Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fr… (NCT06776003) | Clinical Trial Compass
RecruitingNot Applicable
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
Denmark64 participantsStarted 2025-02-20
Plain-language summary
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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Contra-indications for spine surgery.
* 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.
* Psychological or psychiatric disorder that is expected to interfere with compliance.
* Active malignancy.
* Mini Mental State Examination (MMSE) test score below 24.
* History of chronic back pain requiring ongoing opiate use.
* Systemic or local infection of the spine.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in physical activity before and after intervention
Timeframe: One week preoperatively to the end of the fourth postoperative week.