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    Clinical Trial Results:
    Repeat dose steroid to prevent pain relapse after Total Knee Arthroplasty in patients with high pain response - A randomized blinded placebo-controlled trial

    Summary
    EudraCT number
    		 2020-006110-20
    Trial protocol
    		 DK  
    Global end of trial date
    19 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2025
    First version publication date
    09 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RepeatDoseTKAHPR2020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05563155
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vejle sygehus
    Sponsor organisation address
    Beriderbakken 4, Vejle, Denmark, 7100
    Public contact
    Forskningsenheden Ortopædkirurgisk, Ortopædkirurgisk Department. Vejle Sygehus. Denmark, + 4579405779, clausvarnum@gmail.com
    Scientific contact
    Forskningsenheden Ortopædkirurgisk, Ortopædkirurgisk Department. Vejle Sygehus. Denmark, + 4579405779, clausvarnum@gmail.com
    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
    25 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after TKA in an HPR population to a standard single high dose systemic preoperative administration in an HPR population.
    Protection of trial subjects
    The study will not bring other changes to the patient’s course of treatment in relation to the preoperative preparation, level of information, type of anesthesia, surgical procedure, postoperative care, physiotherapy and discharge, the exceptions being the repeat-dosing program, Dexamethasone vs. Placebo. All these other steps will be following our Fast-Track program.
    Background therapy
    		 Standardised fast-track regime according to local guidelines.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2022
    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: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    44
    From 65 to 84 years
    64
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 25 November 2021 and 20 March 2024, 110 patients were included and randomised. The inclusion took place at Hvidovre and Vejle Hospitals in Denmark.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 287 [1]
    Number of subjects completed
    		 110

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 30
    Reason: Number of subjects
    		 Protocol deviation: 21
    Reason: Number of subjects
    		 Not meeting criteria: 118
    Reason: Number of subjects
    		 Discharged on day 0: 5
    Reason: Number of subjects
    		 Could not complete primary outcome: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 10 subjects were added as an amendment.
    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, Carer, Assessor
    Blinding implementation details
    The randomization-sequence will be stored in a sealed envelope at the Pharmacy at Lillebaelt Hospital who carried out the packaging-process. The randomization personnel have no contact to the patient. Sealed coding-envelopes containing data on randomization are stored in a locked cabinet at Dept. of Orthopaedic Surgery, Lillebaelt Hospital – Vejle and Dept. of Anesthesiology, Hvidovre Hospital.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dexamethasone
    Arm description
    		 Patients receiving the active regime of repeat dose oral dexamethasone 24 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    24 mg oral dexamethasone administered on the evening of day 1 after surgery.

    Arm title
    		 Placebo
    Arm description
    		 Subjects receiving inactive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule administered on the evening on day 1 after surgery.

    Number of subjects in period 1
    		Dexamethasone Placebo
    Started
    55
    55
    Completed
    48
    53
    Not completed
    7
    2
         Consent withdrawn by subject
    4
    2
         Lost to follow-up
    1
    -
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    		 Patients receiving the active regime of repeat dose oral dexamethasone 24 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects receiving inactive placebo.

    Reporting group values
    		 Dexamethasone Placebo Total
    Number of subjects
    		 55 55 110
    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 (full range (min-max))
    		 67 (50 to 81) 68 (50 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 28 31 59
        Male
    		 27 24 51

    End points

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    End points reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    		 Patients receiving the active regime of repeat dose oral dexamethasone 24 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects receiving inactive placebo.

    Primary: Moderate to severe pain (VAS > 30) upon ambulation in a 5-meter walk test, on the morning of day 2 after TKA surgery.

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    End point title
    		 Moderate to severe pain (VAS > 30) upon ambulation in a 5-meter walk test, on the morning of day 2 after TKA surgery.
    End point description
    End point type
    Primary
    End point timeframe
    Assessed 48 hours after surgery.
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    48
    53
    Units: Number of patients
    31
    42
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.16

    Secondary: Cumulated pain upon ambulation in a 5-meter walk test day 2-3

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    End point title
    		 Cumulated pain upon ambulation in a 5-meter walk test day 2-3
    End point description
    End point type
    Secondary
    End point timeframe
    Days 2 to 3 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: VAS
        arithmetic mean (standard deviation)
    168 ( 75 )
    186 ( 68 )
    No statistical analyses for this end point

    Secondary: Cumulated pain score at rest from day 2-7

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    End point title
    		 Cumulated pain score at rest from day 2-7
    End point description
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 after surgery.
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: VAS
        arithmetic mean (standard deviation)
    425 ( 219 )
    405 ( 206 )
    No statistical analyses for this end point

    Secondary: Cumulated pain score upon ambulation in a 5-meter walk test from day 2-7

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    End point title
    		 Cumulated pain score upon ambulation in a 5-meter walk test from day 2-7
    End point description
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: VAS
        arithmetic mean (standard deviation)
    477 ( 218 )
    486 ( 213 )
    No statistical analyses for this end point

    Secondary: Cumulated pain score at night from day 2-7

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    End point title
    		 Cumulated pain score at night from day 2-7
    End point description
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: VAS
        arithmetic mean (standard deviation)
    228 ( 111 )
    219 ( 109 )
    No statistical analyses for this end point

    Secondary: Cumulated pain at rest on days 2-3

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    End point title
    		 Cumulated pain at rest on days 2-3
    End point description
    End point type
    Secondary
    End point timeframe
    Days 2 to 3 postoperatively
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: VAS
        arithmetic mean (standard deviation)
    137 ( 75 )
    152 ( 64 )
    No statistical analyses for this end point

    Secondary: Cumulated pain at night days 2-3

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    End point title
    		 Cumulated pain at night days 2-3
    End point description
    End point type
    Secondary
    End point timeframe
    Days 2 to 3 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: VAS
        arithmetic mean (standard deviation)
    76 ( 40 )
    79 ( 42 )
    No statistical analyses for this end point

    Secondary: Cumulative use of rescue analgesics per day from day 2-7

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    End point title
    		 Cumulative use of rescue analgesics per day from day 2-7
    End point description
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: MME
        median (inter-quartile range (Q1-Q3))
    15 (5 to 30)
    19 (7 to 35)
    No statistical analyses for this end point

    Secondary: Quality of sleep from days 2-7

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    End point title
    		 Quality of sleep from days 2-7
    End point description
    Assessed on scale of 0-10, 0 being best and 10 being worst
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: Numeric
        median (inter-quartile range (Q1-Q3))
    3 (2.3 to 4.2)
    3 (2.4 to 4.1)
    No statistical analyses for this end point

    Secondary: Lethargy on days 2-7

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    End point title
    		 Lethargy on days 2-7
    End point description
    Assessed on scale of 0-10, 0 being best and 10 being worst
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: Numeric
        median (inter-quartile range (Q1-Q3))
    3.4 (1.7 to 4.8)
    3.1 (2.0 to 4.3)
    No statistical analyses for this end point

    Secondary: Dizziness from days 2-7

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    End point title
    		 Dizziness from days 2-7
    End point description
    Assessed on scale of 0-10, 0 being best and 10 being worst
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: Numeric
        median (inter-quartile range (Q1-Q3))
    0.4 (0 to 1.6)
    0.3 (0 to 1.6)
    No statistical analyses for this end point

    Secondary: Nausea on days 2-7

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    End point title
    		 Nausea on days 2-7
    End point description
    Assessed on scale of 0-10, 0 being best and 10 being worst
    End point type
    Secondary
    End point timeframe
    Days 2 to 7 postoperatively
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: Numeric
        median (inter-quartile range (Q1-Q3))
    0 (0 to 1.7)
    0.3 (0 to 1.5)
    No statistical analyses for this end point

    Secondary: Patient satisfaction with analgesic regimen

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    End point title
    		 Patient satisfaction with analgesic regimen
    End point description
    Assessed on scale of 0-10, 0 being most and 10 being least
    End point type
    Secondary
    End point timeframe
    Assessed on day 7 postoperatively
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: Numeric
        median (inter-quartile range (Q1-Q3))
    1.5 (0 to 5)
    2 (0 to 5)
    No statistical analyses for this end point

    Secondary: Length of hospital stay

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    End point title
    		 Length of hospital stay
    End point description
    Number of days in hospital after surgery
    End point type
    Secondary
    End point timeframe
    Within 30 days after surgery
    End point values
    		 Dexamethasone Placebo
    Number of subjects analysed
    47
    52
    Units: Days
        median (inter-quartile range (Q1-Q3))
    1 (1 to 1)
    1 (1 to 1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    30 days after surgery
    Adverse event reporting additional description
    Only serious adverse events were reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None used
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    		 Patients receiving the active regime of repeat dose oral dexamethasone 24 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects receiving inactive placebo.

    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: We did not report non-serious adverse events as per protocol, since the active drug dexamethasone is a well-known drug with well-described adverse events.
    Serious adverse events
    		 Dexamethasone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 54 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Vasovagal syncope
    Additional description: Patient was dehydrated
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Prosthetic joint infection
    Additional description: Infection around the prostesis treated with antibiotics and sof-tissue revision.
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dexamethasone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 54 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2022
    10 subjects were added to the study group (5 in each arm) due to drop-outs.

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/40364780
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