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
NCT ID: NCT04187183
Last Updated: 2025-01-03
Study Results
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Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2020-06-23
2024-10-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fresh PRP with concentrate Leukocyte
Three infiltrations of fresh Platelet Rich Plasma with concentrated Leukocytes
1 infiltration weekly, for 3 weeks.
Fresh Platelet Rich Plasma with leukocyte
autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint
Fresh PRP without concentrated Leukocyte
Three infiltrations of fresh Platelet Rich Plasma without concentrated Leukocyte.
1 infiltration weekly, for 3 weeks.
Fresh Platelet Rich Plasma without leukocyte
autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint
Interventions
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Fresh Platelet Rich Plasma with leukocyte
autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint
Fresh Platelet Rich Plasma without leukocyte
autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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References
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Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.
Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.
Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103.
Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. doi: 10.1007/s00167-011-1837-x. Epub 2011 Dec 28.
Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726.
Assirelli E, Filardo G, Mariani E, Kon E, Roffi A, Vaccaro F, Marcacci M, Facchini A, Pulsatelli L. Effect of two different preparations of platelet-rich plasma on synoviocytes. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2690-703. doi: 10.1007/s00167-014-3113-3. Epub 2014 Jun 19.
Romandini I, Boffa A, Di Martino A, Andriolo L, Cenacchi A, Sangiorgi E, Orazi S, Pizzuti V, Zaffagnini S, Filardo G. Leukocytes Do Not Influence the Safety and Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 Nov;52(13):3212-3222. doi: 10.1177/03635465241283500. Epub 2024 Oct 12.
Other Identifiers
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PRP019
Identifier Type: -
Identifier Source: org_study_id
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