Continuing Education Activity

Vertebral augmentation is a medical intervention designed to address vertebral compression fractures, a common complication of osteoporosis. The 2 primary procedures involved are vertebroplasty and kyphoplasty, both involving cement injection into the fractured vertebra to restore height, correct kyphosis, and alleviate pain. Vertebroplasty entails direct injection, while kyphoplasty involves the preliminary inflation of a balloon to create a cavity for cement injection. These procedures aim to enhance patient mobility, reduce pain, and mitigate the risk of complications associated with vertebral fractures, such as adjacent fractures and increased mortality.

Participants will gain comprehensive knowledge of vertebroplasty and kyphoplasty techniques, including indications, contraindications, procedural steps, and potential complications. Participation in this course enhances the competence of interprofessional teams by fostering collaboration and mutual understanding of each member's role in vertebral augmentation procedures. Physicians, radiologists, nurses, and technologists learn to work synergistically, ensuring seamless patient care from diagnosis to post-procedure follow-up. By sharing expertise and insights, the team optimizes patient outcomes and minimizes the risk of complications associated with vertebral fractures.

Objectives:

• Identify the indications for vertebral augmentation, such as osteoporotic compression fractures and other conditions warranting intervention.

• Implement vertebral augmentation procedures with precision and adherence to established protocols, demonstrating proficiency in both vertebroplasty and kyphoplasty techniques to achieve fracture reduction, vertebral height restoration, and kyphotic correction.

• Select appropriate materials, including cement types and delivery methods, for vertebral augmentation procedures, taking into account patient-specific factors and the goals of the intervention.

• Coordinate postoperative care and follow-up, ensuring continuity in patient care and collaborating with rehabilitation professionals to support the patient's recovery and mitigate the risk of future fractures.

Introduction

Vertebral compression fracture (VCF) is the most common complication of osteoporosis, affecting about 1.4 million individuals annually worldwide.[1] Among populations aged 70 and above, the global incidence of osteoporotic vertebral compression fractures is approximately 20%, while postmenopausal women exhibit a 15% incidence rate.[2] In the United States alone, nearly 750,000 new VCF cases surface annually, especially prevalent in cohorts with concurrent osteoporosis, contributing to estimated medical costs of $1.2 billion.[3]

These fractures exhibit a propensity for continuous compression, presenting heightened risks of retropulsion.[4] Notably, VCFs harbinger a 5-fold increase in the likelihood of adjacent or remote fractures, coupled with elevated mortality within the first year. Conservative treatments often prove ineffectual, carrying an augmented risk of medical complications and kyphotic deformities. Propensity-matched studies reveal a substantial mortality risk ranging from 2% to 42% at 12 months among nonsurgical management cohorts. Furthermore, in the osteoporosis milieu, 'kyphosis begets kyphosis,' with nonsurgical management exacerbating osteoporosis, contributing to increased economic burdens and social restrictions.

In contrast, vertebral augmentation (VA) emerges as a promising intervention, restoring vertebral height, enhancing sagittal alignment, and alleviating pain.[3] Significantly, VA mitigates the perils associated with prolonged immobilization and kyphotic deformities, such as compromised pulmonary compliance, decubitus ulcers, and deep vein thromboses.[5] This underscores the pivotal role of VA in managing VCFs, offering a more comprehensive and effective approach to address the multifaceted challenges posed by osteoporosis-related complications.

Anatomy and Physiology

The human spine comprises 33 vertebrae, meticulously arranged in a column with each vertebra neatly stacked upon the other, showcasing a sophisticated design. Among the spinal segments, the lumbar spine, consisting of 5 vertebrae, is the most common site of compression fractures that require VA. Intervertebral discs between each vertebra function as shock absorbers, preventing bone-on-bone contact. The posterior aspect of the vertebra contains a spinous process that is palpable on a physical exam. Lateral to the spinous process are 2 transverse processes connecting to the spinous process via laminae. Pedicles connect the vertebral body to the transverse processes anteriorly. The vertebral arch comprises the pedicles, laminae, spinous, and transverse processes.The spinal canal runs anteriorly within the hollow space created by the vertebral body, transverse processes laterally, and laminae and spinous processes posteriorly.

The spinal cord, approximately 2.5 cm thick, extends from the brainstem to the first lumbar vertebra (L1), diverging into the cauda equina. Thirty-one spinal nerves branch off the spinal canal, exiting under the pedicles at the intervertebral foramen. There are 8 cervical spinal nerves (C1-C8), 12 thoracic spinal nerves (T1-T12), 5 lumbar spinal nerves (L1-L5), 5 sacral spinal nerves (S1-S5), and 1 coccygeal nerve organized and numbered according to their corresponding vertebra.Each vertebra has 4 facet joints, and the 2 superior and 2 inferior facets connect each vertebra. Facet joints also interconnect adjacent vertebrae with 2 superior and 2 inferior facets per vertebra. For instance, the superior facets of L2 connect to the inferior facets of L1 superiorly, forming a continuous chain. Longitudinally running along the spine, paravertebral muscles provide crucial support. The ligamentum flavum, anterior longitudinal ligament, ALL, and posterior longitudinal ligament, PLL, are the 3 main ligaments that contribute to spinal stability. The ALL and PLL are band-like structures traversing the vertebral bodies, preventing excessive vertebral motion, while the ligamentum flavum attaches between the laminae of each vertebra. These intricate components collaborate to uphold the spine's integrity and functionality.

Indications

The literature recommends VA in the instances listed below. Fractures present for over 6 months are unlikely to improve.

• Osteoporotic vertebral compression fractures (VCF) causing non-radicular and intractable pain refractory to conservative treatment measures (rest, medications, bracing, physical therapy, exercise, and nerve root blocks) 
• Symptomatic vertebral body microfracture
• Rapidly progressive fracture harbingering kyphosis
• Severe kyphosis restricting pulmonary compliance
• Recurrent fracture or adjacent fracture
• Painful VCFs associated with osteonecrosis, nonunion, or cystic degeneration
• Primary osteolytic diseases (eg, multiple myeloma) that cause refractory pain, severely restricting activities of daily living 
• Osteolytic metastases that cause refractory pain, severely restricting activities of daily living 
• Vertebral fractures due to osteogenesis imperfecta
• Pseudoarthroses following avascular necrosis of the vertebral body [2][6][7][8]

Contraindications

Absolute Contraindications 

• Fracture that breaches the posterior vertebral wall
• Burst fracture
• Retropulsed bone fragments
• Spinal instability
• Clinical evidence of concurrent myelopathy or radiculopathy
• Osteoblastic vertebral lesions
• Coagulopathy
• Systemic infection (ie, bacteremia)
• Spinal infection (eg, osteomyelitis or spondylodiscitis)
• Medical comorbidities that preclude emergent surgical decompression
• Allergy to bone cement
• Pregnancy
• Vertebra plana

 Relative Contraindications

• A loss of vertebral body height greater than 75%
• Damaged pedicles and facets 
• Tumors invading the spinal canal [8]

Equipment

When performing VA, certain items are necessary, including:

• Local anesthesia
• General anesthesia
• Peripheral intravenous (IV) assess
• Provisions for IV fluids 
• Patient monitoring units
• Fluoroscopy 
• Trochar
• A balloon tamp
• Bone cement delivery system
• Bone cement: The cements currently available in the US are polymethylmethacrylate (PMMA) and a bioactive calcium phosphate micro-glass cement that is 33% difunctional methacrylates and 67% bioactive glass-ceramic. The latter is much stronger than PMMA with a decreased propensity for causing exothermic reactions (60 °C versus 70 °C to 90 °C with PMMA). 

Personnel

Performing VA requires a highly skilled clinician, typically an orthopedic surgeon or neurosurgeon, who has completed an accredited residency and fellowship program. The specialist should be able to evaluate the patient clinically, correctly interpret radiographic imaging, technically perform the procedure, expertly handle imaging systems, have knowledge of radiation safety protocols, and manage complications that may arise during the procedure. In addition to the clinician performing the procedure, intraoperative personnel should include an anesthesiologist, a radiologic technologist, and a nurse.[8]

Preparation

The specifications of the procedure mandate the following:

• Appropriately trained clinicians and support personnel 
• High-resolution fluoroscopy
• Image recording and archiving system
• Patient monitoring units
• Easy access to CT and magnetic resonance imaging (MRI)
• Facility available for emergency support and spinal decompression [8]

Technique or Treatment

Kyphoplasty and vertebroplasty stand out as the predominant modalities of VA, a procedure still endorsed by Medicare since 2001 and facilitated by Food and Drug Administration (FDA)-approved cements since 2004.[4]

Kyphoplasty, in particular, emerges as a highly effective intervention, providing significant advantages over vertebroplasty. Kyphoplasty achieves remarkable vertebral height restoration (97% compared to 30% in vertebroplasty), imparts restored stiffness to the vertebral structure, and exhibits a notably lower incidence of cement leaks. The risk of leaks and embolization of free monomers within the liquid cement is mitigated through kyphoplasty, especially along venous sinuses, osseous cracks, and fissures. The innovative use of an inflatable bone tamp in kyphoplasty compacts trabecular bone, effectively sealing potential paths of cement leakage via bone or veins.

Despite its higher cost, balloon kyphoplasty has gained prominence and is performed 3 times more frequently than vertebroplasty in the United States.[3] This underscores its widespread acceptance and preference, likely attributed to its superior outcomes and risk mitigation features. The continuous advancements in VA techniques, coupled with FDA-approved types of bone cement, reinforce the position of kyphoplasty and vertebroplasty as pivotal interventions in managing VCFs.

The following are the most widely used techniques for VA:

Percutaneous Vertebroplasty 

Percutaneous vertebroplasty (PVP) was first performed by Galibert and Deramondet in 1987 to manage cervical vertebral hemangioma.[2] PVP for osteoporotic fractures was first described by Lapras et al in 1989.[5] PVP involves fluoroscopy to guide the percutaneous injection of bone cement, such as PMMA, through the pedicle and into the collapsed vertebral bodies. The goal is to stabilize the fractures and optimize pain reduction.[3] 

Percutaneous Kyphoplasty 

Percutaneous kyphoplasty (PKP), a technique designed for fracture reduction, vertebral height restoration, and kyphosis correction, was introduced nearly a decade after the advent of PVP.[3][5] PKP facilitates the injection of PMMA or mineralized collagen-modified PMMA into the created cavity under low pressure, effectively minimizing the risk of cement leakage (1% to 8% in PKP vs 30% in PVP).[2]

In this procedure, a balloon or bone tamp is percutaneously introduced under image guidance through the pedicle into the vertebral body and inflated to establish a cavity, simultaneously elevating the endplates. Thicker, partially cured cement with high viscosity is injected into this closed cavity at low velocity. While the bipedicular approach was initially commonplace, the current trend favors the unipedicular approach due to reduced operative time, lower cement volume, and diminished radiation hazards. A meta-analysis has demonstrated no differences in pain, functional outcomes, or the risk of cement leakage between the 2 approaches.[2]

The expedient elevation of the end plate and restoration of vertebral body height within 1 month characterizes the efficacy of this procedure. Some proponents recommend performing VA within 10 days before the impending fracture impaction to prevent deformity. Kyphoplasty also offers the advantage of providing an option for biopsy. However, drawbacks include increased cost, exposure to contrast agents, and the general anesthesia requirement. Compared to vertebroplasty, kyphoplasty is typically executed via a bipedicular approach.

Radiofrequency Kyphoplasty 

During radiofrequency kyphoplasty (RFK), an osteotome creates multiple channels within the cancellous portion of the fractured vertebra. The radiofrequency then enables ultrahigh viscosity injections and accelerates the polymerization process. RFK is just as effective as PKP in stabilizing and restoring the height of the fractured vertebra. This also improves pulmonary function. Additionally, RFK is a fast procedure that minimizes damage to the trabecular bone and reduces the risk of cement leaks. RFK is superior in managing postoperative fractures and the secondary loss of height.[2] 

SpineJack System

The SpineJack system restores the height of the compressed vertebral, followed by balloon kyphoplasty and bone cement injection (cement volume of only 10% compared to 30% in PKP).[2] 

OsseoFix System

The OsseoFix system consists of an expandable titanium mesh cage implanted into the anterior third of the body of stable Arbeitsgemeinschaft fur Osteosynthesefragen (AO) fractures (Type A1.1 to A1.3 or A3.1) and then slowly expanded. The cement is then injected into the cage.[2] 

KIVA System

This polymer-based flexible implant system restores the vertebral body's height and holds the cement.[3] A nitinol coil guidewire is advanced through a deployment cannula percutaneously into the cancellous portion of the vertebra. A polyetheretherketone implant is placed over the coil until the desired fractured vertebral height is restored. The guidewire is removed, and the column is filled with bone cement injected through the implant pipe. The complications, such as adjacent fractures and cement leaks, are low when compared to PKP.[2] 

Vertebral Body Stenting

The vertebral body stenting system involves inserting a balloon-expandable metal stent mounted on a balloon catheter into the vertebral body. Two stents are inserted bilaterally and inflated with a contrast-saline solution under pressures up to 30 atm. This symmetrically expands both stents. The stent implants are made of a strong and ductile cobalt-chromium alloy commonly used in coronary and peripheral artery stenting. The unexpanded stent comes pre-crimped on the balloon and gradually expands to its final large-diameter configuration. This expansion is facilitated by its laser-cut mesh pattern where individual 1/4 x 1/2 mm thick struts keep spreading apart until fracture reduction or the maximum diameter of 17 mm is reached. Once the balloon-assisted stent expansion is complete, the balloons are deflated and retrieved, leaving both stents behind to keep the restored height. PMMA cement is injected into the cavities supported by the stent mesh structures to produce a stent-reinforced cement implant within the treated vertebral body.[9]

Vertebroplasty Procedure

When performing vertebroplasty, it is important to rule out tenderness in the sacroiliac and facet joints.[4] In cases of multiple compression fractures, the severity of the fractures can be determined by examining marrow edema in T1 and short-tau inversion recovery MRI sequences, focal intense uptake in bone scans, and end plate fracture line alongside paravertebral soft tissue density in CT images.[4] Vertebroplasty involves passing through the neural arch beyond the spinal canal into the vertebral body, so it must be extremely reliable, precise, accurate, and safe.[4] A thorough understanding of the fluoroscopic anatomy of the vertebral column is crucial. Obtaining true lateral projections, identifying the medial cortex of the pedicle on the anteroposterior views, and obtaining biplanar fluoroscopic images during needle placement are important. PVP can be performed with the patient under local or conscious sedation, but PKP requires general anesthesia. The salient steps involved in the procedure include:

• Adherence to sterile precautions is imperative throughout the procedure to ensure its safety and efficacy.
• Proper anatomic alignment is crucial, particularly in cases of severe kyphosis. Achieving true midline alignment of the endplates and the spinous process prevents the noncorresponding pedicle from overlapping with the target vertebral body. Superimposing the ribs and demarcating the posterior margin of the vertebral bodies and endplates in the lateral view is essential.
• Centering the pedicle within the vertebral body (craniocaudally) is vital, especially in cases with severe compressions, to ensure the needle traverses through the central portion of the vertebral body. Maintaining a 5° obliquity prevents the needle tip from being obscured by the hub of the trocar.
• The lateral margin of the pedicle is then targeted by a 13-gauge bevel-tipped needle at 9 o'clock or 3 o'clock, respectively, followed by a 'gun barreling' technique using a free hand or a mallet. Advancing the trocar to the midline of the pedicle helps prevent overshooting the vertebral body.
• In the lateral projections, the safe clearance of the spinal canal is confirmed by positioning the needle anterior to the posterior margin of the vertebral body. If the needle remains posterior to this margin, it should be withdrawn, and the process repeated, starting 2 mm lateral to the initial target. Turning the bevel 180° may provide additional space, eliminating the need to restart the entire procedure.
• The needle is then further advanced, stopping 1 cm short of the anterior cortex of the vertebral body. During cement injection under continuous lateral fluoroscopic monitoring, utmost caution is exercised to prevent cement from extending beyond 5 mm anterior to the posterior margin of the vertebral body. Cement volume is carefully regulated based on the spinal level to avoid complications. Cement volumes are restricted to 1 mL on high thoracic levels (total ≤2 mL), 2 mL on low thoracic levels (total ≤ 4 mL), and no more than 3 mL on lumbar levels (total <6 mL). In the anteroposterior projection, cement distribution should be within the lateral third of the vertebrae.[4]

Unilateral curved percutaneous vertebroplasty (PVP) demonstrates advantages such as reduced operative time, injected cement volume, cement leakage rate, and radiation risks, with comparable clinical outcomes to bilateral straight PVP.[10] On the other hand, unilateral percutaneous kyphoplasty (PKP), the more common procedure, carries a higher risk of insufficient bone cement distribution. The second injection in PKP minimizes the risk of cemented vertebral recollapse and adjacent vertebral fracture without increasing the odds of cement leakage rate.[11] Additionally, PKP allows for obtaining a biopsy to rule out multiple myeloma and other neoplasms.[4]

The maintenance therapy consists of diagnosing osteoporosis via a dual x-ray absorptiometry scan and treating it with calcium, vitamin D, and parathyroid hormone analogs (teriparatide). Robotic-assisted surgery holds promise in improving the precision of the procedure.[12]

Complications

In a comprehensive study involving 1932 patients, the overall complication rate was 8.6%. Minor complications occurred at a rate of 2.7%, while major complications were observed at 4.9%. The overall mortality rate was recorded at 2.1%. Notably, mortality exhibited a significant association with cohorts classified under the American Society of Anesthesiologists grade 4, along with elevated creatinine levels. Moreover, an increased white blood cell count and hypoalbuminemia were identified as factors elevating the odds of major complications.[13]

An additional analysis, comprising 15 randomized controlled trials involving 1098 patients undergoing PVP, reported an incidence of procedure-related complications at 1.5%.[5] Two patients (0.18%) experienced serious adverse events. These events included an adjacent segment new fracture with osteomyelitis in the Buchbinder study (where prophylactic antibiotics were omitted due to multiple drug allergies) and respiratory arrest during sedation in the vertebroplasty for acute painful osteoporotic compression fractures (VAPOUR) trial. Significantly, no procedure-related mortality was documented.[5]

Complications related to VA include:

• Vasovagal reactions
• Neuraxial anaesthesia
• Postprocedural pain
• Collateral thermal damage
• Rib fracture
• Pneumothorax
• Bone cement leakage
• Implantation syndrome 
• Pulmonary cement embolism 
• Cerebral fat embolism 
• Infection 
• Incident and adjacent vertebral fractures
• Bone necrosis [1][2][14]

Pain

Intraprocedural pain during VA arises from local ischemia or pressure in the intratrabecular space after injection and typically subsides within a few hours. Immediate postprocedural pain may result from soft tissue hematoma and can be mitigated by applying manual compression to the puncture site after needle removal. Patient education is crucial, emphasizing the prompt resumption of an upright position and early ambulation.

Persistent and severe pain beyond 2 hours postprocedure warrants further investigation. CT imaging should rule out potential causes such as retroperitoneal hematoma following an extrapedicular approach, pedicle fracture, refracture, new fracture, cement leakage, embolism, or infection.[4]  Additionally, facet syndrome, costovertebral point tenderness (due to facet joint capsule overstretching from kyphosis), sacral insufficiency, and sacroiliac joint syndrome can contribute to refractory pain and should be carefully assessed.[4] This comprehensive approach ensures a thorough evaluation of post-procedural pain, facilitating early identification and targeted management of potential complications or underlying causes for a more effective patient-centered care strategy.

Infection

Preexisting spondylitis poses a notable risk factor for potential infection, which can be further exacerbated by procedural intervention or hematogenous seedings. To proactively address this concern, a preoperative evaluation that includes an assessment of inflammatory parameters and a contrast MRI becomes mandatory. This comprehensive preoperative screening is crucial for early detection and preemptive management of potential infection.

In cases where infection proves refractory to antibiotic treatment, the preferred method is surgical debridement coupled with stabilization. This approach addresses the existing infection, provides structural support, and prevents further complications. For cases identified as high-risk, the addition of tobramycin to the cement can be considered. This adjunctive measure enhances the cement's antimicrobial properties, preventing infection in vulnerable individuals.

By systematically integrating preoperative assessments and adopting targeted interventions, healthcare practitioners can effectively mitigate the risks associated with infection in cases of preexisting spondylitis, ensuring a more proactive and patient-centric approach to care.

Cement Leak

A cement leak is most frequently observed in the upper thoracic vertebral levels. Cement leakage into the epidural space is classified into 3 types: B (basivertebral vein), S (segmental vein route), and C (cortical breach).[4] Paravertebral soft tissue leakage, which may manifest as femoral neuropathy, can result from such leaks. Various risk factors contribute to cement displacement and leakage, including high-grade vertebral fractures, cortical disruption, intravertebral clefts, premature cement application before reaching optimal viscosity, significant restoration of the Cobb angle, anterior edge leakage, inadequate bone cement interweaving, nontargeted disposition of bone cement, concurrent osteoporosis, and bone necrosis.[15][16][17] 

Venous leaks and pulmonary embolisms (PEs) are more prone to occur due to insufficient polymerization, improper needle positioning, and high-volume cement injection, particularly in neoplastic lesions compared to osteoporotic fractures. Diagnosis can be confirmed through fluoroscopic evidence of cement leakage into the azygos vein or vena cava. PE may result from the migration of cement, fat, and bone marrow cells, with reported incidences ranging from 3.5% to 23%. Peripheral PE is often asymptomatic, but rigid cement lodged in the right ventricle can lead to cardiac perforation, hemopericardium, and tamponade. Cerebral embolism, resulting from fat emboli during cementation injections, underscores the importance of avoiding cortical breaches and ensuring optimized opacification and viscosity of cement before injection. Diligent attention to these factors is imperative to mitigate the risk of complications associated with cement leakage during VA procedures.

Refracture and New Vertebral Fracture

The cumulative incidence of adjacent vertebral fractures is approximately 15% following VA.[18] New fractures may arise due to underlying bone disease and mechanical stress induced by spinal deformity, particularly since VA restores sagittal balance and preserves the mechanical loading of vertebral endplates. Independent risk factors for subsequent fractures include previous fractures, the presence of an intravertebral cleft, cement leakage, increased fatty infiltration of the psoas, erector spinae, and multifidus muscles, as well as the rate of body angle restoration. According to the receiver operating curve analysis, the body angle restoration rate demonstrated the highest predictive accuracy among these variables.[18] This phenomenon is most prevalent in the 3 segments closest to the augmented vertebra.[19] 

Although there is a moderate and low level of evidence casting uncertainty on the increased risk of vertebral fractures or serious adverse events following PVP and PKP, respectively, a meta-analysis involving 1328 patients in 2017 reported no elevated risk for adjacent or remote body fractures following VA.[3][5] Furthermore, integrating radiomic and machine learning models based on T2 MR images has shown promise in predicting the risk of new vertebral fractures.[20] This multidimensional assessment offers a more nuanced understanding of the factors contributing to subsequent fractures, paving the way for refined risk prediction and improved patient management strategies in the context of VA procedures.

Clinical Significance

There have been conflicting results observed about the effectiveness of VA in reducing pain and improving functional outcomes.[5] Two prospective randomized controlled trials published in the New England Journal of Medicine in 2009 demonstrated this, as did the following trials and studies discussed.

The investigational vertebroplasty safety and efficacy trial (INVEST) compared vertebroplasty with a sham procedure, which included periosteal infiltration of bupivacaine, manual palpation to reproduce bone access, and mixing of PMMA within the close vicinity of patients. No meaningful improvement of pain was observed at 1 month following vertebroplasty. The major limitations of the study included its underpowered nature (only 131 of the intended 250 patients enrolled), the inclusion of patients with old fractures (60% of fractures were more than 3 months duration), a high crossover rate (51%), lack of MRI, or nuclear bone scans to assess fracture acuity, slow patients enrollment, inclusions of patients even with low baseline pain scores, and the sham procedures also being included in the active treatment arm.[5][21] 

The randomized trial conducted by Buchbinder et al on vertebroplasty for painful osteoporotic fractures included cohorts experiencing back pain following fractures lasting up to 12 months, as confirmed by the presence of a fracture line and/or marrow edema on MRI.[5] There were no significant differences in pain, disability scores, or quality of life between the 2 arms of the study. However, several major flaws in the trial design were evident, including being underpowered, a low enrollment rate, nearly 70% of cases recruited from a single center, a lack of comprehensive patient-reported outcomes, assessment of overall pain rather than fracture-related back pain, and an insufficient volume of cement injected per vertebral level within the treatment arm. These shortcomings contributed to a significant decline in accepting and utilizing PVP in the US, with a notable reduction of almost 30% between 2004 and 2014. Moreover, in certain countries like Australia and the Netherlands, the continuity of the procedure was even halted altogether.[5][22]

The 2016 VAPOUR trial investigated the efficacy of PVP in patients experiencing acute VCFs within 6 weeks of onset, accompanied by severe pain, with a numeric rating scale score >7. Notably, the study introduced subcutaneous infiltrations for periosteal local anesthesia at the dorsal pedicle, replacing previous approaches that risked both medial branch and sinuvertebral nerve blockage. Additionally, the cement used lacked the typical odor of PMMA, minimizing bias associated with olfactory perceptions. The study's results favored vertebroplasty regarding both primary and secondary pain scores.[5] The incidence of new fractures was comparable between the PVP and control arms. Furthermore, the PVP group exhibited a median reduction in hospital stay by 5.5 days, indicating potential benefits in terms of healthcare resource utilization. However, a significant limitation of the study was the enrollment of nearly 85% of patients from 1 of the 4 included sites, emphasizing the need for broader representation to enhance the generalizability of findings.[5][23]

The 2018 vertebroplasty vs sham procedure for painful osteoporotic vertebral compression fractures (VERTOS IV) trial initially enrolled cohorts with acute fractures less than 6 weeks old, a visual analog scale (VAS) score ≥5, and evidence of marrow edema on MRI. Due to slow enrollments, the trial was extended to include fractures up to 9 weeks old. In the sham group, the needle was docked at the pedicle, and PMMA was prepared near the patient, accompanied by verbal cues. The VAS score favored PVP only at 12 months.[24] Despite patients reporting moderate to severe pain based on the VAS score, only a third required strong opiates for pain management. Both the VERTOS IV and VAPOUR studies demonstrated the restoration and preservation of vertebral body height in the PVP arms compared to sham treatments.[5]

More recently, a double-blind placebo-controlled PVP (VOPE) trial comparing a sham procedure for painful acute osteoporotic vertebral compression fractures, OCVFs, with vertebroplasty has demonstrated statistically lower VAS scores in the vertebroplasty group at 3 months.[25] 

The studies examining PVP and related procedures exhibit significant heterogeneity in key parameters. Notably, there is variation in the acuity of fractures, ranging from a mean of 3 weeks in the VAPOUR trial to 22 weeks in the INVEST trial. Pain scores also differ, with the INVEST trial requiring an NRS ≥3, while the VAPOUR trial set a higher threshold of NRS ≥7. Additionally, the volume of cement injected varies, from 2.8 mL in the Buchbinder trial to 7.5 mL in VAPOUR.[5]

Current evidence, rated as high to moderate quality, suggests that PVP provides no benefits over sham procedures. Similarly, low-quality evidence indicates a small clinical benefit of PKP compared to nonsurgical management, PVP, vertebral body stenting, or KIVA.[3] These findings highlight the need for careful consideration of study design, patient characteristics, and procedural details when interpreting the evidence on interventions for VCFs.

A comprehensive study utilizing the US Medicare dataset, encompassing almost 860,000 patients with new VCFs, demonstrated substantial survival benefits associated with VA compared to nonsurgical management. The estimated 3-year survival rates were approximately 40% for nonsurgical management, 50% for PVP, and 60% for PKP.[5] Similarly, a study conducted with German health insurance data revealed that cohorts undergoing VA were 43% less likely to die compared to those opting for nonsurgical management within 5 years.[5] Following propensity matching, nonsurgical management showed a 25% higher adjusted mortality risk than individuals who underwent PVP and a 55% higher adjusted mortality risk than those who had PKP.

Further analysis of a Medicare dataset spanning from 2005 to 2014, encompassing the downturn of VA in 2009, demonstrated a 19% lower propensity-adjusted 10-year mortality risk for PKP versus nonsurgical management and a 7% lower propensity-adjusted 10-year mortality risk for PVP versus nonsurgical management.[5] The Fujiwara-kyo osteoporosis risk in men (FORMEN) study also highlighted that OCVFs were associated with an increased risk of death, even after adjusting for pre-fracture frailty status.[5] These findings underscore the potential survival advantages associated with VA procedures, emphasizing the need for further research to elucidate the underlying factors contributing to this observed benefit.

Enhancing Healthcare Team Outcomes

The success of vertebral augmentation relies on the collaborative efforts of a multidisciplinary healthcare team, with each member contributing unique skills and responsibilities to enhance patient-centered care, outcomes, safety, and team performance. Physicians, particularly spinal specialists such as orthopedists or neurosurgeons, bring their expertise to lead the treatment algorithm, make informed decisions, and ensure the appropriateness of the intervention. Advanced practitioners, including physician assistants or nurse practitioners, play a crucial role in the continuum of care, providing additional clinical support and contributing to patient assessment and management.

Nurses are integral to vertebral augmentation procedures, utilizing their specialized training to assist in preoperative preparations, intraoperative care, and postoperative monitoring. Their responsibilities include patient education, ensuring adherence to safety protocols, and effective communication with the broader healthcare team. Pharmacists contribute their expertise in medication management, reviewing drug interactions, and optimizing pain control regimens. Effective interprofessional communication is essential for seamless care coordination. Regular collaboration and information exchange ensures that the entire team is well-informed about patient progress, potential complications, and necessary adjustments to the care plan. This comprehensive approach promotes patient safety and contributes to optimal outcomes and team performance in the context of vertebral augmentation procedures.

Nursing, Allied Health, and Interprofessional Team Interventions

Preprocedural Patient Care

This phase involves meticulous preparation and attention to key aspects of patient care. Electronic medical records should be reviewed to gather comprehensive information on the patient's medical history, medications, and any prior allergic reactions. A thorough neurological examination and a valid pain assessment must be documented. Assessing the bleeding/clotting status is crucial to ensure the patient's safety during the procedure. Informed consent, including a detailed explanation of procedural risks, is essential. Patients should observe a fasting period of at least 6 hours before the procedure.

Procedural Care

Strict adherence to the universal protocol for preventing 'wrong site, wrong procedure, wrong person surgery' is imperative during the procedure. Establishing venous access and continuous physiologic monitoring are essential to ensure the patient's well-being throughout the intervention.

Postprocedural Care

Postprocedure, a detailed operative note should be generated, focusing on complications and the patient's condition at the procedure's conclusion. Patients require monitoring by appropriately trained personnel and should undergo supervised ambulation. Referrals for densitometry and the management of osteoporosis should be initiated. Patients must be educated about the importance of regular follow-up visits with their healthcare or mid-level providers.[8] In the presence of any 'red flags' signs and symptoms, such as a fever exceeding 101 °F (38 °C), signs of inflammation, difficulty walking, maintaining balance, bowel or bladder symptoms, severe and persistent back pain, or acute chest pain or shortness of breath, emergency consultation is necessary. A rehabilitation program that includes back extension exercises can improve pain and functionality and reduce the risk of refracture.[4][26] Patients should avoid strenuous activity, heavy lifting (>5 kg), driving for a few weeks, rolling onto their side before sitting up to exit the bed, and wearing a back brace while ambulating, which should become habitual practices for optimal recovery.

Nursing, Allied Health, and Interprofessional Team Monitoring

VA has an excellent safety profile, governs survival, and improves functional benefits. Meta-analysis has shown cohorts following VA were 22% less likely to die at up to 10 years compared to the nonsurgical management.[27] This has not increased the odds of adjacent or remote fractures.[5] Stringent patient monitoring and follow-up are justified in the context of 'red flags,' which include persistent refractory pain, infections, difficulty in breathing, and chest pain. The time elapsed since the fracture is less relevant in managing VCFs.

Future trials about VA need to be large, adequately powered, and placebo-controlled and should provide sufficient data on adverse events. The enrolled participants and the ethical committees should be fully informed of the current evidence about VA.[3] There must be provisions for proper consent, audit, and clinical governance. Quality, patient education, infection control, and safety policies should be developed and implemented. Success and complication rates and thresholds need to be updated promptly.[8]