Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

NCT01915979 | Completed Phase 3

• 2 other identifiers: HUPA-EC-02-20122012-001056-19
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rotator Cuff Tendinopathy

Keywords

plasma rich in growth factors, tendinopathy, traumatology; ,rotator cuff, effectiveness, plasma rich in platelets

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Plasma rich in growth factors (PRGF)

EXPERIMENTAL

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)

Celestone cronodose (bethametasone)

ACTIVE COMPARATOR

This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.

Drug: Celestone cronodose (Bethametasone)

Interventions

Plasma rich in growth factors (PRGF) BIOLOGICAL

Plasma rich in growth factors (PRGF)

Celestone cronodose (Bethametasone) DRUG

Celestone cronodose (bethametasone)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias: lead

Study Sites (1)

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

Intercellular Signaling Peptides and Proteins

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Victor Vaquerizo, MD, PhD

  Hospital Universitario Principe de Asturias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: August 5, 2013
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 31, 2016
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

ES (1)