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

Phase 3

Completed

• Conditions: Muscle Injuries

• Registration Number: NCT01440725
• Lead Sponsor: Institut de Terapia Regenerativa Tissular

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to complete recover of muscular lesions	weekely assessment during 8 weeks	The complete recovering will be when the patient does his habitual activity.

Secondary Outcome Measures

Name	Time	Method
Percentage of muscular lesion recurrence.	During all study (one year of follow-up)	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.
Percentage of healing	8 weeks	Percentage of patients with the healed lesion
Quality of the regenerated area	at 8 week	By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
Pain	12 months	The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month.
Adverse effects to treatments	12 months	Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.

Trial Locations

Locations (1)

Centro Cochrane Iberoamericano; 🇪🇸 Barcelona, Spain