PLATELET CONCENTRATE for Lateral epicondylitis (tennis elbow)

Inclusion criteria

• {"criterion_text":"- Over 18 years"}
• {"criterion_text":"- Patients who present persistent pain (VAS > 5) at the level of lateral epicondyle of at least 3 months’ duration."}
• {"criterion_text":"- Patients with a confirmed diagnosis of chronic lateral epicondylitis with some complementary diagnostic test such as ECO or MRI."}
• {"criterion_text":"- Availability to be able to follow up on the protocol of the study up to 24 months."}
• {"criterion_text":"- Patients with the ability to understand the study information and give informed consent."}
• {"criterion_text":"- Patients who sign the informed consent."}
• {"criterion_text":"- Normal hematological parameters."}

Exclusion criteria

• {"criterion_text":"- Local infection present."}
• {"criterion_text":"- Coagulation deficiency or abnormalities."}
• {"criterion_text":"- Thrombocytopenia."}
• {"criterion_text":"- Treatment with anticoagulants."}
• {"criterion_text":"- Difficulty understanding and following study procedures."}
• {"criterion_text":"- Participation in a clinical trial with medications."}
• {"criterion_text":"- Patients who have received treatment with infiltrations of corticosteroids in the same area in the last 4 months."}
• {"criterion_text":"- Patients who have received treatment with growth factors, PRP, cytokines or new pharmacological treatments in it area in the last 12 months."}
• {"criterion_text":"- Pregnancy or breastfeeding."}
• {"criterion_text":"- Neoplastic Disease."}
• {"criterion_text":"- Patients undergoing treatment with immunosuppressants (medical assessment)."}
• {"criterion_text":"- Patients undergoing arthroscopic surgery of the same elbow."}
• {"criterion_text":"- Active liver disease."}
• {"criterion_text":"- States of immunosuppression or immunodeficiencies."}

Primary endpoints

• {"endpoint_text":"- In the case of the group of patients treated with SARC, the treatment consists of 2 infiltrations at an interval of 14 to 21 days. If, due to medical criteria, the researcher decides to perform a single infiltration, will consider that the subject has been withdrawn from treatment. However, it will carry out the same monitoring and control visits as for the rest of the patients.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Unexpected systemic infections or infections in the infiltration zone or fever related to suspected infection.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Anaphylactic shock or other serious toxicities related to the treatment. Treatment will be restarted at the discretion of the investigators.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Edema in the treated area not associated with infiltration. It will restart the treatment according to the investigators' criteria.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

14-11-2024

Latest Decision Or Authorization Date

20-11-2024

Processing Time Days

6

Number Of Sites

3

Number Of Participants

86

Primary sponsor

Full Name

Parc Tauli Hospital Universitari

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain