Comparing surgical intervention versus infiltration of cytokine autologous rich serum (proteins derived from the patient's own blood) for the treatment of tennis elbow.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Parc Tauli Hospital Universitari

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2024-11-20

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515941-40-00

EudraCT number

2020-003179-16

ClinicalTrials.gov

NCT04194710

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate the effectiveness of SARC compared to the arthroscopic resection in the reduction of pain in the medium term (6 months) in patients with chronic lateral epicondylitis.

Secondary objectives 3

1. To evaluate the effectiveness of SARC compared to arthroscopic resection in pain reduction in the short (15 days, 1 month, 3 months) and long term period (12 and 24 months) in patients with chronic lateral epicondylitis.
2. To evaluate other efficacy parameters (functional improvement, pain on extension of wrist and grip strength) at short (15 days, 1 month, 3 months), medium (6 months) and long (12 and 24 months) term
3. To evaluate the safety (incidence of adverse events) of SARC to short (15 days, 1 month, 3 months), medium (6 months) and long (12 and 24 months) term.

Conditions and MedDRA coding

Epicondylitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Over 18 years
2. Patients who present persistent pain (VAS > 5) at the level of lateral epicondyle of at least 3 months’ duration.
3. Patients with a confirmed diagnosis of chronic lateral epicondylitis with some complementary diagnostic test such as ECO or MRI.
4. Availability to be able to follow up on the protocol of the study up to 24 months.
5. Patients with the ability to understand the study information and give informed consent.
6. Patients who sign the informed consent.
7. Normal hematological parameters.

Exclusion criteria 14

1. Local infection present.
2. Patients who have received treatment with infiltrations of corticosteroids in the same area in the last 4 months.
3. Patients who have received treatment with growth factors, PRP, cytokines or new pharmacological treatments in it area in the last 12 months.
4. Pregnancy or breastfeeding.
5. Neoplastic Disease.
6. Patients undergoing treatment with immunosuppressants (medical assessment).
7. Patients undergoing arthroscopic surgery of the same elbow.
8. Active liver disease.
9. States of immunosuppression or immunodeficiencies.
10. Coagulation deficiency or abnormalities.
11. Thrombocytopenia.
12. Treatment with anticoagulants.
13. Difficulty understanding and following study procedures.
14. Participation in a clinical trial with medications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. In the case of the group of patients treated with SARC, the treatment consists of 2 infiltrations at an interval of 14 to 21 days. If, due to medical criteria, the researcher decides to perform a single infiltration, will consider that the subject has been withdrawn from treatment. However, it will carry out the same monitoring and control visits as for the rest of the patients.

Secondary endpoints 3

1. Unexpected systemic infections or infections in the infiltration zone or fever related to suspected infection.
2. Anaphylactic shock or other serious toxicities related to the treatment. Treatment will be restarted at the discretion of the investigators.
3. Edema in the treated area not associated with infiltration. It will restart the treatment according to the investigators' criteria.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Parc Tauli Hospital Universitari

Sponsor organisation

Parc Tauli Hospital Universitari

Address

Parc Del Tauli 1

City

Sabadell

Postcode

08208

Country

Spain

Scientific contact point

Organisation

Parc Tauli Hospital Universitari

Contact name

Mireia

Public contact point

Organisation

Parc Tauli Hospital Universitari

Contact name

Mireia

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications