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    Clinical Trial Results:
    CLINICAL TRIAL RANDOMIZED, DOUBLE-BLIND CONTROLLED, PHASE III, TO EVALUATE THE USE OF PLATELET RICH PLASMA IN FRONT HYALURONIC ACID IN COXARTHROSIS.

    Summary
    EudraCT number
    		 2014-004120-21
    Trial protocol
    		 ES  
    Global end of trial date
    09 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2021
    First version publication date
    31 Mar 2021
    Other versions
    Summary report(s)
    		 Final report of results

    Trial information

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    Trial identification
    Sponsor protocol code
    COX1985
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación Pública Andaluza Progreso y Salud
    Sponsor organisation address
    Parque Científico y Tecnológico Cartuja, Avda. Américo Vespucio, 15. Edificio S-2. 41092 Sevilla, Seville, Spain, 41092
    Public contact
    MARTA REBOREDO ARES, FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD, 0034 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
    Scientific contact
    MARTA REBOREDO ARES, FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD, 0034 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
    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
    09 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis
    Protection of trial subjects
    The trial will be conducted in accordance with the recommendations for Clinical Trials and Investigational Product Evaluation in Man, as contained in the Declaration of Helsinki, as revised at successive World Assemblies (WMA, 2013) (see Annex III), and the current Spanish Clinical Trial Legislation (RD 223/2004). The ICH-GCP standards (CPMP/ICH/135/95) will be followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2016
    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: 74
    Worldwide total number of subjects
    74
    EEA total number of subjects
    74
    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)
    74
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We studied the population of patients of both sexes over 30 years of age diagnosed with coxarthrosis who had failed treatment with NSAIDs seen in the orthopaedic and trauma surgery department, who met the inclusion criteria, who did not meet any of the exclusion criteria, and who agreed to participate voluntarily in the study.

    Pre-assignment
    Screening details
    		 We studied the population of patients of both sexes over 30 years of age diagnosed with coxarthrosis who had failed treatment with NSAIDs seen in the orthopaedic and trauma surgery department, who met the inclusion criteria, who did not meet any of the exclusion criteria, and who agreed to participate voluntarily in the study.

    Period 1
    Period 1 title
    Recruitment and follow-up
    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
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Platelet-rich plasma
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Blood fraction modifier
    Routes of administration
    Intravenous use
    Dosage and administration details
    6mL of PRP obtained from the patient's own blood will be applied 20 minutes prior to infiltration.

    Arm title
    		 Comparator
    Arm description
    		 -
    Arm type
    		 Comparator

    Investigational medicinal product name
    Hyaluronic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Blood fraction modifier
    Routes of administration
    Intravenous use
    Dosage and administration details
    Hyaluronic acid 60mg/6ml pre-filled syringe (Synvisc-One ®) shall be applied.

    Number of subjects in period 1
    		Experimental Comparator
    Started
    38
    36
    Completed
    38
    36
    Period 2
    Period 2 title
    Data analysis
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Platelet-rich plasma
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Blood fraction modifier
    Routes of administration
    Intravenous use
    Dosage and administration details
    6mL of PRP obtained from the patient's own blood will be applied 20 minutes prior to infiltration.

    Arm title
    		 Comparator
    Arm description
    		 -
    Arm type
    		 Comparator

    Investigational medicinal product name
    Hyaluronic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Blood fraction modifier
    Routes of administration
    Intravenous use
    Dosage and administration details
    Hyaluronic acid 60mg/6ml pre-filled syringe (Synvisc-One ®) shall be applied.

    Number of subjects in period 2
    		Experimental Comparator
    Started
    38
    36
    Completed
    38
    36

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Reporting group title
    Comparator
    Reporting group description
    		 -

    Reporting group values
    		 Experimental Comparator Total
    Number of subjects
    		 38 36 74
    Age categorical
    Units: Subjects
        Over 30 years old
    		 38 36 74
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.2 ± 9.72 61.1 ± 12.3 -
    Gender categorical
    Units: Subjects
        Female
    		 24 17 41
        Male
    		 14 19 33
    Affected hip
    Units: Subjects
        right
    		 19 20 39
        left
    		 19 16 35
    Cause of osteoarthritis
    Units: Subjects
        idiopathic
    		 38 34 72
        post-traumatic
    		 0 2 2
    Kellgren Lawrence Scale
    Units: Subjects
        grade I
    		 14 13 27
        grade II
    		 18 19 37
        grade III
    		 6 4 10
        grade IV
    		 0 0 0
    IMC
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 28.6 ± 4.2 28.4 ± 4.5 -

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Reporting group title
    Comparator
    Reporting group description
    		 -
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Reporting group title
    Comparator
    Reporting group description
    		 -

    Primary: EVA

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    End point title
    		 EVA [1]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Some of the requested data are not available. However, the report of results of the clinical trial will be published with information on the statistical analysis.
    End point values
    		 Experimental Comparator
    Number of subjects analysed
    38
    36
    Units: EVA
    median (confidence interval 95%)
        Basal
    7 (5 to 8)
    7 (5 to 8)
        1 week
    4 (3 to 6)
    4 (3 to 7)
        1 month
    4 (2 to 6)
    4.5 (2 to 7)
        6 months
    5 (1.5 to 7)
    5 (2 to 8)
        1 year
    5 (2 to 7)
    6 (3 to 8)
    No statistical analyses for this end point

    Primary: WOMAC

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    End point title
    		 WOMAC [2]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Some of the requested data are not available. However, the report of results of the clinical trial will be published with information on the statistical analysis.
    End point values
    		 Experimental Comparator
    Number of subjects analysed
    38
    36
    Units: WOMAC
    median (confidence interval 95%)
        Basal
    55 (35 to 65)
    50 (35 to 60)
        1 week
    30 (20 to 40)
    30 (20 to 40)
        1 month
    30 (20 to 35)
    30 (15 to 45)
        6 months
    30 (20 to 60)
    35 (10 to 40)
        1 year
    35 (20 to 60)
    40 (30 to 70)
    No statistical analyses for this end point

    Primary: HARRS HIP Score

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    End point title
    		 HARRS HIP Score [3]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Some of the requested data are not available. However, the report of results of the clinical trial will be published with information on the statistical analysis.
    End point values
    		 Experimental Comparator
    Number of subjects analysed
    38
    36
    Units: HARRS HIP Score
    median (confidence interval 95%)
        Basal
    50 (45 to 65)
    55 (50 to 60)
        1 week
    70 (55 to 85)
    65 (55 to 80)
        1 month
    70 (60 to 85)
    67.5 (60 to 80)
        1 year
    60 (50 to 90)
    60 (45 to 70)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not known
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Both groups
    Reporting group description
    		 -

    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 non-serious adverse events occurred.
    Serious adverse events
    		 Both groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 74 (9.46%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Musculoskeletal and connective tissue disorders
    Hip arthroplasty
         subjects affected / exposed
    5 / 74 (6.76%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Admission for anxiety-depressive crisis
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal herniorrhaphy
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Both groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 74 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Aug 2015
    It is modified in the protocol: - The masking technique. - The definitions related to subject security information as well as the process of communication and notification to the authorities of the same.
    29 Mar 2017
    It is modified in the protocol: - The participating centres: the participation of the Hospital de Pontevedra is eliminated and, consequently, the researchers from this hospital who were included in the protocol. - The evaluating CEIm as a change of evaluating CEIm was processed during the development of the study. - The duration and timing of the study, with an extension of the study period being processed.

    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.
    - Sample size. - From an analytical point of view, it would have been interesting to perform the ELISA analysis. - It would also be of interest to increase the number of growth factors and cytokines. - Difficulties when examining analgesia
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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