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Trial registered on ANZCTR


Registration number
ACTRN12605000079640
Ethics application status
Approved
Date submitted
26/07/2005
Date registered
5/08/2005
Date last updated
8/10/2021
Date data sharing statement initially provided
8/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised double-blind placebo-controlled trial
Scientific title
Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute/subacute osteoporotic vertebral fractures (within 12 months of onset of symptoms) 154 0
Condition category
Condition code
Musculoskeletal 173 173 0 0
Osteoporosis
Musculoskeletal 174 174 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The procedure used will be standardised across all sites (currently includes four hospitals in Melbourne, Cabrini, Alfred and Royal Melbourne Hospitals and Monash Medical Centre). Participants are randomly allocated to receive either a Vertebroplasty or Placebo Procedure. All participants will receive sedation/analgesia (midazolam and fentanyl), which will be administered by the radiologist performing the procedure. Participants undergoing vertebroplasty will have the left pedicle of the fracture vertebra infiltrated by a needle, which will be gently tapped into place using a hammer. The progress of the needle will be monitored so the correct position is determined. The bone cement (poly-methyl methacrylate) will be injected under Xray guidance, with the working time for the injection being approximately 2 minutes. A unilateral approach will be used unless there is inadequate instillation of cement, in which case a bipedicular approach will be used. Extreme care is taken to ensure that no leakage of cement occurs either into a vein or outside the bone. The injection will be stopped when significant resistance is met, when the cement reaches the posterior quarter of the vertebral body or when there is escape into extraosseous structures or veins. Only patients in the active group will receive antibiotics (Keflin) against infection. Both procedures take approximately 30-60 minutes.
Intervention code [1] 68 0
Treatment: Surgery
Comparator / control treatment
Placebo procedure. Participants undergoing the placebo with have the needle inserted to rest on the lamina and the tapping noise will be simulated. Cement will be mixed in the procedure room to recreate the smell.
Control group
Placebo

Outcomes
Primary outcome [1] 212 0
Overall pain at 3 months
Timepoint [1] 212 0
Measured on a visual analogue scale at 3 months
Secondary outcome [1] 481 0
1. Pain at rest and in bed at night measured on a visual analogue scale.
Timepoint [1] 481 0
Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
Secondary outcome [2] 482 0
2. Assessment of Quality of Life Questionnaire (AQOL).
Timepoint [2] 482 0
Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
Secondary outcome [3] 483 0
3. Osteoporosis Quality of Life Questionnaire (QUALEFFO).
Timepoint [3] 483 0
Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
Secondary outcome [4] 484 0
4. Perceived Recovery measured on a 7 point ordinal scale ranging from 'a great deal worse' to 'a great deal better'.
Timepoint [4] 484 0
Measured at 1 week, 1, 3, 6, 12 and 24 months.
Secondary outcome [5] 485 0
5. Roland-Morris Low Back Pain and Disability Questionnaire.
Timepoint [5] 485 0
Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
Secondary outcome [6] 486 0
6. European Quality of Life (EUROQOL).
Timepoint [6] 486 0
Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
Secondary outcome [7] 487 0
7. Incidence of subsequent vertebral fractures.
Timepoint [7] 487 0
Measured by X rays performed at 12 and 24 months.
Secondary outcome [8] 488 0
8. Timed up and go test, which is a reliable measure of function in older people.
Timepoint [8] 488 0
Measured at baseline, 12 and 24 months.

Eligibility
Key inclusion criteria
1 or 2 acute painful osteoporotic spinal fracture/s confirmed on X ray with pain of no more than 12 months duration. Where more than one fracture is visible, vertebroplasty will only be performed on vertebral fractures that are acute according to MRI criteria (presence of oedema or fracture line within the vertebral body).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent history of trauma, malignant disease in spine as determined by MRI, neurological complications, osteoporotic vertebral collapse of > 90%, contraindication to MRI, fracture through or destruction of the posterior wall, retropulsed bony fragment, pressure of bone fragments on the spinal cord, discitis, osteomyelitis, sepsis, uncorrectable coagulation disorder, medical conditions that would make the patient ineligible for emergency decompressive surgery should it be necessary to treat a procedure complication and inability to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The method of randomisation is by a sealed opaque envelope, opened by the treating radiologist prior to performing the procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generatedRandomisation is by stratified allocation. Stratification factors are sex (M,F), duration of pain (less than or equal to 6 weeks pain, greater than 6 weeks pain) and hospital site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2004
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
30/10/2008
Date of last data collection
Anticipated
Actual
30/10/2010
Sample size
Target
200
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 228 0
Government body
Name [1] 228 0
NHMRC
Country [1] 228 0
Australia
Funding source category [2] 229 0
Commercial sector/Industry
Name [2] 229 0
Arthritis Australia
Country [2] 229 0
Australia
Funding source category [3] 230 0
Other
Name [3] 230 0
Education Institute
Country [3] 230 0
Australia
Funding source category [4] 231 0
Commercial sector/Industry
Name [4] 231 0
Cook Australia
Country [4] 231 0
Australia
Primary sponsor type
University
Name
Cabrini Research and Education Institute and Monash University
Address
Country
Australia
Secondary sponsor category [1] 171 0
None
Name [1] 171 0
N/A
Address [1] 171 0
Country [1] 171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1025 0
Monash University
Ethics committee address [1] 1025 0
Ethics committee country [1] 1025 0
Australia
Date submitted for ethics approval [1] 1025 0
Approval date [1] 1025 0
23/12/2003
Ethics approval number [1] 1025 0
Ethics committee name [2] 1026 0
Cabrini Research and Education Institute
Ethics committee address [2] 1026 0
Ethics committee country [2] 1026 0
Australia
Date submitted for ethics approval [2] 1026 0
Approval date [2] 1026 0
21/08/2003
Ethics approval number [2] 1026 0
Ethics committee name [3] 1027 0
The Alfred Hospital
Ethics committee address [3] 1027 0
Ethics committee country [3] 1027 0
Australia
Date submitted for ethics approval [3] 1027 0
Approval date [3] 1027 0
09/07/2004
Ethics approval number [3] 1027 0
Ethics committee name [4] 1028 0
Melbourne Health
Ethics committee address [4] 1028 0
Ethics committee country [4] 1028 0
Australia
Date submitted for ethics approval [4] 1028 0
Approval date [4] 1028 0
17/03/2004
Ethics approval number [4] 1028 0
Ethics committee name [5] 1029 0
Northern Health
Ethics committee address [5] 1029 0
Ethics committee country [5] 1029 0
Australia
Date submitted for ethics approval [5] 1029 0
Approval date [5] 1029 0
10/08/2004
Ethics approval number [5] 1029 0
Ethics committee name [6] 1030 0
Southern Health
Ethics committee address [6] 1030 0
Ethics committee country [6] 1030 0
Australia
Date submitted for ethics approval [6] 1030 0
Approval date [6] 1030 0
20/08/2004
Ethics approval number [6] 1030 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35470 0
Address 35470 0
Country 35470 0
Phone 35470 0
Fax 35470 0
Email 35470 0
Contact person for public queries
Name 9257 0
Ms Bridie Murphy
Address 9257 0
Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144
Country 9257 0
Australia
Phone 9257 0
+61 3 95081652
Fax 9257 0
+61 3 95081653
Email 9257 0
lwengier@cabrini.com.au
Contact person for scientific queries
Name 185 0
A/Prof Rachelle Buchbinder
Address 185 0
Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144
Country 185 0
Australia
Phone 185 0
+61 3 95081652
Fax 185 0
+61 3 95081653
Email 185 0
rachelle.buchbinder@med.monash.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.