Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

000075

ACTR Number:

ACTRN12605000079640

Trial Status:

Registered

Date Submitted:

26/07/2005

Date Registered:

5/08/2005

Date Last Updated:

28/02/2008

Registration Type:

Retrospective registered

Page 1

Public title:

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised double-blind placebo-controlled trial

ANZCTR registration title:

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised trial

Secondary ID:

UTN:

Trial acronym:

Page 2
Health condition(s) or problem(s) studied:
Acute/subacute osteoporotic vertebral fractures (within 12 months of onset of symptoms)

Musculoskeletal	Osteoporosis
Condition category:	Condition code:
Musculoskeletal	Osteoporosis

Page 3

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:

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

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

Page 5

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

Gender:

Both males and females

Healthy volunteers?

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.

Page 6

Study type:

Interventional

Purpose of the study:

Treatment

Allocation to intervention:

Randomised controlled trial

Describe the 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.

Describe the 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:

Assignment:

Parallel

Other design features (specify):

Type of endpoint(s):

Safety/efficacy

Page 7

Phase

Anticipated or actual date of first participant enrolement:

1/10/2004

Target sample size:

200

Recruitment status:

Open to recruitment

Page 8

Funding source 1:

Government funding body e.g. Australian Research Council

Name:

NHMRC

Address:

Country:

Australia

Funding source 2:

Commercial sector/Industry

Name:

Arthritis Australia

Address:

Country:

Australia

Funding source 3:

Other

Name:

Education Institute

Address:

Country:

Australia

Funding source 4:

Commercial sector/Industry

Name:

Cook Australia

Address:

Country:

Australia

Primary sponsor:

University

Name:

Cabrini Research and Education Institute and Monash University

Address:

Country:

Australia

Secondary sponsor:

None

Name:

N/A

Address:

Country:

Other collaborator:

Page 9

Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name 1:

Monash University

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 2:

Cabrini Research and Education Institute

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 3:

The Alfred Hospital

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 4:

Melbourne Health

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 5:

Northern Health

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 6:

Southern Health

Address:

Country:

Australia

Date of approval:

HREC Number:

Countries of recruitment:

Australia

Brief summary:

Trial website:

Presentations / publication list:

Page 10

Contact person for public queries

Name:

Ms Bridie Murphy

Address:

Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144

Country:

Australia

Tel:

+61 3 95081652

Fax:

+61 3 95081653

Email:

lwengier@cabrini.com.au

Contact person for scientific queries

Name:

A/Prof Rachelle Buchbinder

Address:

Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144

Country:

Australia

Tel:

+61 3 95081652

Fax:

+61 3 95081653

Email:

rachelle.buchbinder@med.monash.edu.au

Trial Details

Page 1

Page 2

Page 3

Page 4

Page 5

Page 6

Page 7

Page 8

Page 9

Page 10