Actively Recruiting
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
Led by Spine Centre of Southern Denmark · Updated on 2025-06-25
64
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis. The focus of the study is on the physical activity and mobility of participants. The main questions the trial aims to answer are: * Does vertebroplasty lead to increased physical activity as measured by accelerometer? * Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)? * Do physical activity and mobility correlate with pain, disability and quality of life? Researchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility. Participants will * Undergo vertebroplasty or sham procedure * Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery * Answer questionnaires regarding pain, disability and quality of life at regular intervals. The knowledge gained from this can help determine who would benefit from vertebroplasty.
CONDITIONS
Official Title
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 50 years or older diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (inclusive)
- Focal tenderness at the level of the vertebral fracture
- Fractures confirmed by oedema of the vertebra on MRI STIR sequence
- Osteoporotic fractures classified as type 1 to 4
- Fracture involves no more than 4 vertebral body levels
- Vertebroplasty can be performed in one surgical session
- Back pain score on Visual Analog Scale (VAS) of 60 or higher
- Ability to understand and read Danish
- Written informed consent provided
- Relevant pain started within 3 months before enrollment
You will not qualify if you...
- Contraindications for spine surgery
- Platelet count less than 30 mia/l
- Osteoporotic fractures classified as type 5 or pincer-type
- Complete collapse of vertebral body preventing needle insertion
- Presence of neurological deficit
- Contraindications for MRI scanning
- Psychological or psychiatric disorders expected to interfere with study compliance
- Active malignancy
- Mini Mental State Examination (MMSE) score below 24
- History of chronic back pain requiring ongoing opioid use
- Systemic or local spinal infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Spine Centre of Southern Denmark
Kolding, Denmark, 6000
Actively Recruiting
Research Team
S
Søren W Sørensen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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