Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorSpine Centre of Southern Denmark
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vertebroplasty
Procedure/SurgeryPolymethyl-methacrylate (PMMA) cement is injected slowly into the vertebral body under constant bi-plane fluoroscopy
Sham Vertebroplasty
Procedure/SurgeryA short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: VertebroplastyActive comparator 1 intervention
Group B: Sham vertebroplastySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in physical activity before and after intervention
Physical activity is measured by accelerometer and presented as mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). An unweighted average of valid days within the preoperative week is compared with the unweighted average of valid days within the four postoperative weeks by relative change in percent.
Time frame
One week preoperatively to the end of the fourth postoperative week.Secondary outcomes
1
Daily and weekly physical activity
Physical activity is measured by accelerometer and presented as difference in mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). Daily means are based on valid wear-time. Weekly means are calculated as unweighted averages of all valid days within the week.
Time frame
One week preoperatively to 4 weeks postoperatively2
Change in daily and weekly physical activity
Physical activity is measured by accelerometer and presented as difference in mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). Daily means are based on valid wear-time. Weekly means are calculated as unweighted averages of all valid days within the week. This outcome supplements the primary outcome to cover changes within the full study period. Changes are reported as relative percentages.
Time frame
One week preoperatively to 4 weeks postoperatively3
Physical activity levels
Based on cut-points applied to the ENMO or count measurements, the valid wear-time is divided into intensity classes "sedentary", "light activity" or "moderate to vigorous activity". Time spent in each class is presented as percentage of valid wear-time.
Time frame
One week preoperatively to 4 weeks postoperatively4
Change in physical activity levels
Based on cut-points applied to the ENMO or count measurements, the valid wear-time is divided into intensity classes "sedentary", "light activity" or "moderate to vigorous activity". Time spent in each class is presented as percentage of valid wear-time and changes as absolute percentage points.
Time frame
One week preoperatively to 4 weeks postoperativelySponsors and contacts
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Source ClinicalTrials.gov