This randomized controlled trial enrolled 139 patients with single-level osteoporotic vertebral compression fractures, comparing percutaneous curved kyphoplasty (PCKP) to unilateral percutaneous kyphoplasty (UPKP) over at least 24 months of follow-up. The study did not report primary outcomes, phase, setting, or safety details such as adverse events. Secondary outcomes included pain, function, cement distribution, leakage, and re-fracture incidence.
Main results showed PCKP was superior to UPKP in early outcomes: at 2 days, VAS was 1.99 ± 0.77 for PCKP versus 3.47 ± 0.50 for UPKP (p < 0.001), and ODI was 27.07 ± 1.78 versus 35.33 ± 3.12 (p < 0.001). Cement distribution excellence rates were 91.04% with PCKP compared to 76.39% with UPKP, and leakage rates were lower at 10.45% versus 26.39%. In moderate-to-severe cases, PCKP provided more symmetric cement distribution (p = 0.02) and a 21% lower leakage risk. However, re-fracture incidence (PCKP: 11.94% vs. UPKP: 15.28%) and anti-osteoporosis compliance (PCKP: 28.36% vs. UPKP: 33.33%) showed no significant differences.
Safety and tolerability were not reported, and limitations include unspecified funding or conflicts. Practice relevance suggests PCKP may enhance early biomechanical stability in moderate-to-severe fractures through optimized cement dispersion, but long-term efficacy depends on anti-osteoporosis therapy. A stepwise decision model is recommended, with PCKP for Genant 2–3 cases and UPKP for mild ones, combined with a vertebral augmentation–bone metabolism modulation–behavioral intervention strategy. Clinicians should consider these findings as preliminary due to unreported safety data and the need for further validation.
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BackgroundPercutaneous curved kyphoplasty (PCKP) demonstrates early advantages in treating osteoporotic vertebral compression fractures (OVCFs), but its long-term efficacy and patient-selection criteria remain controversial.ObjectiveThe aim of this study is to prospectively compare the mid-to-long-term outcomes of PCKP versus unilateral percutaneous kyphoplasty (UPKP) for single-level OVCFs and establish a hierarchical decision model based on vertebral compression severity.MethodsA total of 139 patients with single-level OVCFs (January 2021–January 2023) were randomized to PCKP (n = 67) or UPKP (n = 72), with ≥24-month follow-up. Outcomes included the visual analog score (VAS), Oswestry dysfunction index (ODI), cement distribution (type I–V classification), leakage rate, and re-fracture incidence. Anti-osteoporosis compliance was analyzed for its impact on efficacy.ResultsBoth groups showed significant postoperative improvement in VAS and ODI (p < 0.05). PCKP achieved superior early pain relief (VAS: 1.99 ± 0.77 vs. 3.47 ± 0.50; ODI: 27.07 ± 1.78 vs. 35.33 ± 3.12 at 2 days, p < 0.001), a higher cement distribution excellence rate (91.04% vs. 76.39%), and a lower leakage rate (10.45% vs. 26.39%). However, outcomes converged from 3 months onward (p > 0.05), with no significant differences in re-fracture (11.94% vs. 15.28%) or anti-osteoporosis compliance (28.36% vs. 33.33%). Subgroup analysis revealed that PCKP provided more symmetric cement distribution (p = 0.02) and a 21% lower leakage risk in moderate-to-severe OVCFs (Genant 2–3).ConclusionPCKP enhances early biomechanical stability in moderate-to-severe OVCFs through optimized cement dispersion, while long-term efficacy relies on standardized anti-osteoporosis therapy. A stepwise decision model (“PCKP for Genant 2–3, UPKP for mild cases”), combined with a “vertebral augmentation–bone metabolism modulation–behavioral intervention” strategy, is recommended.