CompletedNo phase
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
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 132 people enrolled
- Started
- 23 Jun 2020
- Ended
- 3 Oct 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Fresh Platelet Rich Plasma with leukocyte
- Fresh Platelet Rich Plasma without leukocyte
- Record updated
- 3 January 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients undergone to intra-articular infiltration of another substance in the previous 6 months
- Patients undergone knee surgery in the previous 12 months
- Patients on anti-anticoagulant therapy
- Patients abusing alcoholic beverages, drugs or drugs
- Patients who have taken NSAIDs within 3 days before taking blood
- Patients with malignant neoplasms
- Patients suffering from rheumatic diseases
- Patients suffering from diabetes
- Patients with hematologic diseases (coagulopathies)
- Patients suffering from thyroid metabolic disorders
- 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
- Body Mass Index> 35
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- Fresh PRP with concentrate LeukocyteTreatment being tested
Three infiltrations of fresh Platelet Rich Plasma with concentrated Leukocytes 1 infiltration weekly, for 3 weeks.
Treatment: Fresh Platelet Rich Plasma with leukocyte
- Fresh PRP without concentrated LeukocyteExisting treatment, for comparison
Three infiltrations of fresh Platelet Rich Plasma without concentrated Leukocyte. 1 infiltration weekly, for 3 weeks.
Treatment: Fresh Platelet Rich Plasma without leukocyte
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 3 January 2025