NCT01440725

Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Institut de Terapia Regenerativa Tissular · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Muscle Injuries

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Platelet-rich plasma (PRP)	4-8cc, a single dose
PROCEDURE	Evacuation of haematoma	Evacuation of the haematoma, a single procedure

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-09-26
• Last updated: 2013-01-10

Locations

1 site across 1 country: Spain