An interventional study of Fresh Platelet Rich Plasma with leukocyte and Fresh Platelet Rich Plasma without leukocyte in Osteoarthritis, Knee, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 132 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 104 are open to participants now.
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Patients with degenerative pathology of the knee cartilage with:
Exclusion Criteria:
Three infiltrations of fresh Platelet Rich Plasma with concentrated Leukocytes 1 infiltration weekly, for 3 weeks.
Other: Fresh Platelet Rich Plasma with leukocyte
Three infiltrations of fresh Platelet Rich Plasma without concentrated Leukocyte. 1 infiltration weekly, for 3 weeks.
Other: Fresh Platelet Rich Plasma without leukocyte
autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint
autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint
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.
Time frame: 12 month
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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: baseline, 2, 6, 12, 24 months
Ran from Jun 2020 to primary completion in Oct 2024, 51 months.
Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 51 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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