To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome will be pain relief at 1 day, 1 week, and 1,3, 6 and 12 months.
The questionnaire consist of the VAS score and questions about use of pain
medication, pain location, and pain type. Other medical treatment and visits to
alternative medical specialists, GP's and physical therapists are recorded and
compared between groups. Patients are asked to fill out the VAS score and use
of analgesics is recorded on a daily basis during the first month after
randomization.
Secondary outcome
Back pain related disability as measured with the Roland Morris Disability
(RMD) Questionnaire. The RMD questionnaire is a disability questionnaire that
measures the functional status of patients with back pain.
The Qualeffo is developed specifically for patients with osteoporosis. This
questionnaire consists of 41 questions. Description: QOL as measured with the
Questionnaire of the European Foundation for Osteoporosis (Qualeffo). The
Qualeffo is developed specifically for patients with osteoporosis. This
questionnaire consists of 41 questions about: pain, physical function, social
function, general health perception, and mental function. The Qualeffo score
ranges from 0 (best quality of life) to 100 (worst quality of life). This
questionnaire will be completed at five measurement moments (before and at 1,
3, 6 and 12 months after the procedure).
Background summary
The standard care in patients with a painful osteoporotic vertebral compression
fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a
minimally invasive technique, is a relatively new treatment option. Recent
randomized controlled trials (RCT) provide conflicting results: two
sham-controlled studies showed no benefit of PV while an unmasked but
controlled RCT (VERTOS II) found effective pain relief at acceptable costs in
patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on
acute VCFs defined as <= 6 weeks. VERTOS III focused on conservative treatment
and found that half of patients still had disabling pain after 3 months or
longer. These patients with sustained pain after 3 months may benefit from PV.
Study objective
To compare pain relief after PV with a sham intervention in selected patients
with a chronic osteoporotic VCF ( three months or longer) using the same strict
inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back
pain related disability and quality of life.
Study design
Primary Purpose: Treatment
Study Phase: Phase 3
Intervention Model: Parallel Assignment
Number of Arms: 2
Masking: Single Blind (Subject)
Allocation: Randomized
Enrollment: 94 [Anticipated]
Intervention
Procedure/Surgery: percutaneous vertebroplasty
Using fluoroscopic guidance, the practitioner infiltrates the skin and
subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae
with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25%
bupivacaine (marcaine. For the vertebroplasty procedure, 11-gauge or 13-gauge
needles are passed into the central aspect of the target vertebra or vertebrae.
Bone cement is prepared on the bench and injected under constant fluoroscopy
into the vertebral body. Injection is stopped when the PMMA reaches to the
posterior aspect of the vertebral body or leaks into an extraosseous space,
such as the intervertebral disk or an epidural or paravertebral vein.
Procedure/Surgery: Sham procedure
Using fluoroscopic guidance, the practitioner infiltrates the skin and
subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae
with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25%
bupivacaine (marcaine. During the sham intervention, verbal and physical cues,
such as pressure on the patient's back, are given, and the methacrylate monomer
is opened to simulate the odor associated with mixing of cement, but the needle
is not placed and cement is not injected.
Study burden and risks
not applicable
Hivarenbeekseweg 60
Tilburg 5022 GC
NL
Hivarenbeekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
•VCF on X-ray of the spine (minimal 15% loss of height)
•level of VCF Th5 or lower
•back pain <= 6 weeks at time of X-ray
•>= 50 years of age
•bone edema on MRI of the fractured vertebral body
•focal tenderness on VCF level
•decreased bone density T-scores <= -1
Exclusion criteria
•severe cardio-pulmonary condition
•untreatable coagulopathy
•systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
•suspected alternative underlying disease (malignancy)
•radicular and/or cauda compression syndrome
•contra-indication for MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01200277 |
| CCMO | NL44553.008.13 |