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Intraosseous PRP for Knee Osteoarthritis: Pilot Study

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
Unidad de Cirugía Artroscópica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of both sexes aged 40 to 77 years.
  • Predominant internal tibiofemoral knee osteoarthritis.
  • Joint pain above 2.5 VAS points.
  • Radiographic severity degrees 3 and 4 according to Ahlbäck scale.
  • Values of body mass index between 20 and 33.
  • Possibility for observation during the follow-up period.

Exclusion Criteria:

  • Bilateral knee osteoarthritis which requires infiltration in both knees.
  • Values of body mass index > 33.
  • Polyarticular disease diagnosed.
  • Severe mechanical deformity (diaphyseal varus of 4∘ and valgus of 16∘).
  • Arthroscopy in the last year prior to treatment.
  • Intra-articular infiltration of hyaluronic acid in the past 6 months.
  • Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
  • Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%).
  • Blood disorders (thrombopathy, thrombocytopenia, and anemia with Hb < 9).
  • Undergoing immunosuppressive therapy and/or warfarin.
  • Treatment with corticosteroids during the 6 months prior to inclusion in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Platelet Rich Plasma

    Arm Description

    Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma

    Outcomes

    Primary Outcome Measures

    Pain according to KOOS scale at 6 months after treatment
    Pain according to KOOS scale

    Secondary Outcome Measures

    Symptoms according to KOOS scale at 6 months after treatment
    According to KOOS scale
    Function according to KOOS scale at 6 months after treatment
    According to KOOS scale
    Sport Activity according to KOOS scale at 6 months after treatment
    According to KOOS scale
    QoL according to KOOS scale at 6 months after treatment
    According to KOOS scale

    Full Information

    First Posted
    May 17, 2017
    Last Updated
    May 18, 2017
    Sponsor
    Unidad de Cirugía Artroscópica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03160781
    Brief Title
    Intraosseous PRP for Knee Osteoarthritis: Pilot Study
    Official Title
    Pilot Study to Evaluate Combination of Intraosseous With Intra-articular Infiltrations of Plasma Rich in Growth Factors (PRGF®-Endoret®) in the Treatment of Knee Osteoarthritis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 28, 2014 (Actual)
    Primary Completion Date
    January 10, 2015 (Actual)
    Study Completion Date
    January 10, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Unidad de Cirugía Artroscópica

    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
    No

    5. Study Description

    Brief Summary
    The aim of this study was to assess a novel approach to treating severe knee osteoarthritis by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and subchondral bone by combining intra-articular injections and intraosseous infiltrations of platelet rich plasma.This study explored a new strategy consisting of intraosseous infiltrations of platelet rich plasma into the subchondral bone in combination with the conventional intra-articular injection in order to tackle several knee joint tissues simultaneously.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet Rich Plasma
    Arm Type
    Experimental
    Arm Description
    Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma
    Intervention Type
    Biological
    Intervention Name(s)
    Platelet Rich Plasma
    Intervention Description
    Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma
    Primary Outcome Measure Information:
    Title
    Pain according to KOOS scale at 6 months after treatment
    Description
    Pain according to KOOS scale
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Symptoms according to KOOS scale at 6 months after treatment
    Description
    According to KOOS scale
    Time Frame
    6 months
    Title
    Function according to KOOS scale at 6 months after treatment
    Description
    According to KOOS scale
    Time Frame
    6 months
    Title
    Sport Activity according to KOOS scale at 6 months after treatment
    Description
    According to KOOS scale
    Time Frame
    6 months
    Title
    QoL according to KOOS scale at 6 months after treatment
    Description
    According to KOOS scale
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    77 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of both sexes aged 40 to 77 years. Predominant internal tibiofemoral knee osteoarthritis. Joint pain above 2.5 VAS points. Radiographic severity degrees 3 and 4 according to Ahlbäck scale. Values of body mass index between 20 and 33. Possibility for observation during the follow-up period. Exclusion Criteria: Bilateral knee osteoarthritis which requires infiltration in both knees. Values of body mass index > 33. Polyarticular disease diagnosed. Severe mechanical deformity (diaphyseal varus of 4∘ and valgus of 16∘). Arthroscopy in the last year prior to treatment. Intra-articular infiltration of hyaluronic acid in the past 6 months. Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%). Blood disorders (thrombopathy, thrombocytopenia, and anemia with Hb < 9). Undergoing immunosuppressive therapy and/or warfarin. Treatment with corticosteroids during the 6 months prior to inclusion in the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intraosseous PRP for Knee Osteoarthritis: Pilot Study

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