Lateral Epicondylitis
Conditions
Interventions
Product Name: Cytokine Rich Serum
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cytokine Rich Serum
Other descriptive name: Autologous platelet rich plasma and blood cells, peripher
Sponsors
FUNDACIÓ PARC TAULÍ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Over 18 years of age Patients with persistent pain (EVA > 5) at lateral epicondyle level of at least 3 months duration. Patients with a diagnosis of chronic lateral epicondylitis confirmed with a complementary diagnostic test such as Echo or MRI. Availability to follow the study protocol for up to 24 months. Patients with the ability to understand study information and give informed consent. Patients who sign informed consent. Normal hematologic parameters. 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 69 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: Local infection present. Patients who have been treated with corticosteroid infiltrations in the same area in the past 4 months. Patients who have received treatment with growth factors, PRP, cytokines, or new drug treatments in the same area in the last 12 months. Pregnancy or breast-feeding. Neoplastic disease. Patients being treated with immunosuppressants (medical evaluation). Patients undergoing arthroscopic surgery of the same elbow. Active liver disease. Immunosuppressive or immunodeficiency states. Coagulation deficit or abnormalities. Thrombocytopenia. Treatment with anticoagulants. Difficulty understanding and following study procedures. Participation in a clinical trial with medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the efficacy of Cytokine Rich Serum (CRS) obtained by QREM CYTOKINE compared to arthroscopic resection in reducing pain in the medium term (6 months) in patients with chronic lateral epicondylitis.;Secondary Objective: The secondary objectives are: - evaluate the efficacy of CRS compared with arthroscopic resection in reducing pain in the short (15 days, 1 month, 3 months) and long term (12 and 24 months) in patients with chronic lateral epicondylitis. - evaluate other efficacy parameters (functional improvement, pain at wrist extension and grip strength) in the short (15 days, 1 month, 3 months), medium (6 months) and long (12 and 24 months) term. - assess the safety (incidence of adverse events) of CRS in the short (15 days, 1 month, 3 months), medium (6 months) and long (12 and 24 months) term.;Primary end point(s): Reduction of pain to 6 months measured with the EVA scale. The specification of the efficacy parameter is an absolute improvement of the 2-point scale.;Timepoint(s) of evaluation of this end point: 6 months after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain assessment: EVA scale Patient-Related Tennis Elbow Evaluation (PRTEE) Functional outcome Grip force measured with a palm grip dynamometer, in kilos Occurrence of pain with resisted wrist extension assessed during medical examination Complications assessment assessed during medical examination Revision of anti-inflammatory medication and its dose assessed during medical examination;Timepoint(s) of evaluation of this end point: 15 days, 1-3-6-12-24 months after intervention | — |
Countries
Spain
Contacts
Public ContactFerran Fillat
FUNDACIÓ PARC TAULÍ
Outcome results
None listed