Tests vertebroplasty against a sham procedure for osteoporotic spine fractures and daily movement
Tests a spine procedure for painful osteoporotic vertebral fractures against a sham procedure.
Plain-language title generated from the registry record
Registry title: Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
Key facts
- Where
- Kolding, DenmarkSee the site
Where in Denmark
- Spine Centre of Southern DenmarkKolding, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Spine Centre of Southern Denmark
- Trial code
- NCT06776003
- Record updated
- 25 June 2025
- Original description
The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis.Read full original descriptionShow less
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial
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.
Inclusion: Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl); Focal tenderness on the level of the vertebral fracture; Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence; Osteoporotic Fractures type 1-4; Fracture involves no more than 4 vertebral body levels; Vertebroplasty can be done in one session; Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60; Able to understand and read Danish; Written informed consent; Relevant pain started ≤ 3 months prior to enrollment.
Exclusion: Contra-indications for spine surgery; Psychological or psychiatric disorder that is expected to interfere with compliance; Active malignancy; History of chronic back pain requiring ongoing opiate use; Systemic or local infection of the spine; Platelets < 30 mia/l; Osteoporotic Fractures type 5 and Pincer-type; Complete collapse of the vertebral body precluding insertion of needle; Presence of neurologic deficit; Contraindications for MRI scanning; Mini Mental State Examination (MMSE) test score below 24.