Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01915979
Study type	Interventional
Source	Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Contact
Status	Completed
Phase	Phase 3
Start date	February 2014
Completion date	December 31, 2016

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.