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

Primary Purpose

Epicondylitis, Lateral

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Autologous Cytokine Rich Serum

Arthroscopic Resection

About this trial

This is an interventional treatment trial for Epicondylitis, Lateral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Corporació Sanitària Parc TaulíRecruiting
Hospital Clínic i Provincial de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthroscopic Resection

Cytokine rich serum injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Grip force

measured with a palm grip dynamometer, in kilos

occurrence of pain with resisted wrist extension

assessed during medical examination

Number of participants with complications related to the treatment

assessed during medical examination

Revision of anti-inflammatory medication and its dose

assessed during medical examination

Full Information

NCT ID

NCT04194710

First Posted

December 9, 2019

Last Updated

December 23, 2020

Sponsor

Corporacion Parc Tauli

Collaborators

Tecnologia Regenerativa Qrem S.L.

1. Study Identification

Unique Protocol Identification Number

NCT04194710

Brief Title

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

Acronym

DA-SARC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Recruiting

Study Start Date

December 22, 2020 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Corporacion Parc Tauli

Collaborators

Tecnologia Regenerativa Qrem S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epicondylitis, Lateral

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arthroscopic Resection

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Cytokine rich serum injection

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Autologous Cytokine Rich Serum

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Arthroscopic Resection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain assessment

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Pain assessment with Visual Analogue Scale (EVA) scale

Description

Visual Analogue Scale (EVA) from 0 to 10 points, being 0 no pain, and 10 maximum pain

Time Frame

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

Title

Patient-Related Tennis Elbow Evaluation (PRTEE)

Description

Time Frame

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

Title

Grip force

Description

measured with a palm grip dynamometer, in kilos

Time Frame

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

Title

occurrence of pain with resisted wrist extension

Description

assessed during medical examination

Time Frame

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

Title

Number of participants with complications related to the treatment

Description

assessed during medical examination

Time Frame

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

Title

Revision of anti-inflammatory medication and its dose

Description

assessed during medical examination

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laia Martínez Carreres, PhD

Phone

937231010

Ext

21652

lmartinezc@tauli.cat

First Name & Middle Initial & Last Name or Official Title & Degree

Mònica Salomó, MD

Phone

937231010

Ext

21652

msalomo@tauli.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mònica Salomó, MD

Organizational Affiliation

Corporacion Parc Tauli

Official's Role

Principal Investigator

Facility Information:

Facility Name

Corporació Sanitària Parc Taulí

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ferran Fillat Gomà, MD

Phone

937231010

Ext

21652

ffillat@tauli.cat

First Name & Middle Initial & Last Name & Degree

Mònica Salomó, MD

Phone

937231010

Ext

21652

msalomo@tauli.cat

Facility Name

Hospital Clínic i Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana M Carreño, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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