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

Osteoarthritis, Knee Clinical Trial

— PRP019  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04187183
• Other study ID #: PRP019
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: December 4, 2024

Study information

• Verified date: April 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: December 4, 2024
• Est. primary completion date: December 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month
Secondary	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	baseline, 2, 6, 12 and 24 months
Secondary	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)	baseline, 2, 6, 12, 24 months
Secondary	EQ-5D (EuroQoL) Current Health Assessment	It is a reliable tools for assessing quality of life of the patient	baseline, 2, 6, 12, 24 months
Secondary	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.	baseline, 2, 6, 12, 24 months