Clinical trial NCT01440725: Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Muscle Injuries
Keywords: muscle
injuries
platelet-rich plasma
autologous
haematoma
Lead sponsor: Institut de Terapia Regenerativa Tissular
Sponsor class: OTHER
Collaborators: name: Asociacion Colaboracion Cochrane Iberoamericana
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2011-09-26
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Time to complete recover of muscular lesions
timeFrame: weekely assessment during 8 weeks
Secondary outcomes:
measure: Percentage of muscular lesion recurrence.
timeFrame: During all study (one year of follow-up)
measure: Percentage of healing
timeFrame: 8 weeks
measure: Quality of the regenerated area
timeFrame: at 8 week
measure: Pain
timeFrame: 12 months
measure: Adverse effects to treatments
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Cochrane Iberoamericano
Study officials:
affiliation: Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
name: Martínez Zapata, Mª José
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Teràpia Regenerativa i Tissular. Centro Médico Teknon. Barcelona
name: Orozco Delclòs, LLuís
role: PRINCIPAL_INVESTIGATOR
References: