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    Clinical Trial Results:
    NSAIDs INFLUENCE ON HEAL OF COLLES FRACTURE

    Summary
    EudraCT number
    		 2010-018543-34
    Trial protocol
    		 DK  
    Global end of trial date
    27 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jan 2018
    First version publication date
    06 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12153599
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01567072
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aalborg University Hospital
    Sponsor organisation address
    Hobrovej 18 - 22, Aalborg, Denmark, 9000
    Public contact
    Sponsor - investigator Marius Aliuskevicius, Aalborg University Hospital, +45 26910156, aliuskevicius@yahoo.dk
    Scientific contact
    Sponsor - investigator Marius Aliuskevicius, Aalborg University Hospital, +45 26910156, aliuskevicius@yahoo.dk
    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
    15 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary point: assessment of radiological secondary dislocation: any migration larger than in the other group will be an expression of instability and thus slower or absent healing. It is possible to determine the migration of approx. 0.5 mm and 1 ° accuracy. Incidence of secondary dislocations and those, which need an operation, will be manufactured in absolute and percentage figures.
    Protection of trial subjects
    Escape medicine for pain treatment: Tramadol 50 mg
    Background therapy
    		 Paracetamaol 1 g 4 times a day
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 95
    Worldwide total number of subjects
    95
    EEA total number of subjects
    95
    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)
    46
    From 65 to 84 years
    48
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with acute unstable Colles fracture were informed about the study and asked to participate. Major exclusion criteria were age less than 40 or older than 85 years; systematic treatment with NSAIDs; previous fracture at the actual wrist; lack of mental and physical capacity to follow study instructions; medical contraindications to NSAIDs.

    Pre-assignment
    Screening details
    		 From 01.06.2012 till 20.06.2015 we have screened 281 patients and included 95. 121 (43%) patients were not asked due to the bustle conditions at the emergency department, 45 (16%) patients were not interested, and 19 patients (6.8%) were excluded due to exclusions criteria. One pack of tablets was lost at the emergency department.

    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, Monitor, Data analyst
    Blinding implementation details
    The Hospital Pharmaceutical Department performed block randomization: five blocks with nine patients in each, eight blocks with six patients in each and one block with three patients in. Tablets according to randomisation was supplied in packets. The patient, operator, data manager and statistician were all blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/Placebo
    Arm description
    		 Placebo treatment during the first 7 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tab. 3 times per day in 7 days

    Arm title
    		 Ibuprofen/Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tab. 3 times per day during the first 3 days days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tab. 3 times per day from the day 4 until day 7

    Arm title
    		 Ibuprofen/Ibuprofen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tab. 3 times per day in 7 days

    Number of subjects in period 1
    		Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Started
    32
    32
    31
    Completed
    28
    28
    27
    Not completed
    4
    4
    4
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    4
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 95 95
    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
    Mean age 64,75 years (min. 42, max 85)
    Units: years
        arithmetic mean (full range (min-max))
    		 64.75 (42 to 85) -
    Gender categorical
    15 of all operated patients in our study them were male, 84 – female
    Units: Subjects
        Male
    		 15 15
        Female
    		 80 80

    End points

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    End points reporting groups
    Reporting group title
    Placebo/Placebo
    Reporting group description
    		 Placebo treatment during the first 7 days

    Reporting group title
    Ibuprofen/Placebo
    Reporting group description
    		 -

    Reporting group title
    Ibuprofen/Ibuprofen
    Reporting group description
    		 -

    Primary: Mean pain score during 1-3 days

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    End point title
    		 Mean pain score during 1-3 days
    End point description
    End point type
    Primary
    End point timeframe
    Day 1-3 from the enrollment
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    29
    28
    28
    Units: Medium VAS pain score
        arithmetic mean (standard deviation)
    4.18 ( 1.9 )
    4.25 ( 1.71 )
    4.3 ( 1.92 )
    Statistical analysis title
    		 Students t-test
    Comparison groups
    Placebo/Placebo v Ibuprofen/Placebo v Ibuprofen/Ibuprofen
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Mean pain score 1-3 days

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    End point title
    		 Mean pain score 1-3 days
    End point description
    End point type
    Primary
    End point timeframe
    First 1-3 days from enrollment
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    29
    28
    28
    Units: VAS pain scala units
        arithmetic mean (standard deviation)
    4.18 ( 1.9 )
    4.25 ( 1.71 )
    4.3 ( 1.92 )
    Statistical analysis title
    		 Students t-test
    Comparison groups
    Placebo/Placebo v Ibuprofen/Placebo v Ibuprofen/Ibuprofen
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Mean pain score during 4-7 days

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    End point title
    		 Mean pain score during 4-7 days
    End point description
    End point type
    Primary
    End point timeframe
    The 4-th - 7-th day from the enrollment
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    29
    28
    28
    Units: VAS pain score units
        arithmetic mean (standard deviation)
    2.98 ( 1.88 )
    3.88 ( 2.04 )
    2.98 ( 1.47 )
    Statistical analysis title
    		 Kruskal wallis test
    Comparison groups
    Ibuprofen/Placebo v Ibuprofen/Ibuprofen v Placebo/Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.13
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Mean pain score 8 - 14 days

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    End point title
    		 Mean pain score 8 - 14 days
    End point description
    End point type
    Primary
    End point timeframe
    The 8-th - 14-th day from the enrollment
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    29
    28
    28
    Units: VAS pain score units
        arithmetic mean (standard deviation)
    2.18 ( 1.35 )
    2.54 ( 1.75 )
    2.17 ( 1 )
    Statistical analysis title
    		 Kruskal wallis test
    Comparison groups
    Placebo/Placebo v Ibuprofen/Placebo v Ibuprofen/Ibuprofen
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Range of movement

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    End point title
    		 Range of movement
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks, 3 months, 1 year
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    29
    28
    27
    Units: Percent of healthy contralateral ROM
    arithmetic mean (standard deviation)
        Pronation suppination 6 weeks
    58.41 ( 19.12 )
    63.62 ( 19.74 )
    66.11 ( 16.72 )
        Flexion extension 6 weeks
    22.42 ( 11.29 )
    29.31 ( 17.87 )
    27.91 ( 13.04 )
        Radial ulnar deviation 6 weeks
    31.95 ( 12.35 )
    38.16 ( 15.91 )
    33.82 ( 14.23 )
        Pronation suppination 3 months
    86.94 ( 12.01 )
    85.72 ( 12.44 )
    91.51 ( 7.59 )
        Flexion extension 3 months
    66.02 ( 11.5 )
    69.63 ( 21.04 )
    71.77 ( 15.65 )
        Pronation suppination 1 year
    94.2 ( 9.18 )
    93.55 ( 9.18 )
    95.91 ( 4.28 )
        Flexion extension 1 year
    87.15 ( 10.12 )
    92.05 ( 15.45 )
    89.47 ( 16.73 )
        Radial ulnar deviation 1 year
    93.86 ( 20.19 )
    89.6 ( 14.57 )
    92.49 ( 18.08 )
        Radial ulnar deviation 3 months
    71.23 ( 19.04 )
    68.22 ( 20.16 )
    77.4 ( 16.07 )
    Statistical analysis title
    		 Kruskal wallis test
    Comparison groups
    Ibuprofen/Placebo v Ibuprofen/Ibuprofen v Placebo/Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≥ 0.148
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Mean DASH score

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    End point title
    		 Mean DASH score
    End point description
    End point type
    Primary
    End point timeframe
    3 months, 1 year
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    28
    27
    27
    Units: DASH score units
        arithmetic mean (standard deviation)
    19.95 ( 14.18 )
    17.87 ( 14.47 )
    15.07 ( 10.77 )
    Statistical analysis title
    		 Kruskal wallis test
    Comparison groups
    Placebo/Placebo v Ibuprofen/Placebo v Ibuprofen/Ibuprofen
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.47
    Method
    		 Kruskal-wallis
    Parameter type
    		 Cox proportional hazard
    Confidence interval

    Primary: Radiological migration

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    End point title
    		 Radiological migration
    End point description
    Changes in radius inclination, lenght and tilt: values, measured at 6 weeks control are substracted from values, measured just after operation
    End point type
    Primary
    End point timeframe
    Just after operation and at 6 weeks control
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    30
    30
    28
    Units: grades and millimetres
    arithmetic mean (standard deviation)
        Inclination
    1.29 ( 2.38 )
    0.7 ( 3.59 )
    2.4 ( 2.88 )
        Lenght
    -1.82 ( 2.36 )
    -1.44 ( 2.41 )
    -1.6 ( 2.28 )
        Tilt
    -1 ( 4.1 )
    -0.13 ( 4.58 )
    -0.71 ( 4.17 )
    Statistical analysis title
    		 Kruskal wallis test
    Comparison groups
    Placebo/Placebo v Ibuprofen/Placebo v Ibuprofen/Ibuprofen
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≥ 0.061
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Use of Tramadol at day two

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    End point title
    		 Use of Tramadol at day two
    End point description
    End point type
    Secondary
    End point timeframe
    at day two
    End point values
    		 Placebo/Placebo Ibuprofen/Placebo Ibuprofen/Ibuprofen
    Number of subjects analysed
    29
    28
    28
    Units: Average of used Tramadol tablets
        arithmetic mean (standard deviation)
    1 ( 1.13 )
    0.6 ( 0.87 )
    0.58 ( 1.09 )
    Statistical analysis title
    		 Kruskal wallis test
    Comparison groups
    Ibuprofen/Ibuprofen v Placebo/Placebo v Ibuprofen/Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 Kruskal-wallis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    01.06.2012 - 20. 06. 2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Ibuprofen/Ibuprofen, operated patients
    Reporting group description
    		 Treatment with Ibuprofen in 7 days

    Reporting group title
    Ibuprofen/Placebo, operated patients
    Reporting group description
    		 Ibuprofen treatment during the first three days, Placebo treatment during the next four days

    Reporting group title
    Placebo/Placebo, operated patients
    Reporting group description
    		 Placebo treatment during the first 7 days

    Serious adverse events
    		 Ibuprofen/Ibuprofen, operated patients Ibuprofen/Placebo, operated patients Placebo/Placebo, operated patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Bradycardia and assystolia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    death by drowning
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ibuprofen/Ibuprofen, operated patients Ibuprofen/Placebo, operated patients Placebo/Placebo, operated patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 29 (55.17%)
    13 / 30 (43.33%)
    10 / 30 (33.33%)
    Surgical and medical procedures
    Loosening of external fixation
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    0
    Nervous system disorders
    numbness in operated arm
         subjects affected / exposed
    5 / 29 (17.24%)
    2 / 30 (6.67%)
    6 / 30 (20.00%)
         occurrences all number
    5
    2
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 29 (27.59%)
    7 / 30 (23.33%)
    4 / 30 (13.33%)
         occurrences all number
    8
    7
    4
    Skin and subcutaneous tissue disorders
    Pinholles infection
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    2
    1
    0
    Musculoskeletal and connective tissue disorders
    Serious secondary dislocation of the fracture
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0

    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.
    Difficulty of treatments’ standardisation is limitation in our study. Patients broke their extremities at different times of the day one and were operated latest on the third day from the injury.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/3063314
    http://www.ncbi.nlm.nih.gov/pubmed/8323840
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