Epicondylitis, LateralDA-SARCNCT04194710
Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis
A study testing Autologous Cytokine Rich Serum and Arthroscopic Resection in people with Epicondylitis, Lateral, run by Corporacion Parc Tauli at 2 sites in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicondylitis, Lateral
- What is being tested?
- Autologous Cytokine Rich Serum and Arthroscopic Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesSpain
- Study dates
- 22 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Ana M Carreño, MD
- Recruiting
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Ferran Fillat Gomà, MD, 937231010 ext. 21652, ffillat@tauli.cat
Mònica Salomó, MD, 937231010 ext. 21652, msalomo@tauli.cat
About this study
Official title: 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).
Read the 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.
- Conditions
- Epicondylitis, Lateral
- Being tested
- Autologous Cytokine Rich Serum, Arthroscopic Resection
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Cytokine Rich SerumBiological
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 ResectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Arthroscopic Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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
Measured: 15 days, 1-3-6-12-24 months after intervention
Grip force
measured with a palm grip dynamometer, in kilos
Measured: 15 days, 1-3-6-12-24 months after intervention
occurrence of pain with resisted wrist extension
assessed during medical examination
Measured: 15 days, 1-3-6-12-24 months after intervention
Number of participants with complications related to the treatment
assessed during medical examination
Measured: 15 days, 1-3-6-12-24 months after intervention
Revision of anti-inflammatory medication and its dose
assessed during medical examination
Measured: 15 days, 1-3-6-12-24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start22 Dec 2020
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, LateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Tecnologia Regenerativa Qrem S.L.
- Responsible party
- Principal investigator, Ferran Fillat Gomà, Corporacion Parc Tauli
- Investigators
- Mònica Salomó, MD, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194710
- Sponsor's protocol ID
- DA-SARC
- Acronym
- DA-SARC
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2019
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04194710
- Acronym / sponsor ID
- DA-SARC / DA-SARC
- Conditions
- Epicondylitis, Lateral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Tecnologia Regenerativa Qrem S.L.
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Resection | Active comparator | Biological: Autologous Cytokine Rich Serum43 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. |
| Cytokine rich serum injection | Experimental | Procedure: Arthroscopic Resection43 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Cytokine Rich SerumProteins, 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. | Biological | Arthroscopic Resection |
| Arthroscopic ResectionSurgical 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. | Procedure or surgery | Cytokine rich serum injection |
Primary outcome
Pain assessment
Time frame: 6 months
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 secondary outcomes
Pain assessment with Visual Analogue Scale (EVA) scale
Time frame: 15 days, 1-3-12-24 months after intervention
Patient-Related Tennis Elbow Evaluation (PRTEE)
Time frame: 15 days, 1-3-6-12-24 months after intervention
Grip force
Time frame: 15 days, 1-3-6-12-24 months after intervention
occurrence of pain with resisted wrist extension
Time frame: 15 days, 1-3-6-12-24 months after intervention
Number of participants with complications related to the treatment
Time frame: 15 days, 1-3-6-12-24 months after intervention
Revision of anti-inflammatory medication and its dose
Time frame: 15 days, 1-3-6-12-24 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mònica Salomó, MD principal investigator
Corporacion Parc Tauli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Cytokine Rich Serum and Arthroscopic Resection in people with Epicondylitis, Lateral, run by Corporacion Parc Tauli at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laia Martínez Carreres, PhD (937231010 ext. 21652, lmartinezc@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.