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To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Platelet rich plasma
Hyaluronic Acid
Sponsored by
Dr. Himanshu Bansal Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Platelet rich plasma

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatients who fulfilled the clinical and radiological criteria set by the American College of Rheumatology for the diagnosis of symptomatic primary knee OA, with pain Visual Analogue Scale (VAS) score of >3 in the previous month. In cases where both the knees were symptomatic, the knee which was comparatively more painful was considered.

Exclusion Criteria:

  1. Evidence of secondary knee OA because of injury, inflammatory or metabolic rheumatic disease, or osteonecrosis;
  2. Prior intra-articular injection of hyaluronic acid (HA), including lavage and corticosteroids within the previous three months;
  3. Severe knee OA, with JSW <1 mm, or surgery required on the evaluated knee in the year
  4. Patients with clinically significant systemic disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    PRP (100billion platelets)

    hyaluronic acid

    Arm Description

    platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood

    Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml

    Outcomes

    Primary Outcome Measures

    changes in womac score
    WOMAC, a widely used measure to assess patients' pain, joint mobility, and physical disability evaluates three dimensions, pain, stiffness, and physical function, with 5, 2, and 17 questions, respectively. The total maximum score is 96 and minimum, 0
    changes in cartilage thickness as assessed on 1.5 T MRI
    Using the 1.5-T field strength with standard MRI acquisition protocols, MRI was performed of each joint individually in coronal, sagittal, and transverse planes. The maximum thickness of the cartilage at posterior,meniscal and patellar level measured at the midsagittal plane through the medial condyle was considered. The medial femoral cartilage of the affected knee was chosen for measurement.

    Secondary Outcome Measures

    changes in joint space width
    Patients were radiographed in a weight-bearing position, joints fully extended, standing at 1 m from the X-ray source20. The width was measured at the narrowest point of the Joint (JSW)
    changes in cartilage thickness as assessed by ultrasonically.
    Having the patients sit with flexed knees,The articular cartilage of the medial femoral condyle was evaluated with a starting point at the level of intercondylar notch to the medial border of the medial condyle by an ultrasound.

    Full Information

    First Posted
    December 9, 2019
    Last Updated
    December 12, 2019
    Sponsor
    Dr. Himanshu Bansal Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04198467
    Brief Title
    To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid
    Official Title
    Randomized Controlled Study to Compare Safety and Efficacy of Intra Articular Administration of Platelet Rich Plasma Versus Hyaluronic Acid as Placebo in Patients With Osteoarthritis of Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 21, 2014 (Actual)
    Primary Completion Date
    April 15, 2016 (Actual)
    Study Completion Date
    July 10, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dr. Himanshu Bansal Foundation

    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
    Randomized, Double-blind, 12-month, placebo-controlled study was conducted on 100 outpatients . Intervention platelet rich plasma( PRP) prepared from 60 ml of blood by adding novel step of filtration to manual centrifuge step to achieve 7 times concentration. the efficacy was compared with administration of hyaluronic acid. Subjective Womac scores ,6 min pain free walking distance as well objective assessments MRI ,synovial fluid assessments were made out .Absolute counts of platelets as dose was evaluated to be effective in alleviating symptoms in early knee OA.
    Detailed Description
    Osteoarthritis (OA) causes substantial physical disability that limits a person ability to indulge in daily activities. OA related disability has been affecting millions of older adults throughout the world, and the number has almost doubled in 2019. Though the process of OA could not be reversed, efficient management strategies could help in minimizing primary pain with physical exercises, surgical procedures, and medications. Prolonged use of nonsteroidal anti-inflammatory drugs (NSAIDs) has been dramatically associated with mild to severe side effects, limiting its continuous use. Chondro-protective agents (CPAs) have been proven to provide only minimal symptomatic benefit. Platelet-rich plasma (PRP) has emerged as a supreme therapy in OA knee however exact dose ,preparation and duration of benefit still remains unclear. Study was undertaken to demonstrate the potential of leukocyte depleted PRP in cartilage repair of knee OA using WOMAC scores as subjective assessment tool. Our research also evaluated objective criteria ing joint space width (JSW),cartilage thickness on MRI, Ultrasound that would improve knee joint function in patients with knee OA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Platelet rich plasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    182 patients screened, 100 were considered eligible for the study and were randomized. The most common reason for exclusion was either the lack of radio graphic evidence of knee OA or the presence of severe disease with JSW less than 2 mm at the narrowest point. Out of the 100 randomized patients, roughly equal numbers, six patients in PRP and 7 in placebo, did not complete the study. Reasons for withdrawal were personal,inefficacy, or adverse event as an increase in pain.
    Masking
    ParticipantInvestigator
    Masking Description
    Hyaluronic acid as placebo both patient and investigator blinded
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PRP (100billion platelets)
    Arm Type
    Experimental
    Arm Description
    platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood
    Arm Title
    hyaluronic acid
    Arm Type
    Placebo Comparator
    Arm Description
    Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml
    Intervention Type
    Biological
    Intervention Name(s)
    Platelet rich plasma
    Other Intervention Name(s)
    PRP
    Intervention Description
    Platelet rich plasma : 100 billion platelets in 10 ml of plasma(PRP) administered intra-articular
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic Acid
    Other Intervention Name(s)
    SYNVISC
    Intervention Description
    Hyaluronic acid :Four ml of high-molecular-weight hyaluronic acid with a concentration of 22mg/ml injected intra-articular
    Primary Outcome Measure Information:
    Title
    changes in womac score
    Description
    WOMAC, a widely used measure to assess patients' pain, joint mobility, and physical disability evaluates three dimensions, pain, stiffness, and physical function, with 5, 2, and 17 questions, respectively. The total maximum score is 96 and minimum, 0
    Time Frame
    baseline,1 month,3 months,6 months, and 1year
    Title
    changes in cartilage thickness as assessed on 1.5 T MRI
    Description
    Using the 1.5-T field strength with standard MRI acquisition protocols, MRI was performed of each joint individually in coronal, sagittal, and transverse planes. The maximum thickness of the cartilage at posterior,meniscal and patellar level measured at the midsagittal plane through the medial condyle was considered. The medial femoral cartilage of the affected knee was chosen for measurement.
    Time Frame
    baseline and at one year
    Secondary Outcome Measure Information:
    Title
    changes in joint space width
    Description
    Patients were radiographed in a weight-bearing position, joints fully extended, standing at 1 m from the X-ray source20. The width was measured at the narrowest point of the Joint (JSW)
    Time Frame
    baseline and at 12months
    Title
    changes in cartilage thickness as assessed by ultrasonically.
    Description
    Having the patients sit with flexed knees,The articular cartilage of the medial femoral condyle was evaluated with a starting point at the level of intercondylar notch to the medial border of the medial condyle by an ultrasound.
    Time Frame
    baseline ,6 months and at 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Outpatients who fulfilled the clinical and radiological criteria set by the American College of Rheumatology for the diagnosis of symptomatic primary knee OA, with pain Visual Analogue Scale (VAS) score of >3 in the previous month. In cases where both the knees were symptomatic, the knee which was comparatively more painful was considered. Exclusion Criteria: Evidence of secondary knee OA because of injury, inflammatory or metabolic rheumatic disease, or osteonecrosis; Prior intra-articular injection of hyaluronic acid (HA), including lavage and corticosteroids within the previous three months; Severe knee OA, with JSW <1 mm, or surgery required on the evaluated knee in the year Patients with clinically significant systemic disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    himanshu bansal, ms
    Organizational Affiliation
    anupam hospital rudrapur uttrakhand
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Anyone interested, Researcher ,Patient or Institute can contact and we would gladly assist him with all information. Nothing is hidden
    IPD Sharing Time Frame
    Data will be always available to anyone interested
    IPD Sharing Access Criteria
    Anyone interested, Researcher ,Patient or Institute can access data anytime.
    IPD Sharing URL
    http://www.drhbf.org
    Citations:
    PubMed Identifier
    25925602
    Citation
    Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 29.
    Results Reference
    result
    PubMed Identifier
    26861957
    Citation
    Paterson KL, Nicholls M, Bennell KL, Bates D. Intra-articular injection of photo-activated platelet-rich plasma in patients with knee osteoarthritis: a double-blind, randomized controlled pilot study. BMC Musculoskelet Disord. 2016 Feb 9;17:67. doi: 10.1186/s12891-016-0920-3.
    Results Reference
    result
    PubMed Identifier
    28146403
    Citation
    Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21. Erratum In: Am J Sports Med. 2017 Apr;45(5):NP10.
    Results Reference
    result

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    To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid

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