Bilateral Percutaneous Kyphoplasty Research Articles

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

To investigate the advantages of unilateral percutaneous kyphoplasty (PKP) for the treatment of osteoporotic vertebral compression fractures(OVCFs). 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. 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). 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.

Comparison of the efficacy and safety of unilateral and bilateral approach kyphoplasty in the treatment of osteoporotic vertebral compression fractures: A meta-analysis.

The study aimed to compare the efficacy and safety of unilateral versus bilateral percutaneous kyphoplasty (PKP) in treating osteoporotic vertebral compression fractures. Adhering to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, three English-language databases were systematically reviewed: PubMed, Web of Science, and the National Library of Medicine. The search was conducted between their inception and January 1, 2023. Studies that were replications or that used regression analysis were excluded. Randomized controlled trials and cohort studies that met the criteria were included, and a meta-analysis was performed. The mean follow-up duration was 17.9±9.7 months for the unilateral group and 18.4±8.3 months for the bilateral group. Eight randomized controlled trials and four cohort studies were included, comprising a total of 1,391 patients (499 males, 697 females; 195 cases did not report sex; mean age: 70.9 years; range, 45 to 82 years). Of these patients, 710 underwent the unilateral surgical approach and 681 the bilateral approach. The meta-analysis revealed that the long-term VAS was marginally higher in the unilateral PKP group (mean difference [MD]=0.09; 95% confidence interval [CI]: 0.06-0.13; p<0.001). The unilateral group also demonstrated a greater recovery rate in the postoperative kyphosis angle (MD=2.27; 95% CI: 0.67-3.87; p=0.006), shorter operation duration (MD=18.56 min; 95% CI: 8.96-28.17; p<0.001), and a lower bone cement dosage (MD=1.20 mL; 95% CI: 0.39-2.01; p=0.004). Unilateral PKP appears equally effective as bilateral PKP for treating osteoporotic vertebral compression fractures but with advantages in terms of procedure time, cement use, and pain reduction.

Comparison of the clinical effect of unilateral transverse process extrapedicular and bilateral transpedicular percutaneous kyphoplasty for thoracolumbar osteoporotic vertebral compression fracture.

Osteoporosis vertebral compression fractures (OVCF) are common with the aging process. This study aimed to compare the effects of unilateral transverse process extrapedicular (UEPKP) and bilateral transpedicular percutaneous kyphoplasty (BTPKP) for patients with thoracolumbar OVCF. Data from 136 patients with OVCF treated with single-level PKP in our hospital between May 2019 and April 2021 were studied. Patients were grouped based on surgical procedure: there were 62 patients in the UEPKP group and 74 in the BTPKP group. All clinical and radiological data were collected from medical records. Clinical outcomes, including visual analog scale (VAS), Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores of the lumbar spine, were evaluated preoperatively, postoperatively, and at the follow-up visit. The radiological evaluations (anterior vertebral height rate and local kyphosis angle) and complications were also collected. All patients had successfully improved after surgery. In the UEPKP group, patients showed a significantly shorter operating time and lower fluoroscopy frequency than patients in the BTPKP group (p < 0.05). However, a significantly better distribution score and cement volume were found in the BTPKP group (p < 0.05). The UEPKP group achieved a significantly better VAS score (0.6 ± 0.5 vs. 0.9 ± 0.8) and ODI (24.7 ± 3.1 vs. 27.5 ± 1.8) at the final follow-up visit than the BTPKP group (p < 0.05). The UEPKP group showed significantly worse radiological outcomes (anterior height rate and local kyphosis angle) at the 6- and 12-month follow-ups (p < 0.05). As for complications, the UEPKP group showed significantly fewer facet joint violations and intraspinal leakages (p < 0.05). UEPKP could be a safe and effective alternative procedure for patients with thoracolumbar osteoporotic vertebral compression fracture, which possesses an apparent advantage in reducing intraspinal leakage and facet joint violation over BTPKP.

Comparison between unilateral and bilateral percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fracture: A meta‑analysis and systematic review.

The present study collected retrospective research data and compared the safety and efficacy of unilateral and bilateral percutaneous puncture kyphoplasty for the treatment of vertebral fractures caused by osteoporosis, to guide the selection of clinical surgical methods. In the present meta-analysis, PubMed, Embase and the Cochrane Library were searched from the establishment of the databases to March 2023. Studies that reported differences in the efficacy and safety between the unilateral and bilateral approaches in the treatment of osteoporotic vertebral compression fractures were included in the analysis. Duplicate published studies, unpublished studies, studies with incomplete data, animal experiments, literature reviews and systematic studies were excluded from the analysis. All data were processed using STATA 15.1 statistical software. The pooled results demonstrated that there were no significant differences between the unilateral and bilateral approaches in the visual analog scores, Oswestry disability index, height restoration rate or incidence of cement leakage. However, the post-kyphotic angle of the unilateral approach was significantly lower than that of the bilateral approach (standardized mean difference, -0.41; 95% confidence interval, -0.68 to -0.14; P=0.003). Furthermore, the pooled results demonstrated that the unilateral approach required less operative time and a lower volume of injected cement, which is safer for elderly patients who are more likely to have underlying diseases.

Clinical outcomes with second injection after insufficient bone cement distribution in unilateral kyphoplasty for osteoporotic vertebral compressive fracture: a cohort retrospective study

BackgroundBone cement distribution is an important factor affecting pain relief and long-term prognosis of osteoporotic vertebral compression fracture (OVCF) treated with vertebral augmentation. Unilateral percutaneous kyphoplasty (PKP) is the most common procedure, and insufficient bone cement distribution is more common than bilateral PKP. However, effective remedies are remain lack. In this study, sufficient cement distribution was achieved by adjusting the working channel followed by second cement injection as a remedy in cases with insufficient cement distribution, and the purpose was to evaluate the clinical outcomes by a retrospective cohort study.MethodsFrom July 1, 2017 to July 31, 2020, OVCF patients treated with unilateral PKP were included in this retrospective cohort study. According to the bone cement distribution (insufficient cement distribution was confirmed when the cement did not exceed the mid line of the vertebral body in frontal film or/and the cement did not contact the upper/lower vertebral endplates in the lateral film.) and whether second injection was performed during surgery, the patients were divided into three groups. Insufficient group: patients with insufficient cement distribution confirmed by fluoroscopy or postoperative x-ray. Second injection group: patients with insufficient cement distribution was found during the procedure, and second injection was performed to improve the cement distribution. Control group: patients with sufficient cement distribution in one injection. The Primary outcome was cemented vertebrae re-collapse rate. The secondary outcomes included operative time, radiation exposure, cement leakage rate, VAS, ODI, and adjacent vertebral fracture rate.ResultsThere are 34 cases in insufficient group, 45 cases in second injection group, and 241 cases in control group. There was no significant difference in baseline data and follow-up time among the three groups. Primary outcome: The injured vertebrae re-collapse rate of insufficient group was significantly higher than that of second injection group (42.22% vs 20.59%, P = 0.000) and control group (42.22% vs. 18.26%, P = 0.000). Kaplan–Meier survival analysis showed that there was no significant difference in the survival time between second injection group and control group (P = 0.741, Log-rank test), both of which were significant less than that in insufficient group (P = 0.032 and 0.000, respectively). Secondary outcomes: There was no significant difference in VAS score and ODI after operation between second injection group and control group, both of which were superior to those in insufficient group (P = 0.000). At the final follow-up, there was no significant difference in VAS and ODI among the three groups (P > 0.05). The operation time of second injection group was significantly higher than that of insufficient group (53.41 ± 8.85 vs 44.18 ± 7.41, P = 0.000) and control group (53.41 ± 8.85 vs 44.28 ± 7.22, P = 0.000). The radiation exposure of the second injection group was significantly higher than that of insufficient group (40.09 ± 8.39 vs 30.38 ± 6.87, P = 0.000) and control group (40.09 ± 8.39 vs 31.31 ± 6.49, P = 0.000). The cement leakage rate of second injection group (20.59%) was comparable with that of insufficient group (24.44%) and control group (21.26%) (P = 0.877). The length of hospital stay of the second injection group (4.38 ± 1.72) was comparable with that of insufficient group (4.18 ± 1.60) and control group (4.52 ± 1.46) (P = 0.431).ConclusionsWhen cement distribution is insufficient during unilateral PKP, second injection may relieve early pain, reduce the incidence of cemented vertebral re-collapse and adjacent vertebral fracture, without increasing the cement leakage rate, although this procedure may increase the operation time and radiation exposure.

Efficacy and Safety of a 3D-printed Guide Device During Percutaneous Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures

BACKGROUND: During percutaneous kyphoplasty (PKP) for the treatment of osteoporotic vertebral compression fractures (OVCFs), repeated fluoroscopic images to adjust the puncture needle and inject the polymethylmethacrylate (PMMA) are critical steps. A method to further reduce the radiation dose would be of great value. OBJECTIVES: To assess the efficacy and safety of a 3D-printed guide device (3D-GD) for PKP in the treatment of OVCFs and compare the clinical efficacy and imaging outcomes of traditional bilateral PKP, bilateral PKP with 3D-GD and unilateral PKP with 3D-GD. STUDY DESIGN: Retrospective study. SETTING: General Hospital of Northern Theater Command of Chinese PLA. METHODS: From September 2018 through March 2021, 113 patients diagnosed with monosegmental OVCFs underwent PKP. The patients were divided into 3 groups: traditional bilateral PKP (B-PKP group, 54 patients), bilateral PKP with 3D-GD (B-PKP-3D group, 28 patients) and unilateral PKP with 3D-GD (U-PKP-3D group, 31 patients). Their epidemiologic data, surgical indices, and recovery outcomes were collected during the follow-up period. RESULTS: The operation time was significantly shorter in the B-PKP-3D group (52.5 ± 13.7 minutes) than in the B-PKP group (58.5 ± 9.5 minutes) (P = 0.044, t = 2.082). The operation time was significantly shorter in the U-PKP-3D group (43.6 ± 6.7 minutes) than in the B-PKP-3D group (52.5 ± 13.7 minutes) (P = 0.004, t = 3.109). The number of intraoperative fluoroscopy applications was significantly lower in the B-PKP-3D group (36.8 ± 6.1) than in the B-PKP group (44.8 ± 7.9) (P = 0.000, t = 4.621). The number of intraoperative fluoroscopy times was significantly lower in the U-PKP-3D group (23.2 ± 4.5) than in the B-PKP-3D group (36.8 ± 6.1) (P = 0.000, t = 9.778). The volume of injected PMMA was significantly lower in the U-PKP-3D group (3.7 ± 0.8 mL) than in the B-PKP-3D group (6.7 ± 1.7 mL) (P = 0.000, t = 8.766). The Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores were significantly decreased one day after surgery in each group. However, there were no differences in postoperative VAS and ODI scores, anterior height or local kyphotic angle of the fractured vertebrae, PMMA leakage, or refracture of the vertebral body. LIMITATIONS: Relatively small sample size and short-term follow-up period. CONCLUSION: This new innovative 3D technique makes PKP safe and effective. The bilateral PKP with 3D-GD technique, even unilateral PKP with 3D-GD, has the advantages of accurate positioning, a short operation time, and reduced intraoperative fluoroscopy times to the patient and surgeon. KEY WORDS: Percutaneous kyphoplasty, osteoporotic vertebral compression fracture, 3D printing, guide device, bilateral, unilateral, operation time, radiation exposure

Comparison of unilateral and bilateral percutaneous kyphoplasty for the treatment of osteoporotic vertebral compression fractures associated with scoliosis.

To assess the clinical and radiographic effectiveness of unilateral and bilateral percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral compression fractures (OVCF) associated with scoliosis, 52 patients with OVCF associated with scoliosis who underwent PKP were retrospectively analysed. The patients were divided into the unilateral PKP group (n=26) and the bilateral PKP group (n=26). The operation time, bone cement injection volume and frequency of intraoperative fluoroscopy were recorded and compared between the groups. Additionally, visual analogue scale (VAS) and Oswestry disability index (ODI) scores, as well as postoperative complications, including bone cement leakage and adjacent vertebral fractures, were also assessed. The operation time, bone cement injection volume and intraoperative fluoroscopy frequency were significantly lower in the unilateral compared with the bilateral group (P<0.001). The VAS score, ODI score, average vertebral body height and kyphotic angle (KA) were improved after surgery in each group with no difference in these clinical parameters between the two groups both before and after surgery. Furthermore, the proportion of cases with bone cement leakage in the unilateral group was significantly lower compared with that in the bilateral group (P<0.05). During the follow-up, there were three cases (11.5%) in the unilateral group and two cases (7.7%) in the bilateral group who suffered adjacent vertebral fractures, but there was no statistically significant difference between the two groups (P>0.05). For treating patients with OVCF accompanied by scoliosis, both unilateral and bilateral PKP could effectively relieve the acute back pain and correct the KA. However, unilateral PKP presents more advantages, such as a short operation duration and reduced intraoperative fluoroscopy frequency and bone cement leakage.

Comparison of Unilateral and Bilateral Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures.

To investigate the clinical efficacy of percutaneous kyphoplasty (PKP) with a unilateral versus bilateral approach in the treatment of osteoporotic vertebral compression fractures (OVCFs). We retrospectively analyzed a total of 147 patients (unilateral group: 79, bilateral group: 68) with OVCFs treated with PKP at the Department of Spine Surgery, Wuhan Fourth Hospital between August 2020 and January 2022. Patients' personal information, operation time, bone cement injection volume, as well as pre- and post-operative visual analogue scale (VAS), Oswestry disability index (ODI), anterior vertebral body height and Cobb angle were recorded. All 147 patients were successfully treated with PKP and were followed up for at least 6 months. Our results showed that the operative time was significantly shorter in the unilateral group (41.60±5.64) minutes than in the bilateral group (66.53±9.40) minutes, and the volume of bone cement injected was also significantly less in the unilateral group (5.27±0.73) mL than in the bilateral group (6.87±0.93) mL (P<0.01). The VAS score, ODI index, vertebral height and Cobb angle at postoperative follow-up were significantly improved in both groups compared to the preoperative period (P<0.01); However, the difference between the two groups was not statistically significant (P>0.05). Repeat thoracic and lumbar radiographs showed cement leakage in seven cases (8.86%) in the unilateral group and five cases (7.35%) in the bilateral group, but all were asymptomatic and required no further management. During our entire follow-up period, there were five adjacent vertebral fractures in the unilateral group (6.33%) and four in the bilateral group (5.88%). There was no significant difference between the two groups in terms of improvement in VAS score, ODI index, restoration of vertebral body height, and posterior convexity deformity, but unilateral puncture had the advantage of shorter operative time and less cement injection.

Effect of different bone cement distributions in percutaneous kyphoplasty on clinical outcomes for osteoporotic vertebral compression fractures: A retrospective study.

Osteoporotic fractures and their complications are becoming increasingly harmful to the elderly. This study aimed to evaluate the clinical results of connected or unconnected bilateral cement after bilateral percutaneous kyphoplasty (PKP) in patients with osteoporotic vertebral compression fractures (OVCF). The clinical data of 217 patients with single-segment OVCF were retrospectively collected. Patients were allocated into 2 groups according to the bilateral bone cement in the vertebrae was connected or unconnected after surgery. The surgery-related indexes of the 2 groups were compared, including operation time; bone cement injection volume; contact situation between bone cement and the upper and lower endplates of the vertebral body; visual analogue scale (VAS) scores before surgery, 1 week and 1 year after surgery; Oswestry disability index (ODI) before surgery, 1 week and 1 year after surgery; local kyphosis angle (LKA) before surgery, 1 week and 1 year after surgery; postoperative vertebral body height at 1 week and 1 year after surgery; vertebral body height restoration rate (HRR) at 1 week and 1 year after surgery. The follow-up results of all patients were recorded. The postoperative VAS, ODI, vertebral body height, LKA and other indexes of the 2 groups were significantly improved compared with those before the operation (P < .05), and there was no significant difference between the 2 groups (P > .05). At the same time, there were no significant difference in vertebral body HRR and bone cement leakage rate between the 2 groups (P > .05). X-ray examination showed that 21 of 217 patients (21/217, 9.8%) had a refracture of the injured vertebral body, including 16 cases (16/121, 13.2%) in the unconnected group and 5 cases (5/96, 5.2%) in the connected group (P < .05). Adjacent vertebrae fractures occurred in 25 cases (25/217, 11.5%), while 19 cases (19/121, 15.7%) were in the unconnected group and 6 cases (6/96, 6.3%) were in the connected group (P < .05). PKP has a good therapeutic effect on OVCF no matter whether the bilateral bone cement is connected or not. However, if the bilateral cement inside the vertebra was connected, the risk of recollapse of the injured vertebrae and the new fracture of adjacent vertebrae could be reduced.

Bilateral percutaneous kyphoplasty achieves more satisfactory outcomes compared to unilateral percutaneous kyphoplasty in osteoporotic vertebral compression fractures: A comprehensive comparative study.

Osteoporotic vertebral compression fractures (OVCFs) are the most common complication of osteoporosis, a worldwide disease that disturbs the elderly. The purpose of the study was to comprehensively compare the clinical efficacy of unilateral percutaneous kyphoplasty (UPKP) and bilateral percutaneous kyphoplasty (BPKP) when treating OVCFs and evaluate their ability to maintain the outcomes in a 2-year follow-up. From January 2015 to December 2016 a total of 79 patients with OVCFs were included in the study. They were divided into UPKP group and BPKP group. Subsequently, perioperative data, radiological outcomes, clinical outcomes, and complications were compared between two groups. The follow-up consultation was 3months, 1year, and 2years after the operation. 37 of patients (14 males, 23 females) were allocated to the UPKP group and 42 patients (13 males, 29 females) were treated with BPKP. The duration of operation and injected cement volume were significantly higher in the BPKP group than those of the UPKP group. BPKP achieved significantly higher improvement in middle height and volume of the fractured vertebral body than UPKP did. There were significantly higher losses of anterior, middle height and volume of the fractured vertebral body in the UPKP group at 2-year follow-up than in the BPKP group. At the final follow-up, Oswestry Disability Index (ODI) of BPKP group was lower than that of UPKP group. Both UPKP and BPKP achieve satisfactory radiological and clinical outcomes when treating OVCFs. However, in a 2-year follow-up, BPKP maintains vertebral height restoration, volume of vertebral body, and ODI better than UPKP do.

Comparative evaluation of an innovative deflectable percutaneous kyphoplasty versus conventional bilateral percutaneous kyphoplasty for osteoporotic vertebral compression fractures: a prospective, randomized and controlled trial

BACKGROUND CONTEXTOsteoporotic vertebral compression fractures (OVCFs) can be treated with percutaneous kyphoplasty (PKP). In contrast to conventional PKP, the novel deflectable percutaneous kyphoplasty (DPKP), is a unilateral transpedicular approach procedure allowing a similar bilateral puncture effect, which owes to the deflectable curved bone expander creating a transcentral line cavity to achieve uniform distribution of cement and biomechanical balance while reducing operative time and radiation exposure. PURPOSEThe purpose of this study was to prospectively compare and evaluate an innovative surgical procedure, DPKP, versus conventional bilateral percutaneous kyphoplasty (BPKP). STUDY DESIGNThis is a prospective randomized controlled trial (RCT). SAMPLEThe totality of the participants (n=90) suffering from OVCFs between May 2019 and October 2020, were randomized by SAS 9.3 to generate a block randomization sequence, which was utilized to randomize the groups in a 1:1 ratio, assigned to the DPKP group (n=45) and the BPKP group (n=45) to undergo accordingly procedures. OUTCOME MEASURESThe primary outcome was the total operative time. The secondary outcomes included: comparative assessment of visual analog scale (VAS) scores, Oswestry disability index (ODI), kyphosis angle (KA), anterior border height (AH) of the injured vertebra, frequency of intraoperative X-ray fluoroscopy, the injection volume, distribution pattern and leakage rate of bone cement. METHODSAll subjects underwent assessment by at least one senior orthopedist and radiologist for the VAS scores, ODI, KA, AH of the injured vertebra, total operative time, the injection volume, distribution pattern, leakage rate of bone cement at preoperative and 24 hours, 6 months, and 1 year postoperatively. Inclusion criteria for subjects in this prospective study were as follows: (1) 60 < age < 80 years old; (2) preoperative spinal X-ray, CT, and MRI confirmed as single-segment, fresh thoracolumbar OVCFs (T5–L5, 15% < collapse < 80%); MRI shows low signal on T1–WI and high signal on T2–WI, especially with STIR high signal characterized by vertebral edema; (3) painful OVCFs refractory to medical treatment, 2 weeks < Symptom duration < 3 months;(4) With significant physical signs of local tenderness; (5) T score of bone mineral density (BMD) < -2.5. RESULTSThe total operative time was significantly reduced in the DPKP group (43.3±19.58 minutes, 95% CI: 37.23–49.37) compared to the BPKP group (55.16±11.56 minutes, 95% CI: 51.78–58.54) (p<.001). Compared to the BPKP group (frequency of intraoperative X-ray fluoroscopy: 43.42±8.64, 95% CI: 40.90–45.95; the volume of bone cement injected: 5.56±0.85 mL, 95% CI: 5.31–5.81), the frequency of intraoperative X-ray fluoroscopy (30.05±17.41, 95% CI: 24.66–35.45) and volume of bone cement injected (5.08±0.97 mL, 95% CI: 4.78–5.38) significantly reduced in the DPKP group compared to the (p<.001). In addition, compared to the preoperative period, both groups showed significant improvements in the postoperative VAS scores, ODI, KA, and AH (p<.001), but there was no statistical difference between the DPKP and BPKP groups (p>.05) at any time-point. Interestingly, although without statistical differences, a tendency towards a lower rate of bone cement leakage was observed in the DPKP group. CONCLUSIONOur study results indicate that the innovative DPKP is as safe and effective as BPKP in relieving pain, improving the patient's quality of life, and reconstructing vertebral body height. Particularly, DPKP did reduce operative time and radiation exposure compared to BPKP, which correlated with unilateral and bilateral exposure procedures. Moreover, the final cement distribution was less predictable in DPKP, and further studies are warranted to clarify the advantages of DPKP versus conventional unilateral percutaneous kyphoplasty (UPKP) and BPKP.

Evaluation of safety and clinical efficacy of bilateral percutaneous kyphoplasty in treatment of osteoporotic thoraco-lumbar burst fractures

Objective: To evaluate the safety and clinical efficacy of bilateral percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral burst fractures. Methods: It was a prospective study, 28 patients with osteoporotic thoraco-lumbar burst fractures who were treated in Beijing Chao-Yang Hospital from January 2021 to July 2021 were included, including 10 males and 18 females, with a median age of 73.6 years (range: 56.0-87.0 years). The X-ray radiographs, bone mineral density (BMD), CT three-dimensional reconstruction scan and MRI were taken and measured before operation to observe the fracture location and the posterior wall of the vertebral body, and further to determine the diagnosis. The X-ray radiographs and CT three-dimensional reconstruction scans were taken on the first day after operation and the last follow-up to observe whether there were bone cement leakage or not. The changes of kyphosis angle (KA), the height of anterior wall (HAW) and the height of posterior wall (HPW) before the operation, on the 1st day post operation and at the last follow-up were recorded. The visual analogue scale (VAS) of back pain and Oswestry dysfunction index (ODI) before the operation, 1 day post operation and at the last follow-up were used to evaluate the clinical effect of the operation. Results: All the patients were followed up for (12.2±6.0) months. The HAW on the 1st day post operation [(22.5±2.0) mm] was significantly increased as compared with that before the operation [(21.2±2.4) mm] (P<0.05). The HAW at the last follow-up [(18.9±1.6) mm] decreased signficantly as compared with that on the 1st day post opertion [(22.5±2.0) mm] (P<0.05). The HPW was also significantly corrected after surgery (P<0.05). At the end of the follow-up, the HPW [(27.2±1.3) mm] was comparable with that on the 1st day after surgery [(27.5±1.6) mm] (P>0.05). The KA on the 1st day after the operation (14.2°±1.5°) decreased significantly when compared with that before the operation (18.8°±1.3°) (P<0.05), but it was increased to 17.6°±1.4° at the last follow-up and was higher than that on the 1st day after the operation (P<0.05). There were bone cement leakage in 5 cases and adjacent vertebral fracture in 1 case. The VAS and ODI scores were all significantly lower on the 1st day and at last follow-up than that before the operation (all P<0.05). Conclusions: Bilateral PKP is effective, safe and reliable in the treatment of osteoporotic vertebral burst fracture. Careful evaluation of preoperative imaging data, accurate puncture and timing of bone cement injection are the key factors to ensure the success of the operation.

The influence of diverse bone cement distribution patterns for metastatic vertebral lesions after bilateral percutaneous kyphoplasty

ObjectiveTo investigate the influence of diverse bone cement distribution patterns in patients with metastatic vertebral lesions after bilateral percutaneous kyphoplasty (PKP).MethodsFifty-nine patients with single-level metastatic vertebral lesions who received bilateral PKP were retrospectively reviewed. According to the different bone cement distribution patterns, patients were divided into confluent (n = 35, CF) and separated (n = 24, SP) groups. Indicators including visual analogue scale (VAS), Oswestry Disability Index (ODI), vertebral body height (VBH) variation, quality of life (QoL), and related complications were reviewed and compared between the two groups.ResultsNo statistically significant differences were observed between the two groups in age, sex, types of lesions, locations of lesions, posterior vertebral body and/or pedicle involvement, percentage of vertebral invasion, procedure duration or cement volume (p > 0.05). There was significant improvement in VAS, ODI, VBH and QoL at any follow-up examination (p < 0.05) compared with those preoperatively. The CF group exhibited better pain relief in VAS scores than did the SP group just at 3 days and 1 month after PKP (p < 0.05). There were no significant differences between the two groups in VAS scores at 3 months or 1 year after PKP (p > 0.05). No statistically significant differences were observed between the two groups in terms of ODI, VBH or QoL (p > 0.05). There was no statistically significant difference in the incidence of complications between the two groups (p > 0.05).ConclusionsMore rapid pain relief was achieved with confluent rather than separated bone cement distribution patterns in PKP for patients with metastatic vertebral lesions.

A Comparison Between Modified Unilateral Extrapedicular and Bilateral Transpedicular Percutaneous Kyphoplasty in the Treatment of Lumbar Osteoporotic Vertebral Compression Fracture

Few researchers have verified the clinical efficacy and safety of the modified unilateral extrapedicular approach (mUEP) applied to the percutaneous kyphoplasty (PKP) in comparative studies with other puncture techniques. Compared with the bilateral transpedicular approach (BTP), whether mUEP PKP is a preferred treatment for lumbar osteoporotic vertebral compression fracture (OVCF) remains unclear. Patients treated by PKP for single-level lumbar OVCF in our institution from September 2019 to December 2020 were retrospectively enrolled. Patients were grouped according to the puncture techniques. Clinical and radiologic outcomes were evaluated preoperatively, postoperatively, and at follow-up. The clinical evaluation was performed by using visual analog scale for pain relief and Oswestry Disability Index for health status. Radiologic measurements contained anterior vertebral height, kyphotic angle, and bone cement distribution. In total, 76 patients with a mean follow-up duration of 16.6 months were enrolled, including 34 patients in the mUEP PK group and 42 patients in the BTP PKP group. In the mUEP group, operation time, fluoroscopy times, and injected cement volume were significantly less than that in the BTP group (P < 0.01). Both visual analog scale and Oswestry Disability Index scores of all patients decreased significantly after surgery (P < 0.01), with no significant differences between the 2 groups at each follow-up. Both mUEP PKP and BTP PKP showed significant anterior height restoration and kyphotic angle correction (P < 0.01), with no significant differences between the 2 groups at each follow-up. Meanwhile, the mUEP PKP reduced the incidence of intraspinal cement leakage (P < 0.05), and no facet joint violation was found in mUEP PKP. mUEP PKP could be clinically and radiographically equivalent to BTP PKP. However, it has advantages in reducing operation time and fluoroscopy times, lowering the risk of intraspinal cement leakage, and preventing the presence of facet joint violation. Compared with BTP PKP, the mUEP PKP seems to be an effective and alternative puncture technique for the treatment of lumbar OVCF after appropriate patient selection.

Development and Internal Validation of Supervised Machine Learning Algorithm for Predicting the Risk of Recollapse Following Minimally Invasive Kyphoplasty in Osteoporotic Vertebral Compression Fractures.

BackgroundThe published literatures indicate that patients with osteoporotic vertebral compression fractures (OVCFs) benefit significantly from percutaneous kyphoplasty (PKP), but this surgical technique is associated with frequent postoperative recollapse, a complication that severely limits long-term postoperative functional recovery.MethodsThis study retrospectively analyzed single-segment OVCF patients who underwent bilateral PKP at our academic center from January 1, 2017 to September 30, 2019. Comparing the plain films of patients within 3 days after surgery and at the final follow-up, we classified patients with more than 10% loss of sagittal anterior height as the recollapse group. Univariate and multivariate logistic regression analyses were performed to determine the risk factors affecting recollapse after PKP. Based on the logistic regression results, we constructed one support vector machine (SVM) classifier to predict recollapse using machine learning (ML) algorithm. The predictive performance of this prediction model was validated by the receiver operating characteristic (ROC) curve, 10-fold cross validation, and confusion matrix.ResultsAmong the 346 consecutive patients (346 vertebral bodies in total), postoperative recollapse was observed in 40 patients (11.56%). The results of the multivariate logistical regression analysis showed that high body mass index (BMI) (Odds ratio [OR]: 2.08, 95% confidence interval [CI]: 1.58–2.72, p < 0.001), low bone mineral density (BMD) T-scores (OR: 4.27, 95% CI: 1.55–11.75, p = 0.005), presence of intravertebral vacuum cleft (IVC) (OR: 3.10, 95% CI: 1.21–7.99, p = 0.019), separated cement masses (OR: 3.10, 95% CI: 1.21–7.99, p = 0.019), cranial endplate or anterior cortical wall violation (OR: 0.17, 95% CI: 0.04–0.79, p = 0.024), cement-contacted upper endplate alone (OR: 4.39, 95% CI: 1.20–16.08, p = 0.025), and thoracolumbar fracture (OR: 6.17, 95% CI: 1.04–36.71, p = 0.045) were identified as independent risk factors for recollapse after a kyphoplasty surgery. Furthermore, the evaluation indices demonstrated a superior predictive performance of the constructed SVM model, including mean area under receiver operating characteristic curve (AUC) of 0.81, maximum AUC of 0.85, accuracy of 0.81, precision of 0.89, and sensitivity of 0.98.ConclusionsFor patients with OVCFs, the risk factors leading to postoperative recollapse were multidimensional. The predictive model we constructed provided insights into treatment strategies targeting secondary recollapse prevention.

Bilateral percutaneous balloon kyphoplasty through unilateral transverse process-extrapedicular approach for osteoporotic vertebral compression fracture of lumbar

To evaluate the feasibility and short-term effectiveness of bilateral percutaneous balloon kyphoplasty through unilateral transverse process-extrapedicular approach for osteoporotic vertebral compression fracture (OVCF) of lumbar. A retrospective analysis was made on the clinical data of 93 patients with OVCF of lumbar who met the selection criteria between January 2018 and June 2019. According to the different surgical methods, they were divided into group A (44 cases, treated with bilateral percutaneous balloon kyphoplasty through unilateral transverse process-extrapedicular approach) and group B [49 cases, treated with percutaneous kyphoplasty (PKP) via bilateral transpedicle approach]. There was no significant difference in gender, age, body mass index, T value of bone mineral density, injury cause, fractured level, time from injury to operation, comorbidities, and preoperative Cobb angle of injured vertebra, visual analogue scale (VAS) score, and Oswestry disability index (ODI) between the two groups ( P>0.05). The operation time, intraoperative fluoroscopy times, bone cement injection amount, and incidence of bone cement leakage were recorded and compared between the two groups; Cobb angle of the injured vertebrae, VAS score, and ODI were measured before operation, at 2 days and 1 year after operation. The contralateral distribution ratio of bone cement was calculated according to the anteroposterior X-ray film at 2 days after operation. The operation time and the intraoperative fluoroscopy times in group A were significantly less than those in group B ( P<0.05). There was no bone cement adverse reactions, cardiac and cerebrovascular adverse events, and no complications such as puncture needles erroneously inserted into the spinal canal and nerve injuries occurred in the two groups. Bone cement leakage occurred in 6 cases and 8 cases in groups A and B, respectively, all of which were asymptomatic paravertebral or intervertebral leakage, and no intraspinal leakage occurred; the bone cement injection amount and incidence of bone cement leakage between the two groups showed no significant differences ( P>0.05). The contralateral distribution ratio of bone cement in group A was significantly lower than that in group B ( t=2.685, P=0.009). Patients in both groups were followed up 12-20 months, with an average of 15.3 months. The Cobb angle of the injured vertebrae, VAS score, and ODI in the two groups were significantly improved at 2 days after operation, however, the Cobb angle of the injured vertebra at 1 year after operation was significantly lost when compared with the 2 days after operation, the VAS score and ODI at 1 year after operation were significantly further improved when compared with the 2 days after operation, the differences were all significant ( P<0.05). There was no significant difference in the Cobb angle of the injured vertebrae, VAS score, and ODI between the two groups at each time point after operation ( P>0.05). Bilateral percutaneous balloon kyphoplasty through unilateral transverse process-extrapedicular approach is comparable to bilateral PKP in short-term effectiveness with regard to fracture reduction, reduction maintenance, pain relief, and functional improvement. It has great advantages in reducing operation time and radiation exposure, although it is inferior in bone cement distribution.

Comparison of unilateral and bilateral puncture percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fractures.

Objectives:To compare the clinical efficacy of unilateral and bilateral puncture PKP in the treatment of OVCFs and explored whether there is a difference in the efficacy of unilateral and bilateral puncture PKP after surgery.Methods:A total of 98 patients with OVCFs treated by PKP from August 2016 to June 2018 were selected. There were 62 cases in the unilateral puncture group and 36 cases in the bilateral puncture group. The operation time, the amount of bone cement injection, the height of the anterior edge of the vertebral body and the visual analog scale (Visual Analog Scale, VAS) scores before and after the operation were analyzed, and whether the differences between the 2 groups were statistically significant was analyzed.Results:All patients were followed up completely. The operation time and the number of X-ray fluoroscopies of the unilateral puncture group were significantly reduced compared to those of the bilateral group, and the difference was statistically significant (p<0.05). In terms of the bone cement injection volume, the average injection volume of the bilateral group was greater than that of the unilateral group, and the difference was statistically significant (p<0.05); the postoperative VAS scores of the 2 groups of patients were significantly improved, and the difference was statistically significant compared with that before surgery (p<0.05) but that of the unilateral group was not statistically significant compared with that of the bilateral group (p>0.05). The height of the anterior edge of the vertebral body in both groups was significantly improved compared with that before the operation, and the difference was statistically significant (p<0.05).Conclusion:Unilateral and bilateral puncture PKP can achieve good clinical efficacy in the treatment of osteoporotic vertebral compression fractures, but unilateral PKP has the advantages of short operation time and low X-ray exposure.

Comparison of percutaneous curved kyphoplasty and bilateral percutaneous kyphoplasty in osteoporotic vertebral compression fractures: a randomized controlled trial

BackgroundHere we compared the clinical efficacy of bilateral percutaneous kyphoplasty (PKP) and percutaneous curved kyphoplasty (PCKP) in the treatment of osteoporotic vertebral compression fractures (OVCF).MethodsSeventy-two patients with single-level thoracolumbar OVCF were randomly divided into 2 groups (36 patients in each) and were subjected to either PCKP or bilateral PKP. The intraoperative fluoroscopy time, total surgical time, bone cement injection volume, bone cement leakage, preoperative and postoperative anterior vertebral height, Cobb angles, visual analog scales (VAS) and oswestry disability index questionnaire (ODI) were recorded.ResultsBoth groups of patients had a trend towards improvements in VAS and ODI scores 24 h and 6 months after surgery, when compared to preoperative results, despite lack of statistical significance. The total surgical and intraoperative fluoroscopy times and intraoperative bone cement injection volume were significantly decreased in the PCKP group than those in the PKP group. The anterior edge height and Cobb angle of the injured vertebra were similarly improved after operation in both groups.ConclusionPCKP is safer, less invasive and quicker than traditional bilateral PKP despite similar short-term effects for the treatment of OVCF.Trial registrationChiCTR, ChiCTR2100042859. Registered 25 January 2021- Retrospectively registered.

Is It Necessary to Approach the Severe Osteoporotic Vertebral Biconcave-Shaped Fracture Bilaterally During the Process of PKP?

PurposeThe goal of this study was to explore the outcomes of unilateral and bilateral approach percutaneous kyphoplasty (PKP) using CT-guidance in the treatment of severe osteoporotic single-level vertebral biconcave-shaped fracture.MethodsWe retrospectively reviewed 89 patients with severe osteoporotic single-level vertebral biconcave-shaped fracture who had undergone unilateral and bilateral PKP surgeries using CT-guidance at our hospital between June 2013 and June 2019, and followed for at least 1 year. All patients were divided into unilateral (the transverse process-pedicle approach, n = 49) and bilateral (the pedicle approach, n = 40) groups. We collected the clinical and radiological evaluation results during postoperative and last follow-up periods.ResultsOur findings revealed that the surgery time for the unilateral group was significantly shorter than that of the bilateral group at P < 0.05. The amount of bone cement and radiation exposure of the unilateral group were significantly lesser than that of the bilateral group (P < 0.05). Relative to preoperative data, the values of the VAS score and Oswestry disability index (ODI) were significantly improved at 1 day after surgery and the last follow-up in the two groups (P < 0.05). Notably, the median height of vertebra at 1 day after surgery and the last follow-up in the unilateral group was significantly restored than that of preoperative data (P < 0.05). However, the median height of vertebra at the same time intervals in the bilateral group showed no significant change compared with preoperative data (P > 0.05). Furthermore, the rate of bone cement leakage and incidence of adjacent-level vertebra fracture were not significantly different in the two groups (P > 0.05). Finally, both groups can obtain an asymmetrical distribution of bone cement in the vertebra.ConclusionCompared to the bilateral PKP, unilateral PKP using CT-guidance in the treatment of the sOVBFs exhibits significantly shorter operation time, lesser radiation dose, and complications. Moreover, unilateral PKP can restore the median height of the vertebral body and eventually obtain a symmetrical distribution of bone cement in the vertebra.

Efficacy and safety of unilateral and bilateral percutaneous balloon kyphoplasty for AOspineA3/A4 osteoporotic thoracolumbar burst fractures.

To retrospectively evaluate the efficacy and safety of unilateral and bilateral percutaneous balloon kyphoplasty (PKP) in the treatment of osteoporotic thoracolumbar burst fractures.Retrospectively collected clinical data of 138 patients with osteoporotic thoracolumbar burst fractures who underwent unilateral (n = 70) and bilateral (n = 68) PKP in our hospital from March 2015 to December 2018. The general conditions, operation time, radiation exposure time, intraoperative blood loss, bone cement dosage, hospitalization expenses, and complications were collected from the two groups. Visual analog scale (VAS) values, Cobb's angle changes, average vertebral height changes, and Oswestry Dysfunction Index (ODI) values before treatment, 1 month, and 6 months after treatment were collected.There was no significant difference in gender (male: 28 vs 22; female 42 vs 46) and age (70.25 ± 7.10 vs 69.82 ± 8.20, P > .05) distribution between the two groups. The VAS score (7.38 ± 1.34 vs 2.52 ± 0.99, P < .05), ODI (77.24 ± 6.98 vs 23.11 ± 3.54, P < .05), vertebral mean height (16.71 ± 2.18 vs 17.05 ± 1.94, P < .05) and Cobb's angle (20.26 ± 3.21 vs 11.58 ± 3.20, P < .05) of the two groups were significantly improved after operation, but there was no significant difference between the two groups (P > .05). There was no significant difference in the rate of cement leakage (10.29% vs 11.42%, P > .05), incision swelling (30.88% vs 19.71%, P > .05) and incidence of adjacent vertebrae (4.41% vs 5.71%, P > .05) between the two groups. Compared with bilateral PKP group, operation time (50.88 ± 7.38 vs 62.18 ± 8.01), intraoperative blood loss (14.54 ± 3.16 vs 22.03 ± 5.92), radiation exposure time (23.74 ± 3.41 vs 15.22 ± 3.70), bone cement dosage (4.36 ± 0.81 vs 5.16 ± 0.77) and hospitalization costs (2.38 ± 0.08 vs 2.74 ± 0.07) were significantly lower in the unilateral PKP group (P < .05).Bilateral PKP and unilateral PKP have the same efficacy and safety in the treatment of osteoporotic thoracolumbar burst fractures. However, the unilateral PKP has the characteristics of short operation time, small trauma, low cost and short radiation exposure time, and has clinical application value.