Clinical management of bone loss in cervical total disc arthroplasty: literature review and treatment recommendations.

PURPOSE: Cervical total disc replacement (cTDR) has been established as an alternative treatment for degenerative cervical radiculopathy and myelopathy. While the rate of complications for cTDR is reasonably low, recent studies have focused on bone loss after cTDR. The purpose of this work is to develop a clinical management plan for cTDR patients with evidence of bone loss. To guide our recommendations, we undertook a review of the literature and aimed to determine: (1) how bone loss was identified/imaged, (2) whether pre- or intraoperative assessments of infection or histology were performed, and (3) what decision-making and revision strategies were employed. METHODS: We performed a search of the literature according to PRISMA guidelines. Included studies reported the clinical performance of cTDR and identified instances of cervical bone loss. RESULTS: Eleven case studies and 20 cohort studies were reviewed, representing 2073 patients with 821 reported cases of bone loss. Bone loss was typically identified on radiographs during routine follow-up or by computed tomography (CT) for patients presenting with symptoms. Assessments of infection as well as histological and/or explant assessment were sporadically reported. Across all reviewed studies, multiple mechanisms of bone loss were suspected, and severity and progression varied greatly. Many patients were reportedly asymptomatic, but others experienced symptoms like progressive pain and paresthesia. CONCLUSION: Our findings demonstrate a critical gap in the literature regarding the optimal management of patients with bone loss following cTDR, and treatment recommendations based on our review are impractical given the limited amount and quality evidence available. However, based on the authors' extensive clinical experience, close follow-up of specific radiographic observations and serial radiographs to assess the progression/severity of bone loss and implant changes are recommended. CT findings can be used for clinical decision-making and further follow-up care. The pattern and rate of progression of bone loss, in concert with patient symptomatology, should determine whether non-operative or surgical intervention is indicated. Future studies involving implant retrieval, histopathological, and microbiological analysis for patients undergoing cTDR revision for bone loss are needed.

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.

Proposal for a classification system of radiographic bone changes after cervical disc replacement.

BACKGROUND: The goal of this study is to propose a classification system with a common nomenclature for radiographic observations of periprosthetic bone changes following cTDR. METHODS: Aided by serial plain radiographs from recent cTDR cases (34 patients; 44 devices), a panel of experts assembled for the purpose of creating a classification system to aid in reproducibly and accurately identifying bony changes and assessing cTDR radiographic appearance. Subdividing the superior and inferior vertebral bodies into 3 equal sections, observed bone loss such as endplate rounding, cystic erosion adjacent to the endplate, and cystic erosion not adjacent to the endplate, is recorded. Determining if bone loss is progressive, based on serial radiographs, and estimating severity of bone loss (measured by the percentage of end plate involved) is recorded. Additional relevant bony changes and device observations include radiolucent lines, heterotopic ossification, vertebral body olisthesis, loss of core implant height, and presence of device migration, and subsidence. RESULTS: Serial radiographs from 19 patients (25 devices) implanted with a variety of cTDR designs were assessed by 6 investigators including clinicians and scientists experienced in cTDR or appendicular skeleton joint replacement. The overall agreement of assessments ranged from 49.9% (95% bootstrap confidence interval 45.1-73.1%) to 94.7% (95% CI 86.9-100.0%). There was reasonable agreement on the presence or absence of bone loss or radiolucencies (range: 58.4% (95% CI 51.5-82.7%) to 94.7% (95% CI 86.9-100.0%), as well as in the progression of radiolucent lines (82.9% (95% CI 74.4-96.5%)). CONCLUSIONS: The novel classification system proposed demonstrated good concordance among experienced investigators in this field and represents a useful advancement for improving reporting in cTDR studies.

Presentation and management of infection in total disc replacement: A review.

Background: Total disc replacement (TDR) is widely used in the treatment of cervical and lumbar spine pathologies. Although TDR infection, particularly delayed infection, is uncommon, the results can be devastating, and consensus on clinical management remains elusive. In this review of the literature, we asked: (1) What are the reported rates of TDR infection; (2) What are the clinical characteristics of TDR infection; and (3) How has infection been managed for TDR patients? Methods: We performed a search of the literature using PubMed and Embase to identify studies that reported TDR infection rates, the identification and management of TDR infection, or TDR failures with positive cultures. Twenty database studies (17 focusing on the cervical spine and 3 on the lumbar spine) and 10 case reports representing 15 patients were reviewed along with device Summary of Safety and Effectiveness Data reports. Results: We found a lack of clarity regarding how infection was diagnosed, indicating a variation in clinical approach and highlighting the need for a standard definition of TDR infection. Furthermore, while reported infection rates were low, the absence of a clear definition prevented robust data analysis and may contribute to underreporting in the literature. We found that treatment strategy and success rely on several factors including patient symptoms and time to onset, microorganism type, and implant positioning/stability. Conclusions: Although treatment strategies varied throughout the extant literature, common practices in eliminating infection and reconstructing the spine emerged. The results will inform future work on the creation of a more robust definition of TDR infection and as well as recommendations for management.

Invasive Treatments for Low Back Disorders.

OBJECTIVE: This abbreviated version of the American College of Occupational and Environmental Medicine's Low Back Disorders guideline reviews the evidence and recommendations developed for invasive treatments used to manage low back disorders. METHODS: Comprehensive systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking and often relied on analogy to other disorders for which evidence exists. A total of 47 high-quality and 321 moderate-quality trials were identified for invasive management of low back disorders. RESULTS: Guidance has been developed for the invasive management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 49 specific recommendations. CONCLUSION: Quality evidence should guide invasive treatment for all phases of managing low back disorders.

Non-Invasive and Minimally Invasive Management of Low Back Disorders.

OBJECTIVE: This abbreviated version of the American College of Occupational and Environmental Medicine's (ACOEM) Low Back Disorders Guideline reviews the evidence and recommendations developed for non-invasive and minimally invasive management of low back disorders. METHODS: Systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking. A total of 70 high-quality and 564 moderate-quality trials were identified for non-invasive low back disorders. Detailed algorithms were developed. RESULTS: Guidance has been developed for the management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 121 specific recommendations. CONCLUSION: Quality evidence should guide treatment for all phases of managing low back disorders.

Lumbar facet joint subchondral bone density in low back pain and asymptomatic subjects.

OBJECTIVE: To report in vivo measurements of lumbar facet joint subchondral bone mineral density used in the description of facet joint loading patterns and to interrogate if low back pain is associated with changes in subchondral bone mineral density. MATERIALS AND METHODS: In vivo measurements of lumbar facet joint subchondral bone mineral density (L1/2 to L5/S1) in Hounsfield units were performed on 89 volunteers (56 controls and 33 with low back pain) by computed tomography osteoabsorptiometry at subchondral regions between 1.5 mm and 2.5 mm below the joint surface. The facet surface was divided into five topographic zones: cranial, lateral, caudal, medial, and central. RESULTS: We analyzed 1780 facet joint surfaces. Facets were denser (p < 0.0001) both in superior facets and in low back pain subjects (p < 0.0001). For the entire cohort, the facet center zone subchondral bone mineral density was higher (p < 0.0001) than that of the peripheral zones. The analyses indicate that subchondral bone mineral density is highest in patients with low back pain, the superior facets, and the center zone of the facets. CONCLUSIONS: Subchondral bone mineral density is thought to reflect cumulative, long-term distribution of stress acting on a joint. This work shows that higher subchondral bone mineral density values in the center zone indicate predominant stress transmission through the center of the facet joints. Finally, the greater subchondral bone mineral density in patients with low back pain may reflect both increased load bearing by the facets secondary to disc degeneration and misdistribution of loading within the joint.

Changes in Lumbar Endplate Area and Concavity Associated With Disc Degeneration.

STUDY DESIGN: Retrospective image-based analysis. OBJECTIVE: To measure endplate three-dimensional (3D) geometry, endplate changes in vivo and to investigate correlations between disc degeneration and endplate 3D geometry dependent on symptoms of low back pain (LBP). SUMMARY OF BACKGROUND DATA: It has been hypothesized that alteration of load transmission from the nucleus pulposus to the annulus fibrosus affects vertebral endplate geometry. METHODS: 3D surface models of inferior/superior lumbar endplates were created from computed tomography scans of n = 92 volunteers with and without LBP. Disc degeneration was evaluated using Pfirrmann scale. Concavity in both coronal and sagittal planes was assessed with the Concavity Index (unitless; larger than 1: concave; flat: 1; and less than 1: convex, respectively). Endplate area and disc height distribution were computed and the effects from demographics and spinal degeneration were sought with an analysis of variance model. RESULTS: Both sagittal and coronal planes revealed significantly decreased concavity in those with terminal grade 5 disc degeneration (mean 0.833 ±â€Š0.235) compared to the other grades in the cohort. Older subjects presented with larger endplate areas than the younger subjects (P = 0.0148) at L4-S1. Overall, symptomatic subjects had significantly larger endplate areas (P = 0.022), especially at the lower lumbar levels (P < 0.001). Analysis of variance showed that sex, disc level, disc degeneration grade, and disc height reached significance (P < 0.0001) as influential parameters in both Concavity Index cases. CONCLUSION: With advancing intervertebral disc degeneration, endplates become more convex over time in both sagittal and coronal planes. Our findings implicate the endplate changes with advancing disc degeneration in the shift in load transmission from the nucleus pulposus to the annulus fibrosus, resulting in changes within the curvature of the endplates. This is also the first study to describe the direct impact of age, sex, and LBP on vertebral endplate anatomy. LEVEL OF EVIDENCE: 5.

Spatial geometric and magnetic resonance signal intensity changes with advancing stages of nucleus pulposus degeneration.

BACKGROUND: With advancing stages of degeneration, denaturation and degradation of proteoglycans in the nucleus pulposus (NP) lead to tissue dehydration and signal intensity loss on T2-weighted MR images. Pfirrmann grading is widely used for grading degeneration of intervertebral discs (IVDs). The criterion to differentiate IVDs of Pfirrmann Grade I from the other grades is NP homogeneity. Pfirrmann grading is qualitative and its assessment may be subjective. Therefore, assessment of quantitative objective measures correlating with early disc degeneration may complement the grading. This study aimed to evaluate the applicability of the distance between the center weighted by signal intensity (weighted center) and the geometric center as a parameter of NP homogeneity. Other phenomena related to advancing stages of degeneration were also investigated. METHODS: MR images of 65 asymptomatic volunteers with a total of 288 lumbar IVDs with clearly identifiable nucleus pulposus boundary (Pfirrmann Grade I, II and III) were included in this study. A custom-written program was developed to determine the IVD longitudinal axis, define the NP boundary, and to locate the coordinates of geometric and weighted NP centers on the mid-sagittal image of each studied IVD. The distances between the weighted and geometric centers on the longitudinal axis and the perpendicular axis of each IVD were calculated. RESULTS: The weighted center located posterior to the geometric center, which indicated the signal intensity was lower at the anterior portion of the NP, in 85.8% of studied IVDs. The distance between the weighted and geometric center on the longitudinal axis was significantly shorter in homogeneous (Pfirrmann Grade I) than in inhomogeneous (Grade II) IVDs. The distance on the perpendicular axis in Grade III IVDs was significantly larger than that in Grade I and Grade II IVDs. CONCLUSION: The relationship between the weighted and geometric centers can serve as an indicator for NP homogeneity. The distance between both centers through advancing stages of degeneration demonstrated decrease of signal intensity progressing along the longitudinal axis initially and then along the cranio-caudal direction at later stages. These findings could provide insights of initiation and subsequent progression of degenerative changes in IVDs.

Utilization of CT scanning associated with complex spine surgery.

BACKGROUND: Due to the risk associated with exposure to ionizing radiation, there is an urgent need to identify areas of CT scanning overutilization. While increased use of diagnostic spinal imaging has been documented, no previous research has estimated the magnitude of follow-up imaging used to evaluate the postoperative spine. METHODS: This retrospective cohort study quantifies the association between spinal surgery and CT utilization. An insurance database (Humana, Inc.) with ≈ 19 million enrollees was employed, representing 8 consecutive years (2007-2014). Surgical and imaging procedures were captured by anatomic-specific CPT codes. Complex surgeries included all cervical, thoracic and lumbar instrumented spine fusions. Simple surgeries included discectomy and laminectomy. Imaging was restricted to CT and MRI. Postoperative imaging frequency extended to 5-years post-surgery. RESULTS: There were 140,660 complex spinal procedures and 39,943 discectomies and 49,889 laminectomies. MRI was the predominate preoperative imaging modality for all surgical procedures (median: 80%; range: 73-82%). Postoperatively, CT prevalence following complex procedures increased more than two-fold from 6 months (18%) to 5 years (≥40%), and patients having a postoperative CT averaged two scans. For simple procedures, the prevalence of postoperative CT scanning never exceeded 30%. CONCLUSIONS: CT scanning is used frequently for follow-up imaging evaluation following complex spine surgery. There is emerging evidence of an increased cancer risk due to ionizing radiation exposure with CT. In the setting of complex spine surgery, actions to mitigate this risk should be considered and include reducing nonessential scans, using the lowest possible radiation dose protocols, exerting greater selectivity in monitoring the developing fusion construct, and adopting non-ferromagnetic implant biomaterials that facilitate MRI postoperatively.

Lumbar disc degeneration is an equally important risk factor as lumbar fusion for causing adjacent segment disc disease.

Treatment of degenerative spinal disorders by fusion produces abnormal mechanical conditions at mobile segments above or below the site of spinal disorders and is clinically referred to as adjacent segments disc disease (ASDD) or transition syndrome in the case of a previous surgical treatment. The aim of the current study is to understand with the help of poro-elastic finite element models how single or two level degeneration of lower lumbar levels influences motions at adjacent levels and compare the findings to motions produced by single or two level fusions when the adjacent disk has varying degree of degeneration. Validated grade-specific finite element models including varying grades of disc degeneration at lower lumbar levels with and without fusion were developed and used to determine motions at all levels of the lumbar spine due to applied moment loads. Results showed that adjacent disc motions do depend on severity of disc degeneration, number of disc degenerated or fused, and level at which degeneration or fusion occurred. Furthermore, single level degeneration and single level fusion produced similar amount of adjacent disc motions. The pattern of increase in adjacent segment motions due to disc degeneration and increase in motions at segment adjacent to fusion was similar. Based on the current study, it can be concluded that disc degeneration should also be considered as a risk factor in addition to fusion for generating adjacent disc degeneration. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:123-130, 2017.

The Kinematics and Spondylosis of the Lumbar Spine Vary Depending on the Levels of Motion Segments in Individuals With Low Back Pain.

STUDY DESIGN: A prospective cohort study. OBJECTIVE: The aim of this study was to identify associations of spondylotic and kinematic changes with low back pain (LBP). SUMMARY OF BACKGROUND DATA: The ability to characterize and differentiate the biomechanics of both the symptomatic and asymptomatic lumbar spine is crucial to alleviate the sparse literature on the association of lumbar spine biomechanics and LBP. METHODS: Lumbar dynamic plain radiographs (flexion-extension), dynamic computed tomography (CT) scanning (axial rotation, disc height), and magnetic resonance imaging (MRI, disc and facet degeneration grades) were obtained for each subject. These parameters were compared between symptomatic and control groups using Student t test and multivariate logistic regression, which controlled for patient age and sex and identified spinal parameters that were independently associated with symptomatic LBP. Disc grade and mean segmental motion by level were tested by one-way analysis of variance (ANOVA). RESULTS: Ninety-nine volunteers (64 asymptomatic/35 LBP) were prospectively recruited. Mean age was 37.3 ±â€Š10.1 years and 55% were male. LBP showed association with increased L5/S1 translation [odds ratio (OR) 1.63 per mm, P = 0.005], decreased flexion-extension motion at L1/L2 (OR 0.87 per degree, P = 0.036), L2/L3 (OR 0.88 per degree, P = 0.036), and L4/L5 (OR 0.87 per degree, P = 0.020), increased axial rotation at L4/L5 (OR 2.11 per degree, P = 0.032), decreased disc height at L3/L4 (OR 0.52 per mm, P = 0.008) and L4/L5 (OR 0.37 per mm, p < 0.001), increased disc grade at all levels (ORs 2.01-12.33 per grade, P = 0.001-0.026), and increased facet grade at L4/L5 (OR 4.99 per grade, P = 0.001) and L5/S1 (OR 3.52 per grade, P = 0.004). Significant associations were found between disc grade and kinematic parameters (flexion-extension motion, axial rotation, and translation) at L4/L5 (P = 0.001) and L5/S1 (P < 0.001), but not at other levels (P > 0.05). CONCLUSION: In symptomatic individuals, L4/L5 and L5/S1 levels were affected by spondylosis and kinematic changes. This study clarifies the relationships between kinematic alterations and LBP, mostly observed at the above-mentioned segments. LEVEL OF EVIDENCE: N/A.

A cost comparison of unicompartmental and total knee arthroplasty.

BACKGROUND: Unicompartmental knee arthroplasty (UKA) is an alternative to total knee arthroplasty (TKA) in appropriately selected patients. There is a paucity of data comparing hospital resource utilization and costs for UKA versus TKA. METHODS: We retrospectively reviewed 128 patients who underwent UKA or TKA for osteoarthritis by a single surgeon in the 2011 Fiscal Year. Sixty-four patients in each group were matched based on sex, age, race, body mass index, Charlson Comorbidity Index, and insurance type. Clinical data were obtained from medical records while costs were obtained from hospital billing. Bivariate analyses were used to compare outcomes. RESULTS: Both anesthesia and operative time (minutes) were significantly shorter for patients undergoing UKA (125.7 vs. 156.4; p<0.001, and 81.4 vs. 112.2; p<0.001). UKA patients required fewer transfusions (0% vs. 11.0%; p=0.007) and had a shorter hospital stay (2.2 vs. 3.8days; p<0.001). 96% of UKAs were discharged home compared with 75% of TKAs (p<0.001). Hospital direct costs were lower for UKA ($7893 vs. $11,156; p<0.001) as were total costs (hospital direct costs plus overhead; $11,397 vs. $16,243; p<0.001). Supply costs and implant costs were similarly lower for UKA ($701 vs. $781; p<0.001, and $3448 vs. $5006; p<0.001). CONCLUSION: Our data suggest that UKA provides a cost-effective alternative to TKA in appropriately selected patients. As the number of patients with end-stage arthritis of the knee requiring surgical care continues to rise, the costs of caring for these patients must be considered. LEVEL OF EVIDENCE: Level III, case control study.

Effects of Axial Torsion on Disc Height Distribution: An In Vivo Study.

OBJECTIVES: Axial rotation of the torso is commonly used during manipulation treatment of low back pain. Little is known about the effect of these positions on disc morphology. Rotation is a three-dimensional event that is inadequately represented with planar images in the clinic. True quantification of the intervertebral gap can be achieved with a disc height distribution. The objective of this study was to analyze disc height distribution patterns during torsion relevant to manipulation in vivo. METHODS: Eighty-one volunteers were computed tomography-scanned both in supine and in right 50° rotation positions. Virtual models of each intervertebral gap representing the disc were created with the inferior endplate of each "disc" set as the reference surface and separated into 5 anatomical zones: 4 peripheral and 1 central, corresponding to the footprint of the annulus fibrosus and nucleus pulposus, respectively. Whole-disc and individual anatomical zone disc height distributions were calculated in both positions and were compared against each other with analysis of variance, with significance set at P < .05. RESULTS: Mean neutral disc height was 7.32 mm (1.59 mm). With 50° rotation, a small but significant increase to 7.44 mm (1.52 mm) (P < .0002) was observed. The right side showed larger separation in most levels, except at L5/S1. The posterior and right zones increased in height upon axial rotation of the spine (P < .0001), whereas the left, anterior, and central decreased. CONCLUSIONS: This study quantified important tensile/compressive changes disc height during torsion. The implications of these mutually opposing changes on spinal manipulation are still unknown.

Ligamentum flavum hypertrophy in asymptomatic and chronic low back pain subjects.

PURPOSE: To examine ligamentum flavum thickness using magnetic resonance (MR) images to evaluate its association with low back pain symptoms, age, gender, lumbar level, and disc characteristics. MATERIALS AND METHODS: Sixty-three individuals were part of this IRB-approved study: twenty-seven with chronic low back pain, and thirty-six as asymptomatic. All patients underwent MR imaging and computed tomography (CT) of the lumbar spine. The MR images at the mid-disc level were captured and enlarged 800% using a bilinear interpolation size conversion algorithm that allowed for enhanced image quality. Ligamentum flavum thickness was assessed using bilateral medial and lateral measurements. Disc height at each level was measured by the least-distance measurement method in three-dimensional models created by CT images taken of the same subject. Analysis of variance and t-tests were carried out to evaluate the relationship between ligamentum flavum thickness and patient variables. RESULTS: Ligamentum flavum thickness was found to significantly increase with older age, lower lumbar level, and chronic low back pain (p < 0.03). No difference in ligamentum flavum thickness was observed between right and left sided measurements, or between male and female subjects. Disc height and both ligamentum flavum thickness measurements showed low to moderate correlations that reached significance (p < 0.01). Additionally, a moderate and significant correlation between disc degeneration grade and ligamentum flavum thickness does exist (p <0.001). CONCLUSION: By measuring ligamentum flavum thickness on MR images at two different sites and comparing degrees of disc degeneration, we found that ligamentum flavum thickness may be closely related to the pathogenesis of pain processes in the spine.