An observational study of quality of motion in the aging cervical spine: sequence of segmental contributions in dynamic fluoroscopy recordings.

BACKGROUND: The term 'physiological motion of the spine' is commonly used although no proper definition exists. Previous work has revealed a consistent sequence of cervical segmental contributions in 80-90% of young healthy individuals. Age has been shown to be associated with a decreased quantity of motion. Therefore, it is of interest to study whether this sequence persists throughout aging. The aim of this prospective cohort study is to investigate if the consistent sequence of cervical segmental contributions in young asymptomatic individuals remains present in elderly asymptomatic individuals. METHODS: In this prospective cohort study, dynamic flexion to extension cinematographic recordings of the cervical spine were made in asymptomatic individuals aged 55-70 years old. Individuals without neck pain and without severe degenerative changes were included. Two recordings were made in each individual with a 2-to-4-week interval (T1 and T2). Segmental rotation of each individual segment between C4 and C7 was calculated to determine the sequence of segmental contributions. Secondary outcomes were segmental range of motion (sRoM) and sagittal alignment. RESULTS: Ten individuals, with an average age of 61 years, were included. The predefined consistent sequence of segmental contributions was found in 10% of the individuals at T1 and 0% at T2. sRoM and total range of motion (tRoM) were low in all participants. There was no statistically significant correlation between sagittal alignment, degeneration and sRoM in the respective segments, nor between cervical lordosis and tRoM. CONCLUSIONS: This study shows that aging is associated with loss of the consistent motion pattern that was observed in young asymptomatic individuals. The altered contribution of the cervical segments during extension did not appear to be correlated to the degree of degeneration or sagittal alignment. Trial registration clinicaltrials.gov NCT04222777, registered 10.01.2020.

The effect of perioperative psychological interventions on persistent pain, disability, and quality of life in patients undergoing spinal fusion: a systematic review.

PURPOSE: Patients undergoing spinal fusion are prone to develop persisting spinal pain that may be related to pre-existent psychological factors. The aim of this review was to summarize the existing evidence about perioperative psychological interventions and to analyze their effect on postoperative pain, disability, and quality of life in adult patients undergoing complex surgery for spinal disorders. Studies investigating any kind of psychological intervention explicitly targeting patients undergoing a surgical fusion on the spine were included. METHODS: We included articles that analyzed the effects of perioperative psychological interventions on either pain, disability, and/or quality of life in adult patients with a primary diagnosis of degenerative or neoplastic spinal disease, undergoing surgical fusion of the spine. We focused on interventions that had a clearly defined psychological component. Two independent reviewers used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) to perform a systematic review on different databases. Risk of bias was evaluated using the Downs and Black checklist. Given study differences in outcome measures and interventions administered, a meta-analysis was not performed. Instead, a qualitative synthesis of main results of included papers was obtained. RESULTS: Thirteen studies, conducted between 2004 and 2017, were included. The majority were randomized-controlled trials (85%) and most patients underwent lumbar fusion (92%). Cognitive behavioral therapy (CBT) was used in nine studies (69%). CBT in the perioperative period may lead to a postoperative reduction in pain and disability in the short-term follow-up compared to care as usual. There was less evidence for an additional effect of CBT at intermediate and long-term follow-up. CONCLUSION: The existing evidence suggests that a reduction in pain and disability in the short-term, starting from immediately after surgery to 3 months, is likely to be obtained when a CBT approach is used. However, there is inconclusive evidence regarding the long-term effect of a perioperative psychological intervention after spinal fusion surgery. Further research is necessary to better define the frequency, intensity, and timing of such an approach in relation to the surgical intervention, to be able to maximize its effect and be beneficial to patients.

Factors associated with an increased risk of developing postoperative symptomatic lumbar spondylolisthesis after decompression surgery: an explorative two-centre international cohort study.

PURPOSE: Symptomatic lumbar spinal stenosis can be treated with decompression surgery. A recent review reported that, after decompression surgery, 1.6-32.0% of patients develop postoperative symptomatic spondylolisthesis and may therefore be indicated for lumbar fusion surgery. The latter can be more challenging due to the altered anatomy and scar tissue. It remains unclear why some patients get recurrent neurological complaints due to postoperative symptomatic spondylolisthesis, though some associations have been suggested. This study explores the association between key demographic, biological and radiological factors and postoperative symptomatic spondylolisthesis after lumbar decompression. METHODS: This retrospective cohort study included patients who had undergone lumbar spinal decompression surgery between January 2014 and December 2016 at one of two Spine Centres in the Netherlands or Switzerland and had a follow-up of two years. Patient characteristics, details of the surgical procedure and recurrent neurological complaints were retrieved from patient files. Preoperative MRI scans and conventional radiograms (CRs) of the lumbar spine were evaluated for multiple morphological characteristics. Postoperative spondylolisthesis was evaluated on postoperative MRI scans. For variables assessed on a whole patient basis, patients with and without postoperative symptomatic spondylolisthesis were compared. For variables assessed on the basis of the operated segment(s), surgical levels that did or did not develop postoperative spondylolisthesis were compared. Univariable and multivariable logistic regression analyses were used to identify associations with postoperative symptomatic spondylolisthesis. RESULTS: Seven hundred and sixteen patients with 1094 surgical levels were included in the analyses. (In total, 300 patients had undergone multilevel surgery.) ICCs for intraobserver and interobserver reliability of CR and MRI variables ranged between 0.81 and 0.99 and 0.67 and 0.97, respectively. In total, 66 of 716 included patients suffered from postoperative symptomatic spondylolisthesis (9.2%). Multivariable regression analyses of patient-basis variables showed that being female [odds ratio (OR) 1.2, 95%CI 1.07-3.09] was associated with postoperative symptomatic spondylolisthesis. Higher BMI (OR 0.93, 95%CI 0.88-0.99) was associated with a lower probability of having postoperative symptomatic spondylolisthesis. Multivariable regression analyses of surgical level-basis variables showed that levels with preoperative spondylolisthesis (OR 17.30, 95%CI 10.27-29.07) and the level of surgery, most importantly level L4L5 compared with levels L1L3 (OR 2.80, 95%CI 0.78-10.08), were associated with postoperative symptomatic spondylolisthesis; greater facet joint angles (i.e. less sagittal-oriented facets) were associated with a lower probability of postoperative symptomatic spondylolisthesis (OR 0.97, 95%CI 0.95-0.99). CONCLUSION: Being female was associated with a higher probability of having postoperative symptomatic spondylolisthesis, while having a higher BMI was associated with a lower probability. When looking at factors related to postoperative symptomatic spondylolisthesis at the surgical level, preoperative spondylolisthesis, more sagittal orientated facet angles and surgical level (most significantly level L4L5 compared to levels L1L3) showed significant associations. These associations could be used as a basis for devising patient selection criteria, stratifying patients or performing subgroup analyses in future studies regarding decompression surgery with or without fusion.

Process Evaluation of Lumbar Interbody Fusion Surgeries in Five Dutch Hospitals: A Qualitative Analysis.

Background and Objectives: Only limited qualitative research concerning instrumented spine surgeries has been published, despite the increasing number of these surgeries and the evident importance of qualitative analysis of the processes surrounding these complex interventions. Current qualitative research is mainly limited to the experiences, emotions and expectations of patients. Insight into the full process, including experiences from the perspective of informal caregivers and healthcare professionals, remains scarce. Materials and Methods: Data were gathered by means of semi-structured face-to-face interviews. In total, there were 27 participants, including 11 patients, 7 informal caregivers and 9 healthcare professionals. The interview process was audiotaped, and each interview was transcribed verbatim. To systematically analyse the gathered data, software for qualitative analysis (NVivo) was used. After immersion in the raw data of transcripts and field notes, a list of broad categories for organising the data into meaningful clusters for analysis was developed. All interviews were coded by the first author, and 25% was independently assessed by the second author. Results: The results of our study describe several promoting and limiting factors concerning the process of lumbar fusion surgery from the perspective of patients, informal caregivers and healthcare providers. The most frequently mentioned promoting factors were: information and opportunities to ask questions during consultations; multidisciplinary consultations; good communication and guidance during hospitalization; and follow-up appointments. The most frequently mentioned limiting factors were: lack of educational material; lack of guidance and communication prior to, during and after hospitalisation. Conclusion: Overall, participants were satisfied with the current healthcare-process in lumbar fusion surgery. However, we found that lack of educational material and guidance during the process led to insecurity about complaints, surgery and recovery. To improve the process of lumbar interbody fusion and to increase patient satisfaction, healthcare providers should focus on guiding and educating patients and informal caregivers about the pre-operative trajectory, the surgery and the recovery. From the healthcare providers' perspective, the process could be improved by multidisciplinary consultations and a dedicated spine team in the operation room. Although this study focusses on lumbar fusion surgery, results could be translated to other fields of spine surgery and surgery in general.

A protocol of a randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis: the Lumbar Interbody Fusion Trial (LIFT).

BACKGROUND: With a steep increase in the number of instrumented spinal fusion procedures, there is a need for comparative data to develop evidence based treatment recommendations. Currently, the available data on cost and clinical effectiveness of the two most frequently performed surgeries for lumbar spondylolisthesis, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are not sufficient. Therefore, current guidelines do not advise which is the most appropriate surgical treatment strategy for these patients. Non-randomized studies comparing TLIF and PLIF moreover suggest that TLIF is associated with fewer complications, less blood loss, shorter surgical time and hospital duration. TLIF may therefore be more cost-effective. The results of this study will provide knowledge on short- and long-term clinical and economical effects of TLIF and PLIF procedures, which will lead to recommendations for treating patients with lumbar spondylolisthesis. METHODS: Multicenter blinded Randomized Controlled Trial (RCT; blinding for the patient and statistician, not for the clinician and researcher). A total of 144 patients over 18 years old with symptomatic single level lumbar degenerative, isthmic or iatrogenic spondylolisthesis whom are candidates for LIF (lumbar interbody fusion) surgery through a posterior approach will be randomly allocated to TLIF or PLIF. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) a process evaluation. The primary clinical outcome measures are: change in disability measured with Oswestry Disability Index (ODI) and change in quality adjusted life years (QALY) measured with EQ-5D-5L. Secondary clinical outcome measures are: Short Form (36) Health Survey (SF-36), VAS back pain, VAS leg pain, Hospital Anxiety Depression Scale (HADS), complications, productivity related costs (iPCQ) and medical costs (iMCQ). Measurements will be carried out at five fixed time points (pre-operatively and at 3, 6, 12 and 24 months). DISCUSSION: It is hypothesized that TLIF, compared to PLIF, has similar clinical outcome or is possibly better in reducing disability. Moreover, direct medical costs are expected to be lower due to less surgical morbidity, shorter hospital stay and shorter surgical time. Indirect costs are assumed to be lower for TLIF as well, because we suspect less working days are lost. Currently, prospective data comparing clinical and cost-effectiveness of both techniques are not available. Therefore, in clinical practice both techniques are used and the choice for technique is greatly based on surgeon's preference. The demand for spinal fusion surgery has risen steeply over the last 10 years and is expected to increase even further in the near future. As a result, the burden on society (and the working population) will increase. In case our hypothesis is confirmed, treatment guidelines will be adapted, and TLIF will be recommended as first choice surgical treatment of lumbar spondylolisthesis. Ultimately this will lead to reduction of (direct and indirect) costs and better clinical outcome for spondylolisthesis patients eligible for instrumented spinal surgery. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry, number 5722 (registration date March 30, 2016).

Efficacy, Safety, and Predictors of Intradiscal Methylene Blue Injection for Discogenic Low Back Pain: Results of a Multicenter Prospective Clinical Series.

STUDY DESIGN: Prospective clinical study of intradiscal methylene blue injection for the treatment of lumbar discogenic pain. OBJECTIVE: The objective of this study was to collect information about efficacy, safety, and acceptability of the intervention, gain and burden of outcome measures, and sample size assumptions for a potential following randomized controlled trial (RCT). If the pilot study demonstrates that this treatment is potentially effective and safe, and the methods and procedures used in this study are feasible, a RCT follows. SUMMARY OF BACKGROUND DATA: Low back pain (LBP) is a highly common problem with a lifetime prevalence of more than 70%. A substantial part of chronic LBP is attributable to degenerative changes in the intervertebral disc. A recently published RCT assessing the treatment intradiscal injection of methylene blue for chronic discogenic LBP, showed exceptionally good results. METHODS: Patients were selected on clinical criteria, magnetic resonance imaging, and a positive provocative discogram. The primary outcome measure was mean pain reduction at 6 months. RESULTS: Fifteen consecutive patients with chronic lumbar discogenic pain enrolled in a multicenter prospective case series in two interventional pain treatment centers in the Netherlands. Six months after the intervention, 40% of the patients claimed at least 30% pain relief. In patients who responded, physical function improved and medication use diminished. We observed no procedural complications or adverse events. Predictors for success were Pfirrmann grading of 2 or less and higher quality of life mental component scores. CONCLUSIONS: Our findings of 40% positive respondents, and no complications, give reason to set up a randomized, double-blind, placebo-controlled, trial.

Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT.

BACKGROUND: When surgically treating cervical degenerative disc disease, the most commonly performed procedure is anterior cervical discectomy. This procedure is performed with, or without fusion promoting methods. For both options the rate of fusion is high and there is much debate whether fusion of the treated segment is a contributing factor to accelerated degeneration of adjacent motion segments. In an effort to prevent degeneration of adjacent segments (ASDeg) due to loss of mobility at the operated level, cervical disc arthroplasty (CDA) was introduced. To evaluate the effectiveness of CDA in preventing ASDeg long term studies are necessary. However, prevention of ASDeg is based on the premise that mobile disc prostheses preserve cervical spine motion in a physiological way. In this article the authors describe a short term protocol for a study that aims to investigate whether CDA reaches the intended goal: restoration or preservation of physiological cervical spine motion. To this end, a technique is used to establish the sequence of contributions of cervical motion segments to flexion/extension of the spine. METHODS: 24 subjects between 18 and 55 years old, with radicular symptoms due to a herniated disc between C5 and C7, refractory to conservative therapy are randomized to simple discectomy, or CDA. These groups are preceded by a pilot group of three subjects receiving CDA. Fluoroscopic flexion-extension recordings are acquired preoperatively, and at three and 12 months postoperative. At these same time points, patient reported outcomes are collected, and a neurological examination is performed by and independent physician. DISCUSSION: Studies investigating arthroplasty determine mobility by measuring segmental range of motion (sROM), which gives no information other than presence, and quantity, of mobility. SROM suffer from high variability. The authors therefore chose to use a method previously used in healthy controls, to describe the dynamic process of cervical spine motion in more detail. Determining cervical spine motion patterns has been reported to be more consistent than sROM. If a physiological motion pattern is absent after surgery in the CDA group, prevention of future ASDeg is less likely. Radiological outcomes will be correlated to clinical outcomes. TRIAL REGISTRATION: NCT00868335.

A randomized controlled trial with extended long-term follow-up: Quality of cervical spine motion after anterior cervical discectomy (ACD) or anterior cervical discectomy with arthroplasty (ACDA).

Introduction: In previous research, a consistent sequence of segmental contributions during dynamic extension X-rays of the cervical spine was observed in 80-90% of healthy participants. Research question: To investigate whether this previously defined 'normal' sequence of segmental contributions was present in patients who underwent anterior cervical discectomy with arthroplasty (ACDA) or anterior cervical discectomy (ACD). Materials & methods: A randomized controlled trial with extended follow-up was conducted. Patients with single level cervical degenerative radiculopathy with a surgical indication were included and randomized. Dynamic X-ray recordings were made before surgery, one-year post-operative, and at long term follow-up. Results: A total of 27 patients were included, three in an ACDA pilot group and 24 were randomized to receive ACDA (N = 12) or ACD (N = 12). A total of 20 patients were available for follow-up. Preoperatively, 16.7% of patients in the ACDA group and 58.3% of patients in the ACD group showed a normal sequence. One-year post-operative, 66.7% showed a normal sequence in the ACDA group versus 30.0% in the ACD group (p = 0.036). After an average of 11-years follow-up, a normal sequence was observed in 9.1% of patients in the ACDA group and in none of the patients in the ACD group (p = 0.588). Discussion & conclusion: These findings suggest that while ACDA can restore and preserve a normal sequence of segmental contributions in the short term, this effect is not maintained in the long term. Throughout the process of ageing, not only the quantity, but also the quality of motion changes.

Accelerometer-based daily physical activity monitoring in patients with postpartum sacroiliac joint dysfunction: a case-control study.

Patients with low back pain caused by sacroiliac joint (SIJ) dysfunction have an impaired quality of life, due to reported pain, disability and activity limitations. There is increasing evidence that minimally invasive sacroiliac joint fusion (MISJF) results in improvement in pain, disability and quality of life in these patients. Some studies have reported improvements in daily physical activity following MISJF but based on bias-prone self-reports. Our aim was to provide objective data on daily physical activity in patients with SIJ dysfunction. Daily physical activity in daily life of participants was measured using a triaxial accelerometer for seven consecutive days, before surgery and 3 months after surgery. Recorded daily activities were the daily number of events and total time spent sitting or lying, standing, walking, cycling, high-activity and number of steps and sit-to-stand transfers. The quality of life was assessed by the validated Dutch EQ-5D-5 L-questionnaire. No statistical differences were observed between daily physical activity in patients with SIJ dysfunction before and 3 months after MISJF. As compared to matched controls, high-intensity physical activity was lower in both the pre- and postoperative period (p = 0.007) for patients with SIJ dysfunction. The quality of life improved significantly in patients after MSIJF, from 0.418 to 0.797 (p = 0.021) but did not reach the level of controls (1.000). Daily physical activity in patients with postpartum SIJ dysfunction does not improve 3 months following MISJF, while quality of life does improve significantly. The discrepancy between these two observations is food for new research.

A Randomized Controlled Trial Using Epidural Analgesia for Pain Relief After Lumbar Interlaminar Decompressive Spine Surgery: The RAPID trial.

STUDY DESIGN: Prospective, double-blind randomized controlled trial. OBJECTIVE: If an intraoperative single bolus of epidural bupivacaine can result in less postoperative pain following lumbar spinal decompression surgery. SUMMARY OF BACKGROUND DATA: Adequate postoperative pain management following lumbar spinal decompression surgery is important, as it will lead to early mobilization, less complications, and a shorter hospital stay. Opioid consumption should be limited due to their frequently accompanied side effects and their addictive nature. During the final phase of lumbar decompression surgery, the epidural space becomes easily accessible. This might be an ideal moment for surgeons to administer an epidural bolus of analgesia as a safe and effective method for postoperative pain relief. MATERIALS AND METHODS: In this trial, we compared a single intraoperative bolus of epidural analgesia using bupivacaine 0.25% to placebo (NaCl 0.9%) and its effect on postoperative pain following lumbar spinal decompression surgery. The primary outcome was the difference in Numeric (Pain) Rating Scale between the intervention and placebo groups during the first 48 hours after surgery. RESULTS: Both the intervention group and the placebo group consisted of 20 randomized patients (N=40). Statistically significant lower mean Numeric (Pain) Rating Scale pain scores were observed in the intervention group in comparison with the control group (main effect group: -2.35±0.77, P =0.004). The average pain score was lower in the intervention group at all postoperative time points. No study-related complications occurred. CONCLUSION: This randomized controlled trial shows that administrating a bolus of intraoperative epidural bupivacaine is a safe and effective method for reducing early postoperative pain following lumbar decompression surgery.

Transforaminal versus posterior lumbar interbody fusion for symptomatic single-level spondylolisthesis (LIFT): a multicentre controlled, patient blinded, randomised non-inferiority trial.

Background: The effectiveness of transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar interbody fusion (PLIF) in patients with single-level spondylolisthesis has not been substantiated. To address the evidence gap, a well-powered randomized controlled non-inferiority trial comparing the effectiveness of TLIF with PLIF, entitled the Lumbar Interbody Fusion Trial (LIFT), was conducted. Methods: In a multicenter randomized controlled non-inferiority trial among five Dutch hospitals, 161 patients were randomly allocated to either TLIF or PLIF (1:1), stratified according to study site. Patients and statisticians were blinded for group assignment. All patients were over 18 years old with symptomatic single-level degenerative, isthmic or iatrogenic lumbar spondylolisthesis, and eligible for lumbar interbody fusion surgery through a posterior approach. The primary outcome was change in disability measured with the Oswestry Disability Index (ODI) from preoperative to one year postoperative. The non-inferiority limit was set to 7.0 points based on the MCID of ODI. Secondary outcomes were change in quality-adjusted life years (QALY) assessed with EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) and Short Form Health Survey (SF-36), as well as back and leg pain (Numerical rating scale, NRS), anxiety and depression (Hospital Anxiety Depression Scale; HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and complications. Trial registration: Netherlands Trial Registry, number 5722 (registration date March 30, 2016), Lumbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis. Findings: Patients were included between August 2017 and November 2020. The total study population was 161 patients. Total loss-to-follow-up after one year was 16 patients. Per-protocol analysis included 66 patients in each group. In the TLIF group (mean age 61.6, 36 females), ODI improved from 46.7 to 20.7, whereas in the PLIF group (mean age 61.9, 41 females), it improved from 46.0 to 24.9. This difference (-4.9, 90% CI -12.2 to +2.4) did not reach the non-inferiority limit of 7.0 points in ODI. A significant difference in the secondary outcome measurement, QALY (SF-36), was observed in favor of TLIF (P < 0.05). However, this was not clinically relevant. No difference was found for all other secondary outcome measurements; PROMs (EQ-5D, NRS leg/back, HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and perioperative and postoperative complications. Interpretation: For patients with single-level spondylolisthesis, TLIF is non-inferior to PLIF in terms of clinical effectiveness. Disability (measured with ODI) did not differ over time between groups. Funding: No funding was received for this trial.

Posterior Cervical Foraminotomy Compared with Anterior Cervical Discectomy with Fusion for Cervical Radiculopathy: Two-Year Results of the FACET Randomized Noninferiority Study.

BACKGROUND: Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery. METHODS: This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536). RESULTS: From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, -0.06 [1-sided 95% confidence interval (CI), -0.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was -2.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, -0.02 [2-sided 95% CI, -0.09 to 0.05]). CONCLUSIONS: This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

The Variability of Lumbar Sequential Motion Patterns: Observational Study.

BACKGROUND: Physiological motion of the lumbar spine is a topic of interest for musculoskeletal health care professionals since abnormal motion is believed to be related to lumbar complaints. Many researchers have described ranges of motion for the lumbar spine, but only few have mentioned specific motion patterns of each individual segment during flexion and extension, mostly comprising the sequence of segmental initiation in sagittal rotation. However, an adequate definition of physiological motion is still lacking. For the lower cervical spine, a consistent pattern of segmental contributions in a flexion-extension movement in young healthy individuals was described, resulting in a definition of physiological motion of the cervical spine. OBJECTIVE: This study aimed to define the lumbar spines' physiological motion pattern by determining the sequence of segmental contribution in sagittal rotation of each vertebra during maximum flexion and extension in healthy male participants. METHODS: Cinematographic recordings were performed twice in 11 healthy male participants, aged 18-25 years, without a history of spine problems, with a 2-week interval (time point T1 and T2). Image recognition software was used to identify specific patterns in the sequence of segmental contributions per individual by plotting segmental rotation of each individual segment against the cumulative rotation of segments L1 to S1. Intraindividual variability was determined by testing T1 against T2. Intraclass correlation coefficients were tested by reevaluation of 30 intervertebral sequences by a second researcher. RESULTS: No consistent pattern was found when studying the graphs of the cinematographic recordings during flexion. A much more consistent pattern was found during extension, especially in the last phase. It consisted of a peak in rotation in L3L4, followed by a peak in L2L3, and finally, in L1L2. This pattern was present in 71% (15/21) of all recordings; 64% (7/11) of the participants had a consistent pattern at both time points. Sequence of segmental contribution was less consistent in the lumbar spine than the cervical spine, possibly caused by differences in facet orientation, intervertebral discs, overprojection of the pelvis, and muscle recruitment. CONCLUSIONS: In 64% (7/11) of the recordings, a consistent motion pattern was found in the upper lumbar spine during the last phase of extension in asymptomatic young male participants. Physiological motion of the lumbar spine is a broad concept, influenced by multiple factors, which cannot be captured in a firm definition yet. TRIAL REGISTRATION: ClinicalTrials.gov NCT03737227; https://clinicaltrials.gov/ct2/show/NCT03737227. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14741.

Referrals, Symptoms and Treatment of Patients Referred to a Secondary Spine Centre-How Can We Help?

INTRODUCTION: Spinal disorders are amongst the conditions with the highest burden of disease. To limit the increase of healthcare-related costs in the ageing population, the selection of different types of care for patients with spinal disorders should be optimized. The first step is to investigate the characteristics of these patients and the relationship with treatment. RESEARCH QUESTION: The primary aim of this study was to provide insights in the characteristics, symptoms, diagnosis and treatment of patients referred to a specialized spinal health care centre. The secondary aim was to perform an in-depth analysis of resource utilization for a representative subgroup of patients. METHODS: This study describes the characteristics of 4855 patients referred to a secondary spine centre. Moreover, an extensive analysis of a representative subgroup of patients (~20%) is performed. RESULTS: The mean age was 58.1, 56% of patients were female, and the mean BMI was 28. In addition, 28% of patients used opioids. Mean self-reported health status was 53.3 (EuroQol 5D Visual Analogue Scale), and pain ranged from 5.8 to 6.7 (Visual Analogue Scale neck/back/arm/leg). Additional imaging was received by 67.7% of patients. Surgical treatment was indicated for 4.9% of patients. The majority (83%) of non-surgically treated patients received out-of-hospital treatment; 25% of patients received no additional imaging or in-hospital treatment. CONCLUSION: The vast majority of patients received non-surgical treatments. We observed that ~10% of patients did not receive in-hospital imaging or treatment and had acceptable or good questionnaire scores at the time of referral. These findings suggest that there is potential for improvement in efficacy of referral, diagnosis, and treatment. Future studies should aim to develop an evidence base for improved patient selection for clinical pathways. The efficacy of chosen treatments requires investigation of large cohorts.

Advocating uniformity in spine surgery: a practical disease-specific guideline for trial-based economic evaluations.

OBJECTIVES: Despite the availability of general and national guidelines for the conduct and reporting of economic evaluations, there is heterogeneity in economic evolutions concerning spine surgery. This is partly the result of differing levels of adherence to the existing guidelines and the lack of disease-specific recommendations for economic evaluations. The extensive heterogeneity in study design, follow-up duration and outcome measurements limit the comparability of economic evaluations in spine surgery. This study has three objectives: (1) to create disease-specific recommendations for the design and conduct of trial-based economic evaluations in spine surgery, (2) to define recommendations for reporting economic evaluations in spine surgery as a complement to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist and (3) to discuss methodological challenges and defining the need for future research. DESIGN: A modified Delphi method according to the RAND/UCLA Appropriateness Method. SETTING: A four-step process was followed to create and validate disease-specific statements and recommendations for the conduct and reporting of trial-based economic evaluations in spine surgery. Consensus was defined as >75% agreement. PARTICIPANTS: A total of 20 experts were included in the expert group. Validation of the final recommendations was obtained in a Delphi panel, which consisted of 40 researchers in the field who were not included in the expert group. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure is a set of recommendations for the conduct and reporting, as a complement to the CHEERS 2022 checklist, of economic evaluations in spine surgery. RESULTS: A total of 31 recommendations are made. The Delphi panel confirmed consensus on all of the recommendations in the proposed guideline. CONCLUSION: This study provides an accessible and practical guideline for the conduct of trial-based economic evaluations in spine surgery. This disease-specific guideline is a complement to existing guidelines, and should aid in reaching uniformity and comparability.

Methodology of economic evaluations in spine surgery: a systematic review and qualitative assessment.

OBJECTIVES: The present study is a systematic review conducted as part of a methodological approach to develop evidence-based recommendations for economic evaluations in spine surgery. The aim of this systematic review is to evaluate the methodology and quality of currently available clinical cost-effectiveness studies in spine surgery. STUDY DESIGN: Systematic literature review. DATA SOURCES: PubMed, Web of Science, Embase, Cochrane, Cumulative Index to Nursing and Allied Health Literature, EconLit and The National Institute for Health Research Economic Evaluation Database were searched through 8 December 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies were included if they met all of the following eligibility criteria: (1) spine surgery, (2) the study cost-effectiveness and (3) clinical study. Model-based studies were excluded. DATA EXTRACTION AND SYNTHESIS: The following data items were extracted and evaluated: pathology, number of participants, intervention(s), year, country, study design, time horizon, comparator(s), utility measurement, effectivity measurement, costs measured, perspective, main result and study quality. RESULTS: 130 economic evaluations were included. Seventy-four of these studies were retrospective studies. The majority of the studies had a time horizon shorter than 2 years. Utility measures varied between the EuroQol 5 dimensions and variations of the Short-Form Health Survey. Effect measures varied widely between Visual Analogue Scale for pain, Neck Disability Index, Oswestry Disability Index, reoperation rates and adverse events. All studies included direct costs from a healthcare perspective. Indirect costs were included in 47 studies. Total Consensus Health Economic Criteria scores ranged from 2 to 18, with a mean score of 12.0 over all 130 studies. CONCLUSIONS: The comparability of economic evaluations in spine surgery is extremely low due to different study designs, follow-up duration and outcome measurements such as utility, effectiveness and costs. This illustrates the need for uniformity in conducting and reporting economic evaluations in spine surgery.

Low-Threshold-For-Surgery Versus Primarily-Conservative Treatment for Odontoid Fractures in the Elderly: Evaluating Practice Variation in The Netherlands.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: Odontoid fractures are the most common cervical spine fractures in the elderly. The optimal treatment remains controversial. The aim of this study was to compare results of a low-threshold-for-surgery strategy (surgery for dislocated fractures in relatively healthy patients) to a primarily-conservative strategy (for all patients). METHODS: Patient records from 5 medical centers were reviewed for patients who met the selection criteria (e.g. age ≥55 years, type II/III odontoid fractures). Demographics, fracture types/characteristics, fracture union/stability, clinical outcome and mortality were compared. The influence of age on outcome was studied (≥55-80 vs ≥80 years). RESULTS: A total of 173 patients were included: 120 treated with low-threshold-for-surgery (of which 22 primarily operated, and 23 secondarily) vs 53 treated primarily-conservative. No differences in demographics and fracture characteristics between the groups were identified. Fracture union (53% vs 43%) and fracture stability (90% vs 85%) at last follow-up did not differ between groups. The majority of patients (56%) achieved clinical improvement compared to baseline. Analysis of differences in clinical outcome between groups was infeasible due to data limitations. In both strategies, patients ≥80 years achieved worse union (64% vs 30%), worse stability (97% vs 77%), and - as to be expected - increased mortality <104 weeks (2% vs 22%). CONCLUSIONS: Union and stability rates did not differ between the treatment strategies. Advanced age (≥80 years) negatively influenced both radiological outcome and mortality. No cases of secondary neurological deficits were identified, suggesting that concerns for the consequences of under-treatment may be unjustified.

Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year: The FACET Randomized Clinical Trial.

Importance: The choice between posterior cervical foraminotomy (posterior surgery) and anterior cervical discectomy with fusion (anterior surgery) for cervical foraminal radiculopathy remains controversial. Objective: To investigate the noninferiority of posterior vs anterior surgery in patients with cervical foraminal radiculopathy with regard to clinical outcomes after 1 year. Design, Setting, and Participants: This multicenter investigator-blinded noninferiority randomized clinical trial was conducted from January 2016 to May 2020 with a total follow-up of 2 years. Patients were included from 9 hospitals in the Netherlands. Of 389 adult patients with 1-sided single-level cervical foraminal radiculopathy screened for eligibility, 124 declined to participate or did not meet eligibility criteria. Patients with pure axial neck pain without radicular pain were not eligible. Of 265 patients randomized (132 to posterior and 133 to anterior), 15 were lost to follow-up and 228 were included in the 1-year analysis (110 in posterior and 118 in anterior). Interventions: Patients were randomly assigned 1:1 to posterior foraminotomy or anterior cervical discectomy with fusion. Main Outcomes and Measures: Primary outcomes were proportion of success using Odom criteria and decrease in arm pain using a visual analogue scale from 0 to 100 with a noninferiority margin of 10% (assuming advantages with posterior surgery over anterior surgery that would justify a tolerable loss of efficacy of 10%). Secondary outcomes were neck pain, disability, quality of life, work status, treatment satisfaction, reoperations, and complications. Analyses were performed with 2-proportion z tests at 1-sided .05 significance levels with Bonferroni corrections. Results: Among 265 included patients, the mean (SD) age was 51.2 (8.3) years; 133 patients (50%) were female and 132 (50%) were male. Patients were randomly assigned to posterior (132) or anterior (133) surgery. The proportion of success was 0.88 (86 of 98) in the posterior surgery group and 0.76 (81 of 106) in the anterior surgery group (difference, -0.11 percentage points; 1-sided 95% CI, -0.01) and the between-group difference in arm pain was -2.8 (1-sided 95% CI, -9.4) at 1-year follow-up, indicating noninferiority of posterior surgery. Decrease in arm pain had a between-group difference of 3.4 (1-sided 95% CI, 11.8), crossing the noninferiority margin with 1.8 points. All secondary outcomes had 2-sided 95% CIs clustered around 0 with small between-group differences. Conclusions and Relevance: In this randomized clinical trial, posterior surgery was noninferior to anterior surgery for patients with cervical radiculopathy regarding success rate and arm pain at 1 year. Decrease in arm pain and secondary outcomes had small between-group differences. These results may be used to enhance shared decision-making. Trial Registration: Netherlands Trial Register Identifier: NTR5536.

Arthroplasty versus fusion in single-level cervical degenerative disc disease.

BACKGROUND: There is ongoing debate about whether fusion or arthroplasty is superior in the treatment of single level cervical degenerative disc disease. Mainly because the intended advantage of arthroplasty over fusion, that is, the prevention of symptoms due to adjacent segment degeneration in the long term, is not confirmed yet. Until sufficient long-term results become available, it is important to know whether results of one of the two treatments are superior to the other in the first one to two years. OBJECTIVES: To assess the effects of arthroplasty versus fusion for radiculopathy or myelopathy, or both due to single level cervical degenerative disc disease. SEARCH METHODS: We searched the following databases for randomised controlled trials (RCTs): CENTRAL (The Cochrane Library 2011, Issue 2), MEDLINE, EMBASE, and EBMR. Additionally, we searched the System for Information on Grey Literature (SIGLE), subheading Biological and Medical Sciences, the US Food and Drug Administration (FDA) database on medical devices, and Clinicaltrials.gov to identify trials in progress. We also screened the reference list of all selected papers. Date of search: 25 May 2011. SELECTION CRITERIA: We included RCTs that directly compared any type of cervical fusion with any type of arthroplasty, with at least one year of follow-up. Primary outcomes were arm pain, neck pain, neck-related functional status, patient satisfaction, neurological outcome, and global health status. Secondary outcomes were the presence of (radiological) fusion, revision surgery at the treated level, secondary surgery on adjacent levels, segmental mobility of treated and adjacent levels, and work status. DATA COLLECTION AND ANALYSIS: Study selection was performed independently by three review authors, and 'Risk of bias' assessment and data extraction were performed by two review authors. In case of missing data or insufficient information for a judgement about risk of bias, we tried to contact the study authors or the study sponsor. The data were entered into RevMan by one review author and subsequently checked by a second review author. We assessed the quality of evidence using GRADE. We analysed heterogeneity and performed sensitivity analyses for the pooled analyses. MAIN RESULTS: We included nine studies (2400 participants), five of which had a low risk of bias. Eight of these studies were industry sponsored. The most important results showed low-quality evidence for a small but significant difference in alleviation of arm pain at one to two years in favour of arthroplasty (mean difference (MD) -1.54; 95% confidence interval (CI) -2.86 to -0.22; 100-point scale). A small study effect could not be ruled out for this outcome in the sensitivity analyses. This means that smaller studies (or small published subsets of larger studies) showed larger differences for this outcome, which may indicate publication bias. Also, moderate-quality evidence showed a small difference in neck-related functional status at one to two years in favour of arthroplasty (MD -2.79; 95% CI -4.73 to -0.85; 100-point scale) and a small difference in neurological outcome in favour of arthroplasty (risk ratio (RR) 1.05; 95% CI 1.01 to 1.09). These two outcomes were robust to sensitivity analyses. For none of the primary outcomes, was a clinically relevant difference shown. Additionally, there was high-quality evidence for a large, statistically significant difference in segmental mobility at one to two years (measured as degrees segmental range of motion) at the treated level (MD 6.90; 95% CI 5.45 to 8.35). There was low-quality evidence that there was no statistically significant difference in secondary surgery at the adjacent levels at one to two years (RR 0.60; 95% CI 0.35 to 1.02). The latter was not robust to sensitivity analyses. AUTHORS' CONCLUSIONS: There was a tendency for clinical results to be in favour of arthroplasty; often these were statistically significant. However, differences in effect size were invariably small and not clinically relevant for all primary outcomes. Significance was often gained or lost in the varying sensitivity analyses, probably owing to the relatively small number of studies, in combination with the small differences that were found. Given the fact that all of the included studies were not blinded, this could be due to patient or carer expectations. However, at this time both treatments can be seen as valid options with respect to results at a maximum of one to two years. Given the current absence of truly long-term results, use of these mobile disc prostheses should still be limited to clinical trials. There was high-quality evidence that the goal of preservation of segmental mobility in arthroplasty was met. A statistically significant effect on the incidence of secondary symptoms at adjacent levels, the primary goal of arthroplasty over fusion, was not found at one to two years. If there was a protective effect, this should become clearer over time. A future update, when studies with 'truly long-term' results (five years or more) become available, should focus on this issue.

Intraoperative MRI-guided resection of glioblastoma multiforme: a systematic review.

We did a systematic review to address the added value of intraoperative MRI (iMRI)-guided resection of glioblastoma multiforme compared with conventional neuronavigation-guided resection, with respect to extent of tumour resection (EOTR), quality of life, and survival. 12 non-randomised cohort studies matched all selection criteria and were used for qualitative synthesis. Most of the studies included descriptive statistics of patient populations of mixed pathology, and iMRI systems of varying field strengths between 0·15 and 1·5 Tesla. Most studies provided information on EOTR, but did not always mention how iMRI affected the surgical strategy. Only a few studies included information on quality of life or survival for subpopulations with glioblastoma multiforme or high-grade glioma. Several limitations and sources of bias were apparent, which affected the conclusions drawn and might have led to overestimation of the added value of iMRI-guided surgery for resection of glioblastoma multiforme. Based on the available literature, there is, at best, level 2 evidence that iMRI-guided surgery is more effective than conventional neuronavigation-guided surgery in increasing EOTR, enhancing quality of life, or prolonging survival after resection of glioblastoma multiforme.