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

January 8, 2013 updated by: Institut de Terapia Regenerativa Tissular

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08041
        • Centro Cochrane Iberoamericano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PRP
Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.
4-8cc, a single dose
Other Names:
  • Platelet-rich plasma
  • Growth factors from platelet-rich plasma
ACTIVE_COMPARATOR: Evacuation of haematoma
Evacuation of the hematoma, and simulation of the administration of PRP
Evacuation of the haematoma, a single procedure
Other Names:
  • Drainage of haematoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
weekely assessment during 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

During all study (one year of follow-up)
Percentage of healing
Time Frame: 8 weeks
Percentage of patients with the healed lesion
8 weeks
Quality of the regenerated area
Time Frame: at 8 week
By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
at 8 week
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (ESTIMATE)

September 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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