| Trial name or title |
The effectiveness and safety of vertebroplasty for osteoporotic vertebral compression fractures. A double blind, prospective, randomised, controlled study |
| Methods |
Randomised controlled trial, participant blinded |
| Participants |
Planned sample size = 164
Inclusion criteria
More than or equal to 50 years of age Back pain (more than or equal to 4 on 0 to 10 scale) 1 to 3 recent painful osteoporotic vertebral fractures (minimum 15% loss of height, oedema or fracture line within vertebral body) from T5 through L5 Decreased bone density T‐score less than or equal to ‐1.
Exclusion criteria
More than 3 recent spine fractures, pedicle fracture, or previous vertebroplasty or kyphoplasty and neurological deficit, radicular pain, radicular and/or myelum compression syndrome or canal narrowing More than 90% osteoporotic vertebral collapse, fracture through/destruction of posterior wall, retropulsed bony fragment or bone fragments impinging on spinal cord Spinal or systemic infections Vertebral fractures resulting from primary bone tumours osteoblastic metastases or current malignancy Severe cardio‐pulmonary condition Dementia Untreatable coagulopathy or uninterruptible anticoagulation therapy Allergies to materials used in vertebroplasty or kyphoplasty materials and contraindications to MRI Unable to give informed consent
|
| Interventions |
Vertebroplasty Three weeks period of bed rest, wearing a rigid hyperextension suspension brace, with positive three‐point suspension (sternal, suprapubic and thoracolumbar) |
| Outcomes |
Duration of follow‐up to 24 months
Primary outcome
VAS score (10 cm scale ‐ 0 (no pain) to 10 (worst pain ever)
Secondary outcomes
RMDQ ODI (version 2.0) Assessment of Quality of life (AQoL) Utility score (Health‐related questionnaire) Incidence of new fractures (plain film examination of the thoracic and lumbosacral spine at 1, 3, 6, 12 and 24 months)
|
| Starting date |
Not specified |
| Contact information |
Principal Investigator: Umile Giuseppe Longo, MD, Italy
Phone: +39 06 22 54 11
E‐mail: g.longo@unicampus.it |
| Notes |
Unclear if registered in a trial registry
Primary sponsor: Not specified
Status of trial unknown |
