Status:
COMPLETED
Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Conditions:
Rotator Cuff Tendinopathy
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief 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 object...
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 tube...
Eligibility Criteria
Inclusion
- Patients within 40 -70 years old.
- Both sex
- Moderate to severe symptoms according to the QuickDASH scale during the last 3 months.
- Patients with tendinitis, inflammatory or calcium, tendinosis or partial tears of the rotator cuff, diagnosed by ultrasound or MRI, evaluated by an expert radiologist and independent of research team.
- Patients resistant to conservative treatment.
Exclusion
- Patients with complete tear of the rotator cuff diagnosed by ultrasound or MRI.
- Patients who have previously received treatment with infiltrations in the last 6 months.
- Patients with poorly controlled arterial Hypertension (AHT) and Diabetes mellitus.
- Allergic to some of the components of Celestone Cronodose ®, either the drug or some of the excipients.
- Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for the infiltrations.
- Positive serology for sifilis, hepatitis B, hepatitis C or IHV I/II.
- Uncapable to understand health questionnaires and / or complete them properly.
- Women who might be pregnant and don't have a negative pregnancy test at the start of the study.
- Breastfeeding women.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01915979
Start Date
February 1 2014
End Date
December 31 2016
Last Update
December 20 2018
Active Locations (1)
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1
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain, 28805