Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

Rotator Cuff Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915979
• Other study ID #: HUPA-EC-02-2012
• Secondary ID: 2012-001056-19
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: December 2018
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 31, 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Rotator Cuff Tendinopathy
• Tendinopathy

Intervention

Biological:
• Plasma rich in growth factors (PRGF)

Drug:
• Celestone cronodose (Bethametasone)

Locations

Country	Name	City	State
Spain	Hospital Universitario Príncipe de Asturias	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	15% of change in the score of the UCLA scale		Baseline and 6 months
Primary	15% of change in the score of the QuickDash scale		Baseline and 6 months
Secondary	changes in the UCLA, Quickdash and Constant scales		12 months
Secondary	Concentration of the platelet levels in the plasma administered and its relationship with the clinical effect measured with the UCLA and QuickDash scales.		24 months