search
Back to results

Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Platelet rich plasma
Hyaluronic acid
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Platelet-rich plasma, Pain's treatment

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
  • VAS greater than 5
  • Between 40and 80 years of age

Exclusion Criteria:

  • Level IV arthritis of the knee
  • Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
  • Frontal deformity greater than 10 degrees
  • Ipsilateral pathology of the knee or ankle
  • Range of motion or flexibility of the knee less than 90 degrees
  • Deficit of knee extension greater than 15 degrees
  • Anticoagulation treatment, antiplatelet treatment
  • Hepatopathy
  • Hematological neoplastic pathology
  • Active infection
  • Fibromyalgia
  • Chronic fatigue syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Platelet rich plasma

    Hyaluronic acid

    Arm Description

    Three intraarticular injection, one each fifteen days

    Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)

    Outcomes

    Primary Outcome Measures

    Changes from baseline Visual Analogue Scale (VAS) value
    The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees

    Secondary Outcome Measures

    Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value
    KOOS is an instrument to assess the patient's opinion about their knee and associated problems. It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life
    Effects on quality of life
    EUROQOL (European Quality of Life) for the evaluation of function and quality of life
    All reported adverse events

    Full Information

    First Posted
    April 27, 2015
    Last Updated
    May 15, 2015
    Sponsor
    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02448407
    Brief Title
    Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
    Official Title
    Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.
    Detailed Description
    This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Knee osteoarthritis, Platelet-rich plasma, Pain's treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet rich plasma
    Arm Type
    Experimental
    Arm Description
    Three intraarticular injection, one each fifteen days
    Arm Title
    Hyaluronic acid
    Arm Type
    Active Comparator
    Arm Description
    Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)
    Intervention Type
    Biological
    Intervention Name(s)
    Platelet rich plasma
    Other Intervention Name(s)
    PRP, Platelet Concentrate
    Intervention Description
    Three intraarticular injections of platelet-rich plasma, one each fifteen days
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic acid
    Other Intervention Name(s)
    Adant
    Intervention Description
    Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
    Primary Outcome Measure Information:
    Title
    Changes from baseline Visual Analogue Scale (VAS) value
    Description
    The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees
    Time Frame
    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
    Secondary Outcome Measure Information:
    Title
    Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value
    Description
    KOOS is an instrument to assess the patient's opinion about their knee and associated problems. It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life
    Time Frame
    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
    Title
    Effects on quality of life
    Description
    EUROQOL (European Quality of Life) for the evaluation of function and quality of life
    Time Frame
    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
    Title
    All reported adverse events
    Time Frame
    Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale) VAS greater than 5 Between 40and 80 years of age Exclusion Criteria: Level IV arthritis of the knee Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months Frontal deformity greater than 10 degrees Ipsilateral pathology of the knee or ankle Range of motion or flexibility of the knee less than 90 degrees Deficit of knee extension greater than 15 degrees Anticoagulation treatment, antiplatelet treatment Hepatopathy Hematological neoplastic pathology Active infection Fibromyalgia Chronic fatigue syndrome
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elvira Montañez Heredia, MD, PhD
    Organizational Affiliation
    Hospital Universitario Virgen de la Victoria. Málaga
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee

    We'll reach out to this number within 24 hrs