Spine (Phila Pa 1976). 2023 Feb 8. doi: 10.1097/BRS.0000000000004593. Online ahead of print.
ABSTRACT
STUDY DESIGN: Prospective randomized controlled trial.
OBJECTIVE: To clarify whether percutaneous curved vertebroplasty (PCVP) is superior to conventional unipedicular approach vertebroplasty (UVP) in patients with acute osteoporotic vertebral compression fractures (OVCFs).
SUMMARY OF BACKGROUND DATA: Unilateral curved vertebroplasty devices were designed and applied to provide better control of cement placement, which may be superior to traditional UVP for the treatment of acute OVCFs.
METHODS: Patients with single level osteoporotic vertebral compression fractures of less than 6 weeks’ duration and visual analogue scale (VAS) of back pain 5 or more were randomly allocated to undergo PCVP or UVP and were followed up for one year. The primary outcome was overall VAS scores for back pain during 12 months’ follow-up. The secondary outcomes were scores on Oswestry disability index (ODI) at each post-procedure clinic visit. Radiographic (cement distribution) and surgical data (operation time, fluoroscopy frequency and cement volume) were assessed. Complications and adverse events were recorded.
RESULTS: No statistical difference was found between the PCVP and UVP groups with respect to VAS and ODI scores at any follow-up time point. Operative time, fluoroscopy frequency and cement leakage were similar in both groups, while the PCVP techniques had a larger injection of PMMA (5.5±1.4 mL vs. 4.2±1.0 mL) and a greater dispersion pattern of cement (P<0.001). Post hoc observations found that the analgesic effect was positively correlated with the symmetry of bone cement distribution, but not with the surgical method. Two serious adverse events occurred in the vertebroplasty group: one stress ulcer and one allergic reaction.
CONCLUSIONS: While PCVP achieved more symmetrical cement distribution, which appeared to be associated with greater analgesic effect, PCVP did not result in significantly greater pain relief than a UVP in the 12 months following treatment.
PMID:36763817 | DOI:10.1097/BRS.0000000000004593
