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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01440725

Acronym

PRP-RICE

Enrollment

Registered

2011-09-26

Start date

2009-10-31

Completion date

2012-12-31

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Injuries

Keywords

muscle, injuries, platelet-rich plasma, autologous, haematoma

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)

Interventions

BIOLOGICALAutologous Platelet-rich plasma (PRP)

4-8cc, a single dose

PROCEDUREEvacuation of haematoma

Evacuation of the haematoma, a single procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026