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Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee

Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand (Other)
Overall Status
Completed
CT.gov ID
NCT05737173
Collaborator
(none)
93
Enrollment
1
Location
3
Arms
25.9
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy of intraarticular knee injection between leukocyte-rich and leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment

Condition or Disease Intervention/Treatment Phase
  • Drug: Leukocyte-rich platelet-rich plasma
  • Drug: Leukocyte-poor platelet-rich plasma
  • Drug: Corticosteroid
 Phase 2/Phase 3

Detailed Description

Participants were randomized into 3 groups (leukocyte-rich platelet-rich plasma (LR-PRP), leukocyte-poor platelet-rich plasma (LP-PRP), and Corticosteroid (CS)). The primary outcome of this study is The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and was measured pre-treatment and post-treatment at follow-up at 1, 3, and 6 months

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Efficacy of Intraarticular Knee Injection in Knee Osteoarthritis With Leukocyte-rich and Leukocyte-poor Platelet-rich Plasma
Actual Study Start Date :
Aug 3, 2020
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Leukocyte-rich platelet-rich plasma

Leukocyte-rich PRP: Centrifuge at 300 G for 5 min, separate the plasma and buffy coat layers, and then centrifuge at 700 G for 17 min with calcium chloride at the ratio of 1:5 to PRP by volume.

Drug: Leukocyte-poor platelet-rich plasma
Intra-articular knee injection
Other Names:
  • LPPRP

    • Drug: Corticosteroid
    Intra-articular knee injection
    Other Names:
  • CS

    		•
    Experimental: Leukocyte-poor platelet-rich plasma

    Leukocyte-poor PRP: Centrifuge at 123 G for 15 min, separate the plasma and buffy coat layers, and then centrifuge at 448 G for 10 min. Calcium chloride was added 1:5 to PRP by volume.

    Drug: Leukocyte-rich platelet-rich plasma
    Intra-articular knee injection
    Other Names:
  • LRPRP

    • Drug: Corticosteroid
    Intra-articular knee injection
    Other Names:
  • CS

    		•
    Experimental: Corticosteroid

    Corticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml.

    Drug: Leukocyte-rich platelet-rich plasma
    Intra-articular knee injection
    Other Names:
  • LRPRP

    • Drug: Leukocyte-poor platelet-rich plasma
    Intra-articular knee injection
    Other Names:
  • LPPRP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [6 months]

      a self-administered questionnaire consisting of 24 items divided into 3 subscales Pain (5 items) Stiffness (2 items) Physical Function (17 items)

    Secondary Outcome Measures

    1. VAS pain [6 months]

      total of 10 score

    2. the time up and go test [6 months]

      unit: second

    3. 30-second chair stand test [6 months]

      unit second

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age greater than or equal to 50 years old, Plain radiographs knee AP shows Kellgren-Lawrence classification 1-4, Refuse the use of NSAIDs for 2 weeks.
    Exclusion Criteria:
      1. Previous intra-articular injection therapy in the past 6 months; 2) Previously treated with intra-knee PRP injection; 3) History of knee arthritis from other causes such as rheumatoid arthritis, pseudogout or infectious joints 4) History of blood disorder including anemia and thrombocytopenia (Hb < 12 g/dl, plt < 150,000/ml ) 5) History of surgery on the aforementioned knee 6) Obvious knee deformity (valgus > 15, varus > 20, flexion ROM < 90 , extension lag > 20) 7) Pregnancy and lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen Savang Vadhana Memorial Hospital Si Racha Chonburi Thailand 20110

    Sponsors and Collaborators

    • Queen Savang Vadhana Memorial Hospital, Thailand

    Investigators

    • Study Director: Surapol Athiprayul, MD, Queen Savang Vadhana Memorial Hospital, Thailand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Queen Savang Vadhana Memorial Hospital, Thailand
    ClinicalTrials.gov Identifier:
    NCT05737173
    Other Study ID Numbers:
    • 023/2563
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Queen Savang Vadhana Memorial Hospital, Thailand
    OA knee
    PRP
    Leukocyte concentration
    Osteoarthritis Knee
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Feb 21, 2023