Development of Symptomatic Adjacent and Remote Level Compression Fractures Following Balloon-assisted Kyphoplasty in a Series of 1,318 Patients.

BACKGROUND: Balloon-assisted kyphoplasty (BAK) is a minimally invasive procedure to treat vertebral compression fractures (VCF). BAK not only restores vertebral height and corrects kyphotic deformity by cement augmentation, but it also may alter spinal biomechanics, leading to subsequent adjacent level VCFs. OBJECTIVES: This study aims to investigate the timing, location, and incidence of new VCFs following BAK and identify the risk factors associated with their occurrence. STUDY DESIGN: Single-institution observational study. METHODS: A prospectively collected cohort of 1,318 patients who underwent BAK by a single-surgeon from 2001 through 2022 was analyzed. The patients had pain that was unresponsive to nonsurgical management and a VCF secondary to osteoporosis, trauma, or neoplasm. The time between the index and subsequent fracture, fracture level, number of initial fractures, age, body mass index (BMI), tobacco use, and chronic corticosteroid use were recorded. RESULTS: Of 1,318 patients, 204 (15.5%) patients underwent a second BAK procedure an average of 373 days following BAK (range: 2-3,235 days). Third, fourth, and fifth procedures were less common (45, 12, and 6 patients, respectively). A total of 142 patients (69.6%) developed a subsequent fracture adjacent to the index level; adjacent and remote level fractures developed at different times (mean: 282 vs 581 days, P = 0.001). Patients treated for multiple VCFs in a single surgery were more likely to develop subsequent VCFs (P = 0.024) and at adjacent levels (P = 0.007). Subsequent VCFs were associated with older age (P < 0.001), women (P = 0.045), osteoporosis (P < 0.001), and chronic corticosteroid use (P < 0.001). A subgroup analysis of 812 (61.6%) patients who underwent BAK for degenerative indications revealed that osteoporosis (b = 0.09; 95% CI, 0.03-0.16; P = 0.005) and chronic corticosteroid use (b = 0.06; 95% CI, 0-0.11; P = 0.055) were associated with adjacent level fracture. For the entire cohort, almost every patient treated for both a thoracic and lumbar fracture (92.3%) developed an adjacent level second fracture (P = 0.005). LIMITATIONS: The true incidence of post-BAK fractures may be underestimated as surveillance is not routine in asymptomatic or osteoporotic patients. CONCLUSIONS: Symptomatic post-BAK VCFs are infrequent and may occur long after the initial procedure. Nearly two-thirds of subsequent fractures in our study occurred adjacent to the initially treated level; almost every patient who suffered thoracic and lumbar fractures at the same time developed an adjacent level second fracture. Additionally, osteoporosis and chronic corticosteroid use were associated with adjacent level fractures in patients who underwent surgery for degenerative indications.

Vertebral augmentation plus short-segment fixation versus vertebral augmentation alone in Kümmell's disease: a systematic review and meta-analysis.

Osteoporotic vertebral compression fractures of the thoracolumbar spine can progress to Kümmell's disease, an avascular vertebral osteonecrosis. Vertebral augmentation (VA)-vertebroplasty and/or kyphoplasty-is the main treatment modality, but additional short-segment fixation (SSF) has been recommended concomitant to VA. The aim is to compare clinical and radiological outcomes of VA + SSF versus VA alone. Systematic review, including comparative articles in Kümmell's disease, was performed. This study assessed the following outcome measurements: visual analog scale (VAS), Oswestry Disability Index (ODI), anterior vertebral height (AVH), local kyphotic angle (LKA), operative time, blood loss, length of stay, and cement leakage. Six retrospective studies were included, with 126 patients in the VA + SSF group and 152 in VA alone. Pooled analysis showed the following: VAS, non-significant difference favoring VA + SSF: MD -0.61, 95% CI (-1.44, 0.23), I2 91%, p = 0.15; ODI, non-significant difference favoring VA + SSF: MD -9.85, 95% CI (-19.63, -0.07), I2 96%, p = 0.05; AVH, VA + SSF had a non-significant difference over VA alone: MD -3.21 mm, 95% CI (-7.55, 1.14), I2 92%, p = 0.15; LKA, non-significant difference favoring VA + SSF: MD -0.85°, 95% CI (-5.10, 3.40), I2 95%, p = 0.70. There were higher operative time, blood loss, and hospital length of stay for VA + SSF (p < 0.05), but with lower cement leakage (p < 0.05). VA + SFF and VA alone are effective treatment modalities in Kümmell's disease. VA + SSF may provide superior long-term results in clinical and radiological outcomes but required a longer length of stay.

Minding the Gap in Vertebroplasty: Vertebral Body Fracture Clefts and Cement Nonunion.

BACKGROUND: Vertebroplasty and kyphoplasty are leading treatments for patients with vertebral body compression fractures. Although cement augmentation has been shown to help relieve pain and instability from fractures containing a cleft, there is some controversy in the literature regarding the procedure's efficacy in these cases. Additionally, some of the literature blurs the distinction between clefts and cement patterns (including cement nonunion and cement fill pattern). Both clefts and cement patterns have been mentioned in the literature as risks for poorer outcomes following cement augmentation, which can result in complications such as cement migration. OBJECTIVES: This study aims to identify the prevalence of fracture clefts and cement nonunion, the relationship between them as well as to cement fill pattern, and their association with demographics and other variables related to technique and outcomes. STUDY DESIGN: Retrospective cohort study. SETTING: Interventional radiology department at a single site university hospital. METHODS: This retrospective cohort study assessed 295 vertebroplasties/kyphoplasties performed at the University of Colorado Hospital from 2008 to 2018. Vertebral fracture cleft and cement nonunion were the main variables of interest. Presence and characterization of a fracture cleft was determined on pre-procedural imaging, defined as an air or fluid filled cavity within the fractured vertebral body on magnetic resonance or computed tomography. Cement nonunion was evaluated on post-procedural imaging, defined as air or fluid surrounding the cement bolus on magnetic resonance or computed tomography or imaging evidence of cement migration. Cement fill pattern was assessed on procedural and/or post-procedural imaging. Pain improvement scores were based on a visual analog score immediately prior to the procedure and during clinical visits in the short-term follow-up period. Additional patient demographics, medical history, and procedure details were obtained from electronic medical chart review. RESULTS: Pre-procedural vertebral fracture clefts were demonstrated in 29.8% of our cases. Increasing age, secondary osteoporosis, and thoracolumbar junction location were associated with increased odds of clefts. There was no significant difference in pain improvement outcomes in patients following cement augmentation between clefted and non-clefted compression fractures. Clefts, especially large clefts, and cleft-only fill pattern were associated with increased odds of cement nonunion. Procedure techniques (vertebroplasty, curette, and balloon kyphoplasty) demonstrated similar proportion of cement nonunion and distribution of cement fill pattern. LIMITATIONS: Cement nonunion was observed in only 6.8% of cases. Due to this low proportion, statistical inference tends to have low power. Multiple levels were treated in nearly half of the study's patients undergoing a single vertebroplasty/kyphoplasty session; in these cases, each level was treated as independent rather than spatially correlated within the same study patient. CONCLUSIONS: Vertebral body fracture clefts are not uncommon and are related to (but distinct from) cement nonunion and cement fill patterns. Our study shows that, although patients with clefts will benefit from cement augmentation just as much as patients without a cleft, the performing provider should take note of cement fill and take extra steps to ensure optimal cement fill. These providers should also identify cement nonunion and associated complications (such as cement migration) on follow-up imaging.

Radiculopathy Following Vertebral Body Compression Fracture: The Role of Percutaneous Cement Augmentation.

BACKGROUND: Vertebral cement augmentation is a commonly used procedure in patients with vertebral body compression fractures from primary or secondary osteoporosis, metastatic disease, or trauma. Many of these patients present with radiculopathy as a presenting symptom, and can experience symptomatic relief following the procedure. OBJECTIVES: To determine the incidence of preprocedural radiculopathy in patients with vertebral body compression fractures presenting for cement augmentation, and present their postoperative outcomes. STUDY DESIGN: Retrospective cohort study. SETTING: Interventional pain practice in a tertiary care university hospital. METHODS: In this cohort study, all patients who underwent kyphoplasty (KP) or vertebroplasty (VP) procedures in a 7-year period within our practice were evaluated through a search of the electronic medical records. The primary endpoint was to evaluate the prevalence of noncompressive preprocedural radiculopathy in our patients. Evaluation of each patient's relative improvement following the procedure, respective to the initial presence or absence of radicular symptoms (including and above T10, above and below T10, and below T10) was included as a secondary endpoint. Additional subanalysis was performed with respect to patients demographics, fracture location, and primary indication for the procedure (osteoporosis, trauma, etc.). RESULTS: A total of 302 procedures were performed during this time period, encompassing 544 total vertebral body levels. After exclusion criteria were applied to this cohort, 31.6% of patients demonstrated radiculopathy prior to the procedure that could not be explained by nerve impingement. Nearly half of patients demonstrated an optimal clinical outcome (48.5% nearly complete/complete resolution of symptoms, 40.1% partial resolution of symptoms, 11.4% little to no resolution of symptoms). Patients with fractures above T10 were more likely to see complete resolution, whereas patients with fractures above and below T10 were likely to not see any resolution. Men and women without initial radiculopathy symptoms were more likely to see little to no resolution, regardless of fracture location. LIMITATIONS: This retrospective study used an electronic chart review of clinicians' notes to determine the presence of radiculopathy and their relative improvement following the procedure. CONCLUSIONS: Preprocedural radiculopathy is a common symptom of patients presenting for the evaluation of VP or KP. The presence of radiculopathy in the absence of nerve impingement may be an important marker for those patients who may experience greater benefit from the procedure. KEY WORDS: Radiculopathy, kyphoplasty, vertebroplasty, osteoporosis, compression fracture, spine, cement augmentation.

Effect of an Outer Sleeve on an Inflatable Balloon Tamp in Terms of Height Restoration Under Simulated Physiological Load.

STUDY DESIGN: An in vitro biomechanical study. OBJECTIVE: The aim of this study was to determine the effect of an optional sleeve on height restoration and compare it with the fracture reduction achieved by a commercially available inflatable bone tamp under simulated physiological load (110 N). SUMMARY OF BACKGROUND DATA: Loss of reduction after bone tamp deflation before cement injection still remains a concern. The optional sleeve surrounds the bone tamp to help maintain height during the kyphoplasty procedure while filling the created cavity with bone cement on the contralateral side. METHODS: Eighteen osteoporotic vertebral bodies (VBs) (T11-L4) were alternately assigned to 1 of the 2 treatment groups: group A: KYPHON (Kyphon Inc.) and group B: AFFIRM with sleeve (Globus Medical Inc.). The VBs were compressed axially at a rate of 5 mm/min until compressed to 40% of the initial anterior height. The fractured VBs then underwent kyphoplasty with cement augmentation while still maintaining load (110 N). The augmented VBs were then recompressed and anterior VB height (mm) and wedge angle (degrees) were measured initially after mechanically creating an anterior wedge fracture, and after repairing the compression fracture. The effect of kyphoplasty on vertebral height, kyphotic angle, cement volumes, and inflation pressures were compared between the treatment groups. Failure load (N) data were compared between intact and repaired VBs. RESULTS: Average percentage of lost VB height restored in group A was 30%, compared with 56% for group B. The mean changes in wedge angle were similar to those of vertebral height measurements. No significant difference in mean inflation pressures (group A: 175±37 psi; group B: 160±36 psi) were found between the 2 groups. Average percentage increase in failure load was 241% and 212% in groups A and B, respectively. CONCLUSIONS: Some height restoration was observed using the commercially available bone tamp in fractured VBs under simulated physiological load. The use of an outer sleeve significantly enhanced height restoration compared with the inflatable bone tamp alone.

An In Vitro Evaluation of Fracture Reduction Achieved by Inflatable Bone Tamps Under Simulated Physiological Load.

STUDY DESIGN: An in vitro biomechanical study. OBJECTIVE: To determine the fracture reduction achieved by a novel inflatable bone tamp under simulated physiological load. SUMMARY OF BACKGROUND DATA: Previous biomechanical studies have showed that kyphoplasty allows near-total restoration of lost vertebral height in unloaded conditions and partial height restoration under simulated physiological loads. Clinically, loss of reduction has been observed after bone tamp deflation, before cement injection. The present study evaluated fracture reduction achieved by an inflatable bone tamp during kyphoplasty while maintaining physiological load. Comparison to commercially available inflatable bone tamp was also performed. MATERIALS AND METHODS: Eighteen osteoporotic vertebral bodies (T11-L4) were alternately assigned to one of the 2 treatment groups: group A-AFFIRM (Algea Thearpies, a division of Globus Medical Inc., Audubon, PA); and group B-KYPHON (Kyphon Inc., Sunnyvale, CA). The vertebral bodies were compressed axially on an MTS Bionix 858 machine at a rate of 5 mm/min until compressed to 40% of the initial anterior height. Load versus displacement was recorded. The fractured VBs then underwent kyphoplasty with cement augmentation. The augmented vertebral bodies were then recompressed and anterior vertebral body height (mm) and wedge angle (degrees) was measured initially, after mechanically creating an anterior wedge fracture, and after repairing the compression fracture. Each vertebral body was subjected to 111 N load to simulate in vivo physiological loading during inflation and cement augmentation. The vertebral height, wedge angle, cement volume, and inflation pressures were compared between the treatment groups using an unpaired t test (P<0.05). Failure loads were compared between intact and repaired VBs using a paired t test (P<0.05). RESULTS: Average lost height restored in group A was 29%, and 30% in group B compared to the compressed state. Similar trends were observed in the mean changes of vertebral body wedge angle in both the groups. No significant difference in mean inflation pressures (group A 182±33 psi; group B 175±37 psi) were found between the 2 groups. Average percentage increase in failure load was 218% and 241% for groups A and B, respectively. Mean injected cement volume was 6.65±0.65 and 6.73±0.41 mL for groups A and B, respectively. CONCLUSIONS: Some height restoration was observed using the 2 bone tamps in fractured vertebral bodies under simulated physiological load. The fracture reduction achieved by the 2 inflatable bone tamps was equivalent. No significant difference between mean inflation pressures and failure load was demonstrated between the 2 groups.

Cifoplastia guiada por TC: una opción técnica en el tratamiento de fracturas vertebrales patológicas / CT-guided kyphoplasty: a technical option in the treatment of pathological vertebral fractures

Pathological vertebral fractures are caused by various entities. They cause significant pain and impaired quality of life of patients. The CT-guided kyphoplasty relieves or eliminates pain and stabilizes the fractured vertebral bodies. 49 patients were treated. The procedure is performed percutaneously by inserting a needle that is subsequently removed, leaving a cannula. Through this a balloon-like device is introduced and subsequently inflated to create a cavity, which is then filled with polymethylmethacrylate (PMMA). The technique was performed successfully in all cases without serious complications, with good results. Its advantages are that the needle placement as well as the injection of PMMA can be correctly visualized using real-time CT fluoroscopy. In addition a single needle is used throughout the entire procedure, which minimizes the risk of complications as it is less traumatic.

Las fracturas vertebrales patológicas se originan por diversas entidades. Producen dolor importante y deterioro de la calidad de vida de los pacientes. La cifoplastia guiada por tomografía computarizada (TC) alivia o elimina el dolor y estabiliza los cuerpos vertebrales fracturados. Se han tratado 49 pacientes. El procedimiento se realiza por vía percutánea, mediante la inserción de una aguja que posteriormente se retira dejando una cánula. A través de la misma se introduce un dispositivo que lleva incorporado un balón que se infla creando una cavidad, que se rellena con polimetilmetacrilato (PMMA). La técnica se practicó con éxito en todos los casos sin complicaciones graves, con buenos resultados. Sus ventajas son visualizar correctamente la posición de la aguja y la inyección del PMMA mediante la escopia del TC en tiempo real. Además se utiliza una sola aguja para todo el procedimiento, lo cual minimiza el riesgo de complicaciones siendo menos traumático.

Clinical evaluation of a new kyphoplasty technique with directed cement flow.

STUDY DESIGN: Prospective, single-center 2-year study. OBJECTIVE: The long-term clinical performance of a new cement-directing kyphoplasty system was evaluated for treatment of painful osteoporotic compression fractures. SUMMARY OF BACKGROUND DATA: Cement leakage is a common clinical complication of vertebroplasty and kyphoplasty procedures. Balloon kyphoplasty restricts cement flow and reduces leakage by injection of high-viscosity cement into a compacted bone cavity. Biomechanical reinforcement of surrounding bone is limited, leaving the vertebral body vulnerable to continued collapse. METHODS: The patient population consisted of 20 patients at least 50 years of age with up to 3 painful osteoporotic vertebral compression fractures between T4-L5. The cement-directing kyphoplasty system procedure was performed unipedicularly using a curved drill and reamer to create a central cavity. The cement-directing implant was positioned inside the cavity and cement was injected through it. A total of 37 levels were treated. Pain relief was assessed using a verbal pain scale. The Roland-Morris Questionnaire was used to evaluate disability. Cement leakage was determined from radiographs (anterior/posterior and lateral) obtained within 24 hours of the procedure. RESULTS: : Significant pain relief was achieved immediately after the procedure, as shown by a decrease in the mean pain scores from 8.20 (±1.40) measured preoperatively to 2.85 (±2.13) measured postoperatively. Pain relief was sustained throughout the 2-year follow-up period. Mean Roland-Morris Questionnaire scores improved from 21.8 (±3.5) measured preoperatively to 11.6 (±5.6) measured 6 weeks postoperatively. The investigators reported 1 moderate cortical leak (2.7%) and an independent reviewer identified 8 additional minor segmental vein and cortical leaks (24.3%). None of the leaks was symptomatic. CONCLUSIONS: Directed cement flow allows cement to fill the anterior vertebral body, stabilizing fractures and supporting biomechanical loading. Control of cement flow may help minimize the risk of posterior leakage into the basivertebral vein or spinal canal.

Kyphoplasty versus percutaneous vertebroplasty using the traditional and the new side-opening cannula for osteoporotic vertebral fracture.

AIM: The aim of this article was to study the results of two different types of percutaneous vertebroplasty (PV) and kyphoplasty (KPs) to osteoporotic vertebral fractures (OVF). METHODS: It was prospectively analyzed a series of 47 PVs from January 2003 to February 2008, and a consecutive series 30 KPs from March 2008 to January 2010, performed for patients with painful OVFs. Twenty-five PVs were performed using the frontal-opening cannula (FOC) and 22 using the new side-opening cannula (SOC), randomly distributed in the PV group. RESULTS: The incidence of cement extrusion was 16.7% with KP, comparing with PV, it was 27.3% using the SOC (P<0.05) and 68,0% with the FOC (P<0.05), but comparing SOC with FOC, the cement extrusion was significantly lower using the SOC (P<0.05), all asymptomatic. The pain control was similar for all groups (P<0.05), with good improvement of pain in most of the patients, and there were no clinical relevant complications. CONCLUSION: The cement leakage was significantly reduced with the KP (16.7%) and the SOC (27.3%) for PV, in comparison with the FOC (68.0%). The cement extrusion was slightly lower with KP, but not a significant difference, comparing with SOC, increasing the safety of the procedure using both the KP and this new SOC.

Kyphoplasty in the treatment of osteoporotic Vertebral Compression Fractures (VCF) : procedure description and analysis of the outcomes in 128 patients.

In recent years, the advent of percutaneous techniques in the management of osteoporotic vertebral compression fractures has proven to be a great step forward in the evolution of patients suffering from this pathology.Vertebroplasty, which was developed in 1984 by Galibert and Deramond, presents the disadvantage of leakage of the cementation material and the impossibility to restore spinal deformity. Kyphoplasty has shown to be almost a definite solution to these problems. The description of the technique, its indications, and the outcomes resulting from our series of 200 vertebral fractures in 128 patients are presented in this paper.