Muscle Injuries Clinical Trial
Official title:
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
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)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01601782 -
Impact of Volume Imaging Using Diagnostic Ultrasound
|
N/A |