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

NCT04194710 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2020-12-24

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Tecnologia Regenerativa Qrem S.L.

    collaborator UNKNOWN

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Mònica Salomó, MD · Corporacion Parc Tauli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2023-07-01
Completion
2023-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04194710 on ClinicalTrials.gov