A Phase 3 interventional study of Plasma rich in growth factors (PRGF) and Celestone cronodose (Bethametasone) in Rotator Cuff Tendinopathy, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias. Completed at 1 site in Spain. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias · Phase 3, Interventional, and Treatment
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:
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).
415 studies on the registry are indexed under Tendinopathy; 63 are open to participants now.
This study's enrollment of 84 is above the median of 50 across 341 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks.
Biological: Plasma rich in growth factors (PRGF)
This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.
Drug: Celestone cronodose (Bethametasone)
15% of change in the score of the UCLA scale
Time frame: Baseline and 6 months
15% of change in the score of the QuickDash scale
Time frame: Baseline and 6 months
changes in the UCLA, Quickdash and Constant scales
Time frame: 12 months
Concentration of the platelet levels in the plasma administered and its relationship with the clinical effect measured with the UCLA and QuickDash scales.
Time frame: 24 months
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias