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)

April 19, 2024 updated by: Istituto Ortopedico Rizzoli

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fresh PRP with concentrate Leukocyte

Three infiltrations of fresh Platelet Rich Plasma with concentrated Leukocytes

1 infiltration weekly, for 3 weeks.
Other: Fresh Platelet Rich Plasma with leukocyte
autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint
Active Comparator: Fresh PRP without concentrated Leukocyte

Three infiltrations of fresh Platelet Rich Plasma without concentrated Leukocyte.

1 infiltration weekly, for 3 weeks.
Other: Fresh Platelet Rich Plasma without leukocyte
autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC-subjective score (International Knee Documentation Committee)
Time Frame: 12 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS score (Knee Injury and Osteoarthritis Outcome Score)
Time Frame: baseline, 2, 6, 12 and 24 months
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
EQ-VAS (EuroQol-visual analogue scales)
Time Frame: baseline, 2, 6, 12, 24 months
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
EQ-5D (EuroQoL) Current Health Assessment
Time Frame: baseline, 2, 6, 12, 24 months
It is a reliable tools for assessing quality of life of the patient
baseline, 2, 6, 12, 24 months
Tegner Activity Level Scale
Time Frame: baseline, 2, 6, 12, 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Estimated)

December 4, 2024

Study Completion (Estimated)

December 4, 2024

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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