Aim: To evaluate the efficacy and safety of vertebroplasty in acute painful osteoporotic fractures of less than 6 weeks duration in a randomized, blinded, parallel group, placebo controlled trial.
Methods: Patients presenting with acute painful osteoporotic fractures were randomly assigned to receive either vertebroplasty or placebo. Entry criteria included fracture duration <6 weeks, positive MRI or SPECT-CT and Numerical Rating Scale (NRS) pain score >7/10. The primary outcome measure was the proportion of patients who achieved a NRS pain score <4/10 at 14 days post intervention. Secondary outcome measures were NRS pain, Roland-Morris Low Back Pain and Disability Questionnaire (RDQ) scores recorded at 3, 14, 28 days, 3 and 6 months and change in %vertebral body height loss at 6 months. Effectiveness analyses were by intention-to-treat principle.
Results: 120 subjects were enrolled (61 vertebroplasty group and 59 placebo group) over 3 years. Mean age was 80 years, 73% were females and 59% were inpatients at time of enrolment. Average duration of fracture at time of intervention was 2.6 weeks. The proportion of patients achieving a NRS <4/10 at 14 days was 44% in the vertebroplasty group and 21% in the control group (between group difference 23%, 95%CI, 6 to 39, p=0.01). The advantage in the vertebroplasty group remained similar throughout the study. Mean reductions in NRS pain and RDQ from baseline favoured vertebroplasty at all-time points. The mean loss of vertebral body height at 6 months was 27% in the vertebroplasty group and 63% in the control group. Vertebroplasty was more beneficial for fractures occurring in the thoracolumbar region. Two patients in the vertebroplasty group had serious adverse events not related to the procedure itself.
Conclusion: Vertebroplasty is superior to a placebo in reducing back pain and its related disability in patients with painful osteoporotic vertebral fractures of less than 6 weeks duration.