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

Completed

• Conditions: Acute/subacute osteoporotic vertebral fractures (within 12 months of onset of symptoms); Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12605000079640
• Lead Sponsor: Cabrini Research and Education Institute and Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-05
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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).

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall pain at 3 months[Measured on a visual analogue scale at 3 months]

Secondary Outcome Measures

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