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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Muscle Injuries

Intervention / Treatment
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* Biological: Autologous Platelet-rich plasma (PRP)
* Procedure: Evacuation of haematoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma. | Biological: Autologous Platelet-rich plasma (PRP)<br>* 4-8cc, a single dose<br>* Other names: Growth factors from platelet-rich plasma;|
| Active Comparator: Evacuation of haematoma<br>Evacuation of the hematoma, and simulation of the administration of PRP | Procedure: Evacuation of haematoma<br>* Evacuation of the haematoma, a single procedure<br>* Other names: Drainage of haematoma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete recover of muscular lesions | The complete recovering will be when the patient does his habitual activity. | weekely assessment during 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of muscular lesion recurrence. | Percentage of patients with muscular lesion recurrence. Muscular lesion recurrence will be considered if there are symptoms and a lesion gap by ultra sound scan. | During all study (one year of follow-up) | 
| Percentage of healing | Percentage of patients with the healed lesion | 8 weeks | 
| Quality of the regenerated area | By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis) | at 8 week | 
| Pain | The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month. | 12 months | 
| Adverse effects to treatments | Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle, injuries, platelet-rich plasma, autologous, haematoma