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Use of Fresh Leukocyte-rich Platelet Rich Plasma or Fresh Leukocyte-poor Platelet Rich Plasma for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial (PRP019)

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ClinicalTrials.gov Identifier: NCT04187183
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Tracking Information
First Submitted Date  ICMJE November 27, 2019
First Posted Date  ICMJE December 5, 2019
Last Update Posted Date February 17, 2020
Estimated Study Start Date  ICMJE March 5, 2020
Estimated Primary Completion Date December 4, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • 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
  • 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)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Fresh Leukocyte-rich Platelet Rich Plasma or Fresh Leukocyte-poor Platelet Rich Plasma for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
Official Title  ICMJE Use of Fresh Platelet-rich Plasma With Leukocytes or Fresh Platelet-rich Plasma Without Leukocytes for Treating Knee Cartilage Degeneration: a Randomized Controlled Trial
Brief Summary The aim of the study is to compare the triple infiltration of Fresh Leukocyte-rich Platelet Rich Plasma against triple infiltration of Fresh Leukocyte-poor Platelet Rich Plasma 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 Leukocyte-rich Platelet Rich Plasma and the second will undergo to three infiltrations of Fresh Leukocyte-poor Platelet Rich Plasma, each infiltrations will be done weekly.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Other: Fresh Platelet Rich Plasma with leukocyte
    autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint
  • Other: Fresh Platelet Rich Plasma without leukocyte
    autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint
Study Arms  ICMJE
  • Experimental: Fresh Leukocyte-rich PRP

    Three infiltrations of fresh Platelet Rich Plasma with Leukocyte.

    1 infiltration weekly, for 3 weeks.

    Intervention: Other: Fresh Platelet Rich Plasma with leukocyte
  • Active Comparator: Fresh Leukocyte-poor PRP

    Three infiltrations of fresh Platelet Rich Plasma without Leukocyte.

    1 infiltration weekly, for 3 weeks.

    Intervention: Other: Fresh Platelet Rich Plasma without leukocyte
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2019)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 4, 2024
Estimated Primary Completion Date December 4, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04187183
Other Study ID Numbers  ICMJE PRP019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Ortopedico Rizzoli
Study Sponsor  ICMJE Istituto Ortopedico Rizzoli
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istituto Ortopedico Rizzoli
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP