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

NCT04194710 | Unknown DMC

• 1 other identifier: DA-SARC
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain assessment with Visual Analogue Scale (EVA) scale

  15 days, 1-3-12-24 months after intervention

• Patient-Related Tennis Elbow Evaluation (PRTEE)

  15 days, 1-3-6-12-24 months after intervention

• Grip force

  15 days, 1-3-6-12-24 months after intervention

• occurrence of pain with resisted wrist extension

  15 days, 1-3-6-12-24 months after intervention

• Number of participants with complications related to the treatment

  15 days, 1-3-6-12-24 months after intervention

Study Arms (2)

Arthroscopic Resection

ACTIVE COMPARATOR

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

Cytokine rich serum injection

EXPERIMENTAL

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

Interventions

Autologous Cytokine Rich Serum BIOLOGICAL

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

Arthroscopic Resection PROCEDURE

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.

Cytokine rich serum injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Tecnologia Regenerativa Qrem S.L.: collaborator

Study Sites (2)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Meniscectomy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Mònica Salomó, MD

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laia Martínez Carreres, PhD

CONTACT

937231010; lmartinezc@tauli.cat

Mònica Salomó, MD

CONTACT

937231010; msalomo@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: December 22, 2020
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)