BACKGROUND CONTEXT: In the treatment of cervical radiculopathy due to a herniated disc, potential surgical treatments include: anterior cervical discectomy (ACD), ACD and fusion using a cage (ACDF)... Show moreBACKGROUND CONTEXT: In the treatment of cervical radiculopathy due to a herniated disc, potential surgical treatments include: anterior cervical discectomy (ACD), ACD and fusion using a cage (ACDF), and anterior cervical disc arthroplasty (ACDA). Previous publications yielded com-parable clinical and radiological outcome data for the various implants, but research on their com-parative costutility has been inconclusive.PURPOSE: To evaluate the cost utility of ACD, ACDF, and ACDA.STUDY DESIGN: Cost-utility analysis.PATIENT SAMPLE: About 109 patients with cervical radiculopathy randomized to undergo ACD, ACDF, or ACDA as part of the NEtherlands Cervical Kinetics trial.OUTCOME MEASURES: Quality-adjusted life-years (QALYs) estimated from patient-reported utilities using the EuroQol-5D questionnaire and EuroQol Visual Analogue Scale (EQ VAS), mea-sured at baseline, 2, 4, 8, 12, 26, 52, and 104 weeks postprocedure. Societal costs including admis-sions to hospital (related and otherwise), GP visits, specialist visits, physical therapy, medications, home care, aids, informal care, productivity losses, and out of pocket condition-related expenses.METHODS: The cost utility of the competing strategies over 1 and 2 years was assessed following a net benefit (NB) approach, whereby the intervention with the highest NB among competing strat-egies is preferred. Cost effectiveness acceptability curves were produced to reflect the probability of each strategy being the most cost effective across various willingness-to-pay (WTP) thresholds. Five sensitivity analyses were conducted to assess the robustness of results. RESULTS: ACDF was more likely to be the most cost-effective strategy at WTP thresholds of euro20,000 to 50,000/QALY in all but one of the analyses. The mean QALYs during the first year were 0.750, 0.817, and 0.807 for ACD, ACDF, and ACDA, respectively, with no significant differ-ences between groups. Total healthcare costs over the first year were significantly higher for ACDA, largely due to the higher surgery and implant costs. The total societal costs of the three strategies were euro12,173 for ACD, euro11,195 for ACDF, and euro13,746 for ACDA, with no significant differences between groups.CONCLUSION: Our findings demonstrate that ACDF is likely to be more cost-effective than ACDA or ACD at most WTP thresholds, and this conclusion is robust to most sensitivity analyses conducted. It is demonstrated that the difference in costs is mainly caused by the initial surgical costs and that there are only minimal differences in other costs during follow-up. Since clinical data are comparable between the groups, it is to the judgment of the patient and surgeon which intervention is applied. (c) 2023 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) Show less
BACKGROUND CONTEXT: Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment dis-ease as compared... Show moreBACKGROUND CONTEXT: Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment dis-ease as compared to anterior cervical discectomy and fusion (ACDF). PURPOSE: To evaluate the long-term outcome in patients with cervical radiculopathy due to a herniated disc undergoing ACDA, ACDF or ACD (no cage, no plate) in terms of clinical outcome measured by the Neck Disability Index (NDI). Likewise, clinically relevant adjacent segment dis-ease is assessed as a long-term result. STUDY DESIGN: Double-blinded randomized controlled trial.PATIENT SAMPLE: A total of 109 patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without cage.OUTCOME MEASURES: Clinical outcome was measured by patients' self-reported NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, perceived recovery and reopera-tion rate. Radiological outcome was assessed by radiographic cervical curvature and adjacent seg-ment degeneration (ASD) parameters at baseline and up until five years after surgery.METHODS: To account for the correlation between repeated measurements of the same individ-ual Generalized Estimated Equations (GEE) were used to calculate treatment effects, expressed in difference in marginal mean values for NDI per treatment group. RESULTS: Clinical outcome parameters were comparable in the ACDA and ACDF group, but significantly worse in the ACD group, though not reaching clinical relevance. Annual reoperation rate was 3.6% in the first two years after surgery, declined to 1.9% in the years thereafter. The num-ber of reoperations for ASD was not lower in the ACDA group, while the number of reoperations at the index level was higher after ACD, when compared to ACDF and ACDA.CONCLUSIONS: A persisting absence of clinical superiority was demonstrated for the cervical disc prosthesis five years after surgery. Specifically, clinically relevant adjacent level disease was not prevented by implanting a prosthesis. Single level ACD without implanting an intervertebral device provided worse clinical outcome, which was hypothesized to be caused by delayed fusion. This stresses the need for focusing on timely fusion in future research.(c) 2022 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) Show less
Background context: The lumbar sinuvertebral nerve (SVN) innervates the outer posterior intervertebral disc (IVD); it is thought to mediate discogenic low-back pain (LBP). Controversy, however,... Show moreBackground context: The lumbar sinuvertebral nerve (SVN) innervates the outer posterior intervertebral disc (IVD); it is thought to mediate discogenic low-back pain (LBP). Controversy, however, exists on its origins at higher (L1-L2) versus lower (L3-L5) lumbar levels. Additionally, lack of knowledge regarding its foraminal and intraspinal branching patterns and extensions may lead to iatrogenic damage.Purpose: To systematically describe the origins of the L2 and L5 SVNs, their morphological variation in the intervertebral foramen (IVF) and intraspinal distribution.Study design: Dissection-based study of 20 SVNs with histological confirmation in five embalmed human cadavers.Methods: The origin, branching pattern and distribution of the L2 and L5 SVNs was investigated bilaterally in five human cadavers using dorsal and anterolateral dissection approaches. Parameters studied included somatic and/or autonomic SVN root contributions, foraminal SVN morphology and course, diameter, branching point, intraspinal distribution and IVD innervation pattern. Nerve tissue was confirmed by immunostaining for neurofilament and S100 proteins.Results: The SVN and its origins was identified in all except one IVF at L2 and in all foramina at L5. At L2, the SVN arose in nearly 90% of sides from both somatic and autonomic roots and at L5 in 40% of sides. The remaining SVNs were formed by purely autonomic roots. The SVN arose from significantly more roots at L2 than L5 (3.1 ± 0.3 vs. 1.9 ± 0.3, respectively; p=.022). Four different SVN morphologies could be discerned in the L2 IVF: single filament (22%), multiple (parallel or diverging) filament (33%), immediate splitting (22%) and plexiform (22%) types, whereas the L5 SVN consisted of single (90%) and multiple (10%) filament types. SVN filaments were significantly thicker at L2 than L5 (0.48 ± 0.06 mm vs. 0.33 ± 0.02 mm, respectively; p=.043). Ascending SVN filaments coursed roughly parallel to the exiting spinal nerve root trajectory at L2 and L5. Branching of the SVN into ascending and descending branches occurred mostly intraspinal both at L2 and L5. Spinal canal distribution was also similar for L2 and L5 SVNs. Lumbar posterior IVDs were innervated by the descending branch of the parent SVN and ascending branch of the subjacent SVN.Conclusions: The SVN at L2 originates from both somatic and autonomic roots in 90% of cases and at L5 in 40% of cases. The remaining SVNs are purely autonomic. In the IVF, the L2 SVN is morphologically heterogeneous, but generally consists of numerous filaments, whereas at L5 90% contains a single SVN filament. The L2 SVN is formed by more roots and is thicker than the L5 SVN. Intraspinal SVN distribution is confined to its level of origin; lumbar posterior IVDs are innervated by corresponding and subjacent SVNs (ie, two spinal levels).Clinical significance: Our findings indicate that L5 discogenic LBP may be mediated both segmentally and nonsegmentally in 40% of cases and nonsegmentally in 60% of cases. Failure of lower lumbar discogenic pain treatment may be the result of only interrupting the nonsegmental pathway, but not the segmental one as well. Relating SVN anatomy to microsurgical spinal approaches may prevent iatrogenic damage to the SVN and the formation of postsurgical back pain. Show less
BACKGROUND CONTEXT: Patients with modic changes (MC) form a distinct clinical subset with reports of higher intensity of pain, poor clinical and surgical outcomes and higher incidence of recurrence... Show moreBACKGROUND CONTEXT: Patients with modic changes (MC) form a distinct clinical subset with reports of higher intensity of pain, poor clinical and surgical outcomes and higher incidence of recurrence. MC also is an independent risk factor for increased post-operative surgical site infection.PURPOSE: This study aimed to investigate the biological changes at molecular level, in discs with MCs. We also aim to identify biological biomarkers and potential targets for molecular therapy.STUDY DESIGN: Experimental analysisMATERIALS AND METHODS: Nucleus pulposus (NP) from 24 patients undergoing microdiscectomy for disc herniation [14 discs with MC and 10 without modic changes (NMC)] were procured. The overall expression of proteins, biological processes, protein-protein and metabolite interactions were analysed and compared. Host defense response proteins (HDRPs) and immunological pathways activated in patients with MC were documented and analysed.RESULTS: Label-free proteomic approach with stringent filters revealed a total of 208 proteins in MC and 193 in NMC groups. 45 proteins were specific to MC; 30 to NMC and 163 common to both. Downregulated proteins in MC belonged to components of extracellular matrix such as collagens (COL-6A1, 6A2, 6A3, 11A1, 12A1, and 20A1), and proteoglycans (versican (VCAN), and biglycan (BGN)). Inflammatory molecules [plasminogen (PLG), angiogenin (ANG), fibroblast growth factor-binding protein 2 (FGFBP2), tetranectin (CLEC3B), cartilage acidic protein 1 (CRTAC1), kininogen (KNG-1), chitinase-3-like protein 2 (CHI3L2), and ferritin (FTL) were expressed only in the MC group. The significantly altered pathways in MC included Fc Fragment of IgG Receptor IIIa (FCGR3A)-mediated phagocytosis, regulation of Toll-like receptors (TLR) by endogenous ligand, neutrophil and platelet degranulation.50 HDRPs were identified in the study, 14 of which were specific to MC and included acute phase reactants, antimicrobial peptides, complement cascade proteins, inflammatory molecule and stress response proteins. Metabolite-protein interaction analysis revealed a significant interaction between 19 proteins, specifically involving ubiquitin mediating proteasome degradative pathway and an association with the metabolite-glutamic acid in the MC group. Accumulation of glutamic acid in MC discs was confirmed by quantitative amino acid analysis using High-performance liquid chromatography.CONCLUSION: Our study confirms that MC represents an intense inflammatory status and activation of host defense response and immunological pathways. Downstream effects leading to ubiquitin mediated proteasomal degradation of ECM proteins and the resulting metabolites such as glutamic acid could cause excessive pain and needs further investigation.CLINICAL SIGNIFICANCE: We have documented the expression of inflammatory molecules, immune mechanisms and host defense response proteins which throw molecular insights into the pathological mechanisms of MC. Further, ubiquitin mediated proteasomal degradation and accumulation of glutamate in discs with MC might serve as targets for molecular therapy. (C) 2021 Elsevier Inc. All rights reserved. Show less
Veeger, T.T.J.; Trigt, B. van; Hu, H.; Bruijn, S.M.; Dieen, J.H. van 2020
BACKGROUND: Literature describing differences in motor control between low back pain (LBP) patients and healthy controls is very inconsistent, which may be an indication for the existence of... Show moreBACKGROUND: Literature describing differences in motor control between low back pain (LBP) patients and healthy controls is very inconsistent, which may be an indication for the existence of subgroups. Pain-related psychological factors might play a role causing these differences.PURPOSE: To examine the relation between fear of movement and variability of kinematics and muscle activation during gait in LBP patients.STUDY DESIGN: Cross-sectional experimental design.PATIENT SAMPLE: Thirty-one Chinese LBP patients.OUTCOME MEASURES: Self-report measures: Visual Analog Score for pain; TAMPA-score; Physiologic measures: electromyography, range of motion.FUNCTIONAL MEASURES: LBP history; the physical load of profession, physical activity.METHODS: Patients were divided in high and low fear of movement groups. Participants walked on a treadmill at four speeds: very slow, slow, preferred and fast. Kinematics of the thorax and the pelvis were recorded, together with the electromyography of five bilateral trunk muscle pairs. Kinematic and electromyography data were analysed in terms of stride-to-stride pattern variability. Factor analysis was applied to assess interdependence of 11 variability measures. To test for differences between groups, a mixed-design multivariate analysis of variance was conducted.RESULTS: Kinematic variability and variability of muscle activation consistently loaded on different factors and thus represented different underlying variables. No significant Group effects on variability of kinematics and muscle activation were found (Hotelling's Trace F=0.237; 0.396, p=.959; .846, respectively). Speed significantly decreased kinematic variability and increased variability in muscle activation (Hotelling's Trace F=8.363; 4.595, p<.0001; <.0001, respectively). No significant interactions between Group and Speed were found (Hotelling's Trace F=0.204; 0.100, p=.762; .963, respectively).CONCLUSIONS: The results of this study do not support the hypothesis that variability in trunk kinematics and trunk muscle activation during gait in LBP patients are associated with fear of movement. (C) 2020 The Author(s). Published by Elsevier Inc. Show less
BACKGROUND CONTEXT: Defining clinically meaningful success criteria from patientreported outcome measures (PROMs) is crucial for clinical audits, research and decision-making.PURPOSE: We aimed to... Show moreBACKGROUND CONTEXT: Defining clinically meaningful success criteria from patientreported outcome measures (PROMs) is crucial for clinical audits, research and decision-making.PURPOSE: We aimed to define criteria for a successful outcome 3 and 12 months after surgery for cervical degenerative radiculopathy on recommended PROMs.STUDY DESIGN: Prospective cohort study with 12 months follow-up.PATIENT SAMPLE: Patients operated at one or two levels for cervical radiculopathy included in the Norwegian Registry for Spine Surgery (NORspine) from 2011 to 2016.OUTCOME MEASURES: Neck disability index (NDI), Numeric Rating Scale for neck pain (NRS-NP) and arm pain (NRS-AP), health-related quality-of-life EuroQol 3L (EQ-5D), general health status (EQ-VAS).METHODS: We included 2,868 consecutive cervical degenerative radiculopathy patients operated for cervical radiculopathy in one or two levels and included in the Norwegian Registry for Spine Surgery (NORspine). External criterion to determine accuracy and optimal cut-off values for success in the PROMs was the global perceived effect scale. Success was defined as "much better" or "completely recovered." Cut-off values were assessed by analyzing the area under the receiver operating curves for follow-up scores, mean change scores, and percentage change scores.RESULTS: All PROMs showed high accuracy in defining success and nonsuccess and only minor differences were found between 3- and 12-month scores. At 12 months, the area under the receiver operating curves for follow-up scores were 0.86 to 0.91, change scores were 0.74 to 0.87, and percentage change scores were 0.74 to 0.91. Percentage scores of NDI and NRS-AP showed the best accuracy. The optimal cut-off values for each PROM showed considerable overlap across those operated due to disc herniation and spondylotic foraminal stenosis.CONCLUSIONS: All PROMs, especially NDI and NRS-AP, showed good to excellent discriminative ability in distinguishing between a successful and nonsuccessful outcome after surgery due to cervical radiculopathy. Percentage change scores are recommended for use in research and clinical practice. (C) 2020 The Author(s). Published by Elsevier Inc. Show less
BACKGROUND CONTEXT: Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, polyetheretherketone (PEEK) with (auto)... Show moreBACKGROUND CONTEXT: Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, polyetheretherketone (PEEK) with (auto) graft is frequently used for interbody fusion although alternative implant tech- nology like 3-D printing titanium has been introduced recently. PURPOSE: Reporting the clinical and quantitative radiological outcome of a prospective cohort of 3-D printed porous titanium implants. STUDY DESIGN/SETTING: Prospective study of patients with single level ACDF using 3-D printed porous titanium cervical implants. These data were compared with 48 patients from the PEEK with autograft group of the previously performed CAncellous Structured Ceramic Arthrode- sis DEvice trial. PATIENT SAMPLE: Fourty-nine patients were included. OUTCOME MEASURES: Neck disability index (NDI), visual analog scale (VAS), self -reported perceived recovery, and fusion status. METHODS: The clinical outcomes and fusion rates were documented at 3, 6, and 12 months. Dynamic X-rays were analyzed to determine range of motion (ROM) of the operated level. Fusion was defined as rotation <= 4 degrees and <= 1.25 mm translation on flexion -extension films. RESULTS: The mean NDI improved from 41.2 preoperatively to 19.4 at 12 months postopera- tively. Both VAS arm and VAS neck improved significantly after surgery and 77.1% of the patients reported complete or nearly complete recovery at 12 months. The mean ROM of the affected disc level decreased from 8.7 degrees (range 2.6 -21.4) before surgery to 1.6 degrees (0.0 -4.6 degrees) after 12 months. The fusion rate at 3, 6, and 12 months was 84%, 89%, and 91% respectively, compared with 67%, 72%, and 90%, in the PEEK group. CONCLUSIONS: 3-D printed porous titanium cervical implants resulted in significant clinical improvement after surgery. The fusion rate of porous titanium compared with PEEK with autograft at 12 months was similar, although porous titanium resulted in faster consolidation. In addition, one level anterior cervical fusion can be successfully achieved without additional plating. (c) 2020 Elsevier Inc. All rights reserved. Show less
BACKGROUND: The contribution of Modic changes (MCs) in relation to spinal pain and degenerative changes has been evaluated frequently. However, most studies focus on lumbar spine. The association... Show moreBACKGROUND: The contribution of Modic changes (MCs) in relation to spinal pain and degenerative changes has been evaluated frequently. However, most studies focus on lumbar spine. The association between MCs, neck pain, and cervical disc degeneration is not clear.PURPOSE: The objective of this study was to review current literature on the association between MCs, cervical disc degeneration, and neck pain.STUDY DESIGN: A systematic reviewMETHODS: A literature search was performed in PubMed, Embase, and Web of Science using a sensitive search string combination. Studies were selected by predefined selection criteria and risk of bias was assessed using a validated Cochrane Checklist adjusted for this purpose.RESULTS: Fourteen articles that associated MCs with neck pain and/or cervical disc degeneration were included in the present study. Ten articles showed low risk of bias and four showed intermediate risk of bias. The prevalence of MCs in cervical spine varied from 5% to 40% and type II was predominant. Patients with MCs were reported to experience more neck pain and disability. Cervical disc degeneration was detected more frequently in patients with MCs.CONCLUSIONS: Modic changes were found to be associated with neck pain and with disc degeneration. Therefore, the large variation in prevalence that is reported is highly dependent on the nature of the studied population. (C) 2019 Elsevier Inc. All rights reserved. Show less
CONCLUSIONS: Implantation of IPD as indirect decompressing device is highly unlikely to be cost effective compared with bony decompression for patients with intermittent neurogenic claudication... Show moreCONCLUSIONS: Implantation of IPD as indirect decompressing device is highly unlikely to be cost effective compared with bony decompression for patients with intermittent neurogenic claudication caused by LSS. (C) 2014 Elsevier Inc. All rights reserved. Show less
Barzouhi, A. el; Vleggeert-Lankamp, C.L.A.M.; Nijeholt, G.J.L.A.; Kallen, B.F. van der; Hout, W.B. van den; Koes, B.W.; ... ; Leiden Hague Spine Intervention Pr 2014
