Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

• Status: Completed
• Trial end date: 2016-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Mitogens

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.