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

Muscle Injuries Clinical Trial

— PRP-RICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440725
• Other study ID #: PRP-RICE
• Secondary ID: ISCIII; Spain
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2011
• Last updated: January 8, 2013
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Institut de Terapia Regenerativa Tissular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematoma
• Muscle Injuries

Intervention

Biological:
• Autologous Platelet-rich plasma (PRP)
4-8cc, a single dose

Procedure:
• Evacuation of haematoma
Evacuation of the haematoma, a single procedure

Locations

Country	Name	City	State
Spain	Centro Cochrane Iberoamericano	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Terapia Regenerativa Tissular	Asociacion Colaboracion Cochrane Iberoamericana, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete recover of muscular lesions	The complete recovering will be when the patient does his habitual activity.	weekely assessment during 8 weeks	No
Secondary	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)	No
Secondary	Percentage of healing	Percentage of patients with the healed lesion	8 weeks	No
Secondary	Quality of the regenerated area	By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)	at 8 week	No
Secondary	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	No
Secondary	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	Yes