Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis
NCT ID: NCT04194710
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
86 participants
INTERVENTIONAL
2020-12-22
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arthroscopic Resection
43 patients will be assigned to this arm. This is the standard technique to treat lateral epicondylitis. After randomization, patients will be informed and the surgery will be scheduled.
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.
Cytokine rich serum injection
43 patients will be assigned to this arm. After randomization, patients will be informed and the first injection of serum rich cytokines will be scheduled. After 15 days, they will be injected again with serum rich cytokines.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tecnologia Regenerativa Qrem S.L.
UNKNOWN
Corporacion Parc Tauli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ferran Fillat Gomà
Co-Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mònica Salomó, MD
Role: PRINCIPAL_INVESTIGATOR
Corporacion Parc Tauli
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ferran Fillat Gomà, MD
Role: primary
Mònica Salomó, MD
Role: backup
Ana M Carreño, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DA-SARC
Identifier Type: -
Identifier Source: org_study_id