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Abstract BACKGROUND Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care. OBJECTIVE To investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice. METHODS A total of 354 patients with painful VCFs were enrolled at 24 US sites with 350 undergoing kyphoplasty. Four coprimary endpoints—Numerical Rating Scale (NRS) back pain, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D)—were evaluated for statistically significant improvement 3 mo after kyphoplasty. Data were collected at baseline, 7 d, and 1, 3, 6, and 12 mo (www.clinicaltrials.gov registration NCT01871519). RESULTS At the 3-mo primary endpoint, NRS improved from 8.7 to 2.7 and ODI improved from 63.4 to 27.1; SF-36 PCS was 24.2 at baseline improving to 36.6, and EQ-5D improved from 0.383 to 0.746 (P < .001 for each). These outcomes were statistically significant at every follow-up time point. Five device-/procedure-related adverse events, intraoperative asymptomatic balloon rupture, rib pain, and aspiration pneumonia, and a new VCF 25 d postprocedure, and myocardial infarction 105 d postprocedure were reported and each resolved with proper treatment. CONCLUSION This large, prospective, clinical study demonstrates that kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis or cancer.

Background Degeneration of the intervertebral disc is a significant source of chronic axial low back pain. Direct supplementation of degenerated nucleus pulposis (NP) tissue with intradiscally delivered allogeneic NP represents an opportunity to bridge the treatment gap between failed conservative care and spine surgery for patients with lumbar discogenic pain. Methods Prospective, single-arm clinical study conducted at 6 sites in the US. The primary objective was to determine the magnitude of improvement in back pain severity and back function in patients with chronic lumbar discogenic pain at 12 months after a single intradiscal supplementation procedure using a commercially available NP allograft at up to two vertebral levels identified on magnetic resonance imaging. Back pain severity was evaluated using an 11-point numeric rating scale (NRS) and back function using the Oswestry Disability Index (ODI). Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) were set at ≥ 30% and ≥ 50% over baseline, respectively. The patient acceptable symptom state (PASS) threshold for pain severity was ≤ 3. Results Twenty-eight participants with a mean age of 44 ± 13 yrs. were enrolled and 22 provided 12-month outcomes. The average overall improvement in back pain severity was 43% through 12 months ( p  < 0.001). Approximately 64% (14 of 22) achieved the MCID in back pain at 12 months, with 55% (12 of 22) realizing SCB. Almost 60% (13 of 22) reported a 12-month back pain severity score of ≤ 3. The corresponding average decrease in ODI values was 50% ( p  < 0.001) with approximately 59% (13 of 22) of study participants achieving the MCID. At baseline approximately 82% (23 of 28) of participants reported severe or crippled back impairment compared to 18% (4 of 22) at 12 months ( p  < 0.001). Conclusion The results of this study provide additional evidence that supplementation of the degenerated intervertebral disc with intradiscally delivered allogeneic NP is associated with clinically significant pain palliation and functional improvement. Trial registration This trial was prospectively registered at ClinicalTrials.gov on December 30, 2021 (NCT05201287).

There is an enormous body of literature that has identified the intervertebral disc as a potent pain generator. However, with regard to lumbar degenerative disc disease, the specific diagnostic criteria lack clarity and fail to capture the primary components which include axial midline low back pain with or without non-radicular/non-sciatic referred leg pain in a sclerotomal distribution. In fact, there is no specific ICD-10-CM diagnostic code to classify and define discogenic pain as a unique source of pain distinct from other recognized sources of chronic low back pain including facetogenic, neurocompressive including herniation and/or stenosis, sacroiliac, vertebrogenic, and psychogenic. All of these other sources have well-defined ICD-10-CM codes. Corresponding codes for discogenic pain remain absent from the diagnostic coding vernacular. The International Society for the Advancement of Spine Surgery (ISASS) has proposed a modernization of ICD-10-CM codes to specifically define pain associated with lumbar and lumbosacral degenerative disc disease. The proposed codes would also allow the pain to be characterized by location: lumbar region only, leg only, or both. Successful implementation of these codes would benefit both physicians and payers in distinguishing, tracking, and improving algorithms and treatments for discogenic pain associated with intervertebral disc degeneration.

Vertebral compression fractures (VCFs) are a common pathologic process seen in 30–50% of individuals over the age of 50 years. Historically, VCFs were first treated with nonsurgical management while vertebral augmentation was reserved for severe cases resulting in deformity or significant disability. Current treatment algorithms based on established appropriateness criteria have changed recommendations towards supporting early vertebral augmentation for the VCFs causing the most clinically difficulty and taking into account the degree of vertebral body height loss, kyphotic deformity, and the degree of clinical progression. Percutaneous vertebroplasty (PVP) involves injecting primarily polymethacrylate (PMMA) bone cement directly into the cancellous bone of the vertebral body. There is recent literature showing the effectiveness of PVP including data comparing vertebroplasty to sham treatment. Vertebroplasty evolved into balloon kyphoplasty (BKP) where a balloon is first inserted into the vertebral body to create a cavity and reduce the fracture followed by an injection of bone cement. Both PVP and BKP have been shown to be significantly more effective at treatment of VCFs compared to nonsurgical management. The benefits shown in the literature have been demonstrated randomized control trials, cohort matched trials, post-market trials, registries, and many other data sources with approximately 250 manuscripts produced per year dedicated to the topic of vertebral augmentation.

BACKGROUND: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines. OBJECTIVE: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine. METHODS: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and recommendations were provided. RESULTS: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives. The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness. The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness. Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness. The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. LIMITATIONS: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain. CONCLUSIONS: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations. KEY WORDS: Chronic spinal pain, interventional techniques, epidural procedures, caudal epidural, lumbar interlaminar epidural, cervical interlaminar epidural, thoracic interlaminar epidural, lumbar transforaminal epidural, percutaneous adhesiolysis DISCLAIMER: These guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a “standard of care.” There was no external funding in the preparation of this manuscript.

The manuscript by Cianfoni et al discusses the use of SAIF in treating patients with VCFs involving the middle-column (MC), the pedicles and burst-type fractures.1 This report documents significant success not only in reducing their pain and improving their clinical condition but also in maintaining structural integrity.1 Fractures involving the posterior wall, the pedicle-vertebral body junction and low energy burst fractures are common and represent fractures that need to be treated with a greater amount of anterior and middle column support than typical anterior column only fractures. The screw reinforcement of the MC along with reduction and cementation of the anterior column has been shown to protect the middle column5 and to be superior to a single level fracture treated with a spanning pedicle screw and rod construct one level above and one level below the VCF.6 That biomechanical analysis by La Barbara et al also showed negligible additional stability by adding spanning the fracture treated by SAIF with spanning pedicle screws and rods.6 If the current thought is that open surgery with spanning pedicle screws and rods provide optimal stability for VCFs, then this evidence indicates that this opinion should be reconsidered. There is existing literature support for the treatment of traumatic fractures with vertebral augmentation and the SAIF technique could be a valuable addition to the existing techniques.7–11 If the single level screw, stent, and cement construct provides comparable or better stability than spanning pedicle screw and rod constructs then optimal fixation may be provided in a much less invasive way.

Degenerative disc disease (DDD) is the most common cause of chronic low back pain (CLBP). In DDD, proteoglycans within the nucleus pulposus break down and lose their ability to retain water, thereby reducing the volume of intervertebral discs and decreasing their weight-bearing capacity. Mechanical loading shifts to the annulus fibrosus, creating fissures and tears that leak crucial factors in the pain to cascade into the intradiscal space and trigger inflammation. When conventional treatments for CLBP fail, surgical options may be required. These surgeries carry risks and require months to heal. For intervertebral discs requiring augmentation, an implant in the form of an injectable, polymer-based hydrogel was developed for the percutaneous treatment of CLBP secondary to lumbar DDD. We hypothesize that the implant's hydrophilic properties will increase water retention and hydration, improve biomechanics, distribute axial loading more evenly across the annulus fibrosus, and reduce some mechanical sources of discogenic disc pain. To evaluate the safety and efficacy of a novel, injectable hydrogel implant for the treatment of CLBP. Prospective, single-arm, multicenter feasibility and safety study. Patients with CLBP lasting for longer than 6 months, DDD (modified Pfirrmann grades 4-8), competent outer annuli, numeric rating scale (NRS) scores >= 4, and Oswestry Disability Index (ODI) scores >= 30 were enrolled in 3 outpatient clinics in Canada and Colombia. The hydrogel implant, melted and equilibrated to 65°C, was injected intradiscally with a 17G needle under local anesthesia, using fluoroscopic guidance. The hydrogel cooled to approximately 42°C as it exited the needle directly into the nucleus. Patients were discharged that day. Clinical assessments included ODI and NRS (taken at one, 3, 6, and 12 months), radiographs, computed tomography, and magnetic resonance imaging (MRI) scans. The primary outcome was the successful insertion  of the implant in a lumbar disc nucleus. Sixty patients (36 women, 24 men), 49.0 ± 9.3 years old, received 83 implants (one disc-level: n = 37; 2 disc-levels: n = 23). All patients were implanted successfully without complications during the procedure or at discharge. One patient died (for reasons unrelated to the device/procedure), and one patient was lost to follow-up, for n = 58 at the 12-month follow-up. Five patients (8.6%) experienced increased low back pain (LBP) or leg pain and/or leg paresthesia, due to what radiological procedures confirmed was partial implant migration. Migrated implant portions were removed endoscopically from those patients 2 weeks to 10 months after implantation, constituting a 6% (5/83) failure rate. Mean (standard error [SE]) ODI scores in the patients was 9.6 (1.7) at the final follow-up. In the full cohort, ODI scores improved from the baseline mean (SE) of 57.4 (1.5) to 12.7 (1.8) at one month and 11.2 (2.0) at 12 months (P < 0.001). NRS back pain scores improved from the baseline of 7.3 (0.2) to 2.2 (0.3) at one month and 2.1 (0.3) at 12 months (P < 0.001). NRS leg pain scores improved from the baseline of 5.5 (0.4) to 1.1 (0.2) at one month and 1.4 (0.3) at 12 months (P < 0.001). The number of disc levels treated was not correlated with outcomes. As was inherent to a feasibility and safety study, limitations included a relatively small patient cohort and lack of a control group. A novel, injectable, polymer-based hydrogel implant was successfully inserted in 83 of the intervertebral discs of 60 patients for the effective treatment of CLBP secondary to DDD. Clinically significant improvements in function, LBP, and low leg pain were maintained through 12 months.

Background: Percutaneous access to the vertebral bodies is commonly done via the transpedicular approach for both diagnoses and treatment of spinal pathology. While this approach is effective in most cases, it is difficult in certain situations such as a patient with obstructing hardware from prior surgery. Objectives: To investigate and illustrate an alternative to the typical percutaneous access to the vertebral body via an extrapedicular approach and to determine the complications associated with this approach. Study Design: Description of a novel percutaneous vertebral body access technique developed during cadaver dissection and a report of complication rates in cases that were performed using this technique. Setting: Radiology department at a private institution. Methods: An effective extrapedicular access technique that could safely and consistently allow the needle tip to be placed in the center of the vertebral body was developed from cadaver dissection observations for the purpose of clinical use. A total of 96 vertebral compression fractures from T5 to L5 were treated via the extrapedicular technique at our institution between July 2008 and August 2012. There were 72 patients between ages 27 and 98 (mean age 73.2 years) who underwent treatment. Results: Cadaver dissection revealed a relatively avascular and aneural portion of the inferior vertebral body just anterior to the pedicle. A total of 96 vertebral fractures were treated using the extrapedicular technique without any recognized clinical complications from the needle access or the instrumentation. Limitations: The trial included a relatively small sample size, representing 7.4 percent of total patients treated at our institution. This was likely the result of a smaller patient population with contraindications to typical transpedicular access. Conclusions: The thoracic and lumbar vertebral bodies may be accessed using a percutaneous extrapedicular access technique which represents a relatively avascular and aneural approach to the vertebral body. The technique presented allows access to the vertebral body around existing hardware and can accommodate the placement of large instruments. This technique was not associated with any known complications in our series of patients. Key words: Vertebral body, spine, extrapedicular, kyphoplasty, vertebroplasty, paraspinal, thoracic, lumbar

Specific clinical diagnostic criteria have established a consensus for defining patients with lumbar discogenic pain. However, if conservative medical management fails, these patients have few treatment options short of surgery involving discectomy often coupled with fusion or arthroplasty. There is a rapidly-emerging research effort to fill this treatment gap with intradiscal therapies that can be delivered minimally-invasively via fluoroscopically guided injection without altering the normal anatomy of the affected vertebral motion segment. Viable candidate products to date have included mesenchymal stromal cells, platelet-rich plasma, nucleus pulposus structural allograft, and other cell-based compositions. The objective of these products is to repair, supplement, and restore the damaged intervertebral disc as well as retard further degeneration. In doing so, the intervention is meant to eliminate the source of discogenic pain and avoid surgery. Methodologically rigorous studies are rare, however, and based on the best clinical evidence, the safety as well as the magnitude and duration of clinical efficacy remain difficult to estimate. Further, we summarize the US Food and Drug Administration's (FDA) guidance regarding the interpretation of the minimal manipulation and homologous use criteria, which is central to designating these products as a tissue or as a drug/device/biologic. We also provide perspectives on the core evidence and knowledge gaps associated with intradiscal therapies, propose imperatives for evaluating effectiveness of these treatments and highlight several new technologies on the horizon.