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RECRUITING
NCT06040203
NA

Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

Summary

The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment

Official title: Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-03-23

Completion Date

2027-03

Last Updated

2025-09-29

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)

Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.

BIOLOGICAL

Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)

Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.

DRUG

Placebo (saline solution)

Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy