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Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients

Primary Purpose

Osteoarthritis Knee, Corticosteroid, Platelet Rich Plasma

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Corticosteroid
Platelet Rich Plasma
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Knee

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs. Patients diagnosed according to ACR classification criteria. Exclusion Criteria: Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies. Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs. Pregnant and breast feeding females. Patients have hemoglobin values <10 g/dl or platelet values<150,000/ml.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    OA group injected by corticosteroid

    OA group injected by Platelet Rich Plasma

    Arm Description

    Group l include 50 patients who will be injected with one intra_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine

    Group lI include 50 patients who will be injected with a single 5 ml intra_articular injection of PRP prepared in our hospital

    Outcomes

    Primary Outcome Measures

    Assessment of knee pain, stiffness and physical function prior knee injection
    Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
    Assessment of knee pain, stiffness and physical function 2 weeks after injection
    Assessment through WOMAC score
    Assessment of knee pain, stiffness and physical function 6 weeks after injection
    Assessment through WOMAC score
    Assessment of knee pain, stiffness and physical function 12 weeks after injection
    Assessment through WOMAC score

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 21, 2023
    Sponsor
    Benha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05742061
    Brief Title
    Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients
    Official Title
    Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis Knee, Corticosteroid, Platelet Rich Plasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OA group injected by corticosteroid
    Arm Type
    Active Comparator
    Arm Description
    Group l include 50 patients who will be injected with one intra_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine
    Arm Title
    OA group injected by Platelet Rich Plasma
    Arm Type
    Active Comparator
    Arm Description
    Group lI include 50 patients who will be injected with a single 5 ml intra_articular injection of PRP prepared in our hospital
    Intervention Type
    Drug
    Intervention Name(s)
    Corticosteroid
    Intervention Description
    The injection will be given at a site near the superolateral pole of patella in the suprapatellar pouch under aseptic conditions and the patient will be advised to take one day of rest after injection and apply ice to the area if there are any signs of inflammation.
    Intervention Type
    Other
    Intervention Name(s)
    Platelet Rich Plasma
    Intervention Description
    PRP preparation :- 20 ml of venous blood will be drawn from the antecubital vein using an 18G needle to avoid traumatizing platelets and will be collected in a sterile tube containing 2 ml of Sodium Citrate anticoagulant. Approximately 2 ml of whole blood will be separated for a complete blood count.The blood with anticoagulant will centrifuged at 4000 rpm for 6-10 minutes to separate erythrocytes and then at 4000 rpm for 6-10 min to concentrate platelets.The final product was 4-5 ml of PRP containing leukocytes with platelet concentration of 3-5 times the average normal value.
    Primary Outcome Measure Information:
    Title
    Assessment of knee pain, stiffness and physical function prior knee injection
    Description
    Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
    Time Frame
    Assessment will be done just before injection
    Title
    Assessment of knee pain, stiffness and physical function 2 weeks after injection
    Description
    Assessment through WOMAC score
    Time Frame
    2 weeks after injection
    Title
    Assessment of knee pain, stiffness and physical function 6 weeks after injection
    Description
    Assessment through WOMAC score
    Time Frame
    6 weeks after injection
    Title
    Assessment of knee pain, stiffness and physical function 12 weeks after injection
    Description
    Assessment through WOMAC score
    Time Frame
    12 weeks after injection

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Patients 40-70 years of age suffering from knee OA
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs. Patients diagnosed according to ACR classification criteria. Exclusion Criteria: Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies. Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs. Pregnant and breast feeding females. Patients have hemoglobin values <10 g/dl or platelet values<150,000/ml.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arwa S. Amer, MD
    Phone
    01550465282
    Email
    arwa.amer@fmed.bu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benha University
    Phone
    0133213517
    Email
    info@bu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients

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