Vertebral Augmentation

Anatomy and Physiology

The human spine comprises 33 vertebrae, 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 roughly to the first lumbar vertebra (L1), but can extend down to L2, diverging into the cauda equina.[7] 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, which are organized and numbered according to their corresponding vertebrae.

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. Running longitudinally along the spine, the 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 work together to maintain the spine's integrity and functionality.

Indications

The literature recommends VA in the following instances. Fractures that have been present for over 6 months are unlikely to improve.

• Osteoporotic VCF causing nonradicular 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 harboring 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)
  • This can cause refractory pain that severely restricts daily activities. 
• Osteolytic metastases
  • This can also cause refractory pain, severely restricting activities of daily living. 
• Vertebral fractures due to osteogenesis imperfecta
• Pseudoarthroses following avascular necrosis of the vertebral body [2][8][9][10]
• Potential treatment for burst fractures

Contraindications

Absolute Contraindications 

• Widely dispersed 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 [10]
• Some fractures that breach the posterior vertebral wall

Equipment

When performing VA, certain items are necessary, including:

• Local anesthesia
• General anesthesia
• Peripheral intravenous (IV) assessment
• Provisions for IV fluids 
• Patient monitoring units
• Fluoroscopy 
• Trochar—usually in "the kit"
• A balloon tamp or the standard "kit"
  • This is from the manufacturer for whatever system is being used.
• Bone cement delivery system
• Bone cement
  • The cements currently available in the United States are polymethylmethacrylate (PMMA) and a bioactive calcium phosphate microglass cement, which is composed of 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). 
• Established relationship with neurosurgery
  • This is necessary if the proceduralist is not a neurosurgeon for urgent decompression in the event of cement or bone fragment migration into the spinal canal.
• Bone marrow aspiration
  • On occasion, the proceduralist may be asked to obtain a bone marrow aspiration during VA. In that case, a technician is required to handle and process the aspirate.
• Postanesthesia care unit monitoring and care with neurochecks of the lower extremities
• Core biopsy
  • The equipment is adequate for handling the core biopsy that is usually obtained.
• Dorsal column monitoring
  • This may be used in thoracic VA for an increased margin of safety, especially with general anesthesia.[11] Not all proceduralists use it, as this is not available at all facilities, and opinions vary.    

Personnel

Personnel and Interdisciplinary Roles in Vertebral Augmentation

Performing VA requires the expertise of a highly trained specialist, most commonly an interventional pain clinician, an orthopedic surgeon, a neurosurgeon, or an interventional radiologist. These clinicians must possess a comprehensive skill set, including the ability to perform thorough clinical evaluations, interpret complex radiographic images, operate fluoroscopic or computed tomography-guided imaging systems, and adhere to strict radiation safety protocols. Proficiency in the technical execution of the procedure and readiness to manage potential intraoperative or postoperative complications are essential. The procedural team typically includes an anesthesiologist for sedation or general anesthesia, a radiologic technologist to assist with imaging acquisition, and a perioperative monitoring and support nurse.[10]

In many settings, especially community or smaller hospitals, a technical representative from the equipment manufacturer is also present in the operating or procedure room. Although not part of the sterile field, these representatives often play a crucial support role, particularly in hospitals where staff may be less experienced or procedural volume is low enough that equipment is not kept on-site. Reps commonly assist by guiding the team in equipment setup, including the proper mixing of PMMA and loading of injectors, often using visual cues such as laser pointers to direct staff without breaching sterile boundaries.

Radiologists also play a pivotal role in VA planning and execution. Preprocedural imaging—particularly magnetic resonance imaging with attention to T1 and short-tau inversion recovery sequences—to detect vertebral edema is typically interpreted by a radiologist, who may assess for retropulsed fragments or canal compromise. In cases where MRI is contraindicated, such as in patients with cardiac pacemakers, a composite interpretation of nuclear bone scan (preferably with bone windows) and plain radiographs is required. Collaborative decision-making between radiologists and proceduralists is critical to ensure accurate diagnosis and appropriate patient selection for VA.

Postprocedural Support and Multidisciplinary Care

Following vertebral augmentation, multidisciplinary care continues to optimize recovery and prevent recurrence. Smoking cessation is a key component of secondary fracture prevention, supported through behavioral counseling, pharmacotherapy, or a combination of modalities. Referral to physical or occupational therapy is also essential to initiate safe, weight-bearing exercise—an intervention shown to improve bone mineral density and functional mobility.[12] An orthotist or prosthetist may sometimes be consulted for spinal bracing, particularly when a conservative trial precedes VA. Braces such as a lumbosacral or thoracolumbar corset may reduce pain, limit range of motion, and facilitate healing in stable fractures. This interdisciplinary approach highlights the importance of coordinated, patient-centered care in managing osteoporotic vertebral fractures.

Preparation

Proper preparation for VA is critical to patient safety, procedural success, and post-procedural outcomes. Patient selection begins with a thorough clinical evaluation and confirmation of an acute or subacute VCF. Magnetic resonance imaging (MRI) is the gold standard, as it identifies bone marrow edema, indicative of an active fracture. In cases where MRI is contraindicated, a diagnostic combination of bone scan, computed tomography (CT) with bone windows, and plain radiographs is used. The radiologist and proceduralist should review preprocedural imaging collaboratively to evaluate for retropulsed fragments, posterior wall integrity, or canal compromise. These features may influence the procedural approach and level of caution required.

The procedure must be performed in a hospital or a well-equipped ambulatory surgery center with advanced imaging capabilities and emergency support. Essential infrastructure includes high-resolution fluoroscopy, image recording and archiving systems, and easy access to CT and MRI. A facility must also have established protocols for emergency intervention and spinal decompression, should complications like cement extravasation or neurologic compromise arise.[10] Anesthesia is typically general endotracheal, though heavy conscious sedation may be used in select cases depending on patient stability and procedural complexity. The anesthesia team generally manages patient monitoring, while dorsal column monitoring, if used, requires appropriate equipment and a trained technician.

Preprocedure optimization involves correcting coagulopathies and holding anticoagulant or antiplatelet medications to minimize bleeding risk. The international normalized ratio should be corrected to 1.5 to 1.8, platelets should be transfused if less than 50,000/μL, aspirin should be held for 3 to 5 days, clopidogrel for 5 days, and low-molecular-weight heparin should be held for 1 prophylactic or 2 therapeutic doses. Informed consent is obtained after discussing the risks and benefits of VA, including potential complications such as cement leakage, infection, or nerve injury.

Procedural logistics include assembling the VA kit, which typically consists of all necessary tools, except for drapes, a specimen container (if a biopsy is performed), and a local anesthetic. The clinician must be proficient in interpreting imaging, managing intraoperative complications, and performing the technical aspects of the procedure. Support staff—including a radiologic technologist, circulating nurse, and potentially a technical representative from the device manufacturer—are integral to proper setup and execution. The patient is positioned prone with careful padding and spinal alignment. Procedural planning should determine the appropriate approach (eg, unipedicular vs bipedicular) based on anatomy and fluoroscopic visualization. This comprehensive preparation ensures that VA can be performed safely and effectively to restore function and alleviate pain in patients with osteoporotic VCFs.

Technique or Treatment

Kyphoplasty and vertebroplasty stand out as the predominant modalities of VA, a procedure endorsed by Medicare since 2001 and facilitated by the 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 pathways of cement leakage through the 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 minimize pain.[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%–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 costs, exposure to contrast agents, and the requirement for general anesthesia. 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
  • This system restores the height of the compressed vertebra, followed by balloon kyphoplasty and bone cement injection, with a cement volume of only 10% compared to 30% in traditional PKP.[2] 
• OsseoFix system
  • This system consists of an expandable titanium mesh cage implanted into the anterior third of the vertebral body in stable fractures classified by the Arbeitsgemeinschaft für Osteosynthesefragen as type A1.1 to A1.3 or A3.1, followed by gradual expansion of the implant. 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 in place.[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 precrimped on the balloon and gradually expands to its final large-diameter configuration. This expansion is facilitated by its laser-cut mesh pattern, where individual one-fourth by one-half 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 the stents in place to maintain 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.[13]
• 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 endplate fracture lines 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 highly reliable, precise, accurate, and safe.[4] A thorough understanding of the fluoroscopic anatomy of the vertebral column is crucial. Obtaining accurate lateral projections, identifying the medial cortex of the pedicle on the anteroposterior views, and obtaining biplanar fluoroscopic images during needle placement are essential. 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 accurate 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 PVP demonstrates advantages, including reduced operative time, injected cement volume, cement leakage rate, and radiation risks, with comparable clinical outcomes to bilateral straight PVP.[14] On the other hand, unilateral 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 collapse and adjacent vertebral fracture, reducing the likelihood of cement leakage.[15] 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.[16]

Complications

Results from a comprehensive study involving 1932 patients showed the overall complication rate to be 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 significant complications.[17]

Results from 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/migration
• Implantation syndrome 
• Pulmonary cement embolism 
• Cerebral fat embolism 
• Infection 
• Incident and adjacent vertebral fractures
• Bone necrosis [1][2][18]

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 a retroperitoneal hematoma following an extrapedicular approach, a pedicle fracture, refracture, new fracture, cement leakage, embolism, or infection.[4] Additionally, facet syndrome, costovertebral point tenderness (resulting from facet joint capsule overstretching due to 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 the early identification and targeted management of potential complications or underlying causes, thereby enabling 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 seeding. 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, clinicians 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 occur as a result of 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.[19][20][21] 

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.[22] 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.[22] This phenomenon is most prevalent in the 3 segments closest to the augmented vertebra.[23] 

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.[24] This multidimensional assessment provides a more nuanced understanding of the factors contributing to subsequent fractures, thereby paving the way for refined risk prediction and enhanced patient management strategies in the context of VA procedures.

Clinical Significance

Conflicting results have been 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. 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 patient enrollment, inclusions of patients even with low baseline pain scores, and the sham procedures also being included in the active treatment arm.[5][25] 

The randomized trial conducted by Buchbinder et al on vertebroplasty for painful osteoporotic fractures included cohorts experiencing back pain following fractures that lasted 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 the acceptance and utilization of PVP in the United States, with a notable reduction of almost 30% between 2004 and 2014. Moreover, in certain countries, such as Australia and the Netherlands, the continuity of the procedure was even halted altogether.[5][26]

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 greater than 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 the findings.[5][27]

The 2018 vertebroplasty versus sham procedure for painful osteoporotic vertebral fractures (VERTOS IV) trial initially enrolled cohorts with acute fractures less than 6 weeks old, a visual analog scale (VAS) score of 5 or greater, 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.[28] 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 VCFs with vertebroplasty has demonstrated statistically lower VAS scores in the vertebroplasty group at 3 months.[29] 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 a numerical rating scale (NRS) of 3 or greater, while the VAPOUR trial set a higher threshold of NRS at 7 or greater. 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 underscore the importance of carefully considering study design, patient characteristics, and procedural details when interpreting the evidence on interventions for VCFs.

A comprehensive study using the United States 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, results from a study conducted with German health insurance 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 compared to nonsurgical management and a 7% lower propensity-adjusted 10-year mortality risk for PVP compared to nonsurgical management.[5] The Fujiwara-kyo osteoporosis risk in men (FORMEN) study also highlighted that osteoporotic CVFs were associated with an increased risk of death, even after adjusting for prefracture 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

Optimal delivery of VA depends on a coordinated, interprofessional team approach involving clinicians, nurses, pharmacists, radiologists, anesthesiologists, and allied health professionals. Clinicians and proceduralists must possess advanced skills in diagnostic imaging interpretation, patient selection, and the technical execution of procedures. Advanced clinicians assist in pre- and postprocedural evaluations, ensuring that patients are medically optimized and appropriate candidates. Nurses play a vital role in preoperative education, intraoperative support, and postoperative monitoring, including neurologic assessments and wound care. Radiologists provide critical imaging interpretations, identifying fracture acuity and anatomical risks, while anesthesiologists ensure patient stability and manage sedation or general anesthesia throughout the procedure. Pharmacists contribute by reviewing medications, adjusting anticoagulation regimens, and advising on postoperative pain control and bone health pharmacotherapy.

Interprofessional communication is essential to ensure seamless transitions across phases of care, from diagnosis through rehabilitation. Accurate information sharing through integrated electronic health records enables timely pathology review, particularly in cases where a vertebral biopsy reveals malignancy. Coordinated follow-up with physical therapy, occupational therapy, dietary services, and smoking cessation support helps promote functional recovery, address underlying osteoporosis, and reduce future fracture risk. Regular interdisciplinary huddles or case reviews can further improve outcomes by aligning treatment plans and clarifying roles. This high-functioning team model enhances patient safety, facilitates early mobilization, and supports comprehensive, patient-centered care throughout the VA treatment continuum.

Nursing, Allied Health, and Interprofessional Team Interventions

Effective care for patients undergoing VA hinges on coordinated, multidisciplinary efforts across nursing, allied health, and interprofessional teams. These interventions span the continuum of care—preprocedural, intraprocedural, and postprocedural—ensuring patient safety, optimizing outcomes, and promoting recovery.

Preprocedural Care

Nursing staff and allied health professionals are central to the preparation phase. A comprehensive electronic medical record review is crucial for assessing a patient's medical history, medications, comorbidities, and previous allergic reactions. Nurses should perform and document a focused neurological examination and valid pain assessment using standardized tools. Coagulation status must be evaluated to ensure International Normalized Ratio and platelet counts are within safe ranges, and periprocedural medication adjustments (eg, holding aspirin, clopidogrel, low-molecular-weight heparin) must be confirmed. Informed consent should be verified, including a detailed discussion of procedural risks, benefits, and alternatives. Patients should be educated on the pre-procedure fasting requirement—typically at least 6 hours—and assessed for any contraindications. Preoperative instructions should reinforce expectations regarding anesthesia, postprocedural mobility, and discharge planning.

Procedural Care

During the procedure, nurses and technologists must strictly follow universal protocols to prevent wrong-site, wrong-procedure, or wrong-patient errors. This includes time-outs, confirmation of imaging, and procedural documentation. Establishing IV access and initiating continuous physiological monitoring (eg, electrocardiogram, pulse oximetry, blood pressure) are crucial for patient safety and effective anesthesia management. Intraoperative support includes patient positioning, infection control measures, and assisting the proceduralist with sterile field management and equipment handoffs. A trained technician ensures appropriate neurophysiological surveillance in facilities where dorsal column monitoring is used.

Postprocedural Care

Postoperatively, nursing staff are responsible for documenting a comprehensive operative summary, highlighting any complications, patient response, and subsequent steps. Once stable, patients must be monitored by appropriately trained personnel, including ambulation under supervision. Nurses and midlevel clinicians should initiate referrals for bone densitometry, osteoporosis management, and rehabilitation. Patient education is crucial at this stage; discharge instructions must address early warning signs that necessitate urgent evaluation, including fever greater than 101 °F (38 °C), neurological deficits, bowel or bladder dysfunction, new or severe pain, and symptoms of cardiopulmonary distress. Patients must be educated about the importance of regular follow-up visits with their clinicians.[10]

Rehabilitation interventions often involve collaboration with physical and occupational therapy. Patients are encouraged to perform basic weight-bearing activities, such as lifting light objects (eg, a 10-ounce can), and engage in gentle back extension exercises to reduce pain, improve functionality, and decrease the risk of refracture.[4][30] A back brace during ambulation should be emphasized as a routine part of recovery, along with careful bed mobility techniques, such as rolling to the side before sitting up. Patients should avoid driving, strenuous activity, and lifting more than 5 kg for several weeks.

Smoking cessation is a vital component of long-term recovery and fracture prevention, and may require behavioral counseling, pharmacologic support, mindfulness techniques, or spiritual interventions. Nutritional counseling by nursing staff, dietitians, or other allied health professionals should ensure adequate intake of protein, calcium, and vitamin D, either through diet or supplementation. These interventions embody a holistic, patient-centered approach to care that extends beyond the procedure, enhancing safety and outcomes through collaborative teamwork.

Nursing, Allied Health, and Interprofessional Team Monitoring

VA has demonstrated an excellent safety profile, significant survival benefits, and notable improvements in patient function. Meta-analyses show that patients undergoing VA are 22% less likely to die within 10 years compared to those receiving nonoperative management.[31] Importantly, this survival advantage does not come at the cost of increased adjacent or remote vertebral fractures.[5] These findings reinforce the value of VA in managing VCFs, irrespective of the time elapsed since the fracture. However, vigilant follow-up remains essential, especially in "red flag" symptoms such as persistent or refractory pain, signs of infection, dyspnea, chest pain, or any neurologic changes that may suggest procedural complications or evolving pathology.

Future clinical trials evaluating VA should be large-scale, sufficiently powered, and designed with realistic expectations, as placebo-controlled studies are unlikely to receive Institutional Review Board approval due to ethical constraints. Studies should report comprehensive adverse event data and include provisions for robust informed consent, safety auditing, and ethical oversight. As evidence evolves, updates to institutional policies on quality assurance, patient education, infection control, and safety benchmarks will be essential. Complication rates and thresholds for procedural success should also be regularly revised based on current data.[10]

The interdisciplinary team plays a vital role in both acute and long-term management. Nursing personnel are integral to postanesthesia care unit monitoring, particularly for detecting neurologic changes or respiratory compromise early due to rare but serious complications, such as fat embolism or cement migration. Dietitians should be consulted to assess and optimize nutritional intake, ensuring sufficient calcium, vitamin D, and protein to support bone health. Postoperative care includes wound management, suture removal when applicable, reinforcement of activity restrictions, and follow-up instructions.

Pathology review is essential, as a core biopsy is routinely performed during trocar entry. While the proceduralist typically receives the pathology report, modern integrated electronic medical records enable all care team members to access the results. If the biopsy unexpectedly reveals malignancy, determining the most appropriate clinician to disclose the findings requires thoughtful coordination. This may be a proceduralist, a primary care clinician, or an oncologist, particularly if the patient has a prior history of cancer. Communicating serious diagnoses with empathy and clarity remains a shared and often challenging responsibility.

Rehabilitation is a key aspect of recovery and secondary prevention. Physical therapy plays a central role in restoring range of motion and overall conditioning and guiding patients through weight-bearing exercises that can strengthen bone and improve functional mobility. Occupational therapy may overlap, focusing on safety with daily activities. For patients whose pain limits traditional physical therapy participation, aquatic therapy can provide an alternative. Even standing in water offers hydrostatic support and resistance while minimizing axial load, making it a valuable starting point for patients with pain or instability. This team-based, patient-centered approach is crucial for achieving sustained improvements in quality of life and reducing the risk of future fractures.