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

Epicondylitis, Lateral Clinical Trial

— DA-SARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194710
• Other study ID #: DA-SARC
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2020
• Source: Corporacion Parc Tauli
• Contact: Laia Martínez Carreres, PhD
• Phone: 937231010
• Email: lmartinezc[@]tauli.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age

• 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:

• Local infection present.

• 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.

Related Conditions & MeSH terms

• Epicondylitis, Lateral
• Tennis Elbow

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Tecnologia Regenerativa Qrem S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	reduction of pain to 6 months measured with the Visual Analogue Scale (EVA) scale. The specification of the efficacy parameter is an absolute improvement of the 2-point scale.	6 months
Secondary	Pain assessment with Visual Analogue Scale (EVA) scale	Visual Analogue Scale (EVA) from 0 to 10 points, being 0 no pain, and 10 maximum pain	15 days, 1-3-12-24 months after intervention
Secondary	Patient-Related Tennis Elbow Evaluation (PRTEE)	The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis. It is a is a 15-item questionnaire allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists in two subscales: PAIN subscale (0 = no pain, 10 = worst imaginable) - 5 items; FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items	15 days, 1-3-6-12-24 months after intervention
Secondary	Grip force	measured with a palm grip dynamometer, in kilos	15 days, 1-3-6-12-24 months after intervention
Secondary	occurrence of pain with resisted wrist extension	assessed during medical examination	15 days, 1-3-6-12-24 months after intervention
Secondary	Number of participants with complications related to the treatment	assessed during medical examination	15 days, 1-3-6-12-24 months after intervention
Secondary	Revision of anti-inflammatory medication and its dose	assessed during medical examination	15 days, 1-3-6-12-24 months after intervention