Use of Fresh Platelet Rich Plasma With Concentrated Leukocytes or Fresh Platelet Rich Plasma Without Concentrated Leukocytes in the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial (PRP019)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Other: Fresh Platelet Rich Plasma without leukocyte; Other: Fresh Platelet Rich Plasma with leukocyte

Study type: Interventional

Funder types: Other

Identifiers

NCT04187183

PRP019

Details and patient eligibility

About

The aim of the study is to compare the triple infiltration of Fresh Platelet Rich Plasma with concentrated Leukocytes against triple infiltration of Fresh Platelet Rich Plasma Without Concentrated Leukocytes in the treatment of Knee Cartilage Degeneration in a Double Blind Randomized Controlled Trial

Full description

Platelet Rich Plasma has a consolidated use in the field of orthopedic surgery to reduce inflammation, promoting bone regeneration and healing of surgical wounds.

Some clinical studies demonstrated the utility of the intra-articular infiltration of Platelet Rich Plasma in the treatment of knee articular cartilage lesions, becoming a common conservative strategies in the management of these diseases.

Actually, there are some different kinds of PRP formulations, in particular, the scientific debate is focusing on the role of Leukocytes and if it is better using fresh or frozen PRP.

At the moment don't exist randomized controlled clinical studies comparing fresh PRP rich in Leukocyte against PRP poor in Leukocyte in the treatment of knee cartilage lesions.

The study has two groups of patients, the first will undergo to three infiltrations of Fresh Platelet Rich Plasma With Concentrated Leukocytes and the second will undergo to three infiltrations of Fresh Platelet Rich Plasma Without Concentrated Leukocytes, each infiltrations will be done weekly.

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with degenerative pathology of the knee cartilage with:

1. Age between 18 and 75 years;
2. Unilateral involvement;
3. Signs and symptoms of degenerative pathology of the cartilage of the knee;
4. Radiographic or MRI signs of degenerative pathology of the cartilage of the knee (Kellgren-Lawrence 1-4 degrees);
5. Hemoglobin> 11 g / dl; Platelet count> 150,000 plt / mm3 (recently performed blood count);
6. No clinically significant electrocardiographic alteration (recently performed ECG).
7. Patients' ability and consent to actively participate in clinical follow-up;
8. Signature of informed consent.

Exclusion criteria

1. Patients undergone to intra-articular infiltration of another substance in the previous 6 months;
2. Patients undergone knee surgery in the previous 12 months;
3. Patients with malignant neoplasms;
4. Patients suffering from rheumatic diseases;
5. Patients suffering from diabetes;
6. Patients with hematologic diseases (coagulopathies);
7. Patients on anti-anticoagulant therapy;
8. Patients suffering from thyroid metabolic disorders;
9. Patients abusing alcoholic beverages, drugs or drugs;
10. Body Mass Index> 35;
11. Patients who have taken NSAIDs within 3 days before taking blood;
12. Patients with cardiovascular diseases for which the 150 ml blood test would be contraindicated;
13. Patients with a recently performed blood count with Hb values <11 g / dl and Platelets <150,000 plt / mm3.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Fresh PRP with concentrate Leukocyte

Experimental group

Description:

Three infiltrations of fresh Platelet Rich Plasma with concentrated Leukocytes 1 infiltration weekly, for 3 weeks.

Treatment:

Other: Fresh Platelet Rich Plasma with leukocyte

Fresh PRP without concentrated Leukocyte

Active Comparator group

Description:

Three infiltrations of fresh Platelet Rich Plasma without concentrated Leukocyte. 1 infiltration weekly, for 3 weeks.

Treatment:

Other: Fresh Platelet Rich Plasma without leukocyte