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Vertebral augmentation

Vertebral augmentation encompasses a range of minimally invasive percutaneous procedures designed to treat vertebral compression fractures (VCFs) by injecting orthopedic cement, typically polymethylmethacrylate (PMMA), into the affected vertebral body to stabilize the fracture, restore height, and alleviate severe back pain.^[1] These techniques are primarily indicated for painful VCFs caused by osteoporosis, trauma, malignancy, or other pathologies, particularly when conservative management such as pain medications, bracing, or physical therapy fails to provide relief within weeks.^[1] The history of vertebral augmentation traces back to the development of vertebroplasty in 1984 at the University Hospital of Amiens in France, where it was initially used to treat a painful vertebral hemangioma by injecting methylmethacrylate cement under fluoroscopic guidance.^[2] This procedure gained wider recognition in the early 1990s for managing osteoporotic VCFs, with the first report published in 1987.^[3] Kyphoplasty, an evolution of vertebroplasty, was introduced in 1998 in the United States, incorporating balloon tamp inflation to create a cavity prior to cement injection, aiming to improve vertebral height restoration and reduce cement extravasation risks.^[4] Over the subsequent decades, additional variants such as radiofrequency kyphoplasty and vesselplasty have emerged, refining the approach to enhance safety and efficacy.^[1] Common techniques under vertebral augmentation include vertebroplasty, which involves direct transpedicular or parapedicular needle insertion into the vertebral body followed by cement injection under real-time imaging like fluoroscopy or CT guidance; and kyphoplasty, which adds a preliminary step of inflating a balloon to compact fractured bone and form a void for controlled cement placement.^[5] Procedures are typically performed on an outpatient basis under local anesthesia with sedation, lasting 30-60 minutes per level, and patients often experience rapid pain relief within 24-48 hours, allowing resumption of normal activities soon after.^[6] Contraindications include active systemic or local infection, uncorrectable coagulopathy, spinal instability requiring open surgery, or fractures present for more than six months, which are unlikely to improve with the procedure.^[1] Clinical studies demonstrate that vertebral augmentation provides significant short-term pain reduction and functional improvement compared to non-surgical management, with success rates exceeding 80% in appropriately selected patients, though long-term benefits on mortality or subsequent fractures remain debated. However, randomized trials, including sham-controlled studies published in 2009, have sparked debate on its superiority over conservative care, though recent meta-analyses as of 2025 reaffirm short-term benefits in selected patients.^[7]^[1] For osteoporotic VCFs, meta-analyses show comparable pain relief between balloon kyphoplasty and vertebroplasty, with kyphoplasty potentially offering better height restoration in some cases but no significant difference in adjacent-level fracture rates.^[8] Potential risks, occurring in 1-10% of cases, encompass cement leakage (which can lead to pulmonary embolism or nerve compression), infection, hematoma, or allergic reactions to cement, necessitating careful patient selection and procedural expertise to minimize complications.^[1] Ongoing research emphasizes multidisciplinary approaches, integrating vertebral augmentation with osteoporosis pharmacotherapy to prevent recurrent fractures.^[9]

Overview

Definition and indications

Vertebral augmentation refers to a group of minimally invasive percutaneous procedures designed to stabilize vertebral compression fractures (VCFs) by injecting bone cement, typically polymethylmethacrylate (PMMA), directly into the affected vertebral body under imaging guidance.^[10] These techniques, including vertebroplasty and kyphoplasty, aim to restore structural integrity to the fractured vertebra, thereby alleviating associated pain and improving spinal stability.^[11] The procedure is performed to address the mechanical instability caused by the fracture, which often results from bone weakening or direct injury.^[12] The primary purposes of vertebral augmentation are to provide rapid pain relief, stabilize the fracture to prevent further vertebral collapse, and potentially restore some lost height in the spine, particularly in cases of osteoporotic or traumatic VCFs.^[13] By filling voids or clefts within the vertebra with cement, the procedure enhances biomechanical support and reduces the risk of progressive deformity.^[10] This intervention is particularly beneficial for patients experiencing debilitating back pain that impairs daily activities and does not respond adequately to conservative treatments like analgesics or bracing.^[11] Common indications include acute painful VCFs, typically those occurring within the past 12 weeks, caused by osteoporosis—the most frequent etiology, affecting weakened vertebrae due to low bone density—malignancy such as metastatic tumors or multiple myeloma, or trauma from low-velocity injuries like falls.^[10]^[13] The procedure is not recommended for chronic fractures without ongoing pain or for asymptomatic VCFs, as these do not typically require intervention.^[11] Diagnosis is confirmed through imaging, such as MRI showing edema in acute cases, to ensure suitability.^[12] The anatomical focus of vertebral augmentation is primarily on the thoracic and lumbar regions of the spine, where VCFs most commonly occur due to the higher mechanical loads and prevalence of osteoporosis-related changes in these areas.^[10] Sacral involvement may also be addressed in select cases, but cervical vertebrae are generally avoided due to higher risks.^[11]

Patient selection criteria

Patient selection for vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, involves a thorough evaluation to identify candidates with symptomatic vertebral compression fractures (VCFs) who are likely to benefit while minimizing risks.^[14] This process emphasizes confirming the fracture's acuity, assessing pain severity, and ensuring the absence of contraindications through imaging and clinical assessment.^[15] Diagnostic tools play a central role in eligibility determination. Magnetic resonance imaging (MRI) is preferred to identify acute or subacute fractures via hyperintense signals on short tau inversion recovery (STIR) or fat-suppressed T2-weighted sequences, indicating bone marrow edema.^[14] Computed tomography (CT) or single-photon emission computed tomography (SPECT) serves as an alternative when MRI is contraindicated, helping to evaluate fracture type and posterior wall integrity.^[14] Bone density scans, such as dual-energy X-ray absorptiometry (DEXA), are recommended to confirm underlying osteoporosis and guide long-term management.^[15] Inclusion criteria focus on patients with severe, localized pain attributable to the fracture that persists despite conservative therapy. Suitable candidates typically have pain rated ≥5-7 on the numeric rating scale (NRS) that has not responded to 2-6 weeks of non-surgical management, including analgesics, bracing, and activity modification.^[14]^[15] An intact posterior vertebral wall is essential, as breaches could lead to complications during cement injection.^[14] Fractures should ideally be recent (within 8 weeks) for optimal outcomes, though subacute cases up to 12 weeks may qualify if imaging shows active involvement.^[16]^[15] High-risk patients are excluded to prevent adverse events. Absolute contraindications include active infections such as osteomyelitis or discitis, uncorrectable coagulopathy, and neurological deficits from retropulsed fragments or spinal cord compression.^[14]^[15] Relative exclusions encompass severe vertebral collapse (>75%), pregnancy, or allergies to procedure materials.^[14]^[15] A multidisciplinary approach ensures comprehensive decision-making. Interventional radiologists interpret imaging and perform the procedure, while orthopedists assess structural stability and endocrinologists manage osteoporosis therapy.^[14] This collaboration, often involving pain specialists, optimizes patient outcomes by addressing both immediate pain relief and underlying bone health.^[14]

Procedures

Vertebroplasty

Vertebroplasty is a minimally invasive procedure designed to stabilize vertebral compression fractures (VCFs) by injecting bone cement directly into the affected vertebral body. Performed percutaneously under fluoroscopic guidance, it involves the insertion of a needle through the skin and pedicle into the vertebra, followed by the controlled injection of polymethylmethacrylate (PMMA) cement to fill fractures and provide structural support.^[1]^[17] The procedure typically begins with the patient positioned prone on the fluoroscopy table to ensure proper spinal alignment for anteroposterior (AP) and lateral imaging views. Local anesthesia, often combined with conscious sedation, is administered to the skin and deeper tissues along the planned needle trajectory, minimizing patient discomfort while maintaining safety. A sterile field is established, and a large-bore needle—commonly 11- to 13-gauge—is inserted using either a unipedicular approach (single needle through one pedicle to reach the anterior third of the vertebral body) or a bipedicular approach (needles through both pedicles to fill the mid-hemivertebrae). Needle placement is confirmed in real-time with fluoroscopy to avoid encroachment on the spinal canal or neural structures, advancing the tip to approximately 1 cm short of the anterior vertebral cortex.^[1]^[17] Once positioned, biocompatible PMMA cement, opacified with barium sulfate for radiographic visibility, is prepared by mixing to achieve the desired viscosity—typically dough-like to reduce the risk of leakage. The cement is then slowly injected through the needle under continuous lateral fluoroscopy, with volumes limited (e.g., ≤2 mL in high thoracic vertebrae and ≤6 mL in lumbar) to fill the vertebral body fractures without over-pressurization. Viscosity is closely monitored during injection to prevent extravasation into surrounding veins, epidural space, or disc spaces, with immediate cessation if any leakage is detected. The procedure, which does not involve cavity creation, generally lasts 30 to 60 minutes and is conducted as an outpatient intervention in a hospital or equipped ambulatory surgery center, allowing most patients to return home the same day after brief observation.^[1]^[17]^[5]

Kyphoplasty

Kyphoplasty is a percutaneous minimally invasive procedure designed to treat vertebral compression fractures by first creating a controlled cavity within the fractured vertebral body using an inflatable balloon tamp, followed by the injection of higher-viscosity bone cement to stabilize the structure.^[14] This balloon-based approach allows for more precise cement placement compared to direct injection methods, as the pre-formed cavity reduces the pressure required during filling and minimizes extravasation risks.^[18] The procedure typically begins with the patient positioned prone under fluoroscopic guidance, using a bilateral transpedicular approach. Two trocars are inserted through the pedicles into the vertebral body to access the fracture site bilaterally. An inflatable bone tamp, often 10 mm in diameter for thoracic vertebrae or 15 mm for lumbar, is then advanced into each hemivertebra and inflated incrementally with contrast-enhanced fluid to a pressure of up to 300 psi, typically for 1-2 minutes, to compact cancellous bone and create bilateral voids while aiming to restore vertebral height.^[14]^[18] Once inflated to the manufacturer's recommended volume or anatomical limits—monitored to avoid posterior overextension—the balloon is deflated, removed, and the cavity is filled with viscous polymethyl methacrylate (PMMA) cement injected in small aliquots (e.g., 0.5 cc) under low pressure, allowing the putty-like material to conform to the space before hardening within about 20 minutes.^[14]^[16] A key advantage of kyphoplasty lies in its potential for partial correction of kyphotic deformity, with studies reporting height restoration of 30-50% in many cases, particularly when performed early after fracture onset.^[18] The use of low-profile, high-pressure balloons (e.g., KyphX system) combined with highly viscous PMMA cement further reduces the risk of cement leakage to approximately 9%, as the pre-created cavity and thicker cement consistency limit uncontrolled flow into surrounding tissues or veins.^[18]^[19]

Emerging techniques

Radiofrequency kyphoplasty (RFK) represents an advancement in vertebral augmentation by employing radiofrequency energy to create a targeted cavity within the fractured vertebra prior to cement injection, allowing for precise ablation and controlled delivery of low-volume, high-viscosity polymethylmethacrylate (PMMA) cement.^[20] This technique minimizes thermal damage to surrounding tissues while enhancing structural restoration and reducing the risk of cement leakage compared to traditional balloon kyphoplasty.^[21] Clinical studies have demonstrated significant pain relief and functional improvement, with no reported cement extravasation in initial cohorts, potentially lowering the incidence of adjacent-level fractures through improved biomechanical stability.^[22] Discoplasty, often implemented as percutaneous vertebral-disc plasty (PVDP), integrates cement augmentation of both the vertebral body and adjacent intervertebral disc to address very severe osteoporotic compression fractures exceeding two-thirds anterior height loss.^[23] The procedure utilizes a unilateral transpedicular approach under fluoroscopy to inject cement, stabilizing the segment and preventing further collapse.^[24] It has shown superior outcomes in restoring intervertebral height, correcting kyphosis, and alleviating disability over standard vertebroplasty alone in randomized trials, with sustained benefits observed at 24 months.^[23] Vesselplasty employs a vessel-like polyethylene terephthalate (PET) balloon implant (Vessel-X) inserted percutaneously into the vertebral body to contain and distribute bone cement, thereby elevating the collapsed structure while containing potential extravasation.^[25] This method targets fractures with cortical breaches, restoring vertebral height and reducing kyphotic deformity more effectively than balloon kyphoplasty, with lower rates of cement leakage into adjacent spaces.^[26] Short-term clinical data indicate marked reductions in visual analog scale (VAS) pain scores and Oswestry Disability Index (ODI) measures, alongside improved overall health at six-month follow-ups.^[27] Post-2020 developments in nano-cement and bioresorbable materials aim to enhance osseointegration and mitigate complications associated with traditional PMMA cements. Nano-enhanced formulations, such as PMMA composites incorporating carbon nanotubes or graphene oxide at low concentrations (0.25-0.5%), improve mechanical toughness, reduce polymerization exothermic heat by up to 99%, and promote osteogenic differentiation without compromising injectability.^[28] Bioresorbable alternatives like calcium phosphate cements (CPCs) modified with poly(lactic-co-glycolic acid) or magnesium phosphate cements (MPCs) with chitosan exhibit controlled degradation, fostering bone ingrowth and lowering leakage risks through higher viscosity and bioactivity.^[29] These materials demonstrate compressive strengths exceeding 40 MPa in preclinical models, supporting better long-term vertebral remodeling.^[30] As of 2025, these emerging techniques remain largely investigational or limited to specialized centers, with adoption constrained by the need for larger randomized trials to confirm long-term efficacy and safety.^[28] Ongoing clinical investigations, including multicenter trials evaluating novel implants like the AGN1 LOEP system, focus on malignancy-related vertebral compression fractures (VCFs) to address osteolytic lesions in conditions such as multiple myeloma.^[31] Preliminary evidence supports their role in providing symptomatic relief and structural support in cancer patients, though broader regulatory approval awaits comprehensive outcome data.^[32]

Effectiveness

Clinical evidence

Clinical evidence on vertebral augmentation, encompassing procedures such as vertebroplasty and kyphoplasty, primarily derives from randomized controlled trials (RCTs) and subsequent meta-analyses evaluating pain relief and functional improvements in patients with vertebral compression fractures (VCFs). These studies typically measure outcomes using the Visual Analog Scale (VAS) for pain intensity and the Oswestry Disability Index (ODI) for functional disability, with a focus on osteoporotic VCFs as the predominant indication. Early RCTs demonstrated short-term benefits, while later analyses have clarified the role of placebo effects and long-term durability.^[33] The VERTOS II trial, a 2010 open-label RCT involving 202 patients with acute osteoporotic VCFs, compared vertebroplasty to conservative treatment and found significantly greater pain relief with vertebroplasty. At 1 month, the mean VAS score reduction was 5.2 points in the vertebroplasty group versus 2.7 points in the conservative group (difference 2.6 points, 95% CI 2.0-3.2, p<0.0001), with benefits sustained at 1 year (5.7 vs. 3.7 points reduction). Similarly, the 2009 INVEST trial, a multicenter double-blind RCT with 131 patients, assessed vertebroplasty against a sham procedure and reported comparable VAS reductions at 1 month (-3.7 vs. -3.3 points, p=0.81), indicating no superiority over sham but highlighting potential non-inferiority in pain control relative to procedural controls.^[34] Meta-analyses from 2020 onward have synthesized these and additional RCTs, consistently showing vertebral augmentation achieves substantial short-term pain relief, often 70-90% reduction in VAS scores at 1 month compared to baseline or conservative care, though effects may wane by 1 year with smaller differences (1-2 points on VAS). A 2023 network meta-analysis of 34 RCTs (n=4,384) ranked augmentation techniques superior to conservative treatment for VAS pain scores in both short-term (e.g., kyphoplasty with facet joint injection highest at 87.7% surface under the cumulative ranking curve) and long-term outcomes, with ODI improvements also favoring intervention (e.g., vertebroplasty with injection at 98.4% short-term). These analyses emphasize rapid VAS declines from baseline levels of 7-8 to 2-3 points post-procedure, establishing scale of impact without exhaustive enumeration of all variants.^[35] In subgroup analyses, vertebral augmentation shows pronounced benefits for malignant VCFs, such as those from multiple myeloma or metastases, where pain and disability are often more severe. A 2016 systematic review confirmed both vertebroplasty and kyphoplasty yield significant VAS reductions (typically 4-6 points) in cancer-related VCFs, outperforming conservative management in functional recovery.^[36] Limitations in the evidence base include placebo effects observed in sham-controlled trials like INVEST, where unblinded benefits in open-label studies (e.g., VERTOS II) may overestimate efficacy. The 2018 Cochrane review, the most comprehensive synthesis to date, concluded vertebroplasty provides no clinically important benefits over sham or conservative care for pain or function at 1-12 months, rating evidence quality as low to moderate due to risks of bias, imprecision, and inconsistency across trials. No major updates have altered these assessments by 2025, underscoring the need for further high-quality RCTs in targeted subgroups.^[37]

Comparisons to alternatives

Vertebral augmentation provides faster pain relief compared to conservative management, often within days rather than weeks, for patients with acute osteoporotic vertebral compression fractures (VCFs), with sustained benefits at 1 year as shown in randomized trials such as VERTOS II.^[34]^[38] Conservative approaches, including bracing for spinal support and bisphosphonates to address underlying osteoporosis, focus on gradual healing through rest, analgesics, and physical therapy, which can take 6-12 months for substantial improvement but avoid procedural risks.^[39] These non-invasive options are preferred initially for stable fractures without neurological compromise, particularly in patients with comorbidities that increase procedural risks. In contrast to open surgical alternatives like vertebrectomy, which is reserved for severe traumatic or neoplastic cases with instability or cord compression, vertebral augmentation offers minimally invasive benefits including lower morbidity, shorter operative times, and quicker recovery, making it more suitable for elderly patients with osteoporotic VCFs.^[9] Vertebrectomy involves extensive decompression and reconstruction, leading to longer hospital stays and higher complication rates, whereas augmentation stabilizes the fracture percutaneously with cement injection, reducing kyphosis and enabling same-day discharge in many cases.^[40] According to the 2024 North American Spine Society guidelines, vertebral augmentation is recommended over watchful waiting for select acute VCFs with moderate to severe edema on MRI, providing Grade A evidence for rapid pain and function gains in the short term, while conservative management remains appropriate for chronic or asymptomatic cases. A 2025 meta-analysis of over two million patients further indicated a 22% reduction in mortality with vertebral augmentation compared to conservative care.^[40]^[41] Choice depends on fracture acuity, patient frailty, and symptom severity, with augmentation favored when conservative measures fail to alleviate debilitating pain within 2-4 weeks.

Risks and complications

Adverse effects

Vertebral augmentation procedures, including vertebroplasty and kyphoplasty, carry risks of immediate and short-term complications, primarily related to the injection of bone cement. The most common adverse effect is cement leakage, occurring in 8-75% of cases depending on the technique, with higher rates (30-75%) reported in vertebroplasty compared to kyphoplasty (8-33%); most instances are asymptomatic and detected only on imaging.^[42]^[43] Transient radiculopathy, often resulting from cement extravasation into the foraminal or epidural space, affects 3-6% of patients and typically resolves with conservative measures such as steroids and analgesics.^[44] Serious complications are less frequent but can be life-threatening. Pulmonary cement embolism occurs in approximately 4.6% of procedures on imaging, though clinically significant cases range from 0.3% to 3%, often managed conservatively with monitoring or brief anticoagulation if symptomatic.^[45]^[46] Infection rates are low, at less than 1% (e.g., 0.32-0.46%), but can lead to spondylitis requiring antibiotics or surgical debridement.^[47] Spinal cord compression from cement extravasation is rare, with an incidence under 1%, but may necessitate urgent decompression if neurological deficits arise.^[46] Management focuses on prevention and prompt intervention. Intra-procedural monitoring for hypotension, which can occur due to bone cement implantation syndrome during injection, involves continuous vital sign assessment and readiness for vasoppressor support.^[48] Post-procedure, patients with new symptoms such as pain or neurological changes should undergo CT imaging to evaluate for leakage or embolism.^[49] Key risk factors for complications include high-volume cement injection (e.g., >7 mL) and use of low-viscosity cement, which increase the likelihood of extravasation; higher-viscosity formulations and controlled volumes can mitigate these risks.^[50]^[46]

Contraindications and precautions

Vertebral augmentation procedures, including vertebroplasty and kyphoplasty, carry specific absolute contraindications to prevent severe complications such as infection spread, neurological worsening, or procedural failure. These include uncorrectable coagulopathies, which pose an unmanageable bleeding risk during needle insertion and cement injection.^[14] Systemic infections like bacteremia or sepsis are also absolute contraindications, as they increase the likelihood of introducing pathogens into the vertebral body or bloodstream.^[14] Local spinal infections, such as osteomyelitis or discitis, similarly preclude the procedure to avoid exacerbating the infection.^[17] Allergy to bone cement components, typically polymethylmethacrylate (PMMA), or contrast agents used in imaging is an absolute contraindication due to the risk of anaphylaxis or severe allergic reactions.^[14] Additionally, spinal instability with neurological compromise—manifesting as symptomatic myelopathy or radiculopathy from retropulsed bone fragments, burst fractures, or significant posterior vertebral wall breaches—contraindicates the procedure, as cement injection could worsen cord compression or fragment displacement.^[14] Pregnancy represents an absolute contraindication owing to potential fetal exposure to radiation and cement materials.^[14] Severe cardiopulmonary comorbidities are likewise absolute, given the heightened risk of cement or marrow embolism leading to pulmonary or cardiac events.^[14] Relative contraindications apply in scenarios where the procedure may proceed with heightened caution or after risk mitigation, but they warrant careful evaluation to balance benefits against potential harms. Asymptomatic vertebral compression fractures fall into this category, as the lack of pain may indicate stability or healing without intervention.^[17] Vertebral body collapse exceeding 75% of original height is relative, complicating needle access and cement distribution while increasing leakage risk.^[14] Other relative factors include moderate, correctable coagulopathies; tumors extending into the spinal canal without full compromise; multiple compression fractures; or deficiencies in the posterior vertebral cortex, all of which require individualized judgment.^[14] Precautions emphasize preventive measures to optimize safety during vertebral augmentation. Prophylactic antibiotics, such as 1 g intravenous cefazolin administered 1 hour pre-procedure, are recommended to reduce infection risk, particularly in patients with potential bacteremia or local contamination.^[17] Coagulation parameters must be corrected beforehand: the international normalized ratio (INR) should be ≤1.5–1.8, platelets transfused if below 50,000/μL, and antiplatelet agents like aspirin held for 3–5 days or clopidogrel for 5 days.^[14] Preoperative intraosseous venography (vertebrogram) is a key precaution to predict cement leakage pathways by visualizing venous flow and fracture communications, allowing adjustments in needle placement or cement volume to minimize extravasation.^[51] Updated protocols stress the selection of FDA-approved bone cements and delivery systems to reduce embolism risks, with guidance emphasizing low-viscosity formulations and real-time fluoroscopic monitoring during injection.^[52] These steps, informed by clinical guidelines, help mitigate adverse effects like cement embolism referenced in procedural overviews.^[1]

Epidemiology

Prevalence of vertebral compression fractures

Vertebral compression fractures (VCFs) represent a significant public health concern, with an estimated 1 to 1.5 million new cases occurring annually in the United States alone.^[53] Globally, the annual incidence was approximately 7.5 million in 2021, reflecting the growing burden in aging populations.^[54] These fractures predominantly affect individuals over 50 years of age, with prevalence increasing sharply; for instance, up to 25% of postmenopausal women experience a VCF at some point in their lifetime, rising to 40% in those over 80 years old.^[55] The primary risk factor for VCFs is osteoporosis, which accounts for the majority of cases in older adults due to reduced bone density leading to fractures from minimal trauma.^[53] Trauma contributes to a smaller proportion of cases, often involving higher-energy impacts in younger individuals, while malignancy, such as multiple myeloma or metastatic disease, underlies a subset of VCFs, particularly in patients with underlying cancers.^[56] Additional risks include advanced age, with incidence rates of 10.7 per 1,000 women and 5.7 per 1,000 men in populations over 65.^[53] VCFs are frequently underdiagnosed, as up to two-thirds of cases are asymptomatic or cause only mild symptoms, often going undetected without routine imaging.^[57] This underrecognition is particularly pronounced in the elderly population over 65 years, where incidental findings on radiographs reveal higher rates of occult fractures, contributing to delayed intervention and increased morbidity.^[58] Geographic variations in VCF prevalence are largely driven by demographic factors, with higher rates observed in aging regions such as Europe and North America compared to other areas. In Europe, prevalence among postmenopausal women ranges from 18% in Eastern Europe to 26% in Scandinavia, while similar patterns in North America reflect the proportion of elderly residents.^[59] These disparities underscore the influence of population aging and osteoporosis management on fracture epidemiology.^[54]

Procedure utilization trends

In the United States, vertebral augmentation procedures, encompassing both kyphoplasty and vertebroplasty, are estimated at approximately 60,000 episodes annually among the Medicare population as of 2018, representing the majority of cases given the elderly demographic affected by vertebral compression fractures (VCFs). Of these, kyphoplasty comprised about 84% (49,520 episodes), while vertebroplasty accounted for 16% (9,240 episodes).^[60] This distribution reflects kyphoplasty's preference due to its potential for better height restoration and lower cement leakage risk compared to vertebroplasty.^[1] Utilization trends show a notable decline following the 2009 publication of randomized controlled trials that cast doubt on vertebroplasty's superiority over sham procedures, leading to an overall 24% reduction in total episodes from 76,860 in 2009 to 58,760 in 2018, with vertebroplasty experiencing a steeper 66% drop.^[60] Kyphoplasty volumes remained stable during this period, though rates per 100,000 Medicare beneficiaries fell by 23%.^[60] From 2016 to 2019, the utilization rate of vertebral augmentation for compression fractures decreased slightly from 11% to 8%, though absolute procedure volumes increased with a compound annual growth rate of 5.38%.^[61] Subsequent evidence from the 2020s affirming benefits in select patients with acute, painful VCFs has contributed to a rebound, with market analyses projecting a 5.6% compound annual growth rate through 2029.^[62] Disparities in procedure adoption are evident, with 60% of kyphoplasty and 67% of vertebroplasty cases performed in urban teaching hospitals, indicating higher access in metropolitan areas compared to rural settings.^[63] In Asia, where VCF prevalence is rising rapidly due to aging populations, vertebral augmentation remains underutilized relative to Western rates, as conservative management—such as bracing and analgesics—is the primary approach for most osteoporotic vertebral fractures.^[64] This preference stems from cultural and guideline emphases on non-invasive care. Projections indicate steady growth in global utilization through 2025, driven by increasing VCF incidence from demographic shifts, though adoption will likely vary by region.^[65]

History

Development and milestones

Vertebral augmentation originated with the development of percutaneous vertebroplasty in 1984 by French physicians Pierre Galibert and Hervé Deramond at the University Hospital of Amiens, initially as a treatment for painful vertebral hemangiomas using polymethylmethacrylate (PMMA) bone cement injected under fluoroscopic guidance.^[66] The technique was first described in a seminal 1987 publication reporting successful pain relief in seven patients with aggressive spinal angiomas, marking the procedure's early clinical validation. In the United States, vertebroplasty gained traction among interventional neuroradiologists starting in 1993, with the first case series published in 1997 demonstrating its efficacy for osteoporotic compression fractures.^[67] Although vertebroplasty itself is a surgical procedure not subject to direct FDA approval, PMMA bone cement had received FDA clearance for orthopedic applications in 1984, enabling its off-label use in spinal interventions by the mid-1990s.^[68] A key advancement came in 1998 with the introduction of balloon kyphoplasty by Kyphon Inc. (later acquired by Medtronic), which incorporated inflatable bone tamps to create a cavity in the vertebral body prior to cement injection, aiming to restore height and reduce cement leakage.^[69] The FDA granted 510(k) clearance for the KyphX inflatable bone tamp in July 1998, facilitating the procedure's commercialization and initial clinical adoption.^[70] During the 2000s, vertebral augmentation procedures expanded significantly for treating osteoporotic vertebral compression fractures, driven by growing recognition of their role in rapid pain relief and improved mobility in elderly patients.^[71] Hospital discharge data indicated a 741% increase in spine augmentation procedures from 2001 to 2008, reflecting widespread integration into clinical practice amid rising osteoporosis prevalence.^[72] In the 2010s, refinements focused on optimizing cement formulations to enhance safety and performance, including the development of high-viscosity PMMA variants to minimize leakage and embolization risks while maintaining injectability.^[73] Alternative cements, such as calcium phosphate-based materials, emerged to offer better biocompatibility and resorption properties, though PMMA remained dominant; these innovations addressed complications observed in earlier applications and supported broader procedural indications.^[29] Pivotal randomized controlled trials published in 2009, including sham-controlled studies by Buchbinder et al. and Kallmes et al., challenged the perceived superiority of vertebroplasty over conservative management, showing no significant pain relief difference in acute fractures and igniting international debate on its efficacy. These trials, involving over 200 patients each, prompted scrutiny of patient selection and placebo effects, influencing subsequent research and practice patterns despite earlier observational support.^[74]

Evolution of guidelines

The evolution of guidelines for vertebral augmentation reflects a progression from initial broad support based on observational data to caution following randomized controlled trials (RCTs) in the late 2000s, and subsequently to more nuanced, evidence-based recommendations emphasizing patient selection for acute cases. In the early 2000s, interventional radiology societies, including the Society of Interventional Radiology (SIR) and the American College of Radiology (ACR), endorsed percutaneous vertebroplasty as a safe and effective option for managing pain from osteoporotic vertebral compression fractures (VCFs), citing high success rates in pain relief from non-randomized studies.^[75] This early optimism shifted following two landmark sham-controlled RCTs published in 2009, which found no significant benefit of vertebroplasty over placebo for pain or function in patients with osteoporotic VCFs. In response, the American Academy of Orthopaedic Surgeons (AAOS) issued a 2010 clinical practice guideline strongly recommending against vertebroplasty for neurologically intact patients with symptomatic osteoporotic spinal compression fractures, while offering a limited endorsement for kyphoplasty based on available evidence at the time.^[76] These trials prompted a decline in procedure utilization, including a 32% drop in the United States between 2004 and 2014.^[77] Post-2010 meta-analyses and additional RCTs refined the evidence, highlighting benefits in specific subgroups such as those with acute fractures and severe pain. For instance, a 2018 meta-analysis of 25 studies involving over 1,900 patients demonstrated superior short-term pain relief and functional improvement with vertebral augmentation compared to conservative management in acute osteoporotic VCFs, without increased risk of adjacent fractures.^[78] Similarly, the 2016 VAPOUR RCT showed rapid and sustained pain reduction in patients with fractures less than 6 weeks old and severe baseline pain. These findings influenced updated positions, such as the 2019 American Society for Bone and Mineral Research (ASBMR) Task Force report, which endorsed vertebral augmentation for selected patients with acute or subacute painful VCFs refractory to optimal medical therapy, while advising against its use in chronic cases lacking active inflammation.^[79] Global variations persist in guideline stringency. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) 2013 technology appraisal limited recommendations to patients with severe, ongoing pain from recent unhealed osteoporotic VCFs unresponsive to conservative care, reflecting a conservative approach to balance benefits and risks. In contrast, U.S. guidelines from interventional societies like SIR remain more permissive, supporting vertebral augmentation for painful VCFs confirmed by imaging and refractory to non-operative management, with Medicare coverage aligned accordingly.^[80]^[81]^[15] Subsequent updates include the 2020 North American Spine Society (NASS) clinical practice guideline, which issued a strong recommendation (Grade A, Level I evidence) for vertebral augmentation to achieve rapid and sustained improvements in pain and function in adults with acute osteoporotic VCFs compared to medical therapy alone.^[40]

Societal and economic aspects

Cost and reimbursement

The cost of vertebral augmentation procedures in the United States typically ranges from $5,000 to $10,000 per vertebral level, based on 2025 national averages that encompass physician fees, facility charges, imaging guidance, and associated materials such as bone cement.^[82]^[83] For percutaneous vertebroplasty (CPT codes 22510-22512), outpatient costs average approximately $2,000 to $3,600, while kyphoplasty (CPT codes 22513-22515) averages $4,000 to $7,600 in ambulatory surgical centers or hospital outpatient departments, with higher totals in inpatient settings due to extended facility use.^[84]^[85] Medicare Part B provides coverage at 80% of the approved amount for vertebral augmentation when performed for approved indications, such as painful osteoporotic vertebral compression fractures refractory to conservative management, leaving beneficiaries responsible for the remaining 20% deductible and coinsurance after meeting the Part B annual deductible.^[84]^[85] Reimbursement is all-inclusive for the procedure, incorporating cavity creation, cement injection, venography, and imaging, with no separate billing for these components under Medicare guidelines.^[86] Private insurers generally cover the procedure for similar indications but often require prior authorization to verify medical necessity, with coverage levels varying by plan—typically 70-90% after deductibles—leading to potential out-of-pocket variability for patients.^[87]^[88] Kyphoplasty tends to incur higher costs than vertebroplasty primarily due to the additional expense of inflatable balloons used for cavity creation and height restoration, which can add $1,000 to $3,000 per level compared to cement-only injection in vertebroplasty.^[89]^[90] The adoption of bundled payment models, such as those under Medicare's Prospective Payment System, further standardizes reimbursement by grouping all procedure-related services into a single payment, which helps reduce cost variability across providers and settings while incentivizing efficient care delivery.^[86]^[91] Vertebral augmentation demonstrates economic benefits through reduced hospitalization compared to open surgical alternatives for vertebral fractures, often allowing same-day or overnight discharge versus 4-7 days for invasive decompression or fusion procedures, yielding significant overall cost savings per case by minimizing inpatient facility charges.^[90]^[92] These savings are particularly pronounced in elderly populations, where shorter lengths of stay mitigate risks of hospital-acquired complications and support broader utilization trends in outpatient settings.^[63]

Regulatory responses and controversies

In the United States, vertebral augmentation devices, including those used for vertebroplasty and kyphoplasty, are classified by the Food and Drug Administration (FDA) as Class II medical devices subject to special controls under 21 CFR 888.3027.^[52] This classification requires premarket notification via the 510(k) process, with special controls including the use of polymethylmethacrylate (PMMA) bone cement guidance to ensure safety and effectiveness for treating spinal insufficiency fractures.^[93] In the European Union, the Medical Device Regulation (MDR) 2017/745, fully applicable from May 26, 2021, imposes stricter post-market surveillance requirements on such Class IIa or IIb devices, mandating enhanced adverse event reporting, periodic safety update reports, and proactive vigilance systems to monitor incidents and improve transparency in risk management. Medicare coverage for percutaneous vertebral augmentation (PVA) in osteoporotic vertebral compression fractures has evolved through Local Coverage Determinations (LCDs), with no national non-coverage decision but significant scrutiny following 2009 randomized trials that raised efficacy concerns. Utilization peaked at 24% of vertebral fracture patients in 2007-2008 before declining to 14% by 2014 amid debates over benefits versus sham procedures, though coverage persisted under contractor-specific LCDs emphasizing medical necessity.^[94] As of the 2023 revision (effective July 20, 2023) of LCD L38737, Medicare covers PVA for acute (<6 weeks) or subacute (6-12 weeks) fractures at T1-L5 levels when supported by recent imaging showing edema, pain scores of ≥5 (non-hospitalized) or ≥8 (hospitalized) unresponsive to optimal conservative therapy, and documentation of bone mineral density evaluation and osteoporosis management.^[15] Relative contraindications include more than three fractures or spinal instability, requiring rigorous provider documentation to justify the procedure. Controversies surrounding vertebral augmentation intensified in the late 2000s, particularly over perceived overpromotion by device manufacturers amid rapid adoption. In the early 2000s, spine device firms faced Department of Justice scrutiny for kickbacks and sham consulting payments to surgeons promoting implants, including those for vertebral procedures, leading to multimillion-dollar settlements and highlighting conflicts of interest in procedural expansion.^[95] The 2009 New England Journal of Medicine trials further fueled debate by demonstrating no significant pain relief from vertebroplasty compared to sham procedures, attributing benefits to placebo effects and prompting a sharp drop in U.S. procedure volumes from 76,860 episodes in 2009.^[96] Follow-up analyses in 2010, including NEJM Journal Watch discussions, reinforced questions about placebo contributions, influencing payer reviews and guideline revisions while industry-sponsored studies often reported more favorable outcomes.^[97] As of 2025, debates persist with renewed scrutiny from recent randomized controlled trials, such as the 2023 Carli et al. study, which reported overall benefits but reactivated discussions on efficacy versus placebo, and analyses claiming vertebroplasty provides no statistically greater pain relief than sham procedures.^[98]^[99] A 2025 Lown Institute report highlighted ongoing overuse of vertebroplasty among Medicare patients, noting its relative commonality despite evidence concerns.^[100] Ethical debates center on risks of overtreatment in mild or non-acute cases and undue industry influence on clinical guidelines. Critics argue that applying augmentation to asymptomatic or mildly symptomatic fractures exposes patients to unnecessary risks like cement leakage without proven long-term benefits, raising concerns about resource allocation and informed consent in innovative procedures.^[101] Systematic reviews have identified a positive correlation between author conflicts of interest—often tied to device manufacturers—and favorable reporting of augmentation outcomes, potentially biasing guidelines and eroding trust in evidence-based recommendations.^[102] These issues underscore the need for transparent disclosure and independent oversight to balance innovation with patient safety.

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