Authorised Therapeutic use (Phase IV) Epicondylitis

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

EU CTIS ID: 2024-515941-40-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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

You likely can't join if

  • Local infection present.
  • Coagulation deficiency or abnormalities.
  • Thrombocytopenia.
  • Treatment with anticoagulants.
  • Difficulty understanding and following study procedures.
  • Participation in a clinical trial with medications.
See the full eligibility criteria
Who can join
  • Over 18 years
  • Patients who present persistent pain (VAS > 5) at the level of lateral epicondyle of at least 3 months’ duration.
  • Patients with a confirmed diagnosis of chronic lateral epicondylitis with some complementary diagnostic test such as ECO or MRI.
  • Availability to be able to follow up on the protocol of the study up to 24 months.
  • Patients with the ability to understand the study information and give informed consent.
  • Patients who sign the informed consent.
  • Normal hematological parameters.
What rules you out
  • Local infection present.
  • Coagulation deficiency or abnormalities.
  • Thrombocytopenia.
  • Treatment with anticoagulants.
  • Difficulty understanding and following study procedures.
  • Participation in a clinical trial with medications.
  • Patients who have received treatment with infiltrations of corticosteroids in the same area in the last 4 months.
  • Patients who have received treatment with growth factors, PRP, cytokines or new pharmacological treatments in it area in the last 12 months.
  • Pregnancy or breastfeeding.
  • Neoplastic Disease.
  • Patients undergoing treatment with immunosuppressants (medical assessment).
  • Patients undergoing arthroscopic surgery of the same elbow.
  • Active liver disease.
  • States of immunosuppression or immunodeficiencies.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.