Vertebroplasty versus bracing in acute vertebral compression fractures: A prospective randomized trial.

BACKGROUND: The treatment of stable vertebral compression fractures remains controversial.

OBJECTIVE: To compare the efficacy of vertebroplasty and bracing for acute vertebral compression fractures.

METHODS: We conducted a prospective, randomized, non-blinded, single-center study. Adult participants were randomized to undergo vertebroplasty or bracing. Both groups were stratified by age. The primary outcome was functional disability (Roland-Morris disability questionnaire [RMDQ]). Secondary outcomes were pain intensity (Visual Analogue Scale [VAS]), and change in vertebral body height and kyphosis angle. Outcomes were assessed on day 2, and 1, 3 and 6 months after treatment.

RESULTS: Ninety-nine people were included, 51 in the vertebroplasty group and 48 in the brace group. Treatment was performed within 2 weeks of the trauma. On day 2 post-treatment, pain was lower in the vertebroplasty group (mean [SD] 2.3 [1.5] versus 3.4 [2.1], p = 0.004) but the difference was no longer significant at 6 months. Functional disability was significantly lower in the vertebroplasty than brace group at all time-points (RMDQ score 7.5 [5.7] vs 11.4 [5.3], p<0.001 at 1 month). At 6 months, the increase in kyphosis angle was smaller in the vertebroplasty than the brace group (+1.5°versus +4°, p<0.001).

CONCLUSION: In people with acute vertebral compression fractures, the immediate effect of vertebroplasty was greater than that of bracing on pain and function, and for restoring sagittal balance. At 6 months, the superiority of vertebroplasty decreased, except for the maintenance of sagittal balance.

DATABASE REGISTRATION: ClinicalTrials.gov number, NCT01643395.