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    Clinical Trial Results:
    Vertebroplasty versus periost infiltration with lidocain as pain treatment in osteoporotic fractures in the thoracic and lumbar spine

    Summary
    EudraCT number
    		 2010-024050-10
    Trial protocol
    		 DK  
    Global end of trial date
    18 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Feb 2021
    First version publication date
    27 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2010001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rygcenter Syddanmark
    Sponsor organisation address
    Østre Hougvej 55, Middelfart, Denmark, 5500
    Public contact
    Mikkel Andersen, Rygkirurgisk forskningsenhed, Rygcenter Syddanmark, 0045 63484198, mikkel@dadlnet.dk
    Scientific contact
    Mikkel Andersen, Rygkirurgisk forskningsenhed, Rygcenter Syddanmark, 0045 63484198, mikkel@dadlnet.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
    18 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of the RCT was to compare the pain relieving effect and health related quality of life during a one-year follow-up period, between PVP procedure and a SHAM-procedure, in patients with acute OVCF affecting T6-L5
    Protection of trial subjects
    All patients were examined with preoperative blood samples, to exclude infections, disease of the coagulation system or malignancies.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2011
    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: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    6
    From 65 to 84 years
    45
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Osteoporotic fractures, with a history of pain less than 8 weeks from the level T6-L5 and MRI that included a STIR with edema present at the time of inclusion. Baseline value at least 7 on a VAS score in either rest or activity

    Pre-assignment
    Screening details
    		 Osteoporotic fractures, with a history of pain less than 8 weeks from the level T6-L5 and MRI that included a STIR with edema present at the time of inclusion. Baseline value at least 7 on a VAS score in either rest or activity.

    Pre-assignment period milestones
    Number of subjects started
    		 52
    Number of subjects completed
    		 52

    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, Data analyst
    Blinding implementation details
    The OR-nurse opened the designated envelope with a given patients project-number after the surgeon placed the Jamshidi needles within the fractured vertebral body through the pedicles. In all cases, PMMA cement was mixed to create the odor similar to a PVP-procedure. If the subject was randomized to PVP, the PMMA cement was mixed, and 2 ml of cement were injected into the pedicle under constant fluoroscopic guidance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PVP Group
    Arm description
    		 If the subject was randomized to PVP, the PMMA cement was mixed, and 2 ml of cement were injected into the pedicle under constant fluoroscopic guidance, injection was stopped if the cement reached the posterior border of the vertebrae
    Arm type
    		 Experimental

    Investigational medicinal product name
    PVP cement
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intraosseous use
    Dosage and administration details
    PMMA cement was mixed, and 2 ml of cement were injected into the pedicle under constant fluoroscopic guidance

    Arm title
    		 Sham
    Arm description
    		 The SHAM procedure was a procedure where 2 ml of lidocaine (10 mg/ml) were injected into each Jamshidi needle
    Arm type
    		 Placebo

    Investigational medicinal product name
    lidocaine (10 mg/ml)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intraosseous use
    Dosage and administration details
    2 ml of lidocaine (10 mg/ml) were injected into each Jamshidi needle

    Number of subjects in period 1
    		PVP Group Sham
    Started
    26
    26
    Completed
    22
    24
    Not completed
    4
    2
         Physician decision
    4
    2

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    PVP Group
    Reporting group description
    		 If the subject was randomized to PVP, the PMMA cement was mixed, and 2 ml of cement were injected into the pedicle under constant fluoroscopic guidance, injection was stopped if the cement reached the posterior border of the vertebrae

    Reporting group title
    Sham
    Reporting group description
    		 The SHAM procedure was a procedure where 2 ml of lidocaine (10 mg/ml) were injected into each Jamshidi needle

    Subject analysis set title
    VAS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Back pain VAS-score (0-100) was collected at inclusion, 6 hours postoperatively, and every week for the first 3 months.

    Primary: Pain VAS

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    End point title
    		 Pain VAS
    End point description
    End point type
    Primary
    End point timeframe
    Back pain VAS-score (0-100) was collected at inclusion, 6 hours postoperatively, and every week for the first 3 months
    End point values
    		 PVP Group Sham
    Number of subjects analysed
    22
    24
    Units: 0-100
        arithmetic mean (standard error)
    6.88 ± 4.35
    8.64 ± 4.55
    Statistical analysis title
    		 Stats
    Statistical analysis description
    The statistical analyses were conducted in SAS version 9,4 (SAS institute, Carry, NC). Unpaired student’s t-test was used to compare continuous variables.
    Comparison groups
    PVP Group v Sham
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    one year post-treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    PVP group
    Reporting group description
    		 -

    Reporting group title
    Sham
    Reporting group description
    		 The SHAM procedure was a procedure where 2 ml of lidocaine (10 mg/ml) were injected into each Jamshidi needle

    Serious adverse events
    		 PVP group Sham
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PVP group Sham
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (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: Very small sample size – lidocaine is a well-tolerated drug

    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.
    None reported
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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
    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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