Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis (DA-SARC)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Epicondylitis, Lateral
• Intervention / Treatment: Biological: Autologous Cytokine Rich Serum; Procedure: Arthroscopic Resection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laia Martínez Carreres, PhD; Phone Number: 21652 937231010; Email: lmartinezc@tauli.cat
• Study Contact Backup: Name: Mònica Salomó, MD; Phone Number: 21652 937231010; Email: msalomo@tauli.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Hospital Clinic i Provincial de Barcelona
    • Contact: Ana M Carreño, MD
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Corporacio Sanitaria Parc Tauli
      • Contact: Mònica Salomó, MD; Phone Number: 21652 937231010; Email: msalomo@tauli.cat
      • Contact: Ferran Fillat Gomà, MD; Phone Number: 21652 937231010; Email: ffillat@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Grip force	measured with a palm grip dynamometer, in kilos	15 days, 1-3-6-12-24 months after intervention
occurrence of pain with resisted wrist extension	assessed during medical examination	15 days, 1-3-6-12-24 months after intervention
Number of participants with complications related to the treatment	assessed during medical examination	15 days, 1-3-6-12-24 months after intervention
Revision of anti-inflammatory medication and its dose	assessed during medical examination	15 days, 1-3-6-12-24 months after intervention

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Tecnologia Regenerativa Qrem S.L.
• Investigators: Principal Investigator: Mònica Salomó, MD, Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: DA-SARC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No