Clinical trial NCT04187183: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

Patients with degenerative pathology of the knee cartilage with:

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:

1. Patients undergone to intra-articular infiltration of another substance in the previous 6 months;
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.

Primary outcomes:
measure: IKDC-subjective score (International Knee Documentation Committee)
timeFrame: 12 month
Secondary outcomes:
measure: KOOS score (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: baseline, 2, 6, 12 and 24 months
measure: EQ-VAS (EuroQol-visual analogue scales)
timeFrame: baseline, 2, 6, 12, 24 months
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: baseline, 2, 6, 12, 24 months
measure: Tegner Activity Level Scale
timeFrame: baseline, 2, 6, 12, 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.