Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis

NAUnknownINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

December 22, 2020

Primary Completion Date

July 1, 2023

Study Completion Date

December 1, 2023

Conditions
Epicondylitis, Lateral
Interventions
BIOLOGICAL

Autologous Cytokine Rich Serum

"Proteins, called cytokines, released from blood platelets and leukocytes, play an important role in the repair and regeneration of the injured tissue that causes lateral epicondylitis.~Autologous Cytokine Rich Serum is prepared by the medical devise Q-Cytokine (CE MED31489) from patient's blood. The company Tecnologia Regenerativa Qrem S.L., with licence number 7096-PS from Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), is the manufacturer of this product. Q-Cytokine is a lab-in-a-box devise, and consist of an automatic centrifuge and a sterile disposable kit. After 9 steps of centrifugation, that take place in 36 minutes, Cytokine Rich Serum is obtained. This Cytokine Rich Serum is then injected to the epicondyle.~Patients randomized to this treatment will receive 1 injections of Autologous Cytokine Rich Serum right after randomization and another one after 15 days.~This process will take place at outpatient clinics."

PROCEDURE

Arthroscopic Resection

"Surgical treatment of resection by arthroscopy is the standard treatment for chronic epicondylitis. The surgery is performed in the operating room under local anesthesia and lasts approximately 30 minutes. During the surgery, the doctor accesses the tendon by arthroscopy to perform an exeresis of the degenerated tendon. After the operation, the patient is directed to the recovery room where the responsible doctor will perform a physical examination and examination before leaving the center.~This process will take place at the major ambulatory surgery center of the investigator's hospital."

Trial Locations (2)

08208

RECRUITING

Corporació Sanitària Parc Taulí, Sabadell

08036

NOT_YET_RECRUITING

Hospital Clínic i Provincial de Barcelona, Barcelona

Sponsors
All Listed Sponsors
collaborator

Tecnologia Regenerativa Qrem S.L.

UNKNOWN

lead

Corporacion Parc Tauli

OTHER