Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier:
NCT01915979
First received: July 18, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention Phase
Rotator Cuff Tendinopathy
Biological: Plasma rich in growth factors (PRGF)
Drug: Celestone cronodose (Bethametasone)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias:

Primary Outcome Measures:
  • 15% of change in the score of the UCLA scale [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • 15% of change in the score of the QuickDash scale [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in the UCLA, Quickdash and Constant scales [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: March 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plasma rich in growth factors
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)

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).

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915979

Contacts
Contact: Victor Vaquerizo, MD, PhD +34 91 887 81 00 ext 2454 vaquerizovictor@yahoo.es
Contact: Miguel Angel Plasencia Arriba, MD, PhD +34 91 887 81 00 ext 2454

Locations
Spain
Hospital Universitario Príncipe de Asturias Recruiting
Alcalá de Henares, Madrid, Spain, 28805
Contact: Víctor Vaquerizo, Doctor    +34 91 887 81 00 ext 2454    vaquerizovictor@yahoo.es   
Principal Investigator: Víctor Vaquerizo, MD, PhD         
Sub-Investigator: Miguel Angel Plasencia Arriba, MD, PhD         
Sub-Investigator: Eulogio Benito Martin, MD         
Sub-Investigator: Marta Garcia Lopez, MD         
Sub-Investigator: Jose A Pareja Esteban, MD, PhD         
Sub-Investigator: Alfredo Madruga, MD         
Sub-Investigator: Elena Sanchez Villanueva, MD         
Sub-Investigator: Miriam Gamo, MD         
Sub-Investigator: Jesus A Jimenez del Rio, MD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Investigators
Principal Investigator: Victor Vaquerizo, MD, PhD Hospital Universitario Principe de Asturias
  More Information

No publications provided

Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier: NCT01915979     History of Changes
Other Study ID Numbers: HUPA-EC-02-2012, 2012-001056-19
Study First Received: July 18, 2013
Last Updated: April 9, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias:
plasma rich in growth factors, tendinopathy, traumatology
,rotator cuff, effectiveness, plasma rich in platelets

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014