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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01482793




Registration number
NCT01482793
Ethics application status
Date submitted
28/11/2011
Date registered
1/12/2011
Date last updated
13/07/2015

Titles & IDs
Public title
A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures
Scientific title
A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.
Secondary ID [1] 0 0
VAPOUR
Secondary ID [2] 0 0
WGT4P
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vertebral Compression Fractures 0 0
Osteoporotic Vertebral Compression Fractures 0 0
Acute Vertebral Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Vertebroplasty

Active Comparator: AVAMAX - Avamax vertebroplasty kits provided by Care Fusion

No Intervention: Simulated injection procedure - Patient will be unaware as to whether the control procedure or vertebroplasty had been performed since full sterile preparation, sedation and simulated injection procedure will be used.


Treatment: Surgery: Vertebroplasty
AVAmax radiopaque bone cement is injected into the vertebral body using a 13 G or 11 G vertebroplasty needle.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient rated pain intensity
Timepoint [1] 0 0
two weeks
Secondary outcome [1] 0 0
Functional Disability
Timepoint [1] 0 0
two weeks

Eligibility
Key inclusion criteria
Inclusion Criteria/
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is greater than 60 years of age.

- Patient has pain which is not adequately controlled by oral analgesia or which has
required hospitalisation and prevents early mobilisation

- Patient has pain from one or two compression fractures of the vertebrae in the areas
T4 to L5 confirmed with a sagittal STIR (short tau inversion recovery) and sagittal T1
weighted MRI scan of the spine. Patients with three or more recent fractures are
excluded.

- Clinical history verifies that patient's fracture occurred in the previous 6 weeks.

- Patient does not have a known coagulopathy. If on warfarin, the INR should be less
than 2.5 within the last three days.

- Patient has no contraindications for conscious sedation.

- Patient reports pain during ambulation or movement from the compression fracture(s) of
at least seven (7) out of ten (10) on a numerical pain scale.

- Patient has access to a telephone.

- Patient speaks English well enough to answer all health questions via telephone.

- Patient has a confirmed diagnosis of osteoporosis via a BMD within 6 months of
baseline or a QCT at baseline.

- Patient does not have a history of debilitating chronic back pain which requires
regular analgesia.

- Patients with chronic back pain who regularly use medication containing any narcotic
for a period greater than 6 weeks, that is prior to the acute fracture.

- Patient does not have significant retropulsed fragment or spinal canal compromise of
greater than 20% by retropulsed fragment.

- Patient has no mental incapacity or dementia that makes him/her unable to give
informed consent.

- Patient has no history of vertebral osteomyelitis.

- Patient has vertebral body collapse not greater than 60% relative to closest intact
vertebra.

- Patient has no pedicle fractures.

- Patient has no active local or systemic infection.

- Patient has not had surgery (within the last 60 days).

- Patient has no concomitant hip fracture.

- Patient has no malignant tumour deposit (multiple myeloma), tumour mass, or tumour
extension into the epidural space at the level of the fracture to be treated on MRI.

- Patient does not have severely immunocompromised health status (including any patient
who is HIV positive, currently on chemotherapy, taking high doses of long term
corticosteroids - defined as a dose of prednisone exceeding 10mg for greater than 3
months in the last 12 months, has a hematologic malignancy, or a transplant
recipient.)

- Patient able to attend face to face visits.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Optimus Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Optimus Clinical Research
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
CareFusion
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to gather data regarding the efficacy, safety and
cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures
less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all
vertebroplasties.

The primary effectiveness analysis will be based on the number of patients whose numeric
rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks
post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly
larger proportion of patients achieving pain reduction than the control group. A secondary
analysis will compare the change in mean pain scores and specific activity related pain
scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary
effectiveness analysis will include the mean change in the back-pain specific limitation in
function as quantified by the Roland Scale at these same data collection time points.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01482793
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Clark
Address 0 0
St George Private Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries