NCT04194710

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

Randomized Clinical Trial Comparing Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare arthroscopic resection (surgical intervention) versus infiltration of cytokine rich serum (CRS) (proteins derived from the patient's own blood) for the treatment of lateral epicondylitis (LE).

Detailed description

Lateral epicondylitis (LE) is a common debilitating condition that affects the extensor muscles of the forearm at its junction with the lateral humeral epicondyle. This pathology is commonly treated by a surgical intervention. However, advances in research have allowed the discovery of new and less invasive techniques for its treatment, for example the infiltration of cytokine rich serum. The aim of the study is to compare the common treatment of this pathology, arthroscopic resection (surgical intervention) with a new technique, infiltration of cytokine rich serum (CRS) (proteins derived from the patient's own blood) with respect to medium and long-term pain reduction. The study will include a total of 86 patients. Patients will be included by randomization into two groups: * GROUP 1: 43 patients will be treated with 2 infiltrations of cytokine rich serum. * GROUP 2: 43 patients will be treated by a regular surgical treatment consisting of arthroscopic resection. The main objective of this study is to evaluate the efficacy of CRS as compared to arthroscopic resection in reducing pain in the medium term (6 months) in patients with chronic lateral epicondylitis.

Conditions

• Epicondylitis, Lateral

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-22
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2019-12-11
• Last updated: 2020-12-24

Locations

2 sites across 1 country: Spain