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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Use of Fresh Platelet-rich Plasma With Concentrated Leukocytes or Fresh Platelet-rich Plasma Without Concentrated Leukocytes for Treating Knee Cartilage Degeneration: a Randomized Controlled Trial

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Fresh Platelet Rich Plasma with leukocyte
* Other: Fresh Platelet Rich Plasma without leukocyte


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with degenerative pathology of the knee cartilage with: Age between 18 and 75 years; Unilateral involvement; Signs and symptoms of degenerative pathology of the cartilage of the knee; Radiographic or MRI signs of degenerative pathology of the cartilage of the knee (Kellgren-Lawrence 1-4 degrees); Hemoglobin> 11 g / dl; Platelet count> 150,000 plt / mm3 (recently performed blood count); No clinically significant electrocardiographic alteration (recently performed ECG). Patients' ability and consent to actively participate in clinical follow-up; Signature of informed consent. Exclusion Criteria: Patients undergone to intra-articular infiltration of another substance in the previous 6 months; Patients undergone knee surgery in the previous 12 months; Patients with malignant neoplasms; Patients suffering from rheumatic diseases; Patients suffering from diabetes; Patients with hematologic diseases (coagulopathies); Patients on anti-anticoagulant therapy; Patients suffering from thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or drugs; Body Mass Index> 35; Patients who have taken NSAIDs within 3 days before taking blood; Patients with cardiovascular diseases for which the 150 ml blood test would be contraindicated; Patients with a recently performed blood count with Hb values <11 g / dl and Platelets <150,000 plt / mm3.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fresh PRP with concentrate Leukocyte<br>Three infiltrations of fresh Platelet Rich Plasma with concentrated Leukocytes 1 infiltration weekly, for 3 weeks. | Other: Fresh Platelet Rich Plasma with leukocyte<br>* autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint<br>|
| Active Comparator: Fresh PRP without concentrated Leukocyte<br>Three infiltrations of fresh Platelet Rich Plasma without concentrated Leukocyte. 1 infiltration weekly, for 3 weeks. | Other: Fresh Platelet Rich Plasma without leukocyte<br>* autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC-subjective score (International Knee Documentation Committee) | It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS score (Knee Injury and Osteoarthritis Outcome Score) | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale | baseline, 2, 6, 12 and 24 months | 
| EQ-VAS (EuroQol-visual analogue scales) | It is a rating scale for assessing the health state of the patient. The scale ranging from 0 (the worst health state) to 100 (the best health state) | baseline, 2, 6, 12, 24 months | 
| EQ-5D (EuroQoL) Current Health Assessment | It is a reliable tools for assessing quality of life of the patient | baseline, 2, 6, 12, 24 months | 
| Tegner Activity Level Scale | Survey useful for assessing sport activity of the patient. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. | baseline, 2, 6, 12, 24 months |