Back to results

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 (PRP019)

Primary Purpose

Osteoarthritis, Knee

Status

Active

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Fresh Platelet Rich Plasma with leukocyte

Fresh Platelet Rich Plasma without leukocyte

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fresh PRP with concentrate Leukocyte

Fresh PRP without concentrated Leukocyte

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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)

EQ-5D (EuroQoL) Current Health Assessment

It is a reliable tools for assessing quality of life of the patient

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.

Full Information

NCT ID

NCT04187183

First Posted

November 27, 2019

Last Updated

April 18, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT04187183

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 23, 2020 (Actual)

Primary Completion Date

December 4, 2024 (Anticipated)

Study Completion Date

December 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fresh PRP with concentrate Leukocyte

Arm Type

Experimental

Arm Description

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

Arm Title

Fresh PRP without concentrated Leukocyte

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Fresh Platelet Rich Plasma with leukocyte

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Fresh Platelet Rich Plasma without leukocyte

Intervention Description

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

Primary Outcome Measure Information:

Title

IKDC-subjective score (International Knee Documentation Committee)

Description

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.

Time Frame

12 month

Secondary Outcome Measure Information:

Title

KOOS score (Knee Injury and Osteoarthritis Outcome Score)

Description

Time Frame

baseline, 2, 6, 12 and 24 months

Title

EQ-VAS (EuroQol-visual analogue scales)

Description

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)

Time Frame

baseline, 2, 6, 12, 24 months

Title

EQ-5D (EuroQoL) Current Health Assessment

Description

It is a reliable tools for assessing quality of life of the patient

Time Frame

baseline, 2, 6, 12, 24 months

Title

Tegner Activity Level Scale

Description

Time Frame

baseline, 2, 6, 12, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Istituto Ortopedico Rizzoli

City

Bologna

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

30545242

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.

Results Reference

background

PubMed Identifier

16921694

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.

Results Reference

background

PubMed Identifier

12608674

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.

Results Reference

background

PubMed Identifier

22203046

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.

Results Reference

background

PubMed Identifier

24599205

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.

Results Reference

background

PubMed Identifier

24942296

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.

Results Reference

background

Learn more about this trial

We'll reach out to this number within 24 hrs