Use of Fresh Leukocyte-rich Platelet Rich Plasma or Fresh Leukocyte-poor Platelet Rich Plasma for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial (PRP019)
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|ClinicalTrials.gov Identifier: NCT04187183|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Other: Fresh Platelet Rich Plasma with leukocyte Other: Fresh Platelet Rich Plasma without leukocyte||Not Applicable|
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 Leukocyte-rich Platelet Rich Plasma and the second will undergo to three infiltrations of Fresh Leukocyte-poor Platelet Rich Plasma, each infiltrations will be done weekly.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Use of Fresh Platelet-rich Plasma With Leukocytes or Fresh Platelet-rich Plasma Without Leukocytes for Treating Knee Cartilage Degeneration: a Randomized Controlled Trial|
|Estimated Study Start Date :||March 5, 2020|
|Estimated Primary Completion Date :||December 4, 2024|
|Estimated Study Completion Date :||December 4, 2024|
Experimental: Fresh Leukocyte-rich PRP
Three infiltrations of fresh Platelet Rich Plasma with Leukocyte.
1 infiltration weekly, for 3 weeks.
Other: Fresh Platelet Rich Plasma with leukocyte
autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint
Active Comparator: Fresh Leukocyte-poor PRP
Three infiltrations of fresh Platelet Rich Plasma without Leukocyte.
1 infiltration weekly, for 3 weeks.
Other: Fresh Platelet Rich Plasma without leukocyte
autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint
- IKDC-subjective score (International Knee Documentation Committee) [ Time Frame: 12 month ]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.
- KOOS score (Knee Injury and Osteoarthritis Outcome Score) [ Time Frame: baseline, 2, 6, 12 and 24 months ]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
- EQ-VAS (EuroQol-visual analogue scales) [ Time Frame: baseline, 2, 6, 12, 24 months ]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)
- EQ-5D (EuroQoL) Current Health Assessment [ Time Frame: baseline, 2, 6, 12, 24 months ]It is a reliable tools for assessing quality of life of the patient
- Tegner Activity Level Scale [ Time Frame: baseline, 2, 6, 12, 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187183
|Istituto Ortopedico Rizzoli|
|Contact: Alessandro DI Martino 0516366567 firstname.lastname@example.org|