Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy
NCT ID: NCT01915979
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2014-02-28
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Plasma rich in growth factors (PRGF)
This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks.
Plasma rich in growth factors (PRGF)
Celestone cronodose (bethametasone)
This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.
Celestone cronodose (Bethametasone)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Plasma rich in growth factors (PRGF)
Celestone cronodose (Bethametasone)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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.
40 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Victor Vaquerizo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Principe de Asturias
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001056-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HUPA-EC-02-2012
Identifier Type: -
Identifier Source: org_study_id