NCT01915979

Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

Role of Biological Therapy in Rotator Cuff Tendinopathy. Effectiveness of Plasma Rich in Growth Factors Regarding Functional Capacity and Pain Compared With the Conventional Treatment Using Steroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of the study is to assess the effectiveness of the treatment of degenerative rotator cuff tendinopathy using the application of plasma rich in growth factors (PRGF). Main objective: To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the reference test of more than 15% compared to the treatment with corticosteroids. Secondary objective: * To assess the efficacy of the treatment after 12 months. * Quantification of platelet levels in patients treated with plasma rich in growth factors and its correlation with the clinical effect.

Detailed description

Study Group. PRGF Blood extraction was performed in the pre-surgical area using a vacuum system. A total of 20 ml of blood (4 samples of 5 ml) per patient was collected in sterile sodium citrate tubes. PRGF was obtained following Anitua's technique. The tubes with citrated blood were centrifuged at 1,800 rpm for 8 min to obtain a concentrate of platelets suspended in plasma, which was separated into three fractions. Pipetting was carried out with extreme care in all steps, particularly in the last fraction where, in order to avoid inflammation, leukocytes present in the lowermost portion of the centrifuged plasma were not aspirated. PRGF was activated by adding calcium chloride 10%,immediately before infiltration. The proportion required for PRGF activation is 50 ml of activator per 1,000 ml of PRGF. Separation of plasma into three fractions and subsequent activation of the fractions for injection was performed in a laminar flow chamber. Between the collection of blood and its subacromial administration must not exceed 90 minutes to avoid contamination. Control group: Celestone Cronodose® (bethametasone). They were given 3 infiltrations of 2 cc of Celestone cronodose® (bethametasone) every 21 days (If necessary, it could be administered after an application of a small quantity of a local anaesthetic).

Conditions

• Rotator Cuff Tendinopathy

Interventions

Type	Name	Description
BIOLOGICAL	Plasma rich in growth factors (PRGF)
DRUG	Celestone cronodose (Bethametasone)

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-05-01
• Completion: 2016-12-31
• First posted: 2013-08-05
• Last updated: 2018-12-20

Locations

1 site across 1 country: Spain