Comparison of the efficacy and safety of vertebroplasty with different pedicle approaches for osteoporotic vertebral.

OBJECTIVE: To compare the efficacy and safety of vertebroplasty through different pedicle approaches in the treatment of osteoporotic vertebral compression fracture osteoporotic vertebral compression fractures (OVCF) by network meta-analysis. METHODS: Pubmed, Embase, Cochrane Library, Web of Science. Database for literature retrieval, retrieval time from the establishment of the database to April 2023, the randomized controlled trials of unilateral vertebroplasty (UVP), bilateral vertebroplasty (BVP), unilateral kyphoplasty (UKP), bilateral kyphoplasty (BKP), curved vertebroplasty (CVP) and curved kyphoplasty (CKP) were screened, evaluated and the data were extracted and included in the analysis. STATA 15.0 and ReMan 5.3 were used for data analysis. This study was registered in the National Institute for Health Research (NIHR) with the registration number CRD42023405181. RESULTS: This study included 16 articles with a total of 1712 patients. The order of visual analogue scale (VAS) improvement from good to bad is CVP > BVP > UVP > CKP > BKP > UKP. The order of kyphotic angles improvement from good to bad is CKP > UKP > UKP > UVP > BVP > CVP. The order of bone cement injection from less to more is UVP > CVP > UKP > CKP > BVP > BKP. The order of bone cement leakage rate from less to more is CKP > CVP > UKP > BKP > UVP > BVP. The order of X-ray exposure time from less to more is CKP > CVP > UVP > BVP > UKP > BKP. The order of operation time from less to more is CVP > UVP > UKP > CKP > BVP > BKP. CONCLUSION: For patients with kyphotic angles, kyphoplasty has unique advantages in improving kyphotic angles. But generally speaking, curved approach can optimize the distribution of bone cement through unilateral approach to achieve the orthopedic effect of bilateral approach, which is a minimally invasive technique with better curative effect and higher safety in the treatment of OVCF.

Vertebral body collapse after spine stereotactic body radiation therapy: a single-center institutional experience.

BACKGROUND: Spine stereotactic body radiation therapy (SBRT) for the treatment of metastatic disease is increasingly utilized owing to improved pain and local control over conventional regimens. Vertebral body collapse (VBC) is an important toxicity following spine SBRT. We investigated our institutional experience with spine SBRT as it relates to VBC and spinal instability neoplastic score (SINS). PATIENTS AND METHODS: Records of 83 patients with 100 spinal lesions treated with SBRT between 2007 and 2022 were reviewed. Clinical information was abstracted from the medical record. The primary endpoint was post-treatment VBC. Logistic univariate analysis was performed to identify clinical factors associated with VBC. RESULTS: Median dose and number of fractions used was 24 Gy and 3 fractions, respectively. There were 10 spine segments that developed VBC (10%) after spine SBRT. Median time to VBC was 2.4 months. Of the 11 spine segments that underwent kyphoplasty prior to SBRT, none developed subsequent VBC. No factors were associated with VBC on univariate analysis. CONCLUSIONS: The rate of vertebral body collapse following spine SBRT is low. Prophylactic kyphoplasty may provide protection against VBC and should be considered for patients at high risk for fracture.

Percutaneous Kyphoplasty via Transverse Process-Rib-Pedicle Approach for Upper and Middle Thoracic Osteoporosis Fracture With Pedicle Stenosis.

OBJECTIVE: To explore the clinical effect of percutaneous kyphoplasty via Process-Rib-Pedicle approach for upper and middle thoracic osteoporosis fracture with Pedicle Stenosis. METHODS: This study is a retrospective observational study. In this study, we retrospectively analyzed the data of 62 patients with upper thoracic vertebral bone loss compression fracture (OVCF) treated via the Process-Rib-Pedicle pathway PKP at the First Affiliated Hospital of Soochow University from January 2020 to December 2022. The patients were divided into group A(Unilateral PKP, 38 cases) and group B(Bilateral PKP, 24 cases) . The aspects of surgical safety, clinical efficacy and radio-logical outcome were investigated. RESULTS: All 62 patients successfully completed the surgery without any spinal cord, nerve, or vascular injury, and there were no complications such as infection and vascular embolism. The differences in VAS scores（P<0.05）, ODI functional index（P<0.05）, and Cobb angle（P<0.05） were significant when comparing preoperative and postoperative periods, and the differences were not significant when comparing the postoperative periods (P>0.05); There were no statistically significant differences in days of hospital stay(P=0.653), and the rate of bone cement leakage (P=0.537 )between the two groups. CONCLUSION: For upper middle osteoporotic thoracic vertebral fractures with pedicle stenosis, puncture via the Process-Rib-Pedicle path is a safe and reliable puncture route, and more than 2.5 ml of cement can achieve good clinical outcomes, regardless of bilateral or unilateral PKP.

Hydraulic Polymethylmethacrylate Pressure Delivery System Versus Manual Balloon Tamp System in Balloon Kyphoplasty.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Osteoporotic vertebral compression fractures (VCFs) are prevalent among the elderly population, and Balloon kyphoplasty (BKP) is a minimally invasive solution for these. However, Polymethylmethacrylate (PMMA) leakage is a significant complication with potentially severe consequences. This study compares the safety and efficacy of manual balloon tamp system (MTS) and hydraulic Polymethylmethacrylate pressure delivery system (HPDS) in BKP. METHODS: A retrospective study involving 160 patients, comparing MTS (2008-2014) and HPDS (2016-2020) cohorts, assessed PMMA leakage, radiation exposure, and surgery duration. RESULTS: PMMA leakage occurred in 52.8% of MTS and 62.5% of HPDS cases. Intradiscal leakage was the most common pattern in both groups. Multivariate logistic regression revealed that multilevel BKP and HPDS were associated with higher PMMA leakage rates. Radiation exposure was significantly lower with HPDS, while surgery duration was shorter. DISCUSSION: This study provides novel insights into PMMA leakage and radiation exposure in BKP. HPDS was associated with a higher PMMA leakage rate. HPDS, however, offers advantages in terms of reduced radiation exposure and shorter surgery duration. Multilevel BKP also increased the risk of leakage. Further investigation is needed to better understand the impact of HPDS on PMMA leakage. CONCLUSION: This study underscores that while HPDS offers advantages regarding radiation exposure and surgery duration, it is associated with a higher PMMA leakage rate.

Health Care Fraud and Abuse: Lessons From One of the Largest Scandals of the 21st Century in the Field of Spine Surgery.

Up to hundreds of billions of dollars are annually lost to fraud and abuse in the US health care, making it a significant burden on the system. This study investigates a specific instance of health care fraud in spine surgery, in which a medical device company ended up paying $75 million to settle violations of the False Claims Act. We review the surgical background regarding the kyphoplasty procedure, as well as its billing and reimbursement details. We also explore the official legal complaint brought by the US Department of Justice to tell the story of how one of the most significant medical innovations in spine surgery in the 21st century turned into a widespread fraudulent marketing scheme. In the sequence, we provide a detailed root cause analysis of this scandal and propose some proactive measures that can be taken to avoid such type of unfortunate events. Ultimately, this historical health care scandal constitutes a valuable lesson to surgeons, health care administrators, medical device companies, and policymakers on how misaligned incentives and subsequent unscrupulous practices can transform a medical innovation into an unfortunate tale of fraud and deceit.

Percutaneous kyphoplasty in the treatment of Kümmell disease in lumbar scoliosis: A case report.

BACKGROUND: Due to mechanical imbalance in the spine, elderly scoliosis patients tend to develop vertebral fracture nonunion, i.e., Kümmell disease, when osteoporotic vertebral compression fractures occur. However, accompanying vertebral rotational deformities make surgical procedures challenging risky. Such patients are usually compelled to undergo conservative treatment and there are very few reports on minimally invasive surgeries for them. We first-time report a patient with Kümmell disease and lumbar scoliosis treated with percutaneous kyphoplasty (PKP) under O-arm guidance. CASE SUMMARY: An 89-year-old female was admitted to the hospital due to delayed low back pain after a fall. She was diagnosed with Kümmell disease based on physical and radiologic examinations. The patient experienced severe scoliosis and subsequently underwent O-arm-guided kyphoplasty, resulting in a significant alleviation of low back pain. CONCLUSION: PKP has good efficacy in treating Kümmell disease. However, surgical risks are elevated in scoliosis patients with Kümmell disease due to the abnormal anatomical structure of the spine. O-arm assisted operations play a crucial role in decreasing surgical risks.

Related factors of severe osteoporotic vertebral compression fracture and clinical outcomes of percutaneous kyphoplasty: A retrospective study.

BACKGROUND: Osteoporosis is the most common disease in postmenopausal women and the elderly, which can lead to vertebral compression fracture. OBJECTIVE: To investigate the related factors of severe osteoporotic vertebral compression fracture (SOVCF) and evaluate the long-term outcomes of percutaneous kyphoplasty (PKP) for treating SOVCF through comparison with mild OVCF (MOVCF). METHODS: From September 2015 to March 2019, 294 osteoporotic vertebral compression fracture (OVCF) patients treated with PKP were analyzed. Compression of the anterior margin of the fractured vertebral body beyond 2/3 of the original height was defined as SOVCF. Baseline data, clinical and imaging findings before and after surgery and at the last follow-up were recorded. Numerical Rating Scale (NRS) was used to evaluate low back pain, the Oswestry Disability Index (ODI) was used to evaluate activity of daily life. Anterior vertebral height (AVH) and local kyphosis angle (LKA) was used to evaluate radiographic outcomes. During the follow-up, patients with recurrent back pain were examined by MRI to identify new fractures and the incidence of adjacent vertebral fracture (AVF) was recorded. Age, sex, body mass index (BMI), dual energy X-ray absorptiometry based T value, duration of symptom, history of trauma, steroid use, and fracture site were collected for univariate logistic regression analysis Variables with a P-value of less than 0.05 were then included in multivariate analysis to determine the related factors for SOVCF. RESULTS: Logistic regression analysis indicated that longer duration of symptom (OR = 1.109, 95%CI: 1.038-1.185, P= 0.002), lower T value (OR = 0.332, 95%CI: 0.139-0.763, P= 0.001), and steroid use (OR = 31.294, 95%CI: 1.020-960.449, P= 0.049) were related factors of SOVCF. Compared with the MOVCF group, the SOVCF group had longer operation time (57.3 ± 13.51 minutes vs 44.9 ± 8.13 minutes, P< 0.001), more radiation exposure (39.9 ± 7.98 times vs 25.5 ± 4.01 times, P< 0.001), and higher cement leakage rate (55.81% vs 18.73%, P< 0.001). At the last follow-up, the SOVCF group had higher NRS (2.28 ± 0.85 vs 1.30 ± 0.71, P< 0.001), and ODI (16.23 ± 4.43 vs 12.88 ± 3.34, P< 0.001). After operation and at the last follow-up, the SOVCF group had higher LKA and lower AVH (all P< 0.05). The AVF rate at the last follow-up was higher in the SOVCF group at the last follow-up (4.78% vs 18.60%, P< 0.001). CONCLUSION: Lower T value, longer duration of disease, and steroid use were related factors of SOVCF. Compared with MOVCF, PKP for SOVCF had longer operation time, more radiation exposure, and higher cement leakage rate, and the long-term outcomes were worsen.

Can We Rely on Prophylactic Two-Level Vertebral Cement Augmentation in Long-Segment Adult Spinal Deformity Surgery to Reduce the Incidence of Proximal Junctional Complications?

Background and Objectives: Proximal junctional kyphosis (PJK) and failure (PJF), the most prevalent complications following long-segment thoracolumbar fusions for adult spinal deformity (ASD), remain lacking in defined preventive measures. We studied whether one of the previously reported strategies with successful results-a prophylactic augmentation of the uppermost instrumented vertebra (UIV) and supra-adjacent vertebra to the UIV (UIV + 1) with polymethylmethacrylate (PMMA)-could also serve as a preventive measure of PJK/PJF in minimally invasive surgery (MIS). Materials and Methods: The study included 29 ASD patients who underwent a combination of minimally invasive lateral lumbar interbody fusion (MIS-LLIF) at L1-2 through L4-5, all-pedicle-screw instrumentation from the lower thoracic spine to the sacrum, S2-alar-iliac fixation, and two-level balloon-assisted PMMA vertebroplasty at the UIV and UIV + 1. Results: With a minimum 3-year follow-up, non-PJK/PJF group accounted for fifteen patients (52%), PJK for eight patients (28%), and PJF requiring surgical revision for six patients (21%). We had a total of seven patients with proximal junctional fracture, even though no patients showed implant/bone interface failure with screw pullout, probably through the effect of PMMA. In contrast to the PJK cohort, six PJF patients all had varying degrees of neurologic deficits from modified Frankel grade C to D3, which recovered to grades D3 and to grade D2 in three patients each, after a revision operation of proximal extension of instrumented fusion with or without neural decompression. None of the possible demographic and radiologic risk factors showed statistical differences between the non-PJK/PJF, PJK, and PJF groups. Conclusions: Compared with the traditional open surgical approach used in the previous studies with a positive result for the prophylactic two-level cement augmentation, the MIS procedures with substantial benefits to patients in terms of less access-related morbidity and less blood loss also provide a greater segmental stability, which, however, may have a negative effect on the development of PJK/PJF.

Effects of robot-assisted percutaneous kyphoplasty on osteoporotic vertebral compression fractures: a systematic review and meta-analysis.

This study systemically reviewed the effects of robot-assisted percutaneous kyphoplasty (R-PKP) on the clinical outcomes and complications of patients with osteoporotic vertebral compression fracture (OVCF). The articles published from the establishment of the database to 19 April 2024 were searched in PubMed, The Cochrane Library, Web of Science, Embase, Scopus, China National Knowledge Infrastructure (CNKI), and Chinese biomedical literature service system (SinoMed). Meta-analysis was employed to evaluate the status of pain relief and complications between the control and R-PKP groups. Standardized mean difference (SMD) or mean difference (MD), risk ratios (RR), and 95% confidence interval (CI) were selected for analysis, and a common or random effect model was adopted to merge the data. Eight studies involving 773 patients with OCVFs were included. R-PKP could effectively Cobb's angles (MD = -1.00, 95% CI -1.68 to -0.33, P = 0.0034), and decrease the occurrence of cement leakage (RR = 0.36, 95% CI 0.21 to 0.60, P < 0.0001). However, there was no significant effect on the results of visual analog scale (MD = -0.09, 95% CI -0.20 to 0.02, P = 0.1145), fluoroscopic frequency (SMD = 5.31, 95% CI -7.24 to 17.86, P = 0.4072), and operation time (MD = -0.72, 95% CI -7.47 to 6.03, P = 0.8342). R-PKP could significantly correct vertebral angle and reduce cement leakage. Thus, R-PKP maybe an effective choice for correction vertebral Angle and reducing postoperative complications, while its impact on relieving pain, decreasing fluoroscopic frequency, and shortening operation time need further exploration.

The Impact of Sarcopenia on the Clinical Outcomes of Percutaneous Kyphoplasty in Patients With Osteoporotic Vertebral Compression Fracture: A Retrospective Cohort Study.

Objective: This study aimed to explore the impact of sarcopenia on clinical outcomes after percutaneous kyphoplasty (PKP) for osteoporotic vertebral compression fracture (OVCF). Methods: We retrospectively analyzed the medical records of patients with single-segment OVCF who underwent percutaneous kyphoplasty (PKP) between September 2021 and August 2022. Patients were categorized into a sarcopenia group (43 patients) and a non-sarcopenia group (125 patients) based on their Advanced Skeletal Muscle Index (ASMI). Clinical and radiological data were collected and analyzed. Results: There were no significant differences between the sarcopenia and non-sarcopenia groups in age, sex, bone mineral density (BMD), body mass index (BMI), fractured segment, fracture type, surgical approach, bone cement volume, bone cement distribution, comorbidities, preoperative and immediate postoperative VAS and ODI scores (P > .05). However, the time to ambulation, hospital stays, VAS and ODI scores at follow-up, excellent/good rate, and the incidence of residual pain and re-fractures in the non-sarcopenia group were significantly better than those in the sarcopenia group (P < .05). Meanwhile, radiological outcomes, including regional kyphosis and vertebral height loss rate, were significantly better in the non-sarcopenia group than in the sarcopenia group at 6 and 12 month follow-ups (P < .05). Conclusion: Clinical outcomes after PKP in patients with OVCF could be negatively affected by sarcopenia. Therefore, prevention and treatment of sarcopenia should be actively considered in the management of patients with OVCF.

Analysis of injected cement volume and clinical outcomes following balloon-assisted kyphoplasty in a series of 368 patients.

OBJECTIVE: Balloon-assisted kyphoplasty (BAK) is a modified vertebroplasty technique developed to treat vertebral compression fractures (VCFs) secondary to osteoporosis. This study investigates the association between injected cement volume and the development of subsequent VCFs after BAK. METHODS: A retrospective analysis of 368 patients who underwent BAK at a single institution was performed from 2001 to 2021. Inclusion was defined by at least 2 years of follow-up. Clinical characteristics and outcomes following BAK, including subsequent fractures at adjacent and remote levels, were identified. Patients that underwent a thoracic BAK were stratified by injected cement volume: below or equal to the median (≤ 6.0 mL, 265 vertebrae) or above the median (> 6.0 mL, 144 vertebrae). Patients that underwent a lumbar BAK were similarly stratified: below or equal to the median (≤ 8.0 mL, 233 vertebrae) or above the median (>8.0 mL, 160 vertebrae). RESULTS: A total of 802 vertebrae were treated. The average volume of cement was recorded in the thoracic (6.2 ± 1.9 mL) and lumbar (7.8 ± 1.8 mL) vertebrae. In the thoracic spine, vertebrae that were injected with > 6.0 mL of cement underwent a greater change in local kyphotic angle (P = 0.0001) and were more likely to develop adjacent-level VCFs (P = 0.032) after kyphoplasty. Univariate analysis did not elucidate any additional risk factors. There were no statistical differences in clinical outcomes between the three groups of lumbar vertebrae. CONCLUSIONS: Larger volumes of injected cement were associated with a greater change in local kyphosis and subsequent adjacent-level fractures after BAK in the thoracic spine. This association was not found in the lumbar spine. Close attention to injected cement volumes must be made in the thoracic spine and patients who undergo significant kyphotic correction should be carefully observed postoperatively.

[Effects of tramadol hydrochloride preemptive analgesia in kyphoplasty of thoracolumbar osteoporotic fractures under local anesthesia].

OBJECTIVE: To explore preemptive analgesic effect of preoperative intramural tramadol injection in percutaneous kyphoplasty (PKP) of vertebrae following local anesthesia. METHODS: From August 2019 to June 2021, 118 patients with thoraco lumbar osteoporotic fractures were treated and divided into observation group and control group, with 59 patients in each gruop. In observation group, there were 26 males and 33 females, aged from 57 to 80 years old with an average of (67.69±4.75)years old;14 patients on T11, 12 patients on T12, 18 patients on L1, 15 patients on L2;tramadol with 100 mg was injected intramuscularly half an hour before surgery in observation group. In control group, there were 24 males and 35 females, aged from 55 to 77 years old with an average of (68.00±4.43) years old;19 patients on T11, 11 patients on T12, 17patients on L1, 12 patients on L2;the same amount of normal saline was injected intramuscularly in control group. Observation indicators included operation time, intraoperative bleeding, visual analogue scale (VAS) evaluation and recording of preoperative (T0), intraoperative puncture(T1), and working cannula placement (T2) between two groups of patients, at the time of balloon dilation (T3), when the bone cement was injected into the vertebral body (T4), 2 hours after the operation (T5), and the pain degree at the time of discharge(T6);adverse reactions such as dizziness, nausea and vomiting were observed and recorded;the record the patient's acceptance of repeat PKP surgery. RESULTS: All patients were successfully completed PKP via bilateral pedicle approach, and no intravenous sedative and analgesic drugs were used during the operation. There was no significant difference in preoperative general data and VAS(T0) between two groups (P>0.05). There was no significant difference in operation time and intraoperative blood loss between the two groups (P>0.05). VAS of T1, T2, T3, T4 and T5 in observation group were all lower than those in control group(P<0.05), and there was no significant difference in T6 VAS (P>0.05). T6 VAS between two groups were significantly lower than those of T0, and the difference was statistically significant (P<0.05). There was no significant difference in incidence of total adverse reactions between two groups (P>0.05). There was a statistically significant difference in the acceptance of repeat PKP surgery (P<0.05). CONCLUSION: Half an hour before operation, intramuscular injection of tramadol has a clear preemptive analgesic effect for PKP of single-segment thoracolumbar osteoporotic fracture vertebral body under local anesthesia, which could increase the comfort of patients during operation and 2 hours after operation, and improve patients satisfaction with surgery.

[Comparsion of bone setting technique combined with percutaneous vertebroplasty and percutaneous kyphoplasty for the treatment of osteoporotic vertebral compression fractures].

OBJECTIVE: To explore clinical efficacy of osteoplasty combined with percutaneous vertebroplasty(PVP) and percutaneous kyphoplasty (PKP) alone in treating osteoporosis vertebral compression fractures (OVCFs). METHODS: The clinical data of 80 patients with single-level OVCFs treated from January 2021 to June 2022 were retrospectively analyzed, and were divided into treatment group and control group according to different surgical methods, 40 patients in each group. In treatment group, there were 24 males and 16 females, aged from 60 to 83 years old with an average of (70.43±7.31) years old;bone mineral density ranged from -3.30 to -2.50 SD with an average of(-2.84±0.24) SD;1 patient with T10, 4 patients with T11, 11 patients with T12, 7 patients with L1, 7 patients with L2, 5 patients with L3, 3 patients with L4, 2 patients with L5;bone setting technique combined with PVP were performed. In control group, there were 27 males and 13 females, aged from 60 to 82 years old with an average of (68.98±6.94) years old;bone mineral density ranged from -3.40 to -2.50 SD with an average of (-2.76±0.23) SD;2 patients with T10, 3 patients with T11, 13 patients with T12, 11 patients with L1, 5 patients with L2, 3 patients with L3, 2 patients with L4, 1 patient with L5;simple PKP were peformed. Visual analogue scale (VAS) and lumbar Oswestry disability index (ODI) were compared between two groups before operation, 3 days, 3 and 12 months after operation. The changes of local kyphotic angle, vertebral wedge angle and vertebral anterior margin height ratio were compared between two groups before operation, 3 days and 12 months after operation. RESULTS: All patients were successfully completed operation. Treatment group were followed up from 13 to 22 months with an average of (16.82±2.14) months, and control group were followed up from 13 to 23 months with an average of (16.45±2.56) months. Three patients were occurred bone cement leakage in treatment group, while 1 patient were occurred bone cement leakage and 1 patient occurred sensory disturbance of lower limb skin in control group;there were no significant difference in complications between two groups (P>0.05). There were no significant difference in preoperative VAS and ODI between two groups (P>0.05). At 3 days after operation, VAS of treatment group 3.68±0.62 was significantly higher than that of control group 4.00±0.72 (P<0.05). There were no significant difference in VAS and ODI between two groups at 3 and 12 months after operation (P>0.05). There were no significant difference in local kyphotic angle, vertebral wedge angle and vertebral anterior margin height between two groups at 3 days and 12 months after operation (P>0.05). CONCLUSION: Compared with PKP, bone setting manipulation combined with PVP for the treatment of OVCFs has advantages in early postoperative pain relief. In terms of vertebral height recovery, bone setting manipulation combined with PVP and PKP alone have similar clinical effects.

Prognostic Factors Associated with Poor Treatment Outcomes After Balloon Kyphoplasty in Elderly Patients Aged ≥81 years.

OBJECTIVE: Balloon kyphoplasty (BKP) is an effective procedure for osteoporotic vertebral compression fractures; however, there is limited data regarding its outcomes in patients aged ≥81 years. This study investigated the treatment outcomes and prognostic factors for BKP in this age group. METHODS: A retrospective analysis was conducted on 115 patients with osteoporotic vertebral compression fracture undergoing single-level BKP after failed conservative treatment, classified into the <81 years (n=70) and ≥81 years (n=45) groups. Surgical results were evaluated as good outcomes (independent indoors 1 year postoperatively) and poor outcomes, followed by univariate and multivariate analyses to determine prognostic factors correlating with these outcomes. RESULTS AND CONCLUSION: The majority of patients (<81 years: 85.7%; ≥81 years: 73.3%) had a good degree of independence at 1 year postoperatively, which was comparable in both groups. Further analysis of patients aged ≥81 years showed that longer duration from onset to surgery, more subsequent vertebral fractures, and lower preoperative body mass index were correlated with poorer outcomes postoperatively, and low body mass index, time from onset to surgery, and female sex were independent risk factors for these outcomes (area under the receiver operating characteristics curve: 0.91).

Advantages of unilateral percutaneous kyphoplasty for osteoporotic vertebral compression fractures-a systematic review and meta-analysis.

Data from English randomized controlled trials comparing unilateral versus bilateral PKP for the treatment of OVCFs were retrieved and analyzed, and the results showed that unilateral PKP is a better choice for the treatment of patients with OVCFs, which will provide a reliable clinical rationale for the treatment of OVCFs. PURPOSE: To investigate the advantages of unilateral percutaneous kyphoplasty (PKP) for the treatment of osteoporotic vertebral compression fractures(OVCFs). METHODS: The systematic evaluation program met all program requirements (CRD 42023422383) by successfully passing the PROSPERO International Prospective Systematic Evaluation Registry. Researchers searched the references of English-language randomized controlled trials comparing unilateral and bilateral PKP for the treatment of osteoporotic vertebral compression fractures published between 2010 and 2023 and manually searched for known primary and review articles. The study statistically analyzed data from all the included literature, which primarily included time to surgery, visual pain score(VAS) and Oswestry disability index(ODI) at postoperative follow-up time points, polymethylmethacrylate (PMMA, bone cement) injection dose, cement leakage, radiation dose, and improvement in kyphotic angle. RESULTS: This meta-analysis searched 416 articles published from 2010 to 2023 based on keywords, and 18 articles were finally included in this study. The results of the forest plot showed that unilateral PKP operative time, amount of bone cement used, and radiation dose to the patient were significantly reduced (p < 0.01, p < 0.01, and p < 0.01, respectively), and unilateral and bilateral PKP had comparable cement leakage (p = 0.49, 95% CI = 0.58-1.30), and there was no significant difference in the kyphotic angle between unilateral and bilateral PKP (p = 0.42, 95% CI = - 2.29-0.96). During follow-up, there was no significant difference in pain relief between unilateral and bilateral PKP (p = 0.70, 95% CI = - 0.09-0.06), nor was there a significant difference in ODI (p = 0.27, 95% CI = - 0.35-1.24). CONCLUSIONS: There is no difference in clinical efficacy between unilateral PKP and bilateral PKP, but unilateral PKP has a shorter operative time, a lower incidence of cement leakage, a lower amount of cement, and a lower radiation dose to the patient and operator. Unilateral PKP is a better option for patients with OVCFs.

A study on vertebral refracture and scoliosis after percutaneous kyphoplasty in patients with osteoporotic vertebral compression fractures.

PURPOSE: To analyze the association between scoliosis and vertebral refracture after percutaneous kyphoplasty (PKP) in patients with osteoporotic vertebral compression fractures (OVCFs). METHODS: A retrospective study was conducted on 269 patients meeting the criteria from January 2014 to October 2022. All patients underwent PKP with complete data and were followed-up for > 12 months. First, it was verified that scoliosis was a risk factor in 269 patients. Second, patients with scoliosis were grouped based on the Cobb angle to evaluate the impact of the post-operative angle. The cox proportional hazards regression analysis and survival analysis were used to calculate the hazard ratio and recurrence time. RESULTS: A total of 56 patients had scoliosis, 18 of whom experienced refractures after PKP. The risk factors for vertebral refractures included a T-score < - 3.0 and presence of scoliosis (both p < 0.001). The results indicated that the vertebral fractured arc (T10 - L4) was highly influential in scoliosis and vertebral fractures. When scoliotic and initially fractured vertebrae were situated within T10 - L4, the risk factors for vertebral refracture included a postoperative Cobb angle of ≥ 20° (p = 0.002) and an increased angle (p = 0.001). The mean recurrence times were 17.2 (10.7 - 23.7) months and 17.6 (7.9 - 27.3) months, respectively. CONCLUSION: Osteoporosis combined with scoliosis significantly increases the risk of vertebral refractures after PKP in patients with OVCFs. A postoperative Cobb angle of ≥ 20° and an increased angle are significant risk factors for vertebral refractures when scoliotic and initially fractured vertebrae are situated within T10 - L4.

The safety and efficacy of the Stryker OptaBlate™ Bone Tumor Ablation system for vertebral body metastases.

Background: Metastatic spinal lesions are a significant cause of morbidity and decreased quality of life in those with a high tumor burden. Despite treatment modalities such as medical therapy (e.g., chemotherapy, steroids), spinal augmentation procedures, and radiation therapy, many patients still experience refractory back pain due to neoplastic infiltration of the vertebral body and/or pathologic compression fractures. With the aim to address refractory pain in patients who have exhausted conventional treatment options, Stryker developed the OptablateTM Bone Tumor Ablation system (BTA; Stryker Corporation, Kalamazoo, MI), which delivers radiofrequency energy to pathologic vertebral body lesions. In this preliminary single-institution study, we characterize the use of the BTA system in 11 patients undergoing kyphoplasty for pathologic spinal lesions with the goal to demonstrate the impact of this novel technology on refractory pain in this challenging clinical setting. Methods: A single-center retrospective chart review was performed on all patients identified as those receiving tumor ablation/kyphoplasty for spinal neoplasms using the OptablateTM BTA system performed by a single surgeon at the University of Oklahoma Medical Center. Sex, age, primary lesion type, presenting symptomatology, spinal level, time of follow-up, and outcome were obtained from the electronic medical record (EMR). Results: Eleven patients (4 males, 7 females) with a mean age of 62 (range, 38-82) years had an average follow-up time of 6 months. Presenting symptoms attributed to spinal pathology included back pain (n = 11, 100%), pathologic fracture (n = 6, 55%), and lower extremity weakness (n = 3, 27%). A total of 20 lesions were ablated at 12 vertebral levels. Eight patients (73%) had improved pain. No complications were reported. Conclusion: This preliminary study documents the safety of the BTA system, in addition to its diverse use across many levels. The majority of patients reported improvement in their pain. Further study is required to fully characterize the use of the BTA system in those with neoplastic spinal pathology.

Enhancing percutaneous kyphoplasty efficacy in elderly osteoporotic fractures through optimal cement filling ratio.

Objective: To explore the appropriate bone cement filling ratio in percutaneous kyphoplasty (PKP) for the treatment of osteoporotic vertebral compression fractures (OVCF). Methods: Clinical and radiological data from 150 OVCF patients treated with PKP were retrospectively analyzed. Patients were categorized into three groups based on bone cement filling ratio: low (<0.4), medium (0.4-0.6), and high (>0.6) filling ratio groups. The clinical characteristics (age, gender, BMI, etc.) and related study data (bone cement leakage and its location, pre/post-operative Visual Analogue Scale (VAS), pre/post-operative Oswestry Disability Index (ODI), vertebral height restoration, kyphotic Cobb angle, etc.) among the three groups were compared using statistical software to compare to identify the most appropriate cement filling ratio. Results: The 0.4-0.6 group presented a lower cement leakage rate compared to the >0.6 group, and there were no significant differences in pre-operative VAS, post-operative day 2 VAS, post-operative month 1 VAS, and pre-operative ODI (p>0.05). However, significant differences were observed in post-operative month 3 VAS (p=0.002), post-operative day 2 ODI (p=0.002), post-operative month 1 ODI (p<0.001), and post-operative month 3 ODI (p<0.001). The "0.4-0.6" group showed better pain improvement and functional recovery compared with the ">0.6" group at the 3-month follow-up. While presenting the best vertebral height restoration, the ">0.6" group also exhibited the greatest variability. Additionally, no significant difference in Cobb angle changes was observed among the groups. Conclusion: A bone cement filling ratio of 0.4-0.6 in PKP treatment for OVCF strikes a favorable balance between complication reduction and positive patient outcomes, warranting it as an optimal filling volume.

Risk Factors for Residual Back Pain After Balloon Kyphoplasty for Osteoporotic Vertebral Fracture.

Background: Balloon kyphoplasty (BKP) is a method for the management of osteoporotic vertebral body fracture (OVF). However, improvement in back pain (BP) is poor in some patients, also previous reports have not elucidated the exact incidence and risk factors for residual BP after BKP. We clarified the characteristics of residual BP after BKP in patients with OVF. Hypothesis: In this study, we hypothesize that some risk factors may exist for residual BP 2 years after the treatment of OVF with BKP. Patients and Methods: A multicenter cohort study was performed where patients who received BKP within 2 months of OVF injury were followed-up for 2 years. BP at 6 months after surgery and final observation was evaluated by Visual Analog Scale (VAS) score. Patients with a score of 40 mm or more were allocated to the residual BP group, and comparisons between the residual back pain group and the improved group were made for bone density, kyphosis, mobility of the fractured vertebral body, total spinal column alignment, and fracture type (fracture of the posterior element, pedicle fracture, presence or absence of posterior wall damage, etc.). Also, Short Form 36 (SF-36) for physical component summary (PCS) and mental component summary (MCS) at the final follow-up was evaluated in each radiological finding. Results: Of 116 cases, 79 (68%) were followed-up for 2 years. Two years after the BKP, 26 patients (33%) experienced residual BP. Neither age nor sex differed between the groups. In addition, there was no difference in bone mineral density, BKP intervention period (period from onset to BKP), and osteoporosis drug use. However, the preoperative height ratio of the vertebral body was significantly worse in the residual BP group (39.8% vs. 52.1%; p = 0.007). Two years after the operation, the vertebral body wedge angle was significantly greater in the residual BP group (15.7° vs. 11.9°; p = 0.042). In the multiple logistic regression model with a preoperative vertebral body height ratio of 50% or less [calculated by receiver operating characteristic (ROC) curve], the adjusted odds ratio for residual BP was 6.58 (95% confidence interval 1.64-26.30; p = 0.007); similarly, patients with vertebral body height ratio less than 50% had a lower score of SF-36 PCS 24.6 vs. 32.2 p = 0.08. Conclusion: The incidence of residual BP 2 years after BKP was 33% in the current study. The risk factor for residual BP after BKP was a preoperative vertebral body height ratio of 50% or less, which should be attentively assessed for the selection of a proper treatment scheme and to provide adequate stabilization. Level of Evidence: III.