Bilateral Percutaneous Kyphoplasty Research Articles

Risk factors for postoperative residual back pain after percutaneous kyphoplasty for osteoporotic vertebral compression fractures.

To determine the incidence of and risk factors for residual back pain in osteoporotic vertebral compression fracture (OVCF) patients after percutaneous kyphoplasty (PKP) treatment, we performed a retrospective analysis of prospective data. Patients who underwent bilateral PKP and met this study's inclusion criteria were retrospectively reviewed. Back pain intensity was assessed using a visual analogue scale (VAS) after surgery. Residual back pain was defined as the presence of postoperative moderate-severe pain (average VAS score ≥ 4), and the variables included patient characteristics, baseline symptoms, radiological parameters and surgical factors. Univariate and multivariate logistic regression analyses were performed to identify risk factors. A total of 809 patients were included, and residual back pain was identified in 63 (7.8%) patients. Of these patients, 52 patients had complete data for further analysis. Multivariate logistic regression analysis showed that risk factors for back pain included the presence of an intravertebral vacuum cleft (OR 2.93, P = 0.032), posterior fascia oedema (OR 4.11, P = 0.014), facet joint violations (OR 12.19, P < 0.001) and a separated cement distribution (OR 2.23, P = 0.043). The incidence of postoperative residual back pain was 7.8% among 809 OVCF patients following PKP. The presence of an intravertebral vacuum cleft, posterior fascia oedema, facet joint violations and a separated cement distribution were identified as independent risk factors for residual back pain.

Perioperative prevalence of deep vein thrombosis in patients with percutaneous kyphoplasty: A retrospective study with routine ultrasonography.

In recent years, deep venous thrombosis (DVT) after spine surgery has received extensive attention, but perioperative prevalence of DVT in patients undergoing percutaneous kyphoplasty (PKP) is lacking.To assess the perioperative prevalence of deep vein thrombosis (DVT) in patients undergoing PKP with routinely applied ultrasonography.We reviewed 1113 consecutive patients undergoing PKP from January 2014 to August 2017. The surgical procedure was bilateral PKP. All patients were routinely examined with ultrasonography when admitted to the hospital and on the first post-operative day. Clinical signs of DVT were checked and recorded before examination.Forty (3.6%) out of 1113 patients were diagnosed with DVT by ultrasonography. Of the 40 detected cases of DVT, only six (0.54%) patients presented with clinical signs of DVT, demonstrating that there were 34 (3.05%) asymptomatic cases. No patient presenting with clinically suspected pulmonary embolism (PE) was observed. Gender, body mass index (BMI), operative time, hypertension, diabetes, heart disease, and lower limb fracture were not significant risk factors for DVT (P > .05). In contrast, patient age, oncologic conditions, DVT history, and paraplegia appeared to be significant risk factors for DVT (P < .01). There was no significant difference in the incidence of DVT found between the three PKP surgical levels (P > .05).The total incidence of perioperative DVT diagnosed with ultrasonography in patients undergoing PKP was 3.6%, of which only 0.54% was symptomatic cases. It is necessary to assess DVT using ultrasonography during the perioperative procedure of PKP, especially for high-risk patients.Level of evidence: Level IV.

Risk Factors for Cement Leakage and Adjacent Vertebral Fractures in Kyphoplasty for Osteoporotic Vertebral Fractures.

Cement leakage and adjacent vertebral fractures are not uncommon after percutaneous augmentation. However, conclusive identification of risk factors for postprocedural complications remains elusive. The anticipation of leakage and successive fractures through the identification of risk factors will help physicians better inform patients of potential complications and establish procedural refinements key to risk reduction. The aim of this retrospective study was to summarize available reports of the risk factors for cement leak and adjacent vertebral fracture in or after kyphoplasty for osteoporotic vertebral compression fractures. A total of 102 cases of bilateral percutaneous kyphoplasty (PKP), performed between January 2014 and December 2016, were retrospectively reviewed. Each case surveyed in this review included a minimum 1-year follow-up and data on age, sex, bone mineral density, Visual Analog Scale score, preoperative compression rate, kyphotic angle, treatment time, the volume of cement, and the intactness of the vertebral posterior wall (computed tomography scan) were collected. Pearson χ test and independent samples test were used to determine the relative risk factors of cement leak and adjacent vertebral fracture in patient subsets. Diabetic status and alteration in the Cobb angle after PKP exhibited a statistically significant correlation with the incidence of new adjacent vertebral fracture (group B) (P<0.05). In addition, the integrity of vertebral walls (P=0.001) and the volume of injected cement (P=0.026) significantly boosted the potential risk of cement leakage (P<0.05), although these variables did not associate with the adjacent fracture. Additional examined variables, including age, sex, Visual Analog Scale scores, number of fractures were not significantly associated with leakage or adjacent vertebral fracture risk. Diabetes and the alteration of the Cobb angle following PKP are factors positively related to the occurrence of postoperative adjacent vertebral fractures. It is also demonstrated that the integrity of vertebral walls and average volumes of injected cement are the possible risk factors of cement leakage while performing the PKP.

Reduced Puncture Time and Radiation Exposure of Percutaneous Transpedicular Puncture with Electronic Conductivity Device: A Randomized Clinical Trial

The present study introduced an electronic conductivity device (ECD) to reduce time of percutaneous transpedicular puncture and frequency of patient valid radiation exposure in percutaneous kyphoplasty (PKP) or percutaneous vertebroplasty (PVP). A randomized self-control clinical study was undertaken. Medical records of patients with vertebral compression fractures (VCFs) for bilateral PKP or PVP were collected, and each side was performed randomly with ECD or conventional trocar. We enrolled 61 patients (44 women, 17 men) with 75 vertebras with VCF. Compared with the conventional fluoroscopy group, significant reductions in puncture time (504.33 ± 152.03 vs. 652.68 ± 167.60 seconds; P < 0.001) and fluoroscopy frequency (5.11 ± 1.23 vs. 8.15 ± 1.83; P < 0.001) for each percutaneous puncture were observed in the ECD group. When compared with the VCFs ≤50% group, the 2 indexes in the VCFs >50% group were significantly increased. And in the ECD group, the learning curve in the VCFs >50% group showed a steeper decreasing trend than that in the VCFs ≤50% group. No complications were observed in any patient. ECD could reduce puncture time of percutaneous transpedicular puncture and exposure of radiation in PVP and PKP. ECD has more benefits in complicated transpedicular puncture in patients with vertebral compression >50%.

Efficacy of unilateral transverse process-pedicle and bilateral puncture techniques in percutaneous kyphoplasty for Kummell disease.

In the present study, the efficacy of unilateral transverse process-pedicle and bilateral puncture techniques in percutaneous kyphoplasty (PKP) for Kummell disease was compared. Between March 2015 and June 2017, 63 patients with Kummell disease were recruited and underwent PKP with two different puncture techniques: A total of 38 patients were treated by unilateral transverse process-pedicle PKP and 25 patients were treated by bilateral PKP. The operative time, intra-operative fluoroscopy time, volume of bone cement injection and bone cement leakage were recorded. Prior to surgery and 1 day post-surgery, the visual analogue scale (VAS) pain score and Oswestry disability index (ODI) were determined, and the vertebral body height and Cobb angle were measured. The results indicated that the incidence of bone cement leakage in the unilateral group was similar with the bilateral group (15.79% vs. 16.00%), with no statistically significant difference between the two groups. None of the patients in the two groups had any obvious damage of the spinal cord. The operative time, intra-operative fluoroscopy time and volume of bone cement injection in the unilateral group were lower than those in the bilateral group. A chest X-ray examination at 1 day post-surgery revealed no pulmonary embolism in the two groups. The VAS score, ODI, vertebral body height and Cobb angle were significantly improved in the unilateral and bilateral groups at 1 day post-surgery and at the last follow-up (12 months post-surgery) as compared with these parameters prior to surgery. In conclusion, the unilateral transverse process-pedicle and bilateral puncture techniques in PKP exhibited good efficacy as a treatment for Kummell disease. The operative time, intra-operative fluoroscopy time and volume of bone cement injection were lower in the unilateral group.

Efficacy of bilateral sagittal cross percutaneous kyphoplasty for preventing recurrent fracture of the cemented vertebrae

To explore the efficacy of bilateral sagittal cross percutaneous kyphoplasty(PKP) for preventing recurrent fracture of the cemented vertebrae. From January 2017 to June 2017, 85 patients with single-segment osteoporotic vertebral compression fractures(OVCFs) were treated by bilateral sagittal cross PKP(cross group). There were 35 males and 50 females with an average age of (70.1±8.3) years old in cross group. Another 85 patients with single-segment OVCFs were treated by traditional PKP (traditional group). There were 37 males and 48 females with an average age of (73.3±9.5) years old in traditional group. The cement distribution condition, recurrent fracture of the cemented vertebrae, the anterior vertebral body height and sagittal Cobb angle, visual analogue scale(VAS) were observed in two groups. All patients underwent operation successfully. The follow-up time were (11.8±4.5) months in cross group and (12.1±3.7) months in traditional group. In cross group, all patients' bone cement touched the upper and lower endplates of the vertebral body while 67 cases (78.8%) in traditional group did with significant difference between two groups (P<0.05). No patient in cross group suffered recurrent fracture of the cemented vertebrae while 10 cases (11.8%) in traditional group did with significant difference between two groups(P<0.05). The anterior vertebral body height, sagittal Cobb angle and VAS in both groups were obvious improved at 2 days after operation (P<0.05) and there were no significant difference between two groups at 2 days after operation and the final follow-up(P>0.05). Bilateral sagittal cross PKP was a simple, safe and effective technique which can make bone cement distribute in the fractured vertebral body and contact the upper and lower endplates of the vertebral body, thus preventing the recurrent fracture of the cemented vertebrae.

Age, Gender, Level and Side Differences in the Anatomical Distinctions of Unilateral Percutaneous Kyphoplasty through the Transverse ProcessPedicle Approach

Background: Unilateral and bilateral percutaneous kyphoplasty (PKP) have been widely adopted to treat osteoporotic vertebral compression fractures (OVCFs). Unilateral PKP has a shorter operation time and less radiation exposure time compared with bilateral PKP, but the anatomical distinctions of unilateral PKP are not identical in all cases. Objective: The aim of this study was to examine the significance of age, gender, level, and side in relation to the anatomical distinctions of unilateral PKP for lumbar OVCFs through the transverse process-pedicle approach (TPPA). Study Design: This was a retrospective study of 200 patients. Setting: The research took place at General Hospital of Shenyang Military Area Command of Chinese PLA. Methods: Researchers examined 1000 lumbar spines (L1-L5) of 200 patients and simulated PKP on the 3D-CT scans through unilateral TPPA. The distance between the entry point and the midline of the vertebral body (DEM), the puncture inclination angle (PIA), the safe range of the inner inclination angles (SRA), and the success rate (SR) of puncture were measured and compared. Results: There were significant differences (P &lt; 0.05) in the mean DEM between men and women, and between the left and right sides. The DEM was significantly larger in men than women and in right than left. The DEM from L1 to L5 was significantly increased (P &lt; 0.05), from 22.4 ± 2.0 mm to 34.1 ± 4.3 mm. The right maximum PIA was significantly larger than the left. The maximum puncture angle and SRA in men was larger than that in women except for L5. The SRA from L1 to L5 was significantly increased (P &lt; 0.05), from 20.1 ± 6.0 mm to 44.2 ± 8.8 mm. The SR from L1 to L5 was significantly increased (P &lt; 0.05), from 88.3% to 100%. The SR in men was significantly higher than that in women for L1 and L2. Limitations: Sample size was relatively small. Conclusions: The DEM was 22.4 mm to 34.1 mm according to different levels. There were significant gender, side, and age differences in the DEM and PIA. The values of DEM, PIA, SRA and SR were significantly increased from L1 to L5. Key words: Lumbar, osteoporotic vertebral compression fracture, unilateral, percutaneous kyphoplasty, transverse process.

Is it necessary to approach the compressed vertebra bilaterally during the process of PKP?

ObjectiveTo assess the clinical and radiological outcomes following unilateral or bilateral approach in percutaneous kyphoplasty (PKP) for treatment of osteoporotic vertebral compression fractures (OVCF).DesignProspective comparative study.SettingUniversity affiliated hospital.ParicipantsFrom 2012 through 2016, those MRI-diagnosed single-level lumbar OVCF patients.InterventionsThey were randomly assigned for treatment with unilateral or bilateral PKP.Outcome measuresWe assessed the patient’ health status with the Oswestry Disability Index (ODI) questionnaire. Anteroposterior and lateral standing radiographs were obtained to measure the vertebral height and kyphotic angle of the vertebral body in all patients.ResultsEighty-five patients were finally enrolled in this investigation, including 42 in the unilateral and 43 in the bilateral group. The operation time, PMMA volume, radiation dose was 25.6 ± 4.2 minutes, 6.2 ± 3.5 ml and 0.88 ± 0.28 mSv in the unilateral group, while 36.6 ± 8.7 minutes, 8.5 ± 2.2 ml and 1.89 ± 1.05 mSv in the bilateral group, respectively (P < 0.05). The postoperative VAS and ODI were 2.7 ± 1.2 and 19.8 ± 6.4 compared to preoperative 8.7 ± 1.6 and 35.2 ± 4.3 in unilateral group, while 2.6 ± 1.3 and 19.7 ± 2.6 compared to preoperative 8.5 ± 1.3 and 36.7 ± 3.6 in bilateral group, respectively (P > 0.05).ConclusionBoth bilateral and unilateral PKP are relatively safe and provide effective treatment for patients with painful OVCF. However, unilateral PKP need less radiation dose, operation time and PMMA volume.

Incidence and risk factors of facet joint violation following percutaneous kyphoplasty for osteoporotic vertebral compression fractures.

Percutaneous kyphoplasty (PKP) has been widely used to osteoporotic vertebral compression fractures (OVCFs). No previous investigations have reported the incidence and risk factors of facet joint violation (FJV) caused by PKP. To determine the incidence and risk factors of FJV following PKP in patients with OVCFs. We reviewed a total of 153 patients who underwent bilateral PKP. Postoperative computed tomography (CT) scans were assessed to determine the degree of FJV owing to invasion by a puncture trocar. Clinical outcomes, including visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) scores, were collected from all patients. Clinical and radiological data were analyzed to identify the risk factors for FJV. FJV caused by PKP affected 18.9% of patients and 9.6% of facet joints; approximately 3.9% and 5.7% of facet joints were considered to have grade 1 and grade 2 violations, respectively. There were significant differences between the FJV and non-FJV groups in VAS and ODI scores after surgery. Significant differences were found with respect to the facet joint angle (FJA), the pedicle diameter (PD), and the distance from the entry point to the facet joint space (DEF). Multiple logistic regression analysis indicated that an FJA > 55°, a PD < 5 mm, and a DEF < 5 mm were independent risk factors for FJV. The placement of a puncture trocar can cause FJV in patients with OVCFs and impact clinical outcomes after PKP. Special attention should be given to patients with an FJA > 55°, a PD < 5 mm, and a DEF < 5 mm.

Unilateral versus bilateral percutaneous balloon kyphoplasty for osteoporotic vertebral compression fractures: A systematic review of overlapping meta-analyses.

Background:Unilateral and bilateral percutaneous balloon kyphoplasty (PKP) are 2 main approaches for the treatment of patients with osteoporotic vertebral compression fractures (OVCFs). Numerous published systematic reviews and meta-analyses evaluating the effectiveness of 2 approaches remain inconclusive. In order to propose a significant principle to make decisions for comparing clinical safety and efficacy of unilateral versus bilateral PKP for treating OVCFs patients based on the currently best available evidence, a systematic review of overlapping meta-analysis was conducted.Methods:Three electronic databases, Pubmed/Medline, Embase2 and the Cochrance Library, were searched systematically to retrieve and identify all eligible systematic reviews and meta-analyses comparing unilateral and bilateral PKP for the treatment of patients with OVCFs. Only systematic reviews or meta-analyses with an exclusively pooled analysis of randomized controlled trials (RCTs) met the minimum eligibility criteria in this investigation. The Oxford Levels of Evidence, Jadad algorithm and Assessment of Multiple Systematic Reviews (AMSTAR) instrument were adopted for evaluation of the methodological quality for each included literature to select currently best available evidence.Results:Screening determined that out of 2159, 9 meta-analyses with level II or III of evidence met the inclusion criteria in the systematic review of overlapping meta-analyses. The multiple systematic reviews scores ranged from 8 to 9 with a mean of 8.55 (median 8.5). According to the search process and selection strategies of the Jadad algorithm, a meta-analysis by Feng et al with the best available evidence (12 RCTs and an AMSTAR score of 9) demonstrated that unilateral and bilateral PKP are both nice choices for the treatment of patients with OVCFs, and no significant differences were revealed in clinical scores, radiological outcomes, and quality of life with long-term follow-up. However, compared with bilateral PKP, unilateral PKP produced a shorter surgery time, smaller dosage of cement, lower risk of cement leakage, and relieved a higher degree of intractable pain at short-term follow-up after surgery.Conclusion:Unilateral percutaneous balloon kyphoplasty is more advantageous and superior to bilateral percutaneous kyphoplasty, and should be considered an effective option for the treatment of patients with osteoporotic vertebral compression fractures.

The Impact of Facet Joint Violation on Clinical Outcomes After Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures

To determine whether the facet joint violation (FJV) impacts clinical outcomes after percutaneous kyphoplasty (PKP) in patients with osteoporotic vertebral compression fractures. Patients undergoing bilateral PKP were enrolled and divided into FJV and non-FJV groups depending on their postoperative axial computed tomography scans. Radiologic parameters, visual analogue scale (VAS), and Oswestry Disability Index (ODI) scores were obtained preoperatively and each follow-up time postoperatively (1day, 1 week, 1 month, 3 months, 6 months, and 1 year). Finally, patient satisfaction surveys also were noted. A total of 157 patients completed the 1-year follow-up. The incidence of FJV resulting from puncture trocars was 15.9% (25/157). Approximately 5.7% (9/157) and 10.2% (16/157) of patients were considered to have grade 1 and grade 2 violation, respectively. PKP decreased the VAS and ODI scores compared with the preoperative values in both groups. Patients with FJV had much greater VAS and ODI scores than did those without FJV at 1-day, 1-week, and 1-month follow-up. No significant differences were found between groups at 3-month, 6-month, and 1-year follow up. Patients in the FJV group were less satisfied with the surgical outcomes than were those without FJV at the last survey. Approximately 15.9% of patients were diagnosed with FJV by postoperative computed tomography scans. FJV had a negative influence on clinical outcomes after PKP in osteoporotic vertebral compression fractures, primarily at short-term follow-up. In addition, FJV was also a risk factor in the long-term surgical satisfaction.

Percutaneous Kyphoplasty: Is Bilateral Approach Necessary?

A multicenter retrospective study of patients who underwent unilateral and bilateral balloon kyphoplasty. The aim of this study was to compare the radiographic and clinical results of unilateral and bilateral balloon kyphoplasty to treat osteoporotic vertebral compression fractures. Percutaneous kyphoplasty has long been used as a successful method in the treatment of osteoporotic vertebral compression fractures. Although the bilateral approach is considered to be the mainstay application of percutaneous kyphoplasty, the unilateral approach has also been shown to be sufficient and even more effective in some cases. A total of 87 patients who underwent percutaneous kyphoplasty due to osteoporotic vertebral compression fractures between 2009 and 2016 were retrospectively evaluated and divided into two groups as patients who underwent unilateral or bilateral percutaneous kyphoplasty. Unilateral percutaneous kyphoplasty was performed in 36 and bilateral percutaneous kyphoplasty in 51 patients. The groups were compared in terms of clinical outcomes, radiological findings, and complications. Clinical outcomes were evaluated using Visual Analogue Scale and Oswestry Disability Index and the radiological findings were evaluated by comparing the preoperative and postoperative day 1 and year 1 values of anterior, middle, and posterior vertebral heights and kyphosis angle. Clinical improvement occurred in both groups but no significant difference was observed. In radiological workup, no significant difference was found between the groups in terms of improvements in vertebral heights and kyphosis angle. Operative time and the amount of cement used for the surgery were significantly lower in the patients that underwent unilateral kyphoplasty. Unilateral percutaneous kyphoplasty is as effective as bilateral percutaneous kyphoplasty both radiologically and clinically. Operative time and the amount of cement used for the surgery are significantly lower in unilateral kyphoplasty, which may play a role in decreasing complication rates. 3.

Is Unilateral Percutaneous Kyphoplasty Superior to Bilateral Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures? Evidence from a Systematic Review of Discordant Meta-Analyses

Several meta-analyses have been performed to compare unilateral percutaneous kyphoplasty (PKP) and bilateral PKP in the treatment of osteoporotic vertebral compression fractures (OVCFs), but inconsistencies in the results have led to questions as to which technique is preferable. This study was designed to clarify the benefits and disadvantages of unilateral PKP versus bilateral PKP as found in numerous discordant meta-analyses and thereby present surgical treatment recommendations for OVCFs considering the current best evidence. Systematic review/Meta-analysis. Meta-analyses on unilateral and bilateral PKP for OVCFs were included by searching Pubmed, Embase, and Cochrane library. Meta-analysis quality was assessed using Oxford Levels of Evidence and Assessment of Multiple Systematic Reviews (AMSTAR). The Jadad decision algorithm was used to identify the best evidence. Eight eligible meta-analyses were included, 7 of which were Level-II evidence and one was Level-III evidence. The AMSTAR scores varied from 7 to 8. The Jadad decision algorithm suggested that the best meta-analysis should be selected depending upon publication characteristics and methodology of primary studies, language restrictions, and whether data analysis was performed on individual patients. The best available evidence indicated that both unilateral and bilateral PKP could receive similar good clinical and radiological outcomes. However, without increasing the risk of complications, unilateral PKP required shorter surgical time and less cement volume, offering better pain relief and quality of life at post-operative short term follow-ups. Primary studies had defects in their methodologies. Unilateral PKP appears to be superior to bilateral PKP in the treatment of OVCFs. Osteoporotic vertebral compression fractures, percutaneous kyphoplasty, meta-analysis.

Is it Beneficial to Reuse the Balloon in Percutaneous Kyphoplasty for the Treatment of Non-Neoplastic Vertebral Compression Fractures?

BackgroundPercutaneous kyphoplasty (PKP) has been widely used to treat vertebral compression fractures (VCFs). Bilateral percutaneous punctures are always performed to access the fractured vertebrae. However, the procedure has expensive clinical costs, especially the cost for the device, which creates a heavy financial burden for patients.Material/MethodsData from 49 patients who have single-level non-neoplastic vertebral compression fracture (VCF) were collected for 12 months after treated by PKP, including 21 cases that used bilateral puncture with single balloon (S group) and 28 cases that used bilateral puncture with double balloon (D group). We assessed the clinical (visual analogue scale, VAS) and radiological (vertebral height and kyphotic angle, KA) outcomes. Cost data (gross medical cost, cost for the device and cost for drugs) were obtained from the medical bill of each patient.ResultsBaseline patient variables were similar between the two groups except the compensation (S group <D group). No severe cement leakage and only one adjacent-level fracture were observed during the follow-ups. Each group showed significant improvements in the VAS, anterior height (AH) of vertebral body and KA after PKP, while no significant differences were observed when the VAS, vertebral height, and KA at the same time were compared between the S group and the D group. Costs in the S group were significantly lower than those in the D group.ConclusionsBoth single balloon and double balloon bilateral puncture PKP are relatively safe and efficient in non-neoplastic VCFs. However, reuse of the balloon in PKP can decrease the costs.

Effectiveness comparison between unilateral and bilateral percutaneous kyphoplasty for Kümmell disease

To compare the effectiveness between unilateral and bilateral percutaneous kyphoplasty (PKP) in the treatment of Kümmell disease. The clinical data of 45 patients with Kümmell disease that met the criteria between January 2014 and February 2016 were analyzed retrospectively. Among them, 26 cases were treated by unilateral PKP (unilateral group), 19 cases were treated by bilateral PKP (bilateral group). There was no significant difference in gender, age, disease duration, injured vertebral segment, bone mineral density (T value), and the preoperative visual analogue scale (VAS) score, Oswestry disability index (ODI), anterior vertebral height, and kyphosis Cobb angle between 2 groups ( P>0.05). The operation time, intraoperative fluoroscopy times, amount of injected bone cement, and hospitalization time were recorded, and the situation of bone cement leakage was observed. The VAS score, ODI, anterior vertebral height, and kyphosis Cobb angle were evaluated before operation, at 1 day after operation, and at last follow-up. Bone cement leakage during the operation were found in 4 cases (15.38%) of unilateral group and 3 cases (15.79%) of bilateral group without obvious neurological symptoms; there was no significant difference in the incidence of bone cement leakage between 2 groups ( χ2=0.000, P=1.000). The operation time, intraoperative fluoroscopy times, and amount of injected bone cement in the unilateral group were significantly lower than those in the bilateral group ( P<0.05); but there was no significant difference in the hospitalization time between 2 groups ( P>0.05). The X-ray film examination showed that there was no pulmonary embolism in all patients at 1 day after operation. All the patients were followed up 12-24 months, with an average of 16.4 months. There was no complication such as vertebral re-fracture or cement block displacement in the injured vertebra. The VAS score, ODI, anterior vertebral height, and kyphosis Cobb angle at 1 day after operation and at last follow-up were significantly improved when compared with preoperative values in 2 groups ( P<0.05); the VAS score and ODI in 2 groups were further reduced at last follow-up when compared with the value at 1 day after operation ( P<0.05), but the anterior vertebral height and kyphosis Cobb angle in 2 groups at last follow-up did not change significantly ( P>0.05). There was no significant difference in above indexes at 1 day after operation and at last follow-up between 2 groups ( P>0.05). Both unilateral and bilateral PKP can achieve good effectiveness in treatment of Kümmell disease. But the unilateral puncture technique possesses advantages such as shorter operation time, less radiation dose, and less amount of injected bone cement.

Mid and long-term clinical effects of percutaneous kyphoplasty with two methods for vertebral fragility fracture in the elderly

To evaluate the middle-long-term clinical effects of unilateral and bilateral percutaneous kyphoplasty(PKP) for vertebral fragility fracture in the elderly. The clinical data in elderly patients with vertebral fragility fracture treated by unilateral and bilateral PKP between January 2008 and January 2010 was retrospective analyzed. According to a unified criteria to divided into two groups for 104 patients(44 males and 60 females), of them, 50 cases were divided in unilateral group using unilateral pedicle surgical approach for PKP and 54 cases were in bilateral group using bilateral pedicle approach. VAS score, Cobb angle, and the height of anterior and posterior vertebral body were respectively analyzed peroperatively and at 3 d, 3 months, 1 year, 3 years postoperatively and final follow-up. Clinical effects and safety were assessed in two groups. All the operations were successful. Operative time and bone cement injection volume in unilateral group were less than those of bilateral group(P<0.05). Postoperative VAS scores, Cobb angle, and the height of anterior and posterior vertebral body were obviously improved in two groups(P<0.05), and there was no significant difference between two groups(P>0.05). Bone cement leakage occurred in 12 cases(11.5%), recurrent fracture of vertebral body occurred in 5 cases(4.8%), cerebrospinal leak occurred in 2 cases(1.9%), and nerve root irritation occurred in 3 cases(2.9%). The above complications were transient and released after symptomatic treament. Middle-long-term clinical effects of unilateral and bilateral percutaneous kyphoplasty for vertebral fragility fracture are safe and satisfactory, and may be extended as a minimally invasive method. Unilateral approach for PKP has advantages of short operation time, relative less trauma, thus is a more ideal method.

Comparison of unilateral versus bilateral percutaneous kyphoplasty for the treatment of patients with osteoporosis vertebral compression fracture (OVCF): a systematic review and meta-analysis.

To compare the short- and long-term clinical outcomes, operation times, restoration rate, dosage of polymethylmeth-acrylate (PMMA) injected, complications and X-rays exposure frequency between unilateral and bilateral kyphoplasty approaches for the treatment of OVCF. Systematic review and meta-analysis. Randomized or non-randomized controlled trials published up to April 2015 that compared the unilateral and bilateral PKP for the treatment of OVCF were acquired by a comprehensive search in the Cochrane Controlled Trial Register, PubMed, MEDLINE, EMBASE, Web of Science, OVID. Exclusion criteria were patients with neoplastic etiology (metastasis or myeloma), infection, neural compression syndrome, invasive and degenerative disease, traumatic fracture, re-operation, neurological deficits, significant scoliosis and spinal stenosis. The main end points included: operation times, the short- and long-term postoperative Visual Analogue Scale (VAS) scores, the short-term postoperative Oswestry Disability Index (ODI), restoration rate, dosage of PMMA injected, cement leakage, X-ray exposure frequency and postoperative adjacent-level fractures. A total of 8 studies involving 428 patients were included in the meta-analysis. The mean operative time was shorter in the unilateral groups compared with the bilateral groups [P<0.05, weighted mean difference (WMD) -19.74 (-30.56, -8.92)]. There was no significant difference in the short-term postoperative VAS scores [P>0.05, WMD 0.03 (-0.34, 0.40)], the long-term postoperative VAS scores between them [P>0.05, WMD 0.01 (-0.42, 0.45)] and the short-term postoperative ODI [P>0.05, WMD -0.33 (-2.36, 1.69)] between the two groups. The unilateral approaches required significantly less dosage of PMMA than the bipedicular approaches did [P<0.05, WMD -1.56 (-1.59, -1.16)]. The restoration rate in the bilateral groups was higher than the unilateral groups [P<0.05, WMD -7.82 (-12.23, -3.41)]. There was no significant difference in the risk ratio of cement leakage [P>0.05, RR 0.86 (0.36, 2.06)] and postoperative adjacent-level fractures [P>0.05, RR 0.91 (0.25, 3.26)] between the two methods. The mean X-ray exposure frequency in the unilateral groups was greater than the bilateral groups [P<0.05, WMD -5.69 (-10.67, -0.70)]. A definitive verdict could not be reached regarding which approach is better for the treatment of OVCF. Although unilateral PKP was associated with shorter operative time, less X- ray exposure frequency and dosage of PMMA than bilateral PKP. There was no apparent difference in the short- and long-term clinical outcomes and complications between them. However, bilateral PKP approaches were higher than unilateral PKP in term of the restoration rate. But on account of lack of some high-quality evidence, we hold that amounts of high-quality randomized controlled trials should be required and more complications should be analysed to resolve which surgical approach is better for the treatment of OVCF in the future.

The prospective self-controlled study of unilateral transverse process-pedicle and bilateral puncture techniques in percutaneous kyphoplasty.

Many previous studies have reported excellent clinical results with percutaneous kyphoplasty (PKP). In contrast, numerous complications and problems have also been reported, such as puncture difficulty, cement leakage, and adjacent vertebral fracture. This study is to evaluate the application and clinical outcomes of unilateral transverse process-pedicle and bilateral PKP in the treatment of osteoporotic vertebral compression fractures (OVCF). A total of 56 cases with two levels thoracolumbar OVCF were randomly assigned for treatment with unilateral transverse process-pedicle and bilateral PKP. The patients were followed up postoperatively and were assessed mainly with regard to clinical and radiologic outcomes. Clinical outcomes were evaluated with mainly the use of a visual analogue scale (VAS) for pain. Radiologic outcomes were assessed mainly on the basis of radiation dose and bone cement distribution. The operation was completed successfully in 56 cases. In the unilateral level, the operation time, the volume of the injected cement, and radiation dose were significantly less than bilateral level. All patients had significantly improvement on VAS score after the procedures, compared with their preoperative period. In the bilateral level, 7 patients had obvious pain in the puncture sites at 1month postoperatively caused by facet joint violation. With local block treatment, the pain disappeared in all patients at the last follow-up. Both bilateral and unilateral PKP are relatively safe and effective treatments for patients with painful OVCF. But unilateral PKP received less radiation dose and operation time, offered a higher degree of deformity correction, and resulted in less complication than bilateral.