Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma (PRP-RICE)

Institut de Terapia Regenerativa Tissular

Status and phase: Completed; Phase 3

Conditions: Muscle Injuries

Treatments: Biological: Autologous Platelet-rich plasma (PRP); Procedure: Evacuation of haematoma

Study type: Interventional

Funder types: Other

Identifiers

NCT01440725

PRP-RICE

ISCIII ( Spain;Other Grant/Funding Number)

Details and patient eligibility

About

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)

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 2 patient groups

PRP

Experimental group

Description:

Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.

Treatment:

Biological: Autologous Platelet-rich plasma (PRP)

Evacuation of haematoma

Active Comparator group

Description:

Evacuation of the hematoma, and simulation of the administration of PRP

Treatment:

Procedure: Evacuation of haematoma