Robot-assisted modified unilateral percutaneous vertebroplasty for lumbar Kümmell's disease: a randomized controlled trial
Abstract
The clinical value of using a spine robot to guide unilateral PVP for lumbar Kümmell's disease has not been fully established. The traditional bilateral pedicle PVP tends to cause suboptimal cement distribution, longer operation time, and increased exposure to radiation. To compare the safety and effectiveness of spine robot-assisted modified unilateral PVP with conventional bilateral pedicle puncture PVP. We performed a single-blind randomized trial including 110 patients with lumbar Kümmell's disease. Patients were assigned in equal numbers to robot-assisted modified unilateral PVP or manual bilateral pedicle PVP. The main endpoint was 12-month Cobb angle change. Additional endpoints included AVH, PVH, WA, VAS, ODI, operative indicators, and complications. At all time points after the operation, the robot-assisted group showed significantly higher reductions in Cobb angle, WA, VAS, and ODI and significantly better preservation of AVH and PVH (all P < 0.05). Operative time (47.15 ± 8.26 vs. 69.25 ± 10.94 min), blood loss (10.29 ± 2.87 vs. 25.31 ± 4.43 mL), and fluoroscopy times (9.80 ± 1.59 vs. 26.24 ± 4.74) are significantly reduced in the robot-assisted group. The rate of bone cement leakage and vertebral recollapse also decreased. Robot-assisted modified unilateral PVP has better long-term correction of kyphotic deformation, reduced complications, and higher procedural efficacy compared to utilizing conventional bilateral PVP under the limitation of single-center…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 110 participants or records.
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