Incidence and Clinical Risk of Cement Extravasation in Adult Patients Undergoing Prophylactic Vertebroplasty During Surgical Spine Reconstruction.
Bohl Michael A,Sethi Rajiv,Leveque Jean-Christophe
OBJECTIVE:To measure the incidence and severity of cement extravasation in adult patients undergoing prophylactic vertebroplasty as part of a spinal reconstruction procedure. METHODS:Consecutive adult patients treated with prophylactic vertebroplasty during a spinal reconstruction procedure were reviewed over a 46-month period. Patients without a postoperative computed tomography scan were excluded. Spine reconstruction was defined as any procedure involving ≥6 levels of fusion or a 3-column osteotomy. Cement extravasation was graded using a novel grading system. Fisher exact tests were performed to identify independent predictors of cement extravasation. RESULTS:Inclusion and exclusion criteria were met by 34 patients comprising 112 vertebral bodies (VB). All 34 patients (100%) had computed tomography evidence of cement extravasation. Of 112 VBs, 103 (92.0%) demonstrated cement extravasation. Thirteen VBs (11.6%) in 9 patients (26.5%) had cement extending to the vena cava or end-organs or cement causing spinal canal stenosis (grade 4 and 5 extravasation). No permanent clinical sequelae were found in these 9 patients. Upper thoracic vertebrae (C7-T6) had significantly higher rates of grade 4 and 5 extravasation than lower thoracic-lumbar vertebrae (T7-L5) (P = 0.004). CONCLUSIONS:Although no patients in this study experienced known long-term consequences of prophylactic vertebroplasty, 26.5% of patients had cement extravasation that threatened end-organs or neural elements. These results prompted us to change our practice from cementing upper thoracic VBs to using hooks instead. Cement injection is associated with serious risks and should be performed selectively. Larger prospective studies are needed to verify these results.
Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.
Buchbinder Rachelle,Johnston Renea V,Rischin Kobi J,Homik Joanne,Jones C Allyson,Golmohammadi Kamran,Kallmes David F
The Cochrane database of systematic reviews
BACKGROUND:Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice. OBJECTIVES:To update the available evidence of the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures. SEARCH METHODS:We updated the search of CENTRAL, MEDLINE and Embase and trial registries to 15 November 2017. SELECTION CRITERIA:We included randomised and quasi-randomised controlled trials (RCTs) of adults with painful osteoporotic vertebral fractures, comparing vertebroplasty with placebo (sham), usual care, or another intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events. DATA COLLECTION AND ANALYSIS:We used standard methodologic procedures expected by Cochrane. MAIN RESULTS:Twenty-one trials were included: five compared vertebroplasty with placebo (541 randomised participants), eight with usual care (1136 randomised participants), seven with kyphoplasty (968 randomised participants) and one compared vertebroplasty with facet joint glucocorticoid injection (217 randomised participants). Trial size varied from 46 to 404 participants, most participants were female, mean age ranged between 62.6 and 81 years, and mean symptom duration varied from a week to more than six months.Three placebo-controlled trials were at low risk of bias and two were possibly susceptible to performance and detection bias. Other trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding.Compared with placebo, high- to moderate-quality evidence from five trials (one with incomplete data reported) indicates that vertebroplasty provides no clinically important benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success at one month. Evidence for quality of life and treatment success was downgraded due to possible imprecision. Evidence was not downgraded for potential publication bias as only one placebo-controlled trial remains unreported. Mean pain (on a scale zero to 10, higher scores indicate more pain) was five points with placebo and 0.6 points better (0.2 better to 1 better) with vertebroplasty, an absolute pain reduction of 6% (2% better to 10% better, minimal clinical important difference is 15%) and relative reduction of 9% (3% better to14% better) (five trials, 535 participants). Mean disability measured by the Roland-Morris Disability Questionnaire (scale range zero to 23, higher scores indicate worse disability) was 14.2 points in the placebo group and 1.7 points better (0.3 better to 3.1 better) in the vertebroplasty group, absolute improvement 7% (1% to 14% better), relative improvement 10% better (3% to 18% better) (three trials, 296 participants).Disease-specific quality of life measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (scale zero to 100, higher scores indicating worse quality of life) was 62 points in the placebo group and 2.75 points (3.53 worse to 9.02 better) in the vertebroplasty group, absolute change: 3% better (4% worse to 9% better), relative change: 5% better (6% worse to 15% better (two trials, 175 participants). Overall quality of life (European Quality of Life (EQ5D), zero = death to 1 = perfect health, higher scores indicate greater quality of life) was 0.38 points in the placebo group and 0.05 points better (0.01 better to 0.09 better) in the vertebroplasty group, absolute improvement: 5% (1% to 9% better), relative improvement: 18% (4% to 32% better) (three trials, 285 participants). In one trial (78 participants), 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; 95% CI 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute difference: 9% more reported success (11% fewer to 29% more); relative change: 40% more reported success (33% fewer to 195% more).Moderate-quality evidence (low number of events) from seven trials (four placebo, three usual care, 1020 participants), up to 24 months follow-up, indicates we are uncertain whether vertebroplasty increases the risk of new symptomatic vertebral fractures (70/509 (or 130 per 1000; range 60 to 247) observed in the vertebroplasty group compared with 59/511 (120 per 1000) in the control group; RR 1.08 (95% CI 0.62 to 1.87)).Similarly, moderate-quality evidence (low number of events) from five trials (three placebo, two usual care, 821 participants), indicates uncertainty around the risk of other serious adverse events (18/408 or 76 per 1000, range 6 to 156) in the vertebroplasty group compared with 26/413 (or 106 per 1000) in the control group; RR 0.64 (95% CI 0.36 to 1.12). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses indicate that the effects did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Including data from the eight trials that compared vertebroplasty with usual care in a sensitivity analyses altered the primary results, with all combined analyses displaying considerable heterogeneity. AUTHORS' CONCLUSIONS:Based upon high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty for treating acute or subacute osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with placebo (sham procedure) and subgroup analyses indicated that the results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks.Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the high- to moderate-quality evidence that shows no important benefit of vertebroplasty and its potential for harm.
Cement injection and postoperative vertebral fractures during vertebroplasty.
Hu Le,Sun Hao,Wang Hua,Cai Jun,Tao Yuping,Feng Xinmin,Wang Yongxiang
Journal of orthopaedic surgery and research
OBJECTIVE:Vertebroplasty is the most widely used method for treating osteoporotic vertebral compression fractures (OVCF). During this procedure, bone cement is injected into the vertebral body. Fracture and additional fractures can occur adjacent to the treatment site. Thus, we studied factors causing such vertebral fractures after vertebroplasty and calculated the appropriate amount of bone cement to inject. METHODS:From September 2012 to March 2016, 187 patients with OVCF undergoing vertebroplasty were selected, and 112 patients with complete follow-up information were selected. Of these, 28 had adjacent vertebral fractures (refracture group) during the follow-up period, and 84 patients had no adjacent vertebral fractures (control group). Then, sex, age, body weight, bone mineral density (BMD), and bone cement injection (bone cement injection volume and bone fracture vertebral volume percent) were compared. RESULTS:All patients had significant pain relief within 24 h (preoperative and postoperative [24 h later] VAS scores were 7.4 ± 0.8 and 2.3 ± 0.5, respectively). The age and weight were not statistically significantly different (P > 0.05). BMD values were statistically significantly different between groups as was sex (P < 0.05). CONCLUSIONS:Bone cement injection volume, BMD values, and sex were statistically significantly related to adjacent vertebral fractures after vertebroplasty, and cement injection volumes exceeding 40.5% caused adjacent vertebral fractures.
Vertebroplasty for acute painful osteoporotic vertebral compression fractures: An update.
Lamanna Anthony,Maingard Julian,Kok Hong Kuan,Ranatunga Dinesh,Looby Seamus T,Brennan Paul,Chua Michelle,Owen Andrew,Brooks Duncan Mark,Chandra Ronil V,Asadi Hamed
Journal of medical imaging and radiation oncology
Vertebral compression fractures (VCFs) are a common cause of back pain and disability and are usually osteoporotic in nature. Therapy aims to adequately control pain and allow early mobilisation and return of function while preventing additional fractures. A proportion of patients do not achieve adequate pain relief using conservative measures alone. Unwanted adverse effects from medications may also ensue. Vertebroplasty represents an alternative treatment option for VCFs. Patients with acute VCFs (≤6 weeks old) may gain the most benefit from vertebroplasty as healed fractures are not as amenable to cement injection. High-quality studies have reported conflicting results regarding the use of vertebroplasty in the treatment of acute VCFs. Despite high-quality evidence, varying study designs and heterogenous patient cohorts make interpretation of this data difficult. Only one sham-controlled randomised controlled trial (RCT) has evaluated vertebroplasty exclusively in patients with acute VCFs, reporting favourable results. Pooled data from RCTs also suggest vertebroplasty to be safe. This article provides a concise and critical review of the current literature regarding vertebroplasty for the treatment of acute VCFs.
Osteoporotic thoracolumbar compression fractures: long-term retrospective comparison between vertebroplasty and conservative treatment.
Martikos Konstantinos,Greggi Tiziana,Faldini Cesare,Vommaro Francesco,Scarale Antonio
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
PURPOSE:To compare long term clinical and radiographic outcomes in osteoporotic vertebral compression fractures of the thoracolumbar spine treated with conservative treatment and percutaneous vertebroplasty. METHODS:The retrospective study with inclusion criteria focused on osteoporotic fractures of the thoracolumbar junction (T10-L2). Clinical outcomes were evaluated by using the VAS, Oswestry and SF36 questionnaires. Radiographic outcomes were evaluated by comparing the following sagittal parameters: body angle, sagittal index of fractured vertebral body and adjacent vertebral segments kyphosis. Complications in terms of adjacent vertebral fractures and cement leakage are reported. RESULTS:Percutaneous vertebroplasty provided better vertebral body height restoration, but was associated with a higher incidence of adjacent fractures (20%) than conservative treatment (3.5%). This fact may explain why patients treated with percutaneous vertebroplasty had worse overall kyphotic alignment at final follow-up. Cement leakage was frequent, but always asymptomatic and generally no serious complications occurred. CONCLUSIONS:Percutaneous vertebroplasty represents a safe treatment for osteoporotic vertebral compression fractures, although it may be associated with a higher incidence of adjacent fractures and therefore worse thoracolumbar kyphosis and long-term follow-up than conservative treatment. These slides can be retrieved under Electronic Supplementary Material.
The effect of prophylactic vertebroplasty on the incidence of proximal junctional kyphosis and proximal junctional failure following posterior spinal fusion in adult spinal deformity: a 5-year follow-up study.
Raman Tina,Miller Emily,Martin Christopher T,Kebaish Khaled M
The spine journal : official journal of the North American Spine Society
BACKGROUND CONTEXT:The incidence of proximal junctional kyphosis (PJK) ranges from 5% to 46% following adult spinal deformity surgery. Approximately 66% to 76% of PJK occurs within 3 months of surgery. A subset of these patients, reportedly 26% to 47%, develop proximal junctional failure (PJF) within 6 months postoperatively. To date, there are no studies evaluating the impact of prophylactic vertebroplasty on PJK and PJF incidence at long-term follow-up. PURPOSE:The purpose of this study is to evaluate the long-term radiographic and clinical outcomes, and incidence of PJK and PJF, after prophylactic vertebroplasty for long-segment thoracolumbar posterior spinal fusion (PSF). STUDY DESIGN:This is a prospective cohort study. PATIENT SAMPLE:Thirty-nine patients, of whom 87% were female, who underwent two-level prophylactic vertebroplasty at the upper instrumented and supra-adjacent vertebrae at the time of index PSF were included in this study. OUTCOME MEASURES:Clinical outcomes were assessed using the Scoliosis Research Society-22 (SRS-22), and Short-Form (SF) 36 questionnaires, and the Oswestry Disability Index (ODI). Radiographic parameters including PJK angle, and coronal and sagittal alignment, were calculated, along with relevant perioperative complications and revision rates. METHODS:Of the 41 patients who received two-level prophylactic vertebroplasty at the upper instrumented and supra-adjacent vertebrae at the time of index PSF, and comprised a cohort with previously published 2-year follow-up data, 39 (95%) completed 5-year follow-up (average: 67.6 months). Proximal junctional kyphosis was defined as a change in the PJK angle ≥10° between the immediate postoperative and final follow-up radiograph. Proximal junctional failure was defined as acute proximal junctional fracture, fixation failure, or kyphosis requiring extension of fusion within the first 6 months postoperatively. RESULTS:Thirty-nine patients with a mean age of 65.6 (41-87) years were included in this study. Of the 39 patients, 28.2% developed PJK (11: 7.7% at 2 years, 20.5% between 2 and 5 years), and 5.1% developed acute PJF. Two of the 11 PJK patients required revision for progressive worsening of the PJK. There were no proximal junctional fractures. There was no significant difference in preoperative, immediate postoperative, and final follow-up measurements of thoracic kyphosis, lumbar lordosis, and coronal or sagittal alignment between patients who developed PJK, PJF, or neither (p>.05). There was no significant difference in ODI, SRS-22, or SF-36 scores between those with and without PJK or PJF (p>.05). CONCLUSIONS:This long-term follow-up demonstrates that prophylactic vertebroplasty may minimize the risk for junctional failure in the early postoperative period. However, it does not appear to decrease the incidence of PJK at 5 years.
What are the predictors of clinical success after percutaneous vertebroplasty for osteoporotic vertebral fractures?
Denoix Elsa,Viry Flore,Ostertag Agnes,Parlier-Cuau Caroline,Laredo Jean-Denis,Cohen-Solal Martine,Bousson Valérie,Funck-Brentano Thomas
OBJECTIVES:Osteoporotic vertebral fractures are responsible for acute pain and disability that may persist for more than 2 months. We wanted to identify predicting factors for mid-term outcome after vertebroplasty. METHODS:We included consecutive patients who underwent vertebroplasty for fragility fractures with persistent and intense pain between January 2014-June 2016. Outcome was assessed by an independent clinician after 1 month using a standardized questionnaire. Patients were classified as having either a favorable or a poor outcome. Presence of an intravertebral cleft and bone oedema mean signal intensity was assessed by an independent radiologist blinded to the clinical data. Pre-intervention clinical or radiological factors were analysed as predictors for outcome. RESULTS:In the 78 included patients (females 71%, age 75 ± 8.3 years), 61.5% had a favourable outcome. When vertebroplasty was performed within 2 months after fracture, the outcome was favourable in 19 patients (39.6%) and poor in five (16.7%; estimate for favourable outcome: OR = 4.1, 95% CI 1.2-13.8, p = 0.021). Absence of intravertebral cleft on pre-intervention imaging was also a predictor of favourable outcome (OR = 3.7, 95% CI 1.2-11.8, p = 0.024). On pre-intervention MRI, vertebral body oedema intensity signal did not influence the outcome. CONCLUSIONS:In patients with persistent and intense pain after an osteoporotic vertebral fracture, early intervention and absence of intravertebral cleft were predictors of favourable outcome at 1 month after vertebroplasty. KEY POINTS:• Performing vertebroplasty within 2 months following a fragility fracture increases success rate. • Presence of an intravertebral cleft at baseline is a predictor of poor mid-term outcome. • A pre-intervention MRI should be performed to ascertain the indication of vertebroplasty.