Biphasic Calcium Phosphate Bone Graft With a Unique Surface Topography: A Single-Center Ambispective Study for Degenerative Disease of the Lumbar Spine.

STUDY DESIGN: This study is an ambispective evaluation and analysis of a single-center cohort. OBJECTIVE: This study aimed to evaluate the performance of a novel biphasic calcium phosphate (BCP) bone graft with submicron-sized needle-shaped surface topography (BCP<µm) in interbody arthrodesis of the lumbar spine. METHODS: This study was a single-center ambispective assessment of adult patients receiving BCP<µm as part of their lumbar interbody fusion surgery. The primary outcome was a fusion status on computed tomography (CT) 12 months postoperative. The secondary outcomes included postoperative changes in the visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form 12 (SF-12), and length of stay (LOS). RESULTS: Sixty-three patients with one- to three-level anterior (48, 76%) and lateral (15, 24%) interbody fusions with posterior instrumentation were analyzed. Thirty-one participants (49%) had three or more comorbidities, including heart disease (43 participants, 68%), obesity (31 participants, 49%), and previous lumbar surgery (23 participants, 37%). The mean ODI decreased by 24. The mean SF-12 physical health and SF-12 mental health improved by a mean of 11.5 and 6.3, respectively. The mean VAS for the left leg, right leg, and back improved by a mean of 25.75, 22.07, and 37.87, respectively. Of 101 levels, 91 (90%) demonstrated complete bridging trabecular bone fusion with no evidence of supplemental fixation failure. CONCLUSION: The data of BCP<µm in interbody fusions for degenerative disease of the lumbar spine provides evidence of fusion in a complicated cohort of patients.

Finite element analysis comparing a PEEK posterior fixation device versus pedicle screws for lumbar fusion.

BACKGROUND: Pedicle screw loosening and breakage are common causes of revision surgery after lumbar fusion. Thus, there remains a continued need for supplemental fixation options that offer immediate stability without the associated failure modes. This finite element analysis compared the biomechanical properties of a novel cortico-pedicular posterior fixation (CPPF) device with those of a conventional pedicle screw system (PSS). METHODS: The CPPF device is a polyetheretherketone strap providing circumferential cortical fixation for lumbar fusion procedures via an arcuate tunnel. Using a validated finite element model, we compared the stability and load transfer characteristics of CPPF to intact conditions under a 415 N follower load and PSS conditions under a 222 N preload. Depending on the instrumented levels, two different interbody devices were used: a lateral lumbar interbody device at L4-5 or an anterior lumbar interbody device at L5-S1. Primary outcomes included range of motion of the functional spinal units and anterior load transfer, defined as the total load through the disk and interbody device after functional motion and follower load application. RESULTS: Across all combinations of interbody devices and lumbar levels evaluated, CPPF consistently demonstrated significant reductions in flexion (ranging from 90 to 98%), extension (ranging from 88 to 94%), lateral bending (ranging from 75 to 80%), and torsion (ranging from 77 to 86%) compared to the intact spine. Stability provided by the CPPF device was comparable to PSS in all simulations (range of motion within 0.5 degrees for flexion-extension, 0.6 degrees for lateral bending, and 0.5 degrees for torsion). The total anterior load transfer was higher with CPPF versus PSS, with differences across all tested conditions ranging from 128 to 258 N during flexion, 89-323 N during extension, 135-377 N during lateral bending, 95-258 N during torsion, and 82-250 N during standing. CONCLUSION: Under the modeled conditions, cortico-pedicular fixation for supplementing anterior or lateral interbody devices between L4 and S1 resulted in comparable stability based on range of motion measures and less anterior column stress shielding based on total anterior load transfer measures compared to PSS. Clinical studies are needed to confirm these finite element analysis findings.

Cervical Disc Arthroplasty vs Anterior Cervical Discectomy and Fusion at 10 Years: Results From a Prospective, Randomized Clinical Trial at 3 Sites.

BACKGROUND: Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1- and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers. METHODS: This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF. Following completion of the 7-year US Food and Drug Administration study, 10-year follow-up was obtained from consenting patients at 3 high-enrolling centers. The clinical and radiographic endpoints collected at 10 years included composite success, Neck Disability Index, neck and arm pain, short form-12, patient satisfaction, adjacent-segment pathology, major complications, and subsequent surgery. RESULTS: A total of 155 patients were enrolled (105 CDA; 50 ACDF). Follow-up was obtained from 78.1% of patients eligible after 7 years. At 10 years, CDA demonstrated superiority to ACDF. Composite success was 62.4% in CDA and 22.2% in ACDF (P < 0.0001). The cumulative risk of subsequent surgery at 10 years was 7.2% vs 25.5% (P = .001), and the risk of adjacent-level surgery was 3.1% vs 20.5% (P = .0005) in CDA vs ACDF, respectively. The progression to radiographically significant adjacent-segment pathology at 10 years was lower in CDA vs ACDF (12.9% vs 39.3%; P = 0.006). At 10 years, patient-reported outcomes and change from baseline were generally better in CDA patients. A higher percentage of CDA patients reported they were "very satisfied" at 10 years (98.7% vs 88.9%; P = 0.05). CONCLUSIONS: In this postmarket study, CDA was superior to ACDF for treating symptomatic cervical DDD. CDA was statistically superior to ACDF for clinical success, subsequent surgery, and neurologic success. Results through 10 years demonstrate that CDA continues to be a safe and effective surgical alternative to fusion. CLINICAL RELEVANCE: The results of this study support the long-term safety and effectiveness of cervical disc arthroplasty with the Mobi-C.

Metal-Free Cortico-Pedicular Device for Supplemental Fixation in Lumbar Interbody Fusion.

OBJECTIVE: Pedicle screw fixation is a commonly utilized adjunct for lumbar interbody fusion, yet risks include screw malposition, pullout, loosening, neurovascular injury, and stress transfers leading to adjacent segment degeneration. This report describes the preclinical and initial clinical results of a minimally invasive, metal-free cortico-pedicular fixation device used for supplemental posterior fixation in lumbar interbody fusion. METHODS: Safety of arcuate tunnel creation was evaluated in cadaveric lumbar (L1-S1) specimens. A finite element analysis study evaluated clinical stability of the device to pedicular screw-rod fixation at L4-L5. Preliminary clinical results were assessed by analysis of Manufacturer and User Facility Device Experience database complications, and 6-month outcomes in 13 patients treated with the device. RESULTS: Among 35 curved drill holes in 5 lumbar specimens, no breaches of the anterior cortex were identified. The mean minimum distance from the anterior surface of the hole to the spinal canal ranged from 5.1 mm at L1-L2 to 9.8 mm at L5-S1. In the finite element analysis study, the polyetheretherketone strap provided comparable clinical stability and reduced anterior stress shielding compared to the conventional screw-rod construct. The Manufacturer and User Facility Device Experience database identified 1 device fracture with no clinical sequelae among 227 procedures. Initial clinical experience showed a 53% decrease in pain severity (P = 0.009), a 50% decrease in Oswestry Disability Index (P < 0.001), and no device-related complications. CONCLUSIONS: Cortico-pedicular fixation is a safe and reproducible procedure that may address limitations of pedicle screw fixation. Longer term clinical data in large clinical studies are recommended to confirm these promising early results.

Cervical Total Disc Replacement: Indications and Technique.

Cervical total disc replacement devices have been marketed in the United States (US) since 2007, with abundant level 1 evidence published on the treatment. Adherence to the strict inclusion/exclusion criteria and the surgical technique training of the US clinical trials remains the consistent and conservative approach to patient selection and implantation technique. However, patient selection and surgical technique remain debated among US surgeons as the published data and available cervical total disc replacements continue to grow.

Spontaneous regression and near disappearance of a calcified herniated thoracic disc in a 44-year-old male: illustrative case.

BACKGROUND: Herniation of an intervertebral disc (IVD) is found predominantly in the lumbar and cervical spine of both children and adults, but herniated IVDs of the thoracic spine are a rare occurrence. However, approximately 40% of herniated thoracic disc cases are calcified. Approximately 0.65% of all spinal herniations are calcified herniated thoracic discs (CHTDs). CHTDs can be treated conservatively or invasively, depending on the symptoms and degree of neurological deficit present. OBSERVATIONS: The authors report a 44-year-old male with near complete reabsorption and disappearance of a CHTD. A review of the available literature indicates that there are only seven adult patients in whom this phenomenon has been reported. LESSONS: Determining the best form of invasive treatment is a challenge for surgeons given the complexity of this condition. While the disappearance of calcified herniated discs of the lumbar and cervical spine has been reported, reports of the regression of CHTDs are rare. The disappearance of CHTDs is more commonly reported in children who undergo conservative treatment, while surgery is reserved for children who experience progressive pain and neurological deficit. Given the success of conservative treatment of CHTDs in children, conservative treatment methods should be considered when treating mildly symptomatic adults.

One Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.

STUDY DESIGN: A prospective multicenter investigational device exempt trial is underway evaluating a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease. Patients meeting inclusion and exclusion criteria were offered enrollment. There is no comparative group in this study. OBJECTIVE: Establish the short and long-term safety and effectiveness of a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease unresponsive to conservative care. SUMMARY OF BACKGROUND DATA: Transforaminal lumbar interbody fusion remains a critical procedure for patients with degenerative lumbar disc disease. Increasingly minimally invasive techniques have been proposed to minimize muscle dissection and tissue damage with the goal of minimizing pain and length of stay. METHODS: One hundred two subjects were enrolled across 10 sites. Ninety nine subjects remained available for follow-up at 12-months. Physical evaluations/imaging were performed serially through 12-months. Validated assessment tools included 100 mm visual analogue scale (VAS) for pain, Oswestry Disability Index (ODI) for function, and computerized tomography scan for fusion. Independent committees were used to identify adverse events and for assessment of radiographic fusion. RESULTS: Reductions in low back pain (LBP)/leg pain and improvements in functional status occur early and are maintained through 12-month follow-up. Mean VAS-LBP change from baseline to 6-weeks post-op (-46 mm) continued to improve through 12 months (-51 mm). Similar trends were observed for leg pain. Mean ODI change from baseline to 6 weeks post-op (-17) was almost doubled by 12 months (-32). Fusion rates at 12-months are high (98%). No device-related serious adverse events have occurred. CONCLUSION: 12-month outcomes demonstrated excellent patient compliance and positive outcomes for pain, function, fusion, and device safety. Clinical improvements were observed by 6-weeks post-op and appear durable up to 1 year later. A novel mesh interbody device may provide an alternative means of interbody fusion that reduces connective tissue disruption.Level of Evidence: 3.

Two-Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.

BACKGROUND: Interbody fusion is a widely utilized and accepted procedure to treat advanced debilitating lumbar degenerative disc disease (DDD). Increasingly, surgeons are seeking interbody devices that are large for stability and grafting purposes but can be inserted with less invasive techniques. To achieve these contrary objectives a novel, conformable mesh interbody fusion device was designed to be placed in the disc space through a small portal and filled with bone graft in situ to a large size. This design can reduce the risk of trauma to surrounding structures while creating a large graft footprint that intimately contours to the patient's own anatomy. The purpose of this Investigational Device Exempt (IDE) trial was to evaluate the perioperative and long-term results of this novel conformable mesh interbody fusion device. METHODS: This investigation is a prospective, multicenter, single-arm, Food and Drug Administration and Institutional Review Board-approved IDE, performance goal trial. A total of 102 adults presenting with DDD at a single level between L2 and S1 and unresponsive to 6 months conservative care had instrumented lumbar interbody fusion. Validated assessment tools include 100 mm visual analog scale for pain, Oswestry Disability Index (ODI) for function, single question survey for patient satisfaction, and computed tomography (CT) scan for fusion. Patients were enrolled across 10 geographically distributed sites. Pain/ODI surveys, physical evaluations, and imaging were performed serially through 24 months. Specifically, CT was performed at 12 and, if not fused, 24 months. Independent radiologists assessed CTs for fusion. An independent committee adjudicated adverse events. Patients with complete data at 24 months were included in the analysis. RESULTS: Ninety-six (96, 94% follow-up rate) patients (57.0 ± 12.0 years, 50.0% female, Body Mass Index 30.6 ± 4.9) reported average decreased low back pain from baseline of 45.0 ± 26.6 at 6 weeks and 51.4 ± 26.2 at 24 months. Right/left leg pain reduced by 28.9 ± 36.7/37.8±32.4 at 6 weeks and 30.5±33.0/40.3 34.6 at 24 months. Mean ODI improved 17.1 ± 18.7 from baseline to 6 weeks and 32.0 ± 18.5 by 24 months. At 24 months, 91.7% of patients rated their procedure as excellent/good. Fusion rates were 97.9% (94/96) at 12 months, and 99% (95/96) at 24 months. Mean operative time, estimated blood loss, and length of stay were 2.6 ± 0.9 hours, 137 ± 217 mL, and 2.3 ± 1.2 days, respectively. No device-related serious adverse events have occurred. CONCLUSIONS: Clinically significant outcomes for pain, function, fusion, and device safety were demonstrated in this population. Substantial clinical improvements occur by 6 weeks postoperative and continue to improve to 24 months. The successful outcomes observed in this trial support use of this novel device in an instrumented lumbar interbody fusion. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: This reports substantiates that the preliminary 1-year findings published earlier for this investigation are confirmed and the fusion rates and that patient improvements reported are sustained through 2 years.

Critical Evaluation of Biomechanical Principles and Radiographic Indicators for Fusion Assessment in a Novel Conformable Porous Mesh Implant.

INTRODUCTION: The objectives of this paper were to identify and explain specific design factors for lumbar interbody fusion (IBF) devices that can influence bone exchange and stability at the vertebral endplate interface and to provide supporting evidence of these factors through both laboratory and clinical data. The laboratory study (Part 1) compared the pressure profiles and contact areas for a minimally invasive, expandable, and conformable porous mesh (CPM) IBF device and a rigid monolithic lateral PEEK cage (LPC). Furthermore, to demonstrate how these laboratory results translate clinically, a quantitative and qualitative assessment of subject x-rays and computed tomography (CT) scans from a US Food and Drug Administration (FDA) investigational device exemption (IDE) trial of the CPM was performed (Part 2). METHODS: Part 1: Load profile testing. Either CPM or LPC was sandwiched between 2 flat or shaped Grade 15 foam blocks. Each implant type was compressed at a rate of 0.1 mm/s for 3 loads (1100, 2000, or 3000 N). Device and bone graft contact area were analyzed for each test condition, and corresponding load profiles were quantified and mapped using pressure film. Part 2: Radiographic fusion assessment. Two independent radiologists analyzed 12- and 24-month motion studies and CTs for fusion, defined as bridging bone across the intervertebral space. The same CTs were assessed for qualitative biomechanical signs of bone healing. RESULTS: CPM demonstrated significant direct loading on the bone graft across all tested loading conditions, while the LPC graft registered a negligible amount of pressure at only the extreme load of 3000 N. Contact area was in turn statistically greater (P < .05) for CPM. CPM fusion rates were 97.9% and 99% at 12 and 24 months, respectively. Radiographic signs of bone healing are described in terms of radiating bone struts and regions of greater intensity. CONCLUSIONS: CPM allows for an optimized contact area for bone exchange and graft incorporation. The load profiles demonstrate widespread load sharing across the device. The expandable, compliant, porous mesh provides a unique area for bone exchange, contributing to qualitative biomechanical radiographic evidence of bone healing that ultimately leads to clinically acceptable fusion rates as observed in the FDA IDE trial.

Cell and Tissue Response to Polyethylene Terephthalate Mesh Containing Bone Allograft in Vitro and in Vivo.

BACKGROUND: Extended polyethylene terephthalate mesh (PET, Dacron) can provide containment of compressed particulate allograft and autograft. This study assessed if PET mesh would interfere with osteoprogenitor cell migration from vertebral plates through particulate graft, and its effect on osteoblast differentiation or the quality of bone forming within fusing vertebra during vertebral interbody fusion. METHODS: The impact of PET mesh on the biological response of normal human osteoblasts (NHOst cells) and bone marrow stromal cells (MSCs) to particulate bone graft was examined in vitro. Cells were cultured on rat bone particles +/- mesh; proliferation and osteoblast differentiation were assessed. The interface between the vertebral endplate, PET mesh, and newly formed bone within consolidated allograft contained by mesh was examined in a sheep model via microradiographs, histology, and mechanical testing. RESULTS: Growth on bone particles stimulated proliferation and early differentiation of NHOst cells and MSCs, but delayed terminal differentiation. This was not negatively impacted by mesh. New bone formation in vivo was not prevented by use of a PET mesh graft containment device. Fusion was improved in sites containing allograft/demineralized bone matrix (DBM) versus autograft and was further enhanced when stabilized using pedicle screws. Only sites treated with allograft/DBM+screws exhibited greater percent bone ingrowth versus discectomy or autograft. These results were mirrored biomechanically. CONCLUSIONS: PET mesh does not negatively impact cell attachment to particulate bone graft, proliferation, or initial osteoblast differentiation. The results demonstrated that bone growth occurs from vertebral endplates into graft material within the PET mesh. This was enhanced by stabilization with pedicle screws leading to greater bone ingrowth and biomechanical stability across the fusion site. CLINICAL RELEVANCE: The use of extended PET mesh allows containment of bone graft material during vertebral interbody fusion without inhibiting migration of osteoprogenitor cells from vertebral end plates in order to achieve fusion. LEVEL OF EVIDENCE: 5.

Load Share Mapping for Traditional PEEK vs Novel Hybrid PEEK With Expandable Porous Mesh Intervertebral Devices.

BACKGROUND: A successful intervertebral fusion requires biomechanical stability created by the structural support of the interbody device and loading of the bone graft material to accelerate mechanotransduction and bone remodeling. The objective of this study was to generate a quantitative map of the contact area and stress profile for 2 implant designs; a rigid monolithic polyetheretherketone (PEEK) lateral cage (MPLC), and a unique hybrid interbody design, which includes PEEK terminal supports surrounding an expandable porous mesh (P+EPM) that serves to contain bone graft. METHODS: The construct for each test consisted of a device sandwiched between 2 flat or shaped Grade 15 foam blocks. Pressure sensitive film and thin film sensors were placed between the device and each of the foam blocks. A series of each implant type was compressed at a rate 0.1 mm/second for 2 loads (1100 N and 2000 N) with and without bone graft. Device and bone graft contact area were analyzed for each test condition and corresponding load profiles were quantified and mapped. RESULTS: P+EPM demonstrated 34% greater graft volume than MPLC resulting in a 28% larger area for bone exchange when filled. The load profiles for all applied loading paradigms for P+EPM demonstrated significant direct loading on the bone graft contained within the mesh, resulting in at least 170% greater loaded area than MPLC. Furthermore, the P+EPM demonstrated load sharing with the terminal PEEK supports. MPLC for all loading conditions demonstrated negligible bone graft loading. CONCLUSIONS: P+EPM allows for an optimized contact area for bone exchange and graft incorporation. The load profiles confirmed that the filled mesh does not stress shield terminal PEEK supports and will load share. The expandable, compliant, porous mesh provides a greater multiplanar area for bone exchange and allows for direct contact with the viscoelastic vertebral endplates, improving the endplate and graft interface mechanics.

Patient Selection in Cervical Disc Arthroplasty.

BACKGROUND: Patient selection for cervical disc arthroplasty (CDA) in the United States remains a topic of debate among surgeons. Many surgeons base US patient selection for CDA implantation on the Food and Drug Administration (FDA) indications/contraindications. While off-label use does occur, the frequency and extent of off-label use in the US remains largely unknown. Outside the United States, patient selection is notably less stringent; however such data also remain largely unpublished or presented/published with a low level of evidence. Here, we will review the current approved US on-label patient selection criteria for CDA and discuss the rationale and supporting evidence to expand these criteria in the United States. METHODS: A PubMed literature search was completed using the keywords "cervical disc arthroplasty" and "cervical disc replacement." The articles were evaluated by the authors for patient selection criteria. CONCLUSIONS: The current published data do not conclusively prove that the patients excluded from CDA by strict adherence to FDA indications would benefit from CDA surgery over anterior cervical discectomy and fusion. As surgeons, it is a difficult decision regarding when to expand indications to include off-label use of CDA. In our practice, generally CDA patient selection agrees with the FDA indications and contraindications, as there is a lack of level 1 evidence to confirm effectiveness of CDA outside of the current FDA indications. We will likely need more well-constructed studies to include prospective and controlled trials that specifically evaluate the "off-label" applications before US surgeons are convinced to expand indications and insurance companies agree to reimburse.

PEEK versus titanium cages in lateral lumbar interbody fusion: a comparative analysis of subsidence.

OBJECTIVE: The authors have provided a review of radiographic subsidence after lateral lumbar interbody fusion (LLIF) as a comparative analysis between titanium and polyetheretherketone (PEEK) cages. Many authors describe a reluctance to use titanium cages in spinal fusion secondary to subsidence concerns due to the increased modulus of elasticity of metal cages. The authors intend for this report to provide observational data regarding the juxtaposition of these two materials in the LLIF domain. METHODS: A retrospective review of a prospectively maintained database identified 113 consecutive patients undergoing lateral fusion for degenerative indications from January to December 2017. The surgeons performing the cage implantations were two orthopedic spine surgeons and two neurosurgeons. Plain standing radiographs were obtained at 1-2 weeks, 8-12 weeks, and 12 months postoperatively. Using a validated grading system, interbody subsidence into the endplates was graded at these time points on a scale of 0 to III. The primary outcome measure was subsidence between the two groups. Secondary outcomes were analyzed as well. RESULTS: Of the 113 patients in the sample, groups receiving PEEK and titanium implants were closely matched at 57 and 56 patients, respectively. Cumulatively, 156 cages were inserted and recombinant human bone morphogenetic protein-2 (rhBMP-2) was used in 38.1%. The average patient age was 60.4 years and average follow-up was 75.1 weeks. Subsidence in the titanium group in this study was less common than in the PEEK cage group. At early follow-up, groups had similar subsidence outcomes. Statistical significance was reached at the 8- to 12-week and 52-week follow-ups, demonstrating more subsidence in the PEEK cage group than the titanium cage group. rhBMP-2 usage was also highly correlated with higher subsidence rates at all 3 follow-up time points. Age was correlated with higher subsidence rates in univariate and multivariate analysis. CONCLUSIONS: Titanium cages were associated with lower subsidence rates than PEEK cages in this investigation. Usage of rhBMP-2 was also robustly associated with higher endplate subsidence. Each additional year of age correlated with an increased subsidence risk. Subsidence in LLIF is likely a response to a myriad of factors that include but are certainly not limited to cage material. Hence, the avoidance of titanium interbody implants secondary solely to concerns over a modulus of elasticity likely overlooks other variables of equal or greater importance.

Adjacent Segment Pathology After Treatment With Cervical Disc Arthroplasty or Anterior Cervical Discectomy and Fusion, Part 1: Radiographic Results at 7-Year Follow-Up.

BACKGROUND: Adjacent segment pathology (ASP) remains a concern following treatment with cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF). Radiographic ASP (RASP) is ASP identified on imaging, which may or may not include clinical symptoms. The risk factors for development of RASP and its clinical effects remain controversial. In part 1 of a 2-part publication we evaluate the incidence and predictors of RASP as well as determine whether any association exists between RASP and patient-reported outcomes (PROs). METHODS: Data were prospectively collected during a US Food and Drug Administration randomized, multicenter, investigational device exemption trial comparing CDA (Mobi-C; Zimmer Biomet, Westminster, CO) with ACDF. Multiple post hoc analyses were conducted on RASP as it related to demographics and patient outcomes. Kaplan-Meier estimates of time to Kellgren-Lawrence (K-L) grade 3/4 were calculated separately for all groups. Multivariate Cox proportional hazard models were used analyze whether RASP was associated with patient preoperative demographic characteristics and preoperative and postoperative radiographic characteristics. The association of RASP with PROs was analyzed using generalized estimating equations and matched, retrospective cohort analysis. RESULTS: The incidence of grade 3/4 RASP was lower for patients treated with CDA when initial treatment was at 1 level (27% vs 47%, P < .0001) and at 2 levels (14% vs 49%, P < .0001). Kaplan-Meier estimates indicated significantly lower probability of grade 3/4 RASP over time for patients receiving CDA (P < .001). Treatment with ACDF, treatment of 1 level, higher age, body mass index, higher preoperative physical components score, and a lower Cobb angle were associated with elevated risk of grade 3/4 RASP. CDA was shown to be more effective than ACDF (64.4%; 95% CI = 50.9, 74.2; P < .0001) at preventing RASP. CONCLUSIONS: The incidence and risk of RASP is decreased when patients are treated with CDA compared with ACDF. Although the mechanism of CDA that generates this protective effect is not understood, PROs remain unaffected through 7 years despite changes in RASP.

Adjacent Segment Pathology After Treatment With Cervical Disc Arthroplasty or Anterior Cervical Discectomy and Fusion, Part 2: Clinical Results at 7-Year Follow-Up.

BACKGROUND: Adjacent segment pathology (ASP) following cervical disc arthroplasty (CDA) or anterior cervical discectomy and fusion (ACDF) is identified by imaging (RASP) or clinical symptoms (CASP). Clinical symptoms of CASP have been broadly defined, but subsequent adjacent-level surgeries are clear indicators of CASP. Current literature remains inconsistent in the incidence and potential predictors of CASP. Here, we will evaluate a robust data set for the incidence of CASP resulting in subsequent surgery, attempt to identify factors that might affect CASP, and analyze the association of CASP with patient-reported outcomes (PROS) and RASP. METHODS: Data were prospectively collected during a US Food and Drug Administration randomized, multicenter, investigational device exemption trial comparing CDA (Mobi-C, Zimmer Biomet, Westminster, CO) with ACDF. CASP was defined as any adjacent-level subsequent surgical intervention. Post hoc analyses were conducted on the incidence, time to CASP diagnosis, and relationship of CASP with patient demographics. Longitudinal retrospective case-control analysis was used to assess the correlation of CASP to PROs and radiographic adjacent segment pathology (RASP). RESULTS: Kaplan-Meier estimates indicated significantly lower probability of CASP over time for 1-level (P = .002) and 2-level (P = .008) CDA patients. Treatment with ACDF and younger age were associated with higher CASP risk. CDA was more effective than ACDF (70.5%; 95% CI = 45.1, 84.2; P < .0001) at preventing CASP. Case-control analysis indicated increased probability of CASP for patients with grade 3/4 RASP, but the difference was not statistically significant. When we pooled CASP patients, the median grade of RASP at the visit prior to surgery was 1, with only 6 patients presenting with grade 3/4 RASP. CONCLUSIONS: Patients treated with CDA have a lower incidence of CASP than do patients treated with ACDF, although the mechanism remains unclear. CASP and RASP remain uncorrelated in this large data set, but other predictive variables such as treatment, age, and number of levels should be further investigated.

Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years-Prevalence, Progression, Clinical Implications, and Risk Factors.

BACKGROUND: Heterotopic ossification (HO) is a known risk following cervical total disc replacement (CTDR) surgery, but the cause and effect of HO are not well understood. Reported HO rates vary, and few studies are specifically designed to report HO. The effects on outcomes, and the risk factors for the development of HO have been hypothesized and reported in small-population, retrospective analyses, using univariate statistics. METHODS: Posthoc, multiple-phase analysis of radiographic, clinical, and demographic data for CTDR as it relates to HO was performed. HO was radiographically graded for 164 one-level and 225 two-level CTDR patients using the McAfee and Mehren system. Analysis was performed to correlate HO grades to clinical outcomes and to evaluate potential risk factors for the development of HO using demographics and baseline clinical measures. RESULTS: At 7 years, 1-level clinically relevant HO grades were 17.6% grade 3 and 11.1% grade 4. Two-level clinically relevant HO grades, evaluated using the highest patient grade, were 26.6% grade 3 and 10.8% grade 4. Interaction between HO and time revealed significance for neck disability index (NDI; P = .04) and Visual Analog Scale (VAS) neck pain (P = .02). When analyzed at each time point NDI was significant at 48-84 months and VAS neck at 60 months. For predictors 2 analyses were run; odds ratios indicated follow-up visit, male sex, and preoperative VAS neck pain are related to HO development, whereas hazard ratios indicated male sex, obesity, endplate coverage, levels treated, and preoperative VAS neck pain. CONCLUSIONS: This is the largest study to report HO rates, and related outcomes and risk factors. To develop an accurate predictive model, further large-scale analyses need to be performed. Based on the results reported here, clinically relevant HO should be more accurately described as motion-restricting HO until a definitive link to outcomes has been established.

Cervical Disc Arthroplasty: Current Evidence and Real-World Application.

Cervical total disc replacement (cTDR) is still considered a developing technology, with widespread clinical use beginning in the early 2000s. Despite being relatively new to the marketplace, the literature surrounding cTDR is abundant. We conducted a thorough review of literature published in the United States (US) and outside the US to report the current global state of cTDR research and clinical use. Search criteria were restricted to publications with a clinical patient population, excluding finite element analyses, biomechanical studies, cadaver studies, surgical technique-specific papers, and case studies. US publications mostly encompass the results of the highly controlled Food and Drug Administration Investigational Device Exemption trials. The predominantly level I evidence in the US literature supports the use of cTDR at 1 and 2 surgical levels when compared to anterior cervical discectomy and fusion. In general, the outside the US studies typically have smaller patient populations, are rarely controlled, and include broader surgical indications. Though these studies are of lower levels of evidence, they serve to advance patient indications in the use of cTDR. Complications such as secondary surgery, heterotopic ossification, and adjacent segment degeneration also remain a focus of studies. Other external challenges facing cTDR technology include regulatory restrictions and health economics, both of which are beginning to be addressed. Combined, the evidence for cTDR is robust supporting a variety of clinical indications.

Short-term outcomes of lateral lumbar interbody fusion without decompression for the treatment of symptomatic degenerative spondylolisthesis at L4-5.

OBJECTIVE Recently, authors have called into question the utility and complication index of the lateral lumbar interbody fusion procedure at the L4-5 level. Furthermore, the need for direct decompression has also been debated. Here, the authors report the clinical and radiographic outcomes of transpsoas lumbar interbody fusion, relying only on indirect decompression to treat patients with neurogenic claudication secondary to Grade 1 and 2 spondylolisthesis at the L4-5 level. METHODS The authors conducted a retrospective evaluation of 18 consecutive patients with Grade 1 or 2 spondylolisthesis from a prospectively maintained database. All patients underwent a transpsoas approach, followed by posterior percutaneous instrumentation without decompression. The Oswestry Disability Index (ODI) and SF-12 were administered during the clinical evaluations. Radiographic evaluation was also performed. The mean follow-up was 6.2 months. RESULTS Fifteen patients with Grade 1 and 3 patients with Grade 2 spondylolisthesis were identified and underwent fusion at a total of 20 levels. The mean operative time was 165 minutes for the combined anterior and posterior phases of the operation. The estimated blood loss was 113 ml. The most common cage width in the anteroposterior dimension was 22 mm (78%). Anterior thigh dysesthesia was identified on detailed sensory evaluation in 6 of 18 patients (33%); all patients experienced resolution within 6 months postoperatively. No patient had lasting sensory loss or motor deficit. The average ODI score improved 26 points by the 6-month follow-up. At the 6-month follow-up, the SF-12 mean Physical and Mental Component Summary scores improved by 11.9% and 9.6%, respectively. No patient required additional decompression postoperatively. CONCLUSIONS This study offers clinical results to establish lateral lumbar interbody fusion as an effective technique for the treatment of Grade 1 or 2 degenerative spondylolisthesis at L4-5. The use of this surgical approach provides a minimally invasive solution that offers excellent arthrodesis rates as well as favorable clinical and radiological outcomes, with low rates of postoperative complications. However, adhering to the techniques of transpsoas lateral surgery, such as minimal table break, an initial look-and-see approach to the psoas, clear identification of the plexus, minimal cranial caudal expansion of the retractor, mobilization of any traversing sensory nerves, and total psoas dilation times less than 20 minutes, ensures the lowest possible complication profile for both visceral and neural injuries even in the narrow safe zones when accessing the L4-5 disc space in patients with degenerative spondylolisthesis.

Impact of case type, length of stay, institution type, and comorbidities on Medicare diagnosis-related group reimbursement for adult spinal deformity surgery.

OBJECTIVE The aim of this study was to educate medical professionals about potential financial impacts of improper diagnosis-related group (DRG) coding in adult spinal deformity (ASD) surgery. METHODS Medicare's Inpatient Prospective Payment System PC Pricer database was used to collect 2015 reimbursement data for ASD procedures from 12 hospitals. Case type, hospital type/location, number of operative levels, proper coding, length of stay, and complications/comorbidities (CCs) were analyzed for effects on reimbursement. DRGs were used to categorize cases into 3 types: 1) anterior or posterior only fusion, 2) anterior fusion with posterior percutaneous fixation with no dorsal fusion, and 3) combined anterior and posterior fixation and fusion. RESULTS Pooling institutions, cases were reimbursed the same for single-level and multilevel ASD surgery. Longer stay, from 3 to 8 days, resulted in an additional $1400 per stay. Posterior fusion was an additional $6588, while CCs increased reimbursement by approximately $13,000. Academic institutions received higher reimbursement than private institutions, i.e., approximately $14,000 (Case Types 1 and 2) and approximately $16,000 (Case Type 3). Urban institutions received higher reimbursement than suburban institutions, i.e., approximately $3000 (Case Types 1 and 2) and approximately $3500 (Case Type 3). Longer stay, from 3 to 8 days, increased reimbursement between $208 and $494 for private institutions and between $1397 and $1879 for academic institutions per stay. CONCLUSIONS Reimbursement is based on many factors not controlled by surgeons or hospitals, but proper DRG coding can significantly impact the financial health of hospitals and availability of quality patient care.

Neurological Complications after Lateral Transpsoas Approach to Anterior Interbody Fusion with a Novel Flat-Blade Spine-Fixed Retractor.

Introduction. The lateral lumbar interbody fusion (LLIF) surgical approach has potential advantages over other approaches but is associated with some unique neurologic risks due to the proximity of the lumbosacral plexus. The present study analyzed complications following LLIF surgical approach using a novel single flat-blade retractor system. Methods. A retrospective data collection of patients receiving LLIF using a novel single flat-blade retractor system at two institutions in the US. Inclusion criteria were all patients receiving an LLIF procedure with the RAVINE® Lateral Access System (K2M, Inc., Leesburg, VA, USA). There was no restriction on preoperative diagnosis or number of levels treated. Approach-related neurologic complications were collected and analyzed postoperatively through a minimum of one year. Results. Analysis included 253 patients with one to four treated lateral levels. Immediate postoperative neurologic complications were present in 11.1% (28/253) of patients. At one-year follow-up the approach-related neurologic complications resolved in all except 5 patients (2.0%). Conclusion. We observed an 11.1% neurologic complication rate in LLIF procedures. There was resolution of symptoms for most patients by 12-month follow-up, with only 2% of patients with residual symptoms. This supports the hypothesis that the vast majority of approach-related neurologic symptoms are transient.