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

Institut de Terapia Regenerativa Tissular71 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Muscle Injuries

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to complete recover of muscular lesions

The complete recovering will be when the patient does his habitual activity.

Time frame: weekely assessment during 8 weeks

Secondary Outcomes

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.

Time frame: During all study (one year of follow-up)

Percentage of healing

Percentage of patients with the healed lesion

Time frame: 8 weeks

Quality of the regenerated area

By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)

Time frame: 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.

Time frame: 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.