Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.

While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.

Perspective on Intradiscal Therapies for Lumbar Discogenic Pain: State of the Science, Knowledge Gaps, and Imperatives for Clinical Adoption.

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.

Are We Finally Ready for Total Joint Replacement of the Spine? An Extension of Charnley's Vision.

Professor Sir John Charnley has been rightfully hailed as a visionary innovator for conceiving, designing, and validating the Operation of the Century-the total hip arthroplasty. His groundbreaking achievement forever changed the orthopedic management of chronically painful and dysfunctional arthritic joints. However, the well-accepted surgical approach of completely removing the diseased joint and replacing it with a durable and anatomically based implant never translated to the treatment of the degenerated spine. Instead, decompression coupled with fusion evolved into the workhorse intervention. In this commentary, the authors explore the reasons why arthrodesis has remained the mainstay over arthroplasty in the field of spine surgery as well as discuss the potential shift in the paradigm when it comes to treating degenerative lumbar disease.

Minimally Invasive Postero-Inferior Sacroiliac Joint Fusion: Surgical Technique and Procedural Details.

(1) Background: Minimally invasive sacroiliac joint (SIJ) fusion is the preferred surgical intervention to treat chronically severe pain associated with SIJ degeneration and dysfunction. (2) Methods: This paper details the ten-step surgical procedure associated with the postero-inferior approach using the PsiF™ DNA Sacroiliac Joint Fusion System. (3) Results: The posterior surgical approach with an inferior operative trajectory (postero-inferior) utilizes easily identifiable landmarks to provide the safest, most direct access to the articular joint space for transfixing device placement. Implanting the device through the subchondral bone provides maximum fixation and stabilization of the joint by utilizing an optimal amount of cortical bone-implant interface. Approaching the joint from the inferior trajectory also places the implant perpendicular to the S1 endplate at a "pivot point" near the sacral axis of rotation, which addresses the most significant motion of the joint. (4) Conclusions: Further observational data from real-world clinical use are encouraged to further validate this procedure as the surgical preference for minimally invasive SIJ fusion.

Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery.

The primary objective of this review is to evaluate whether the degree of processing and the clinical utility of commercially available mineralized bone allografts for spine surgery meet the 2020 US Food and Drug Administration's (FDA) guideline definitions for minimal manipulation and homologous use, respectively. We also assessed the consistency of performance of these products by examining the comparative postoperative radiographic fusion rates following spine surgery. Based on the FDA's criteria for determining whether a structural allograft averts regulatory oversight and classification as a drug/device/biologic, mineralized bone allografts were judged to meet the Agency's definitional descriptions for minimal manipulation and homologous use when complying with the American Association of Tissue Banks' (AATB) accredited guidelines for bone allograft harvesting, processing, storing and transplanting. Thus, these products do not require FDA medical device clearance. Radiographic fusion rates achieved with mineralized bone allografts were uniformly high (>85%) across three published systematic reviews. Little variation was found in the fusion rates irrespective of anatomical location, allograft geometry, dimensions or indication, and in most cases, the rates were similar to those for autologous bone alone. Continued utilization of mineralized bone allografts should be encouraged across all spine surgery applications where supplemental grafts and/or segmental stability are required to support mechanically solid arthrodeses.

Defining the Patient with Lumbar Discogenic Pain: Real-World Implications for Diagnosis and Effective Clinical Management.

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.

Resisting subsidence with a truss Implant: Application of the "Snowshoe" principle for interbody fusion devices.

The primary objective was to compare the subsidence resistance properties of a novel 3D-printed spinal interbody titanium implant versus a predicate polymeric annular cage. We evaluated a 3D-printed spinal interbody fusion device that employs truss-based bio-architectural features to apply the snowshoe principle of line length contact to provide efficient load distribution across the implant/endplate interface as means of resisting implant subsidence. Devices were tested mechanically using synthetic bone blocks of differing densities (osteoporotic to normal) to determine the corresponding resistance to subsidence under compressive load. Statistical analyses were performed to compare the subsidence loads and evaluate the effect of cage length on subsidence resistance. The truss implant demonstrated a marked rectilinear increase in resistance to subsidence associated with increase in the line length contact interface that corresponds with implant length irrespective of subsidence rate or bone density. In blocks simulating osteoporotic bone, comparing the shortest with the longest length truss cage (40 vs. 60 mm), the average compressive load necessary to induce subsidence of the implant increased by 46.4% (383.2 to 561.0 N) and 49.3% (567.4 to 847.2 N) for 1 and 2 mm of subsidence, respectively. In contrast, for annular cages, there was only a modest increase in compressive load when comparing the shortest with the longest length cage at a 1 mm subsidence rate. The Snowshoe truss cages demonstrated substantially more resistance to subsidence than corresponding annular cages. Clinical studies are required to support the biomechanical findings in this work.

Comparison of Transforaminal Lumbar Interbody Fusion in the Ambulatory Surgery Center and Traditional Hospital Settings, Part 2: Assessment of Surgical Safety in Medicare Beneficiaries.

(1) Background: The clinical benefits and procedural efficiencies of performing minimally invasive fusion procedures, such as transforaminal lumbar interbody fusion (TLIF), in the ambulatory surgery center (ASC) are becoming increasingly well established. Currently, Medicare does not provide reimbursement for its beneficiaries eligible for TLIF in the ASC due to a lack of evidence regarding procedural safety. However, the initiation of the Hospital Without Walls program allowed for traditional hospital procedures to be relocated to other facilities such as ASCs, providing a unique opportunity to evaluate the utility of TLIF in the ASC in Medicare-age patients. (2) Methods: This single-center, retrospective study compared baseline characteristics, intraoperative variables, and 30-day postoperative safety outcomes between 48 Medicare-age patients undergoing TLIF in the ASC and 48 patients having the same procedure as hospital in-patients. All patients had a one-level TLIF using the VariLift®-LX expandable lumbar interbody fusion device. (3) Results: There were similar patient characteristics, procedural efficiency, and occurrence of clinical 30-day safety events between the two study groups. However, there was a marked and statistically significant difference in the median length of stay favoring TLIF patients treated in the ASC (23.9 h vs. 1.6 h, p = 0.001). All ASC-treated patients were discharged on the day of surgery. Postoperative visits to address adverse events were rare in either group. (4) Conclusions: These findings provide evidence that minimally invasive TLIF can be performed safely and efficiently in the ASC in Medicare-age patients. With same-day discharge, fusion procedures performed in the ASC offer a similar safety and more attractive cost-benefit profile for older patients than the same surgery undertaken in the traditional hospital setting. The Centers for Medicare and Medicaid Services should strongly consider extending the appropriate reimbursement codes (CPT ® 22630, 22633) for minimally invasive TLIF and PLIF to the ASC Covered Procedure List so that Medicare-age patients can realize the clinical benefits of surgeries performed in this setting.

Comparison of Transforaminal Lumbar Interbody Fusion in the Ambulatory Surgery Center and Traditional Hospital Settings, Part 1: Multi-Center Assessment of Surgical Safety.

(1) Background: The technological advances achieved with minimally-invasive surgery have enabled procedures to be undertaken in outpatient settings, and there has been growing acceptance of performing minimally-invasive transforaminal interbody fusion (TLIF) in the ambulatory surgery center (ASC). The purposeof this study was to determine the comparative 30 day safety profile for patients treated with TLIF in the ASC versus the hospital setting. (2) Methods: This multi-center study retrospectively collected baseline characteristics, perioperative variables, and 30 day postoperative safety outcomes for patients having a TLIF using the VariLift®-LX expandable lumbar interbody fusion device. Outcomes were compared between patients undergoing TLIF in the ASC (n = 53) versus in the hospital (n = 114). (3) Results: Patients treated in-hospital were significantly older, frailer and more likely to have had previous spinal surgery than ASC patients. Preoperative back and leg pain scores were similar between study groups (median, 7). ASC patients had almost exclusively one-level procedures (98%) vs. 20% of hospital procedures involving two-levels (p = 0.004). Most procedures (>90%) employed a stand-alone device. The median length of stay for hospital patients was five times greater than for ASC patients (1.4 days vs. 0.3 days, p = 0.001). Emergency department visits, re-admissions and reoperations were rare whether the patients were managed in the traditional hospital setting or the ASC. (4) Conclusions: There were equivalent 30 day postoperative safety profiles for patients undergoing a minimally-invasive TLIF irrespective of surgical setting. For appropriately selected surgical candidates, the ASC offers a viable and attractive option for their TLIF procedure with the advantage of same-day discharge and at-home recovery.

Minimally Invasive Inferior Intra-Articular Sacroiliac Joint Fusion: Successful Application of Osseous Stabilization Using Allograft Bone.

Minimally invasive sacroiliac joint (SIJ) fusion is the preferred surgical method for managing patients with recalcitrant, chronically severe SIJ pain and dysfunction refractory to conservative medical measures. The primary surgical objective of all minimally invasive SIJ fusion procedures is to provide immediate stabilization within the joint space to support osseous consolidation and the development of a mechanically solid arthrodesis. The intra-articular surgical approach to the SIJ with allograft bone placement utilizes a trajectory and easily identifiable landmarks that allow the surgeon to control the risk of violating important neuro-vascular structures. The intra-articular approach can employ a superior or inferior operative trajectory, with the former restricted to allograft placement in the ligamentous portion of the SIJ. The inferior approach utilizes decortication to surgically create a channel originating in the purely articular portion of the joint space allowing for truly intra-articular implant placement within the osseous confines of the ilium and sacrum. Positioning the implant along the natural joint line and securing it within the underlying sub-chondral bone, mortise and tenon fashion provides stabilization and large surface area contact at the bone implant interface. The inferior, intra-articular approach also places the implant perpendicular to the S1 endplate, near the sacral axis of rotation, which addresses the most significant biomechanical forces across the joint. Short-term, post-surgical observational data from a 57 patient multi-center registry using the inferior, intra-articular approach show uniform and statistically significant improvement in all clinical outcomes (p < 0.001 for all comparisons), including an average 3-point improvement in back pain severity from 6.8 preoperatively to 3.8 at 6 months. Further clinical evaluation with longer-term follow-up of the inferior, intra-articular SIJ fusion procedure is encouraged.

Bone Mineralization and Spinal Fusion Evaluation of a Truss-based Interbody Fusion Device: Ovine Finite Element Analysis with Confirmatory In Vivo Outcomes.

STUDY DESIGN: Finite element analysis (FEA) and in vivo ovine spinal interbody fusion study. OBJECTIVE: To determine comparative load-induced strain amplitudes, bone mineralization and fusion outcomes associated with different diameter struts in a truss-based interbody fusion device. SUMMARY OF BACKGROUND DATA: Additive manufacturing technology has been employed to develop implants that actively participate in the fusion process. The truss device enables the optimal transfer of compressive and tensile stresses via the struts. Mechanobiologic principles postulate that strut diameter can be regulated to allow different magnitudes of strain distribution within the struts which may affect fusion rates. METHODS: Modeling of strain distributions as a function of strut diameter (0.75, 1.0, 1.25, and 1.5 mm) employed FEA that simulated physiologic loading conditions. A confirmatory in vivo ovine lumbar spinal interbody fusion study compared fusion scores and bone histomorphometric variables for cages with 0.75 and 1.5 mm strut diameters. Outcomes were compared at 3-, 6-, and 12-month follow-up intervals. RESULTS: FEA showed an inverse association between strut diameter and peak strain amplitude. Cages with 1.0, 1.25, and 1.5 mm struts had peak strain values that were 36%, 60%, and 73% lower than the 0.75 mm strut strain value. In vivo results showed the mean fusion score for the 0.75 mm diameter strut cage was significantly greater by 3-months versus the 1.5 mm strut cage, and remained significantly higher at each subsequent interval (P < 0.001 for all comparisons). Fusion rates were 95%, 100%, and 100% (0.75 mm) and 72.7%, 86.4%, and 95.8% (1.5 mm) at 3, 6, and 12 months. Thinner struts had greater mineralized bone tissue and less fibrous/chondral tissue than the thicker struts at each follow-up. CONCLUSION: Validating FEA estimates, cages with smaller diameter struts exhibited more rapid fusion consolidation and more aggressive osseointegration compared with cages with larger diameters struts.Level of Evidence: 4.

Improving the Management of Patients with Osteoporosis Undergoing Spinal Fusion: The Need for a Bone Mineral Density-Matched Interbody Cage.

With an increasingly aging population globally, a confluence has emerged between the rising prevalence of degenerative spinal disease and osteoporosis. Fusion of the anterior spinal column remains the mainstay surgical intervention for many spinal degenerative disorders. However, decreased vertebral bone mineral density (BMD), quantitatively measured by dual x-ray absorptiometry (DXA), complicates treatment with surgical interbody fusion as weak underlying bone stock increases the risk of post-operative implant-related adverse events, including cage subsidence. There is a necessity for developing cages with advanced structural designs that incorporate bioengineering and architectural principles to tailor the interbody fusion device directly to the patient's BMD status. Specifically, lattice-designed cages that mimic the web-like structure of native cancellous bone have demonstrated excellent resistance to post-operative subsidence. This article provides an introductory profile of a spinal interbody implant designed intentionally to simulate the lattice structure of human cancellous bone, with a similar modulus of elasticity, and specialized to match a patient's bone status across the BMD continuum. The implant incorporates an open pore design where the degree of pore compactness directly corresponds to the patient's DXA-defined BMD status, including patients with osteoporosis.

Truss implant technology™ for interbody fusion in spinal degenerative disorders: profile of advanced structural design, mechanobiologic and performance characteristics.

Introduction: Interbody fusion devices are customarily used in fusion of the anterior spinal column for treatment of degenerative disc disease. Their traditional role is to reestablish and maintain intervertebral disc height, contain bone graft and provide mechanical support for the spine while osseointegration takes place. Utilizing the principles of mechanobiology, a unique biokinetic interbody fusion device has been developed that employs an advanced structural design to facilitate and actively participate in the fusion consolidation process.Areas covered: This article profiles and characterizes 4WEB Medical's Truss Implant Technology™ which includes a range of 3D-printed titanium spinal interbody implants and non-spinal implants whose design is based on truss structures enabled by advances in additive manufacturing. Four main areas of the implant design and functionality are detailed: bio-architecture, mechanobiologic underpinnings, bioactive surface features, and subsidence resistance. Pre-clinical and clinical examples are provided to describe and specify the bioactive roles and contributions of each design feature.Expert opinion: The distinct and unique combination of features incorporated within the truss cage design results in a biokinetic implant that actively participates in the bone healing cascade and fusion process.

Interspinous Process Decompression With The Superion® Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry.

BACKGROUND: Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS). METHODS: IPD used the Superion® Indirect Decompression System (Vertiflex, Carlsbad, CA, USA). Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. Three-hundred sixteen physicians at 86 clinical sites in the US participated. Patient data were captured from in-person interviews and a phone survey. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity (100 mm VAS), patient satisfaction and treatment approval at 3 weeks, 6 and 12 months. RESULTS: The mean age of registry patients was 73.0 ± 9.1 years of which 54% were female. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement. Corresponding responder rates were 64% (484 of 751), 72% (1,097 of 1,523) and 75% (317 of 423) at 3 weeks, 6 and 12 months, respectively. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 39.9 ± 32.3 mm at 12 months (48% improvement); 12-month responder rate of 67% (297 of 441). For patient satisfaction at 3 weeks, 6 and 12 months, 89%, 80%, and 80% were satisfied or somewhat satisfied with their treatment and 90%, 75%, and 75% would definitely or probably undergo the same treatment again. In the phone survey, the rate of revision was 3.6% (51 of 1,426). CONCLUSION: These registry findings support the clinical adoption of minimally invasive IPD in patients with neurogenic claudication associated with LSS.

Toward a cure for lumbar spinal stenosis: The potential of interspinous process decompression.

There is a growing impetus to treat aging as a disease in the quest to significantly extend the human life span through cellular regeneration methods. This approach, while promising, overlooks the fact that the evolutionary adaptation to bipedalism puts the human body in a distinctively vulnerable biomechanical and functional position. Orthograde human posture places unusually-high axial compressive loads on the weight-bearing joints of the skeleton, resulting in arthritic deterioration with aging. The effects are particularly robust in the lumbar spine were age-related degeneration, most commonly lumbar spinal stenosis (LSS), is ubiquitous among the elderly. It is postulated that re-establishing a favorable mechanical environment via interventions that unload the affected spinal joint complex may mitigate and potentially reverse the structural damage that is the cardinal pathoanatomical feature of this disease. The hypothesis of this paper is that a minimally-invasive surgical procedure, interspinous process decompression (IPD), which utilizes a stand-alone intervertebral spacer, effectively unloads the diseased spinal motion segment providing a healthy micro-environment to reverse and repair age-related and genetic deterioration of the spinal motion segment. Several lines of supporting evidence are provided from long-term follow-up results of a randomized controlled trial of IPD safety and effectiveness of the Superion® device including clinical outcomes, reoperation rates, opioid analgesic usage and advanced imaging utilization. All of these outcomes show uniquely-favorable trends with time that imply that the benefits of IPD are structural. The compendium of evidence suggests that IPD offers both a durable palliative effect due to direct blocking of back extension and a disease-modifying effect due to unloading of the spinal joint complex.

Maximizing botulinum toxin injections for cosmetic and therapeutic applications with a single use, disposable, exact dose injection assist device.

BACKGROUND: Although freehand injection of botulinum toxin remains the status quo, it is an inaccurate technique for delivering precise amounts of neurotoxin at multiple injection sites with expediency. We developed an inexpensive, ergonomic, single-use, disposable exostructure device that rapidly converts a standard syringe into a highly accurate injection instrument. MATERIALS AND METHODS: Based on the results of two independent injectors, we determined the comparative delivery dose accuracy, precision, and amount of product waste associated with a standard syringe using the freehand injection technique vs a prototype injection assist device. Fifteen experienced injectors were also surveyed regarding their satisfaction using the device in a controlled research setting. RESULTS: The average percentage difference from the expected dose value was <1% (0.00024 mL) for 1-unit doses (ie, 0.025 mL) with the injection assist device. In contrast, accuracy values with the freehand method were more than 10 times worse (ie, >10% or 0.0025 mL). Accuracy estimates were also superior with the device over freehand for 2- and 4-unit doses. Precision estimates favored the device for all comparisons and all dosing regimens. The magnitude of variability around the average difference ranged from 2.2 to 5.4 times worse for the freehand method compared to the device. The overall percentage of product waste was substantial with the freehand method (>10%) compared to the device (4.3%) (P=0.04) for 1-unit injections. The percentage of injections showing measurable product waste was also significantly lower with the device (78% vs 25%, P=0.01). Fourteen of 15 (93%) injectors surveyed would use the device in daily practice if it were included complimentary with the neurotoxin. CONCLUSION: The injection assist device offered superior accuracy and precision compared to the freehand method across the entire injection regimen. The ancillary finding of a significant reduction in product waste with the device was particularly notable.

Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis.

BACKGROUND: Lumbar spinal stenosis (LSS) causes significant pain and functional impairment, and medical management has increasingly included the prescription of opioid-based analgesics. Interspinous process decompression (IPD) provides a minimally-invasive treatment option for LSS. METHODS: This study estimated the type, dosage, and duration of opioid medications through 5 years of follow-up after IPD with the Superion Indirect Decompression System (Vertiflex Inc., Carlsbad, CA USA). Data were obtained from the Superion-treatment arm of a randomized controlled noninferiority trial. The prevalence of subjects using opiates was determined at baseline through 60 months. Primary analysis included all 190 patients randomized to receive the Superion device. In a subgroup of 98 subjects, we determined opioid-medication prevalence among subjects with a history of opioid use. RESULTS: At baseline, almost 50% (94 of 190) of subjects were using opioid medication. Thereafter, there was a sharp decrease in opioid-medication prevalence from 25.2% (41 of 163) at 12 months to 13.3% (20 of 150) at 24 months to 7.5% (8 of 107) at 60 months. Between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids. A similar pattern was also observed among subjects with a history of opiates prior to entering the trial. CONCLUSION: Stand-alone IPD is associated with a marked decrease in the need for opioid medications to manage symptoms related to LSS. In light of the current opiate epidemic, such alternatives as IPD may provide effective pain relief in patients with LSS without the need for opioid therapy.

Length of stay associated with posterior cervical fusion with intervertebral cages: experience from a device registry.

BACKGROUND: Using a multi-center medical device registry, we prospectively collected a set of perioperative and clinical outcomes among patients treated with tissue-sparing, posteriorly-placed intervertebral cage fusion used in the management of symptomatic, degenerative neural compressive disorders of the cervical spine. METHODS: Cervical fusion utilizing posteriorly-placed intervertebral cages offers a tissue-sparing alternative to traditional instrumentation for the treatment of symptomatic cervical radiculopathy. A registry was established to prospectively collect perioperative and clinical data in a real-world clinical practice setting for patients treated via this approach. This study evaluated length of stay as well as estimated blood loss and procedural time in 271 registry patients. RESULTS: The median length of stay was 1.1, 1.1 and 1.2 days for patients having a stand-alone arthrodesis, revision of a pseudoarthrosis, and circumferential fusion (360°), respectively, and was not related to number of levels treated. Historical comparison to published literature demonstrated that average lengths of stay associated with open, posterior lateral mass fixation were consistently ≥4 days. Average blood loss (range, 32-75 mL) and procedural time (range, 51-88 min) were also diminished in patients having tissue-sparing, cervical intervertebral cage fusion compared to open posterior lateral mass fixation. CONCLUSIONS: Adoption of this tissue-sparing procedure may offer substantial cost-constraining benefits by reducing the length of post-operative hospitalization by, at least, 3 days compared to traditional lateral mass fixation.