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    Clinical Trial Results:
    Ensayo clínico aleatorizado, doble ciego, de grupos paralelos, de la inyección intra-articular de plasma rico en plaquetas frente a la inyección intra-articular de betametasona y bupivacaína en la artrosis degenerativa de rodilla A prospective, randomized, double-blinded, clinical trial, comparing platelet-rich plasma intra-articular knee injections Versus Corticosteroid intra-articular knee injections for knee osteoarthritis

    Summary
    EudraCT number
    		 2010-023977-21
    Trial protocol
    		 ES  
    Global end of trial date
    31 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2021
    First version publication date
    31 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PRP2010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Dr Nayana Joshi, VHIR, njoshi@vhebron.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determinar la utilidad clínica de la infiltración intraarticular de plasma rico en plaquetas en el tratamiento de la artrosis de rodilla para la disminución del dolor subjetivo
    Protection of trial subjects
    This clinical trial was conducted in accordance with the principles of the Declaration of Helsinki, authorized by the Spanish Agency for Medicines and Health Products, and registered with the European Clinical Trials Database. Rest, depending on pain, and cryotherapy were indicated in the first 24 hours after injection. Patients were authorized to use painkillers and nonsteroidal anti-inflammatories along with routine clinical practice during the study period
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    65
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 75 patients with symptomatic knee OA (Kellgren-Lawrence grade 3 to 4) were enrolled in this study between August 2013 and July 2014. Patients were randomized to treatment either with a single leukocyte-reduced PRP or corticosteroid intra-articular injection

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PRP injection
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Platelet-rich plama
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Under aseptic conditions, 4 mL of either control or study treatment were injected into the medial compartment with an intramuscular needle (0.8x40 mmwithout local anesthetic, with knees hanging at 90 of flexion. The BST prepared leukocyte-reduced PRP using a doublespin methodology. The entire process was performed in a class C clean room and under the laminar flow of a BioII/A biological safety cabinet. Approximately 60 mL of venous blood was drawn from the anticubital vein and collected into tubes containing 3.2% of citrated dextrose. Tubes were centrifuged at 280g for 15 minutes at RT, the entire plasmatic fraction was isolated in a separate sterile tube avoiding the buffy coat layer, and a 10% vol/vol of anticoagulant (ACD-A Solution) was added. The isolated plasma was centrifuged at 680g for 20 minutes, and platelets were then completely resuspended in 6 mL of autologous plasma. Finally, 4 mL of PRP were dispensed in a syringe for injection.

    Arm title
    		 Corticosteroids
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Betamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Intrarticular injection of 2 mL betamethasone: 6 mg betamethasone sodium phosphate and betamethasone acetate 6 mg [Merck] , along with bupivacaine

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Intrarticular injection of 2 mL bupivacaine 0.25% [B.Braun]) along with betamethasone:

    Number of subjects in period 1
    		PRP injection Corticosteroids
    Started
    35
    30
    Completed
    34
    30
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PRP injection
    Reporting group description
    		 -

    Reporting group title
    Corticosteroids
    Reporting group description
    		 -

    Reporting group values
    		 PRP injection Corticosteroids Total
    Number of subjects
    		 35 30 65
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.5 ( 8.6 ) 68.0 ( 7.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 24 47
        Male
    		 12 6 18

    End points

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    End points reporting groups
    Reporting group title
    PRP injection
    Reporting group description
    		 -

    Reporting group title
    Corticosteroids
    Reporting group description
    		 -

    Primary: Visual analog scale

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    End point title
    		 Visual analog scale
    End point description
    End point type
    Primary
    End point timeframe
    6 moths
    End point values
    		 PRP injection Corticosteroids
    Number of subjects analysed
    34
    30
    Units: unit(s)
        arithmetic mean (standard error)
    38.24 ( 24.80 )
    46.33 ( 29.88 )
    Statistical analysis title
    		 VAS score
    Comparison groups
    PRP injection v Corticosteroids
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.29
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: KOOS score QoL

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    End point title
    		 KOOS score QoL
    End point description
    KOOS score Quality of Life
    End point type
    Secondary
    End point timeframe
    6 motnhs
    End point values
    		 PRP injection Corticosteroids
    Number of subjects analysed
    34
    30
    Units: unit(s)
        arithmetic mean (standard deviation)
    16.36 ( 15 )
    20.91 ( 17.30 )
    Statistical analysis title
    		 KOOS score
    Comparison groups
    PRP injection v Corticosteroids
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.305
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6 months
    Adverse event reporting additional description
    No patient had adverse effects at injection or follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No patient had adverse effects at injection or follow-up

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    A larger trial using a regimen of a serial single injection every 6 months, with objective indicators and imaging assessment to evaluate OA progression, is needed to further assess the efficacy of PRP treatment in patients with advanced knee OA

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28255569
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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