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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Tennis Elbow

Treatments: Biological: Injection of autologous leukocyte poor platelet rich plasma (LP-PRP); Biological: Injection of autologous leukocyte rich platelet rich plasma (LR-PRP); Drug: Placebo (saline solution)

Study type: Interventional

Funder types: Other

Identifiers

NCT06040203

Epic-PRP

Details and patient eligibility

About

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

Full description

Patients with elbow epicondylitis will be included in a double-blind, randomized controlled trial, in which one group of patients will be treated with an echo-guided injection of LP-PRP (low leukocyte PRP), one group of patients will be treated with an echo-guided injection of LR-PRP (high leukocyte PRP), and another group of patients will be treated with an echo-guided injection of saline.All enrolled patients undergo sampling of a venous whole blood bag of approximately 300 cc from which Fresh Autologous PRP (PRP-A) will subsequently be obtained. According to randomization, a "leukodepletion" filter will be used to remove leukocytes in order to obtain LP-PRP. Instead, an aliquot of PRP will be cryopreserved and made available for the patient for a possible second PRP infiltration if there is no benefit after 6 months after the first infiltration.The patient will then be placed on the randomization list and will, therefore, be assigned to one of the three treatment groups (leukocyte-rich PRP, leukocyte-poor PRP, or saline solution). In the case of patients in the saline injection group, PRP will be prepared with or without leukocytes according to a dedicated randomization list, for possible treatment after 6 months if necessary.The patient will subsequently undergo 1 echo-guided infiltration, according to randomization.Patients will be clinically evaluated before the infiltration procedure and at 1-3-6-12 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checkups during follow-up. Any adverse events to treatment will also be evaluated during follow-up visits. The duration and extent of swelling and pain following infiltration will be reported, and any drug therapies given by the patient will be recorded

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with epicondylitis of the elbow:

1. Patients with clinical picture of epicondylitis;
2. Duration of symptoms > 3 months
3. Ultrasound picture of short or long radial extensor carpal tendinopathy;
4. Age > 18 and < 65
5. Both sexes;
6. Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months;
7. Hemoglobin > 11 g/dl;
8. Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
9. Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
10. No clinically significant electrocardiographic changes (Recently performed ECG);
11. Ability and consent of the patient to actively participate in clinical follow-up;
12. Signature of informed consent.

Exclusion criteria

1. Patients undergoing previous surgical treatment on the epicondylar tendons;
2. Patients undergoing epicondylar infiltration in the previous 6 months;
3. Inability of patients to actively participate in clinical follow-up;
4. Incapacitated patients;
5. Patients with states of immunodepression;
6. Patients with fibromyalgia;
7. Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);
8. Patients with uncontrolled thyroid metabolic disorders;
9. Patients abusing alcoholic beverages, drugs or medications;
10. Patients who have taken NSAIDs in the 3 days prior to blood collection;
11. Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;
12. Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;
13. Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
14. Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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240 participants in 3 patient groups, including a placebo group

Leukocyte-rich Platelet rich plasma (LR-PRP)

Experimental group

Description:

This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.

Treatment:

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

Leukocyte-poor Platelet rich plasma (LP-PRP)

Experimental group

Description:

This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.

Treatment:

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

Saline solution

Placebo Comparator group

Description:

This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list.

Treatment:

Drug: Placebo (saline solution)