The Effect of Graded Activity and Pain Education After Lumbar Spinal Fusion on Sedentary Behavior 3 and 12 Months Postsurgery: A Randomized Controlled Trial.

OBJECTIVES: To examine the effect of an early postsurgical intervention consisting of graded activity and pain education (GAPE) in patients with chronic low back pain (CLBP) undergoing lumbar spinal fusion (LSF) on sedentary behavior, disability, pain, fear of movement, self-efficacy for exercise and health-related quality of life (HRQoL) at 3-, 6-, and 12 months follow-up. DESIGN: A parallel-group, observer-blinded randomized controlled trial. SETTING: Department of Occupational- and Physiotherapy and the Centre for Rheumatology and Spine Diseases, Rigshospitalet, Denmark. PARTICIPANTS: In total, 144 participants undergoing an LSF for CLBP were randomly assigned to an intervention or a control group. INTERVENTIONS: The intervention group received 9 sessions of GAPE, based on principles of operant conditioning. MAIN OUTCOME MEASURES: The primary outcome was reduction in time spent in sedentary behavior, measured by an accelerometer at 3 months. The secondary outcomes were reduction in time spent in sedentary behavior at 12 months and changes from baseline to 3-, 6-, and 12 months on disability, pain, fear of movement, self-efficacy for exercise, and HRQoL. RESULTS: No difference in changes in sedentary behavior between groups was found 3 months after surgery. At 12 months after surgery, there was a significant difference between groups (mean difference: -25.4 min/d (95% confidence interval -49.1 to -1.7)) in favor of the intervention group. CONCLUSIONS: Compared with usual care, GAPE had no effect on short-term changes in sedentary behavior but GAPE had a statistical, but possibly not clinical significant effect on sedentary behavior 12 months after LSF. Further, the behavioral intervention was safe to perform.

Expression of cytokines at baseline correlate/predict in the disc the outcome of surgery after disc degeneration: A 12-month follow-up study.

BACKGROUND: Low back pain (LBP) is a highly prevalent condition that comprise a large portion of outpatient practice, challenging the diagnosis and treatment. However, the diagnostic tools are limited to clinical history, physical examination and imaging. Degenerative disc disease (DDD) is a significant cause of LBP, and emerging literature confirms the elevated levels of biomarkers in the discs. These biomarkers may serve as a tool for diagnosis, but may also be useful in predicting the treatment outcome. Here, we examine the expression of various cytokines on 1-year recovery from patients with LBP. METHODS: Patient-reported outcome (PRO) in terms of pain intensity (VAS), disability (ODI), and quality of life (Eq-5D) is collected from 44 patients at baseline and 12 months after surgery to study the influence of baseline TNF-α, IL-1ß, and IL-6 mRNA expression in both annulus fibrosus (AF) and nucleus pulposus (NP). RESULTS: Between baseline and follow-up, our cohort showed improvement in VAS back pain (p < 0.001), VAS leg pain (p < 0.001), ODI (p = 0.02), and Eq-5D (p = 0.01). Baseline levels of IL-1 ß was positively correlated with VAS back pain scores in AF (p = 0.05) and NP (p = 0.01) at 1-year follow-up. TNF-α expression at baseline was also positively correlated to ODI scores (p = 0.01) at follow-up and inversely correlated to improvements in ODI score between baseline and follow-up, suggesting that high TNF-α expression at baseline is associated with poor outcomes from surgery. CONCLUSION: The results from our study support that TNF-α expression at baseline can serve as a very important predictor of treatment response from lumbar fusion surgery.

Transient receptor potential (TRP) channels mRNA transcripts in the lumbar intervertebral discs: biomarkers for inflammation, pain, disability, and clinical outcome.

Transient receptor potential (TRP) channels are widely expressed cation channels that play an essential role in mediating Ca2+ homeostasis and are considered potential regulators of inflammatory pain. This study investigates the expression of the TRP channel subtypes TRPV1, TRPV4, TRPC6, TRPM2, TRPM8 in lumbar intervertebral disc (IVD) biopsies from patients with chronic low back pain (LBP). We determined the expression of these TRP channel subtypes in the annulus fibrosus (AF) and the nucleus pulposus (NP) from 46 patients with LBP undergoing 1-2 level lumbar fusion surgery for degenerative disc disease. The mRNA transcripts were analyzed using quantitative real-time polymerase chain reaction (RT-qPCR), and the expression levels were compared against visual analog scale (VAS) and oswestry disability index (ODI) scores (0-100) for pain and disability. A significant positive correlation was demonstrated between VAS score and the mRNA expression of TRPV1, TRPC6, TRPM2, TRPM8 in the AF. We also found a significant positive correlation between ODI scores and expression of TRPV1 and TRPM8. Further, there is a significant positive correlation between TNF-α and TRPV1, TRPM2 and TRPM8 expression in the AF, and IL-6 to TRPV1 in the NP. Interestingly, when investigating treatment response via a 12-month postoperative follow-up ODI, we found a significant correlation between only TRPV1 expression at baseline and the follow-up ODI scores, which indicates this marker could predict the effectiveness of surgery. These results strongly suggest an association between pain, inflammatory mediators, and TRP channel expression in lumbar disc biopsies of patients with chronic LBP.

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.

Morbidity and mortality following degenerative spine surgery in a prospective cohort of 1687 consecutive surgical procedures.

STUDY DESIGN: Prospective, observational cohort study. OBJECTIVE: To determine the true incidence of adverse events (AEs) in European adults undergoing surgery for degenerative spine diseases. The majority of surgeries performed for degenerative spinal diseases are elective, and the need for adequate estimation of risk-benefit of the intended surgery is imperative. A cumbersome obstacle for adequate estimation of surgery-related risks is that the true incidence of complications or adverse events (AEs) remains unclear. METHODS: All adult patients (≥ 18 years) undergoing spine surgery at a single center from February 1, 2016, to January 31, 2017, were prospectively and consecutively included. Morbidity and mortality were determined using the Spine AdVerse Events Severity (SAVES) system. Additionally, the correlation between the AEs and length of stay (LOS) and mortality was assessed. RESULTS: A total of 1687 procedures were performed in the study period, and all were included for analysis. Of these, 1399 (83%) were lumbar procedures and 288 (17%) were cervical. The overall incidence of AEs was 47.4%, with a minor AE incidence of 43.2% and a major of 14.5%. Female sex (OR 1.5 [95% CI 1.2-1.9), p < 0.001) and age > 65 years (OR 1.5 [95% CI 1.1-1.7], p = 0.012) were significantly associated with increased odds of having an AE. CONCLUSION: Based on prospectively registered AEs in this single-center study, we validated the use of the SAVES system in a European population undergoing spine surgery due to degenerative spine disease. We found a higher incidence of AEs than previously reported in retrospective studies. The major AEs registered occurred significantly more often perioperatively and in patients > 65 years.

Comparison of outcomes and complications between one- and two-level anterior cervical discectomy and fusion: a population-based study of 410 patients.

OBJECTIVE: The objective of this study was to compare outcomes and patient satisfaction, and secondly to compare complication rates between one- and two-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. METHODS: Data from patients receiving one- or two-level ACDF for cervical radiculopathy at two institutions were prospectively collected and retrospectively analysed. Patients were separated into one-level ACDF and two-level ACDF. Comparison analyses of patient-reported outcome measures (PROMs) comprising Visual Analogue Scale for neck pain (VAS-NP) and arm pain (VAS-AP), Neck Disability Index (NDI), and EQ-5D 3-level version (EQ-5D-3L) were performed between baseline and 1-year follow-up and between groups as well as achievement of minimal clinically important differences (MCID) in PROMs and satisfaction. Additionally, complications were compared between groups. RESULTS: A total of 410 patients (270 one-level and 140 two-level) were included. PROMs improved significantly from baseline to 1-year follow-up (p < 0.001) in both groups. When comparing PROMs between one- and two-level ACDF, a trend towards greater improvement was observed in patients undergoing one-level ACDF, notably in EQ-5D-3L (p = 0.073). Significantly more patients in the one-level group achieved MCID in VAS-NP compared to patients in the two-level group (56% vs 44%, p = 0.025). Two hundred and ninety-six (67%) patients reported to be satisfied, but the one-level group trended to be more satisfied (70% vs. 62%). One-level ACDF further demonstrated a trend of more favourable complication profiles; however, complication rates were low in both groups. The risk of intraoperative complications was 2.4%, postoperative complications in-hospital were 1.2%, and patient-reported postoperative events post-discharge 42%. CONCLUSIONS: One- and two-level ACDF are effective procedures for degenerative cervical nerve root compression. Yet, significantly more patients in the one-level group achieved MCID in neck pain compared to patients in the two-level group.

Do Modic changes have an impact on clinical outcome in lumbar spine surgery? A systematic literature review.

PURPOSE: To provide a systematic literature review of the impact of preoperative Modic changes (MCs) on the clinical outcome following lumbar spine surgery for degenerative lumbar spine disease. METHODS: A PubMed search until 31 October 2015 was performed to identify publications correlating preoperative MC with clinical outcome in patients undergoing spine surgery. RESULTS: Inclusion criteria were met by 14 articles (7 prospective and 7 retrospective studies) representing a total of 1652 surgical patients, of which at least 804 (>49 %) showed MC. Of the 14 publications, 6 concerned discectomy (n = 607), 1 fusion versus discectomy (n = 91), 3 fusion surgery (n = 454), and 4 total disc replacement (TDR, n = 500). A trend toward less improvement in low back pain or Oswestry Disability Index score was found in the discectomy studies, and a trend toward increased improvement was demonstrated in the TDR studies when MC was present preoperatively. The fusion studies were of low evidence, and showed conflicting results. CONCLUSION: Preoperative MC showed a trend toward a negative correlation with clinical improvement in patients undergoing discectomy for LDH and a positive correlation with clinical improvement in patients undergoing TDR for degenerative disc disease. However, it is questionable whether the differences surpass the minimal clinically important difference (MCID). In patients undergoing fusion surgery, there was insufficient evidence to draw any conclusions. Future studies should include a larger patient material, focus on MCID, and include known confounding factors of the clinical outcome of spine surgery in the analysis.

Postoperative lordosis distribution index, patient reported outcome measures, and revision surgery following transforaminal lumbar interbody fusion.

Objective: Lordosis Distribution Index (LDI) is a new radiographic parameter associated with postoperative residual symptoms in patients undergoing Transforaminal Lumbar Interbody Fusion (TLIF). Recently, it has been applied on patients undergoing instrumented spine surgery, however not correlated to Patient Related Outcome Measures (PROMs). This study investigates whether the obtained the postoperative LDI after TLIF surgery correlates with the clinical outcome measured with PROMs. Methods: This study was based on prospectively obtained data in patients undergoing TLIF throughout 2017 at a Danish university hospital. Medical records and the DaneSpine Database were accessed to obtain preoperative, operative and follow-up data. Primary outcome was Oswestry Disability Index (ODI) 12 months postoperatively. Secondary outcomes included revision rate and additional PROMs. Results: 126 patients were included. 70 patients were classified with normolordosis (56 %), 42 hypolordosis (33 %) and 14 hyperlordosis (11 %). All groups experienced significant radiological changes undergoing surgery. Average reduction in ODI at 12 months postoperatively was -15.3 (±20.0). Minimally clinical important difference was achieved in 68 patients (54.0 %). No significant difference in PROMs between LDI-groups was observed in unadjusted or adjusted analyses. Revision surgery was performed in 8 patients with normolordosis (11.4 %), 7 hypolordosis (16.7 %) and 4 hyperlordosis (28.6 %). Conclusions: We found no significant correlation between postoperative LDI subgroups of normolordotic, hypo- or hyperlordotic patients and the clinical outcome of posterolateral fusion and TLIF surgery. A trend towards lower rate of revision surgery in the normolordotic group compared to the hypo- and hyperlordotic group was observed.

Age and BMI equal Modified Frailty Index, Modified Charlson Comorbidity Index and ASA in predicting adverse events in spinal surgery for cervical degenerative diseases.

OBJECTIVE: To compare Modified Frailty Index (mFI), Modified Charlson Comorbidity (mCCI) and ASA with demographic data such as age, BMI and gender in the prediction of AEs obtained using a validated systematic reporting system in a prospective cohort undergoing cervical spine surgery. METHODS: All adult patients undergoing spine surgery for cervical degenerative disease at our academic tertiary referral center from February 1, 2016, to January 31, 2017, were included. Morbidity and mortality were determined according to the predefined adverse event (AE) variables using the Spinal Adverse Events Severity (SAVES) System. Area under the curve (AUC) analyses from receiver operating characteristics (ROC) curves were used to assess the discriminative ability in predicting AEs for the comorbidity indices mFI, mCCI, ASA and for BMI, age and gender. RESULTS: A total of 288 consecutive cervical cases were included. BMI was the most predictive demographic factor for an AE (AUC = 0.58), the most predictive comorbidity index was mCCI (AUC = 0.52). No combination of comorbidity indices or demographic factors reached a threshold of AUC ≥ 0.7 for AEs. As predictor of extended length of stay: age (AUC = 0.77), mFI (AUC = 0.70) and ASA (AUC = 0.70) were similar and fair. CONCLUSION: Age and BMI equal mFI, mCCI and ASA in predicting postoperative AEs, amongst patients operated for cervical degenerative disease. No significant difference was found between mFI, mCCI and ASA in the discriminative abilities in predicting morbidity, based on prospectively collected AEs according to the SAVES grading system.

30-and 90-day readmissions in lumbar spine surgery. Differences in prevalence and causes.

BACKGROUND: The morbidity associated with surgical treatment of lumbar degenerative conditions has attracted increasing interest due to the economic impact on society, especially postoperative readmission. Limited studies have assessed this risk in a prospective, single-center consecutive fashion. OBJECTIVE: To assess the incidence and causes of 30- and 90-day unplanned readmission and revision surgery following surgical treatment for lumbar degenerative spine conditions at a tertiary treatment center. STUDY DESIGN: Prospective, single-center cohort study. METHODS: All patients undergoing degenerative lumbar spine surgery in a 1-year period from February 1st, 2016, were prospectively included. Patient characteristics, surgical information and information regarding postoperative complications, including readmission (30- and 90-days) and revision surgery were recorded. Readmissions were classified according to whether they were due to the surgical intervention specifically, or a medical complication. RESULTS: A total of 1399 patients underwent surgery for various lumbar degenerative pathologies in the study period and all were included. Of these, 9.4% (n = 132) were readmitted within 30 days of surgery and in some cases, multiple readmissions occurred (up to 3). The total 90-day readmission rate was 17.6%. Of these, 15% were related to the surgical procedure. The predominant medical related causes were systemic infection (30-day: 14.4%, 90-day: 10.7%), neurological symptoms (30-day: 6.3%, 90-day: 5.0%) and cardiovascular events (30-day: 8.1%, 90-day: 12.9%). The surgical related causes for readmission were pain (30-day: 13.1%, 90-day: 2.9%), wound complications (30-day: 11.3%, 90-day: 5.0% and re-herniation (30-day: 13.1%, 90-day: 2.9%). Age was the only factor with significant influence on readmission. CONCLUSION: The incidence of medical conditions causing unplanned 30-day readmissions following surgery for lumbar degenerative conditions, is significantly higher compared to readmissions related specifically to the surgical procedure. Examples of medical treatment included antibiotics, analgesics, laxatives, anticoagulants and beta blockers. The difference is even more pronounced for the 90-day readmissions. The predominant medical causes were systemic infections, neurological and cardiovascular events. Predominant causes related to the surgery were pain, wound complications and re-herniations. Readmissions may be reduced by optimizing the medical treatment and the pain management before discharge of the patient.

Physiotherapists' prognosis of 1-year outcome after lumbar spinal fusion - A prospective cohort study.

BACKGROUND: Physiotherapists (PTs) have an essential role in the facilitation of patients' mobilization after lumbar spinal fusion (LSF). The aim of this study is to investigate whether PTs can predict one-year post-surgery outcome based on their first meeting with the patient immediately after LSF. METHOD: A prospective cohort study with one-year follow-up was conducted. In the first days after surgery, the PTs from hospital wards were asked to predict the patients' overall LSF outcome one year after surgery. One year after surgery, the patients received a questionnaire including the Oswestry Disability Index (ODI), visual analogue scales (VAS) for leg and back pain, quality of life survey (EQ-5D-3 L), global perceived effect (GPA), and satisfaction with surgery outcome (SSO). Univariate and logistic regression were used to calculate the associations between the prognosis and predictive values. RESULTS: The study included 170 patients. The analyses showed a significant association between the PTs' prognosis and the primary outcome ODI (p < .01), VAS leg and back, EQ-5D-3 L, and GPE one-year post-surgery (p ≤ .04). However, the predictive value of the PTs' prognosis was low (R2 ≤ 0.09). There was no significant association between the PTs' prognosis and the patients' SSO (p = .17; R2 = 0.01). CONCLUSION: There were significant associations between the PTs' prognosis and disability, pain, health-related quality of life and global perceived effect one-year post-surgery, although the associations had low predictive values. There was no significant association between the PTs' prognosis and patients' SSO after one year. The PTs' prognosis should not be used as a single component in further rehabilitation planning.

Postoperative pain treatment after spinal fusion surgery: a systematic review with meta-analyses and trial sequential analyses.

Patients undergoing spinal surgery are at high risk of acute and persistent postoperative pain. Therefore, adequate pain relief is crucial. This systematic review aimed to provide answers about best-proven postoperative analgesic treatment for patients undergoing lumbar 1- or 2-level fusions for degenerative spine diseases. We performed a search in PubMed, Embase, and The Cochrane Library for randomized controlled trials. The primary outcome was opioid consumption after 24 hours postoperatively. We performed meta-analyses, trial sequential analyses, and Grading of Recommendations assessment to accommodate systematic errors. Forty-four randomized controlled trials were included with 2983 participants. Five subgroups emerged: nonsteroidal anti-inflammatory drugs (NSAIDs), epidural, ketamine, local infiltration analgesia, and intrathecal morphine. The results showed a significant reduction in opioid consumption for treatment with NSAID (P < 0.0008) and epidural (P < 0.0006) (predefined minimal clinical relevance of 10 mg). Concerning secondary outcomes, significant reductions in pain scores were detected after 6 hours at rest (NSAID [P < 0.0001] and intrathecal morphine [P < 0.0001]), 6 hours during mobilization (intrathecal morphine [P = 0.003]), 24 hours at rest (epidural [P < 0.00001] and ketamine [P < 0.00001]), and 24 hours during mobilization (intrathecal morphine [P = 0.03]). The effect of wound infiltration was nonsignificant. The quality of evidence was low to very low for most trials. The results from this systematic review showed that some analgesic interventions have the capability to reduce opioid consumption compared with control groups. However, because of the high risk of bias and low evidence, it was impossible to recommend a "gold standard" for the analgesic treatment after 1- or 2-level spinal fusion surgery.

The expression of metalloproteinases in the lumbar disc correlates strongly with Pfirrmann MRI grades in lumbar spinal fusion patients.

Introduction: Increased catabolism of the extracellular matrix is observed under degenerative disc disease (DDD). The cleavage of extracellular matrix proteins in the nucleus pulposus (NP) by either matrix metalloproteinases (MMPs) or a disintegrin and metalloproteinases with thrombospondin motifs (ADAMTSs) is believed to be involved in the degeneration, but the mechanisms are not known. Research question: Here, we examine the correlation between expression of several MMPs and ADAMTSs subtypes in lumbar discs from 34 patients with low back pain (LBP) undergoing 1-2 level lumbar fusion surgery (L4/L5 and/or L5/S1) for DDD with or without spondylolisthesis. Materials and Methods: The mRNA levels of MMPs (subtypes 1, 2, 3, 10, and 13) and ADAMTSs (subtypes 1, 4, and 5) were analyzed using quantitative real-time polymerase chain reaction (RT-qPCR) and correlated to the Pfirrmann magnetic resonance imaging classification system (grade I-V) of lumbar DDD. Results: We find a highly significant positive correlation between Pfirrmann grades and the gene expression of MMP1 (r=0.67, p=0.0001), MMP3 (r=0.61, p=0.0002), MMP10 (r=0.6701, p=0.0001), MMP13 (r=0.48, p=0.004), ADAMTS1 (r=0.67, p=0.0001), and ADAMTS5 (r=0.53, p=0.0017). The similar regulation of these transcript suggests their involvement in disc degeneration. Interestingly, a post hoc analysis (uncorrected p-values) also demonstrated a positive correlation between expression of TNF-α, IL-6 and both ADAMTSs/MMPs and the Pfirrmann grades. Discussion and Conclusion: These findings show that disc degradation in DDD is strongly associated with the expression of some metalloproteinases.

Lordosis Distribution Index in Short-Segment Lumbar Spine Fusion - Can Ideal Lordosis Reduce Revision Surgery and Iatrogenic Deformity?

OBJECTIVE: The demand for spinal fusion is increasing, with concurrent reports of iatrogenic adult spinal deformity (flatback deformity) possibly due to inappropriate lordosis distribution. This distribution is assessed using the lordosis distribution index (LDI) which describes the upper and lower arc lordosis ratio. Maldistributed LDI has been associated to adjacent segment disease following interbody fusion, although correlation to later-stage deformity is yet to be assessed. We therefore aimed to investigate if hypolordotic lordosis maldistribution was associated to radiographic deformity-surrogates or revision surgery following instrumented lumbar fusion. METHODS: All patients undergoing fusion surgery ( ≤ 4 vertebra) for degenerative lumbar diseases were retrospectively included at a single center. Patients were categorized according to their postoperative LDI as: "normal" (LDI 50-80), "hypolordotic" (LDI < 50), or "hyperlordotic" (LDI > 80). RESULTS: We included 149 patients who were followed for 21 ± 14 months. Most attained a normally distributed lordosis (62%). The hypolordotic group had increased postoperative pelvic tilt (PT) (p < 0.001), pelvic incidence minus lumbar lordosis (PI-LL) mismatch (p < 0.001) and decreased global lordosis (p = 0.007) compared to the normal group. Survival analyses revealed a significant difference in revision surgery (p = 0.03), and subsequent multivariable logistic regression showed increased odds of 1-year revision in the hypolordotic group (p = 0.04). There was also a negative, linear correlation between preoperative pelvic incidence (PI) and postoperative LDI (p < 0.001). CONCLUSION: In patients undergoing instrumented lumbar fusion surgery, hypolordotic lordosis maldistribution (LDI < 50) was associated to increased risk of revision surgery, increased postoperative PT and PI-LL mismatch. Lordosis distribution should be considered prior to spinal fusion, especially in high PI patients.

A Comparison of Mortality and Morbidity Between Complex and Degenerative Spine Surgery in Prospectively Collected Data From 2,280 Procedures.

OBJECTIVE: The reported incidence of complications and/or adverse events (AEs) following spine surgery varies greatly. A validated, systematic, reproducible reporting system to quantify AEs was used in 2 prospective cohorts, from 2 spine surgery centers, conducting either complex or purely degenerative spine surgery; in a comparative fashion. The aim was to highlight the differences between 2 distinctly different prospective cohorts with patients from the same background population. METHODS: AEs were registered according to the predefined AE variables in the SAVES (Spine AdVerse Events Severity) system which was used to record all intra- and perioperative AEs. Additional outcomes, including mortality, length of stay, wound infection requiring revision, readmission, and unplanned revision surgery during the index admission, were also registered. RESULTS: A total of 593 complex and 1,687 degenerative procedures were consecutively included with 100% data completion. There was a significant difference in morbidity when comparing the total number of AEs between the 2 groups (p < 0.001): with a mean number of 1.42 AEs per patient (n = 845) in the complex cohort, and 0.97 AEs per patient (n = 1,630) in the degenerative cohort. CONCLUSION: In this prospective study comparing 2 cohorts, we report the rates of AEs related to spine surgery using a validated reproducible grading system for registration. The rates of morbidity and mortality were significantly higher following complex spine surgery compared to surgery for degenerative spine disease.

The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion-study protocol for a randomized controlled trial.

BACKGROUND: Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life. METHODS: The study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient's self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery. DISCUSSION: We hypothesize that, compared with the "usual care group", GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient's self-efficacy for exercise and quality of life. TRIAL REGISTRATION: www.clinicaltrials.gov NCT04103970 , Registered on 24 September 2019.

[Topical haemostatic agents in neurosurgery].

Haemostasis is of fundamental significance in neurosurgery, and insufficient control of bleeding is associated with morbidity and mortality. Topical haemostatic agents play an important role, as the characteristics of neuronal tissue limit the use of classical surgical haemostasis techniques. Appropriate choice of agent depends on the location and type of bleeding, but also on knowledge of the products' mechanisms of action, indications, price and accessibility. Biological products are superior to the mechanical in efficacy but require more preparation and are significantly more cost-intensive.

Clinical outcome of stand-alone ALIF compared to posterior instrumentation for degenerative disc disease: A pilot study and a literature review.

The objective of the article was to: a) present results from a case cohort pilot study comparing stand-alone ALIF and TLIF and, b) review the literature on studies comparing the clinical outcome of stand-alone ALIF with posterior instrumentation including TLIF or PLIF, in patients with disabling low back pain resulting from degenerative disc disease. ALIF surgery has previously been linked with certain high risk complications and unfavorable long term fusion results. Newer studies suggest that stand-alone ALIF can possibly be advantageous compared to other types of posterior instrumented interbody fusion for a selected group of DDD patients. The methods and material consisted of a cohort pilot study of patients, with DDD treated with stand-alone ALIF or TLIF followed by a literature review conducted through a comprehensive PubMed database search of the English literature. Studies comparing stand-alone ALIF with posterior instrumented interbody fusion were selected and reviewed. Results from the pilot study, n = 21, showed a reduced perioperative blood loss, shorter operative time and a trend towards better pain reduction and decreased use of opioid analgesics in patients undergoing stand-alone ALIF compared to posterior instrumented fusion with TLIF. The literature review included three studies, n = 630. All three studies were retrospective cohort studies. The average patient follow-up was 2-years but with heterogeneous selected outcomes. Two of three articles documented significant advantages when using stand-alone ALIF on outcomes such as ODI, VAS, surgical time, blood loss and patient satisfaction. No study found stand-alone ALIF inferior in chosen outcomes including fusion. In conclusion the pilot study and the literature review, finds similar clinical outcomes and fusion rates after stand-alone ALIF and posterior interbody fusion. Stand-alone ALIF was associated with a shorter duration of surgery, less perioperative blood loss and a faster improvement post-operatively. Therefore stand-alone ALIF is a viable and important surgical option, which could be considered first choice as surgical treatment.

Evaluation of the lumbar and ventricular infusion test in the diagnostic strategy of pediatric hydrocephalus and the therapeutic implications.

AIM: To evaluate the infusion test as a diagnostic tool behind the choice of intervention in pediatric hydrocephalus. MATERIALS AND METHODS: Intracranial pressure (ICP) measurement and infusion test were performed intraventricularly, by lumbar route, or combined in 40 consecutive children as a part of the standard diagnostic program in 1996-1999. RESULTS: The median age was 18.5 months, ranging from 2 weeks to 13 years. In the subgroup of patients with radiological aqueductal stenosis (N=14), mean lumbar/intraventricular ICP was 13 (3-35)/10 (2-27). Mean lumbar/ventricular R(out) were 18 (4-49)/17 (6-37). For patients with radiological communication between the third and fourth ventricles (N=14), the mean lumbar/intraventricular ICP was 11 (7-17)/9 (1-16). Mean lumbar/ventricular R(out) were 8 (3-11)/8 (4-12). A total of 13 patients had a shunt insertion, 10 had an endoscopic third ventriculostomy (ETV), 5 had endoscopic fenestration of a cyst, and 12 had no surgery. Of the patients initially treated with EVT, 50% had a shunt insertion shortly after. For communicating hydrocephalus, 75% of the patients initially not operated based on normal R(out) values ended up having a shunt insertion. DISCUSSION: R(out) has doubtful value as an indicator for conducting an operation or not and in the choice between EVT and shunt in children. This should be interpreted in the light of a growing understanding of hydrocephalus on a molecular level.