Preoperative risk factors for nonsatisfaction after lumbar interbody fusion.

Introduction: Low back pain (LBP) is a common cause of impaired quality of life and disability and studies regarding surgical management of patients with LBP show a high variation in patient-reported success rate. Research question: To find valuable preoperative clinical risk factors and variables associated with a non-satisfactory patient-reported outcome following surgery. Materials and methods: The Danish surgical spine database (DaneSpine) was used to collect eight years of pre- and postoperative data on patients undergoing single-level fusions with either posterior- (PLIF) or transforaminal lumbar interbody fusions (TLIF). The primary outcome was patient nonsatisfaction. We collected data on European Quality of Life-5 Dimensions (EQ-5D), visual analogue scale (VAS), Oswestry Disability Index (ODI) score, pain intensity, duration of back pain, previous discectomy, and expectations regarding return to work after surgery at 2-year follow-up. Results: The cohort included 453 patients of which 19% reported treatment nonsatisfaction. The nonsatisfaction group demonstrated higher preoperative VAS scores for back pain (75 ± 19 vs. 68 ± 21, p = 0.006) and leg pain (65 ± 25 vs. 58 ± 28, p = 0.004). The preoperative EQ-5D score was significantly lower in the nonsatisfaction group (0.203 + 0.262 vs. 0.291 ± 0.312, p = 0.016). There was no statistical significance between patient nonsatisfaction and preoperative ODI score, age, body mass index, duration of back pain or expectations regarding return to work after surgery. Discussion and conclusion: Low preoperative EQ-5D scores and high VAS leg and back pain scores were statistically significant with patient nonsatisfaction following surgery and may prove to be valuable tools in the preoperative screening and alignment of patient expectations.

The efficacy and safety of oral antibiotic treatment in patients with chronic low back pain and Modic changes: A systematic review and meta-analysis.

Background: This systematic review and meta-analysis aimed to summarize evidence regarding the effectiveness and safety of oral antibiotic intervention for chronic low back pain (CLBP) patients with/without type-1 Modic changes (MC1). Methods: AMED, CINAHL, Cochrane Library, Embase, and Medline were searched from inception to March 3, 2023. Randomized controlled trials (RCTs) or non-RCTs that investigated the effectiveness or safety of oral antibiotics in treating CLBP patients were eligible for inclusion. Two independent reviewers screened abstracts, full-text articles, and extracted data. The methodological quality of each included article were evaluated by RoB2 and NIH quality assessment tools. The quality of evidence was appraised by GRADE. Meta-analyses were performed, where applicable. A subgroup analysis was conducted to evaluate the RCTs and case series separately, and to evaluate the effect of removing a low-quality RCT. Results: Three RCTs and four case series were included. All Amoxicillin-clavulanate/Amoxicillin treatments lasted for approximately 3 months. Moderate- and low-quality evidence suggested that antibiotic was significantly better than placebo in improving disability and quality of life in CLBP patients with MC1 at 12-month follow-up, respectively. Low-quality evidence from meta-analyses of RCTs showed that oral antibiotic was significantly better than placebo in improving pain and disability in CLBP patients with MC1 immediately post-treatment. Very low-quality evidence from the case series suggested that oral Amoxicillin-clavulanate significantly improved LBP/leg pain, and LBP-related disability. Conversely, low-quality evidence found that oral Amoxicillin alone was not significantly better than placebo in improving global perceived health in patients with CLBP at the 12-month follow-up. Additionally, oral antibiotic users had significantly more adverse effects than placebo users. Conclusions: Although oral antibiotics were statistically superior to placebo in reducing LBP-related disability in patients with CLBP and concomitant MC1, its clinical significance remains uncertain. Future large-scale high-quality RCTs are warranted to validate the effectiveness of antibiotics in individuals with CLBP.

The impact of Diabetes in patients with lumbar stenosis - A propensity-score matched study on patient-reported outcomes after surgery.

STUDY DESIGN: Registry-based cohort study. OBJECTIVE: To evaluate the impact of Diabetes (DM) on Patient-reported Outcomes (PROs) after surgery for lumbar spinal stenosis (LSS). METHOD: Patients from the Danish national spine registry, DaneSpine, scheduled for LSS surgery were identified. MRI of patients with and without DM was graded in regards to lumbar stenosis, disc degeneration (DD), muscular fat infiltration, and Modic changes. In addition, preoperative and two-year postoperative data were collected including PROs. Patients with DM were propensity-score matched (PSM) to non-DM patients. RESULTS: In total, 296 patients were included, 41 DM and 255 non-DM. Of these, 27 patients from each group were successfully matched. The PSM DM group had less improvement and worse leg pain at two-year follow-up compared to the non-DM group, VAS 58 vs. 36 (p = 0.004). Physical disability was significantly worse at two-year follow-up in the DM group compared to the non-DM group, Oswestry Disability Index score of 38 vs. 29 (p = 0.05). On the preoperative MRI, the number of patients with severe grade LSS and severe fat infiltration in Multifidus muscles was significantly higher in the PSM DM group compared to the non-DM group, (p < 0.01). CONCLUSION: Patients with concomitant LSS and DM have a significantly reduced improvement in leg pain, more physical disability, and worse leg pain scores at two-year follow-up post-surgery compared to patients without DM. In elderly patients with LSS, there should be an increased focus on DM and the clinically relevant threshold for spine surgery.

Stand-alone ALIF versus TLIF in patients with low back pain - A propensity-matched cohort study with two-year follow-up.

Introduction: Instrumented lumbar fusion by either the anterior or transforaminal approach has different advantages and disadvantages. Few studies have compared PatientReported Outcomes Measures (PROMs) between stand-alone anterior lumbar interbody fusion (SA-ALIF) and transforaminal lumbar interbody fusion (TLIF). Research question: This is a register-based dual-center study on patients with severe disc degeneration (DD) and low back pain (LBP) undergoing single-level SA-ALIF or TLIF. Comparing PROMs, including disability, quality of life, back- and leg-pain and patient satisfaction two years after SA-ALIF or TLIF, respectively. Material and methods: Data were collected preoperatively and at one and two-year follow-up. The primary outcome was Oswestry Disability Index (ODI). The secondary outcomes were patient satisfaction, walking ability, visual analog scale (VAS) scores for back and leg pain, and quality of life (QoL) measured by the European Quality of Life-5 Dimensions (EQ-5D) index score. To reduce baseline differences between groups, propensity-score matching was employed in a 1:1 fashion. Results: 92 patients were matched, 46 S A-ALIF and 46 TLIF. They were comparable preoperatively, with no significant difference in demographic data or PROMs (P > 0.10). Both groups obtained statistically significant improvement in the ODI, QoL and VAS-score (P < 0.01), but no significant difference was observed (P = 0.14). No statistically significant differences in EQ-5D index scores (P = 0.25), VAS score for leg pain (P = 0.88) and back pain (P = 0.37) at two years follow-up. Conclusion: Significant improvements in ODI, VAS-scores for back and leg pain, and EQ-5D index score were registered after two-year follow-up with both SA-ALIF and TLIF. No significant differences in improvement.

Challenges of circulatory unstable pelvic fracture in Greenland.

Management of circulatory unstable pelvic fracture in Greenland - from a remote village to Level 1 Trauma center. This case report depicts the transportation of an unstable patient in a rural area, where transportation of the critically ill patient is inherently difficult due to infrastructure. The case report brings knowledge to the reader of logistic conditions in Greenland, which differ greatly from those in Denmark. Furthermore, it highlights the importance of knowledge of damage control surgery and of great intercollegiate cooperation.

Improvement in physical function and reduced pain after instrumented lumbar interbody fusion.

INTRODUCTION: Instrumented lumbar fusion has been used as surgical treatment for severe disability with associated low back pain. The overall effect and risks of the most commonly used instrumented lumbar fusion techniques are controversial. The objective of the study was to describe clinical and patient-reported outcomes in patients undergoing single-level instrumented interbody fusion surgery with either posterior or transforaminal lumbar interbody fusion. METHODS: This was a registry-based cohort study on patients from the national Danish surgical spine database - DaneSpine. The primary outcome was Oswestry Disability Index (ODI) score at two-year follow-up. Secondary outcome measures were the 3-Level European Quality of Life-5 Dimensions (EQ5D-3L), a visual analogue scale (VAS) score, patient satisfaction and the rate of intraoperative complications. RESULTS: The cohort included 460 patients. ODI improved from 48 ± 15 preoperatively to 33 ± 20 at the two-year follow-up (p less-than 0.001). The EQ5D-3L score improved from 0.279 ± 0.311 to 0.542 ± 0.340, the VAS score for leg pain from 60 ± 28 to 40 ± 32 and back pain from 70 ± 20 to 47 ± 30. Patient satisfaction was obtained in 58%; 24% were undecided, whereas 18% were not satisfied with the treatment outcome at their two-year follow-up. CONCLUSIONS: Patients suffering from severe back-related disability after failed conservative treatment may expect an improvement in physical function and reduced pain after instrumented lumbar interbody fusion. FUNDING: None. TRIAL REGISTRATION: The national Danish DaneSpine registration.

New Injury Severity Score as a predictor of in-hospital mortality in trauma patients.

The New Injury Severity Score (NISS) is a tool developed to easily assess the injury severity for a trauma patient. This review analysed how well the NISS predicts in-hospital mortality for trauma patients by assessment of 11 observational studies. NISS was found to be a good overall predictor of in-hospital mortality in blunt as well as penetrating trauma cases. However, additional high-quality studies are required in order to draw definite conclusions in a Scandinavian hospital setting and patient population.

The Clinical Significance of the Modic Changes Grading Score.

STUDY DESIGN: Cross-sectional retrospective observational study. OBJECTIVE: To evaluate the reliability and clinical utility of the Modic changes (MC) grading score. METHOD: Patients from the Danish national spine registry, DaneSpine, scheduled for lumbar discectomy were identified. MRI of patients with MC were graded based on vertical height involvement: Grade A (<25%), Grade B (25%-50%), and Grade C (>50%). All MRIs were reviewed by 2 physicians to evaluate the reliability of the MC grade. RESULTS: Of 213 patients included, 142 patients had MC, 71 with MC-1 and 71 with MC-2; 34% were Grade A, 45% were Grade B, and 21% were Grade C. MC grade demonstrated substantial intra-rater (κ = .68) and inter-rater (κ = .61) reliability. A significantly higher proportion (n = 40, 57%) of patients with MC-1 had a severe MC grade compared to patients with MC-2 (n = 30, 43%, P < .001). Severe MC grade was associated with the presence of severe lumbar disc degeneration (DD) (Pfirrmann grade = V, P = .024), worse preoperative ODI (52.49 vs 44.17, P = .021) and EQ-5D scores (.26 vs .46, P = .053). MC alone including type was not associated with a significant difference in patient-reported outcomes (P > .05). CONCLUSION: The MC grade score was demonstrated to have substantial intra- and inter-observer reliability. Severe MC grade was associated with both severe DD and MC type, being more prevalent in patients with MC-1. The MC grade was also significantly associated with worse disability and reduced health-related quality of life. Results from the study suggest that MC grade is more clinically important than MC type.

A definition and clinical grading of Modic changes.

To provide an up-to-date description of knowledge and pitfalls related to the classification, definition and grading of Modic changes (MC) visualized on magnetic resonance imaging (MRI). State-of-the-art review of current knowledge regarding the definition and grading of MC on MRI. MC on MRI have been reported to be associated with low back pain and disability. However, previous studies have shown heterogeneous results in regards to the impact of MC and its clinical relevance in patients with back pain. MC is a term used with considerable variation in the literature. No strict definition has been provided previously, this has contributed to varying diagnostic inclusion criteria, heterogeneous study populations, and discrepancy in results. A definition of MC and a proposal for grading is provided in this state-of-the-art review. MC are important, clinically relevant findings. However, issues with the nomenclature, definition and grading of these changes need to be addressed. Our current review highlights relevant issues related to MC, and provides a definition and grading score for the term MC that includes the Modic type and the extent of vertebral body involvement. Future studies should seek to validate the MC grading score in clinically relevant populations.

Postoperative pain treatment after lumbar discectomy. A protocol for a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Patients undergoing lumbar discectomy usually suffer from moderate to severe pain during the postoperative period. Multimodal, or balanced analgesia, is the leading treatment principle for managing postoperative pain. The rationale is to achieve optimal pain treatment through additive or synergistic effects of several non-opioid analgesics, and thereby, reducing the need for postoperative opioids, facilitating early mobilization and functional rehabilitation. For discectomy surgery, evidence of both the benefit and harm of different analgesic interventions is unclear. OBJECTIVES: This systematic review aims to investigate the benefits and harms of analgesic interventions in adult patients after lumbar discectomy. METHODS: This protocol for a systematic review is written according to The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search The Cochrane Library's CENTRAL, PubMed, EMBASE, and ClinicalTrails.gov for published and ongoing trials. All randomized clinical trials assessing the postoperative analgesics effect of an intervention with a control or no-intervention group undergoing lumbar discectomy will be included. Two authors will independently screen trials for inclusion using Covidence, extract data and assess the risk of bias using Cochrane's risk-of-bias 2 tool. We will analyse the data using Review Manager and Trial Sequential Analysis. Meta-analysis will be performed according to the Cochrane guidelines. We will present our primary findings in a 'summary of findings' table and evaluate the overall certainty of evidence using the GRADE approach. DISCUSSION: This systematic review will assess the benefits and harms of analgesic interventions after lumbar discectomy and have the potential to improve best practices and advance research.

Clinical and Patient-reported Outcomes After Posterior Versus Transforaminal Lumbar Interbody Fusion-A Propensity Score-matched Cohort Study on 422 Patients with 2-year Follow-up.

STUDY DESIGN: This was a dual-center study over an eight-year period on patients undergoing single level fusion surgery with either posterior- (PLIF) or transforaminal lumbar interbody fusion (TLIF). We analyzed prospectively collected pre- and postoperative data from the national Danish surgical spine database (DaneSpine). OBJECTIVE: The aim of this study was to compare clinical and patient-reported outcome (PRO) 2 years after TLIF or PLIF in patients with symptomatic lumbar mechanical disc degeneration. SUMMARY OF BACKGROUND DATA: PLIF and TLIF are well-described techniques for treating lumbar mechanical disc degeneration but whether the theoretical differences between the two techniques translate to different clinical outcomes is unknown. METHODS: The primary outcome was Oswestry Disability Index (ODI) score at 2-year follow-up. Secondary outcome measures were scores on the European Quality of Life-5 Dimensions (EQ-5D) and visual analog scale (VAS) and the rate of intraoperative complications. To minimize baseline differences between the groups, propensity-score matching was employed in a 1:1 fashion, balancing the groups on preoperative factors including age, sex, back and leg pain, ODI, EQ-5D, and previous spine surgery. RESULT: The matched cohort included 211 patients in each cohort. There was no significant difference between the groups in the mean score on the ODI at two years (PLIF: 33 ±â€Š20 vs. TLIF: 35 ±â€Š20, P = 0.328). We found no statistically significant differences in EQ-5D score (0.54 ±â€Š0.35 vs. 0.51 ±â€Š0.34, P = 0.327), VAS score for back pain (47 ±â€Š32 vs. 48 ±â€Š29, P = 0.570) or leg pain (42 ±â€Š33 vs. 41 ±â€Š32, P = 0.936) between the PLIF and TLIF groups, respectively, at 2-year follow-up. Dural tears occurred in 9.5% in the PLIF group and 1.9% in the TLIF group (P = 0.002) corresponding to a relative risk of 5.0 (95% CI 1.7-14.4). CONCLUSION: We found no significant difference in PRO at 2-year follow-up between PLIF and TLIF for the treatment of lumbar disc degeneration. PLIF is associated with a five times higher risk of dural tears.Level of Evidence: 3.

The interrater reliability of the novel Udby classification of Modic Changes: A first estimate.

Background: Modic change grading is heterogeneous, inconsistent, and lacks a single nomenclature across the published literature. A new method of Modic change classification has been established by Dr. Peter Udby which hopes to unify how Modic changes are classified while also adding grading of the cranial/caudal extent of the Modic change across the vertebral body from the respective endplate involved to best capture the clinically relevant information of Modic changes. Methods: Twenty magnetic resonance images of potential basivertebral nerve ablation candidates were independently reviewed by two board-certified and fellowship trained neuroradiologist and two board-certified and fellowship-trained interventional spine physiatrists for the presence and characterization of Modic changes using the newly described Udby classification. 100% agreement of all four reviewers of Modic change presence, Type, and Udby classification was required to be classified as agreement. There were 480 total data points each with 10 unique choices to compare across the four independent reviewers. Results: The kappa value of their agreement was 0.5899 (95% CI 0.4860-0.6939). Conclusion: This study, requiring unanimous agreement between 4 physicians in application of the Udby classification, demonstrated an interrater reliability score of 0.5899 (95% CI 0.4860-0.6939). While this figure provides a first estimate, larger scale research is necessary before definitive claims regarding the interrater agreement validity of the Udby characterization system may be made.

The Association of MRI Findings and Long-Term Disability in Patients With Chronic Low Back Pain.

STUDY DESIGN: Longitudinal cohort study with 13-year follow-up. OBJECTIVE: To assess whether long-term disability is associated with baseline degenerative magnetic resonance imaging (MRI) findings in patients with low back pain (LBP). METHODS: In 2004-2005, patients aged 18 to 60 years with chronic LBP were enrolled in a randomized controlled trial and lumbar MRI was performed. Patients completed the Roland-Morris Disability Questionnaire (RMDQ) and the LBP Rating Scale, at baseline and 13 years after the MRI. Multivariate regression analysis was performed with 13-year RMDQ as the dependent variable and baseline disc degeneration (DD, Pfirrmann grade), Modic changes (MC), facet joint degeneration (FJD, Fujiwara grade) smoking status, body mass index, and self-reported weekly physical activity at leisure as independent variables. RESULTS: Of 204 patients with baseline MRI, 170 (83%) were available for follow-up. Of these, 88 had Pfirrmann grade >III (52%), 67 had MC (39%) and 139 had Fujiwara grade >2 (82%) on at least 1 lumbar level. Only MC (ß = -0.15, P = .031) and weekly physical activity at leisure (ß = -0.51, P < .001) were significantly, negatively, associated with 13-year RMDQ-score (R2 = 0.31). CONCLUSION: DD and FJD were not associated with long-term disability. Baseline MC and weekly physical activity at leisure were statistically significantly associated with less long-term disability.

[Antibiotics should not be used for treating back pain due to Modic changes].

Infection has been proposed as a cause of back pain in individuals with Modic changes. This review summarises the knowledge on this topic in Scandinavia. A Norwegian randomized controlled trial could not replicate results in favor of antibiotic treatment for such patients. A Danish study demonstrated that patients with low back pain and Modic changes had similar physical disability-scores and less sick leave due to back pain than individuals without Modic changes at long-term follow-up (>10 years). A Swedish study displayed equal bacterial presence in discs of patients operated for lumbar disc herniation and in control patients, indicating that the presence of bacteria is caused by contamination during the surgical procedure and is not related to back pain.

[Antibiotics should not be used to treat patients with back/leg pain]. / Antibiotika ska med dagens kunskap inte användas vid ryggvärk ­ med eller utan benvärk.

This report is based on results from three research groups in Sweden (Fritzell et al), Denmark (Udby et al), and Norway (Bråten et al). The groups have conducted studies published in international journals in 2019 [8-10]. The results complement each other and strongly suggest that antibiotics, in the absence of clear signs of a clinically relevant infection (discitis/spondylitis), should not be used for back pain with or without leg pain. The Swedish study showed that bacteria found in the disc/vertebra during surgery are very likely due to contamination [8], the Danish study showed that patients with Modic Changes (MC) on MR in the long term were not associated with more back pain or functional impairment than in patients without MC [9], and the Norwegian study showed that antibiotics for residual back pain after previous disc herniation had no better clinical effect than placebo [10]. Antibiotic resistance is one of the biggest threats to public health today and in the future.

Are Modic Changes Associated With Health-related Quality of Life After Discectomy: A Study on 620 Patients With Two-year Follow-up.

STUDY DESIGN: A registry-based comparative cohort study with 2-year follow-up. OBJECTIVE: To assess whether Modic changes (MCs) are associated with health-related quality of life, long-term physical disability, back- or leg pain after discectomy. SUMMARY OF BACKGROUND DATA: Previous studies have failed to show a clinically significant association between MCs and patient-reported outcomes (PROs) after discectomy. METHODS: Data from the Danish National Spine Registry on patients undergoing first-time lumbar discectomy at a single institution from 2014 to 2017 with an accessible preoperative lumbar magnetic resonance imaging, complete preoperative, and 2-year follow-up questionnaires were obtained. PROs including Oswestry disability index (ODI), European Quality of Life-Five Dimensions (EQ-5D), visual analogue scale (VAS) back and leg pain, and patient satisfaction were collected. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the preoperative MRI. RESULTS: Of 620 patients included, MCs were present in 290 patients (47%). Of these, MC type 1 (MC-1) was present in 73 (25%) and MC type 2 (MC-2) in 217 (75%) patients. Preoperative data for ODI, EQ-5D, VAS-BP, and VAS-LP were comparable for the +MC and -MC groups. Both groups had a statistically significant improvement in PROs from baseline compared with 2-year follow-up (P < 0.001). At 2-year follow-up, both groups had improved with no significant difference between them in regards to ODI (15.5 vs. 17.2, P = 0.208); EQ-5D (0.75 vs. 0.72, P = 0.167); VAS-BP (27.1 vs. 28.3, P = 0.617); VAS-LP (26.8 vs. 25.0, P = 0.446); and patient satisfaction (74% vs. 76%, P = 0.878). CONCLUSION: MCs were not found to be associated with health-related quality of life, disability, back- or leg pain, or patient satisfaction 2 years after discectomy. LEVEL OF EVIDENCE: 2.

Modic Changes Are Not Associated With Long-term Pain and Disability: A Cohort Study With 13-year Follow-up.

STUDY DESIGN: A comparative cohort study with 13-year follow-up. OBJECTIVE: To assess whether Modic changes (MCs) are associated with long-term physical disability, back pain, and sick leave. SUMMARY OF BACKGROUND DATA: Previous studies have shown a conflicting association of low back pain (LBP) with MCs and disc degeneration. The long-term prognosis of patients with MCs is unclear. METHODS: In 2004 to 2005, patients aged 18 to 60 with daily LBP were enrolled in an randomized controlled trial study and lumbar magnetic resonance imaging (MRI) was performed. Patients completed numeric rating scales (0-10) for LBP and leg pain, Roland-Morris Disability Questionnaire (RMDQ), LBP Rating Scale for activity limitations (RS, 0-30), inflammatory pain pattern and sick leave days due to LBP at baseline and 13 years after the MRI. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the MRI. RESULTS: Of 204 cases with baseline MRI, 170 (83%) were available for follow-up; 67 (39%) with MCs and 103 (61%) without MCs. Demographics, smoking status, BMI, use of antibiotics, LBP, leg pain, and inflammatory pain pattern scores at baseline and at 13-year follow-up were similar between the two groups. Also, baseline RMDQ was similar between the +MC and -MC groups. At 13 years, the RMDQ score was statistically significant better in the +MC group (7.4) compared with the -MC group (9.6, P = 0.024). Sick leave days due to LBP were similar at baseline but less in the +MC group (9.0) compared with the -MC group (22.9 d, P = 0.003) at 13 years. CONCLUSION: MCs were not found to be negatively associated with long-term pain, disability, or sick leave. Rather, the study found that LBP patients with MCs had significantly less disability and sick-leave at long-term follow-up. We encourage further studies to elucidate these findings. LEVEL OF EVIDENCE: 2.