Percutaneous Curved Vertebroplasty Versus Unipedicular Approach Vertebroplasty for Acute Osteoporotic Vertebral Compression Fractures : A Randomized Controlled Trial.

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.

MATERIALS AND METHODS

Patients with single-level OVCFs of <6 weeks duration and visual analog scale (VAS) of back pain 5 or more were randomly allocated to undergo PCVP or UVP and were followed up for 1 year. The primary outcome was overall VAS scores for back pain during 12 months of follow-up. The secondary outcomes were scores on the Oswestry disability index at each postprocedure 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 Oswestry disability index 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 polymethylmethacrylate (5.5 ± 1.4 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

Although PCVP achieved more symmetrical cement distribution, which seemed to be associated with a greater analgesic effect, PCVP did not result in significantly greater pain relief than a UVP in the 12 months after treatment.