Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tendinopathy
• Intervention / Treatment: Biological: Plasma rich in growth factors (PRGF); Drug: Celestone cronodose (Bethametasone)

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 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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • Hospital Universitario Príncipe de Asturias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Plasma rich in growth factors (PRGF)
Active Comparator: Celestone cronodose (bethametasone); This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.	Drug: Celestone cronodose (Bethametasone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
15% of change in the score of the UCLA scale	Baseline and 6 months
15% of change in the score of the QuickDash scale	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
changes in the UCLA, Quickdash and Constant scales	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.	24 months

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
• Investigators: Principal Investigator: Victor Vaquerizo, MD, PhD, Hospital Universitario Príncipe de Asturias

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: plasma rich in growth factors, tendinopathy, traumatology; ,rotator cuff, effectiveness, plasma rich in platelets
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Mitogens
• Other Study ID Numbers: HUPA-EC-02-2012; 2012-001056-19 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No