EFFECT OF PLASMA RICH IN GROWTH FACTORS IN ROTATOR CUFF TENDINOPATHY
- Conditions
- ROTATOR CUFF TENDINOPATHYMedDRA version: 14.1 Level: LLT Classification code 10039226 Term: Rotator cuff injury System Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-001056-19-ES
- Lead Sponsor
- FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
Patients between 40 and 70 years old
Male and female
Mild to severe symptoms according to the QuickDASH scale over 3 months of evolution.
Patients with tendinitis, inflammatory or calcium, tendinosis or partial tears of the rotator cuff, diagnosed by ultrasound, evaluated by an expert radiologist independent of the research team.
Patients refractory to the conservative treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
Patients with complete tear of the rotator cuff diagnosed by ultrasound or MRI.
Patients who have previously received treatment with corticoids infiltrations in the last 6 months.
Patients with arterial hypertension or diabetes mellitus poorly controlled.
Patients allergic to some of the medicines in the study or some of their excipients.
Patients treated with anticoagulants or antiplatelet that could not be stopped temporarily for the study.
Inability to understand health questionnaires and / or complete them properly.
Patients uncapable to give informed consent.
Fertile women that do not have a negative pregnancy test before being included in the study.
Breastfeeding women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Show more effectiveness after 6 months of treatment with PRGF-Endoret, with an improvement in the reference tests (UCLA and QuickDash) of more than 15% compared to the treatment with corticosteroids;<br> Secondary Objective: To valorate effectiveness after 12 months of treatment with PRGF-Endoret<br> Quantification of platelet derived growth factor levels in patients treated with PRGF-Endoret and its correlation with the clinical effect<br> ;Primary end point(s): Improvement of more than 15% in the reference tests UCLA and QuickDash after 6 months of treatment with PRGF-Endoret compared to treatment with corticoids.;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Effectiveness of PRGF-Endoret treatment after 12 months.<br> sex<br> age<br> Degrees of cuff injury measured by ultrasounds,<br> laterality<br> Employment status at present (Working, unemployed or retired),<br> Complications<br> Quantification of platelet derived growth factor (PDGF) concentration in all patients in the study group if posible.<br> ;Timepoint(s) of evaluation of this end point: 3,6 and 12 months