en the empty space generated after the hematoma evacuation. Control treatment will be hematoma evacuation. Both treatment groups will use compressive bandage and they will recommend rest, extremity elevation, local ice and lately physiotherapy.
Size sample: 76 patients (38 in each group)
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, Outcomes Assessor)
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
- •Adults over 18 years
- •Lesion with haematoma at the Gastrocnemius muscle or the lower portion of the rectus femoral muscle
- •Acceptance to participate at the clinical trial
- •Not indicated the surgical treatment of the muscle injury
排除标准
- •Patients who do not meet the inclusion criteria
- •History of bleeding disorders
- •Inability to follow-up the patient
- •The use of corticosteroids, acetylsalicylic acid(Aspirin ®) and nonsteroidal antiinflammatory drugs during the study
结局指标
主要结局
Time to complete recover of muscular lesions
时间窗: weekely assessment during 8 weeks
The complete recovering will be when the patient does his habitual activity.
次要结局
- Percentage of muscular lesion recurrence.(During all study (one year of follow-up))
- Percentage of healing(8 weeks)
- Quality of the regenerated area(at 8 week)
- Pain(12 months)
- Adverse effects to treatments(12 months)