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

NCT04187183 | Completed

• 1 other identifier: PRP019
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• KOOS score (Knee Injury and Osteoarthritis Outcome Score)

  baseline, 2, 6, 12 and 24 months

• EQ-VAS (EuroQol-visual analogue scales)

  baseline, 2, 6, 12, 24 months

• EQ-5D (EuroQoL) Current Health Assessment

  baseline, 2, 6, 12, 24 months

• Tegner Activity Level Scale

  baseline, 2, 6, 12, 24 months

Study Arms (2)

Fresh PRP with concentrate Leukocyte

EXPERIMENTAL

Three infiltrations of fresh Platelet Rich Plasma with concentrated Leukocytes 1 infiltration weekly, for 3 weeks.

Other: Fresh Platelet Rich Plasma with leukocyte

Fresh PRP without concentrated Leukocyte

ACTIVE COMPARATOR

Three infiltrations of fresh Platelet Rich Plasma without concentrated Leukocyte. 1 infiltration weekly, for 3 weeks.

Other: Fresh Platelet Rich Plasma without leukocyte

Interventions

Fresh Platelet Rich Plasma with leukocyte OTHER

autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint

Fresh PRP with concentrate Leukocyte

Fresh Platelet Rich Plasma without leukocyte OTHER

autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint

Fresh PRP without concentrated Leukocyte

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients undergone to intra-articular infiltration of another substance in the previous 6 months;
• Patients undergone knee surgery in the previous 12 months;
• Patients with malignant neoplasms;
• Patients suffering from rheumatic diseases;
• Patients suffering from diabetes;
• Patients with hematologic diseases (coagulopathies);
• Patients on anti-anticoagulant therapy;
• Patients suffering from thyroid metabolic disorders;
• Patients abusing alcoholic beverages, drugs or drugs;
• Body Mass Index\> 35;
• Patients who have taken NSAIDs within 3 days before taking blood;
• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

Location

Related Publications (7)

• 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.

  PMID: 30545242 BACKGROUND

• 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.

  PMID: 16921694 BACKGROUND

• 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.

  PMID: 12608674 BACKGROUND

• 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.

  PMID: 22203046 BACKGROUND

• 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.

  PMID: 24599205 BACKGROUND

• 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.

  PMID: 24942296 BACKGROUND

• 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.

  PMID: 39394763 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Leukocyte Count

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 5, 2019
• Study Start: June 23, 2020
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

IT (1)