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Background: The comparison of the efficacy of zoledronate and denosumab for treating osteoporosis is controversial, and few randomized controlled trials have compared these two drugs in practical patients with acute osteoporotic vertebral compression fractures (OVCFs). We conducted a randomized controlled study to compare the efficacy of zoledronate and denosumab in patients with acute OVCF, with a focus on the occurrence of new OVCF. Methods: We enrolled 206 subjects who had their first acute OVCF, without any previous history of osteoporosis medication. The patients were randomly assigned to receive either intravenous zoledronate once a year or subcutaneous denosumab twice a year. We investigated the OVCF recurrence, clinical outcome, bone mineral density (BMD), and bone turnover markers over 12 months. Results: The final cohort comprised 89 participants (mean age of 75.82 ± 9.34 years, including 74 women [83.15%]) in the zoledronate group and 86 patients (mean age of 75.53 ± 10.23 years, including 71 women [82.56%]) in the denosumab group. New OVCFs occurred in 8 patients (8.89%) in the zoledronate group and 11 patients (12.79%) in the denosumab group (odds ratio, 1.485 [95% confidence interval, 0.567-3.891], p = 0.419). No significant difference was observed in the survival analysis between the two groups (p = 0.407). The clinical outcome, including the visual analog scale score for pain and simple radiographic findings, did not differ between the two groups. The changes in BMD and bone turnover markers were also not significantly different between the two groups. Additionally, drug-related adverse events did not differ between the groups in terms of safety. Conclusions: The efficacy of zoledronate was comparable to that of denosumab in terms of the occurrence of new OVCFs, as well as of the overall clinical course in patients with their first acute OVCF. Notably, this study represents the first comparison of these two drugs in patients with acute OVCF. However, further research with large-scale and long-term follow-up is necessary.
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Percutaneous endoscopic lumbar discectomy (PELD) presents a challenging learning curve, and the correlation between surgeon experience and clinical outcomes remains contentious. This retrospective study aimed to compare the outcomes of PELD performed by a single surgeon at beginner and experienced stages. Propensity score matching selected 150 patients (75 per group) with a minimum 3-year follow-up. Clinical and radiological outcomes, perioperative complications, and adverse events were assessed. Baseline characteristics, pain improvement, patient satisfaction, and radiological outcomes did not differ between the groups. However, operation time was longer in the beginner group than in the experienced group (57.5 min [IQR, 50.0-70.0] versus 50.0 min [IQR, 45.0-55.0], p < 0.001). The beginner group had higher perioperative complication rates (eight patients [10.7%] versus one patient [1.3%], with a hazard ratio of 8.836 [95% CI, 1.077-72.514], p = 0.034) and lower 3-year survival without adverse events (19 patients [25.3%] in the beginner group and 10 patients [13.3%] in the experienced group, p = 0.045). Our findings indicate that the clinical outcomes were more favorable in patients operated on at the experienced stage compared to those treated at the beginner stage.
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Adjacent segment foraminal stenosis is a significant adverse event of lumbar fusion. Conventional revision surgery with an extended fusion segment may result in considerable surgical morbidity owing to extensive tissue injury. Transforaminal endoscopic lumbar foraminotomy (TELF) is a minimally invasive surgical approach for symptomatic foraminal stenosis. This study aimed to demonstrate the surgical technique and clinical outcomes of TELF for the treatment of juxta-fusional foraminal stenosis. Full-scale foraminal decompression was performed via a transforaminal endoscopic approach under local anesthesia. A total of 22 consecutive patients who had undergone TELF were evaluated. The included patients had unilateral foraminal stenosis at the juxta-fusional level of the previous fusion surgery, intractable lumbar radicular pain despite at least six months of non-operative treatment, and verified pain focus by imaging and selective nerve root block. The visual analog scale and Oswestry Disability Index scores significantly improved after the two-year follow-up period. The modified MacNab criteria were excellent in six patients (27.27%), good in 12 (55.55%), fair in two (9.09%), and poor in two (9.09%), with a 90.91% symptomatic improvement rate. No significant surgical complications were observed. The minimally invasive TELF is effective for juxta-fusional foraminal stenosis.
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Background: Open decompression with fusion is the gold-standard surgical technique for spondylolisthesis. However, it may be too extensive for patients with foraminal stenosis with stable spondylolisthesis. The endoscopic lumbar foraminotomy (ELF) technique was developed as a minimally invasive surgical option for foraminal stenosis. Some authors have reported the outcomes of ELF for various spondylolistheses. However, few studies have demonstrated foraminal stenosis in advanced stable spondylolisthesis. This study aimed to describe the surgical technique and results of ELF for radiculopathy due to foraminal stenosis in patients with stable spondylolisthesis. Methods: Consecutive 22 patients who suffered from radiculopathy with spondylolisthesis underwent ELF. The inclusion criterion was unilateral radicular leg pain due to foraminal stenosis in stable spondylolisthesis. After the percutaneous transforaminal approach, foraminal decompression was performed using various surgical devices under endoscopic visualization. Surgical outcomes were measured using the visual analog pain score, Oswestry disability index, and modified MacNab criteria. Results: Pain scores and functional outcomes improved significantly during the 12-month follow-up periods. The rate of clinical improvement was 95.5% (21 of 22 patients). One patient experienced a dural tear and subsequent open surgery. Conclusion: ELF can be effective in foraminal stenosis in stable spondylolisthesis. Technical points specializing in foraminal decompression in spondylolisthesis are required for clinical success.
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OBJECTIVE: Although several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill® (Injecta Inc., Gunpo, Korea), a new polymethyl methacrylate product. METHODS: A prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the Visual analog scale (VAS), Korean-Oswestry disability index (K-ODI), and Odom's criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph. RESULTS: The pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) 1 day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49%±21.97% to 80.07%±13.16%, p<0.001) and segmental kyphotic angle (from 11.46°±8.50° to 7.79°±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end. CONCLUSION: The overall outcomes of PVP using Spinofill® were as favorable as those of other conventionally used products.
