Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma (PRP-RICE)
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)
|Muscle Injuries||Biological: Autologous Platelet-rich plasma (PRP) Procedure: Evacuation of haematoma||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Time to complete recover of muscular lesions [ Time Frame: weekely assessment during 8 weeks ]The complete recovering will be when the patient does his habitual activity.
- Percentage of muscular lesion recurrence. [ Time Frame: 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 [ Time Frame: 8 weeks ]Percentage of patients with the healed lesion
- Quality of the regenerated area [ Time Frame: at 8 week ]By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
- Pain [ Time Frame: 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 [ Time Frame: 12 months ]Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.
|Study Start Date:||October 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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)
4-8cc, a single dose
Active Comparator: Evacuation of haematoma
Evacuation of the hematoma, and simulation of the administration of PRP
Procedure: Evacuation of haematoma
Evacuation of the haematoma, a single procedure
Other Name: Drainage of haematoma
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440725
|Centro Cochrane Iberoamericano|
|Barcelona, Spain, 08041|
|Principal Investigator:||Martínez Zapata, Mª José||Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau|
|Principal Investigator:||Orozco Delclòs, LLuís||Institut de Teràpia Regenerativa i Tissular. Centro Médico Teknon. Barcelona|