(Cost-)effectiveness of personalised multimodal physiotherapy compared to surgery in patients with cervical radiculopathy: A systematic review.

RATIONALE: Cervical radiculopathy is initially typically managed conservatively. Surgery is indicated when conservative management fails or with severe/progressive neurological signs. Personalised multimodal physiotherapy could be a promising conservative strategy. However, aggregated evidence on the (cost-)effectiveness of personalised multimodal physiotherapy compared to surgery with/without post-operative physiotherapy is lacking. AIM/OBJECTIVES: To systematically summarise the literature on the (cost-)effectiveness of personalised multimodal physiotherapy compared to surgery with or without post-operative physiotherapy in patients with cervical radiculopathy. METHODS: PubMed, Embase, CINAHL, PsycINFO and Web of Science were searched from inception to 1st of March 2023. Primary outcomes were effectiveness regarding costs, arm pain intensity and disability. Neck pain intensity, perceived recovery, quality of life, neurological symptoms, range-of-motion, return-to-work, medication use, (re)surgeries and adverse events were considered secondary outcomes. Randomised clinical trials comparing personalised multimodal physiotherapy versus surgical approaches with/without post-operative physiotherapy were included. Two independent reviewers performed study selection, data-extraction, and risk of bias assessment using the Cochrane RoB 2 and Consolidated Health Economic Evaluation Reporting Standards statement. Certainty of the evidence was determined using Grading of Recommendations, Assessment, Development and Evaluations. RESULTS: From 2109 records, eight papers from two original trials, with 117 participants in total were included. Low certainty evidence showed there were no significant differences on arm pain intensity and disability, except for the subscale 'heavy work' related disability (12 months) and disability at 5-8 years. Cost-effectiveness was not assessed. There was low certainty evidence that physiotherapy improved significantly less on neck pain intensity, sensory loss and perceived recovery compared to surgery with/without physiotherapy. Low certainty evidence showed there were no significant differences on numbness, range of motion, medication use, and quality of life. No adverse events were reported. CONCLUSION: Considering the clinical importance of accurate management recommendations and the current low level of certainty, high-quality cost-effectiveness studies are needed.

Assessing accuracy of measurement methods for bony fusion assessment after anterior cervical discectomy.

BACKGROUND CONTEXT: Currently, there is no universally accepted method for assessing radiological fusion shortly after anterior cervical discectomy. Five-year follow-up radiological X-rays demonstrating solid fusion or absence of fusion provided a gold standard for comparison with various assessment methods. PURPOSE: Establishing the most accurate diagnostic test for earlier bony fusion assessment by comparing different cut-off values for the difference in interspinous distance and the change in Cobb angle on dynamic radiological images against the established gold standard. DESIGN: Post-hoc analysis from the NEtherlands Cervical Kinematics (NECK) trial (NTR1289). PATIENT SAMPLE: A total of 40 patients with 1 level herniated disc that underwent anterior discectomy between 2010 and 2014 returned for a 5-year follow-up X-ray. OUTCOME MEASURES: Radiological outcome was assessed quantitatively and qualitatively by fusion on radiographic images 5 years after surgery. METHODS: Radiological dynamic X-rays were reviewed for fusion at 5-year follow-up by a senior spine surgeon. At this timepoint, bony continuity was indisputable and served as gold standard. Cobb angles and interspinous distances on flexion-extension images were measured independently by 2 investigators. Optimum agreement between the gold standard and the 2 methods was assessed, evaluating varying cut-off values, considering sensitivity, specificity, and area under the curve (AUC). RESULTS: Dynamic radiographic assessments revealed fusion in 29 out of 40 patients (mean age: 49 years ± 8; 23 women). For Cobb angle (optimal cut-off: ≤3.0°), the AUC was 0.86 with 100% sensitivity and 72.7% specificity. For interspinous distance (optimal cut-off: ≤1.5 mm), the AUC was 0.89 with 96.6% sensitivity and 81.8% specificity. The highest AUC (0.91) was observed for combined cut-off values (Cobb angle ≤3.0° and interspinous distance ≤2.0 mm), yielding 100% sensitivity and 81.8% specificity. CONCLUSION: The combination of cut-off values ≤3.0° difference for Cobb angle and ≤2.0 mm difference for interspinous distance on lateral flexion-extension X-rays was assessed to be an accurate diagnostic criterion for fusion evaluation. This tool provides a practical and easy applicable method for assessing fusion during follow-up after anterior discectomy.

Thromboembolic prophylaxis in neurosurgical practice: a systematic review.

BACKGROUND: In neurosurgical patients, the risk of developing venous thromboembolism (VTE) is high due to the relatively long duration of surgical interventions, usually long immobilization time after surgery, and possible neurological deficits which can negatively influence mobility. In neurosurgical clinical practice, there is lack of consensus on optimal prophylaxis against VTE, mechanical or pharmacological. OBJECTIVE: To systematically review available literature on the incidence of VTE in neurosurgical interventions and to establish an optimum prevention strategy. METHODS: A literature search was performed in PubMed, Embase, Web of Science, Cochrane Library, and EmCare, based on a sensitive search string combination. Studies were selected by predefined selection criteria, and risk of bias was assessed by Newcastle-Ottawa Quality Assessment Scale and Cochrane risk of bias. RESULTS: Twenty-five studies were included, half of which had low risk of bias (21 case series, 3 comparative studies, 1 RCT). VTE was substantially higher if the evaluation was done by duplex ultrasound (DUS), or another systematic screening method, in comparison to clinical evaluation (clin). Without prophylaxis DVT, incidence varied from 4 (clin) to 10% (DUS), studies providing low molecular weight heparin (LMWH) reported an incidence of 2 (clin) to 31% (DUS), providing LMWH and compression stockings (CS) reported an incidence of 6.4% (clin) to 29.8% (DUS), and providing LMWH and intermittent pneumatic compression devices (IPC) reported an incidence of 3 (clin) to 22.3% (DUS). Due to a lack of data, VTE incidence could not meaningfully be compared between patients with intracranial and spine surgery. The reported incidence of pulmonary embolism (PE) was 0 to 7.9%. CONCLUSION: Low molecular weight heparin, compression stockings, and intermittent pneumatic compression devices were all evaluated to give reduction in VTE, but data were too widely varying to establish an optimum prevention strategy. Systematic screening for DVT reveals much higher incidence percentages in comparison to screening solely on clinical grounds and is recommended in follow-up of neurosurgical procedures with an increased risk for DVT development in order to prevent occurrence of PE.

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.

The optimal treatment of type II and III odontoid fractures in the elderly: an updated meta-analysis.

PURPOSE: Odontoid fractures are the most common cervical spine fractures in the elderly, with a controversial optimal treatment. The objective of this review was to compare the outcome of surgical and conservative treatments in elderly (≥ 65 years), by updating a systematic review published by the authors in 2013. METHODS: A comprehensive search was conducted in seven databases. Clinical outcome was the primary outcome. Fracture union- and stability were secondary outcomes. Pooled point estimates and their respective 95% confidence intervals (CIs) were derived using the random-effects model. A random-effects multivariable meta-regression model was used to correct for baseline co-variates when sufficiently reported. RESULTS: Forty-one studies met the inclusion criteria, of which forty were case series and one a cohort study. No clinical differences in outcomes including the Neck Disability Index (NDI, 700 patients), Visual Analogue Scale pain (VAS, 180 patients), and Smiley-Webster Scale (SWS, 231 patients) scores were identified between surgical and conservative treatments. However, fracture union was higher in surgically treated patients (pooled incidence 72.7%, 95% CI 66.1%, 78.5%, 31 studies, 988 patients) than in conservatively treated patients (40.2%, 95% CI 32.0%, 49.0%, 22 studies, 912 patients). This difference remained after correcting for age and fracture type. Fracture stability (41 studies, 1917 patients), although numerically favoring surgery, did not appear to differ between treatment groups. CONCLUSION: While surgically treated patients showed higher union rates than conservatively treated patients, no clinically relevant differences were observed in NDI, VAS pain, and SWS scores and stability rates. These results need to be further confirmed in well-designed comparative studies with proper adjustment for confounding, such as age, fracture characteristics, and osteoporosis degree.

Symptomatic lumbar stenosis due to low-grade degenerative spondylolisthesis can effectively be treated with mere decompression.

PURPOSE: Adding instrumented spondylodesis to decompression in symptomatic spinal stenosis with degenerative spondylolisthesis is subject of debate. The presence of spondylolisthesis due to degeneration is an indicator of severe facet joint and intervertebral disc degeneration, and this may fit increased instability of the spine. We aim to establish the incidence of degenerative spondylolisthesis in spinal stenosis surgical candidates and to evaluate the incidence of failure of decompressive surgery without concomitant spondylodesis as initial treatment. METHODS: Medical files of all operated patients for spinal stenosis between 2007 and 2013 were evaluated. Demographic characteristics, pre-operative radiological characteristics (level of stenosis, presence, and grade of spondylolisthesis), surgical technique, incidence, and indication for reoperation were summarised, as well as the type of reoperation. Patient satisfaction was classified as 'satisfied' or 'unsatisfied' after initial and secondary surgery. The follow-up was 6 to 12 years. RESULTS: Nine hundred thirty-four patients were included, and 253 (27%) had a spondylolisthesis. Seventeen percent of the spondylolisthesis patients receiving decompression were reoperated versus 12% of the stenosis patients (p=.059). Reoperation in the spondylolisthesis group concerned instrumented spondylodesis in 38 versus 10% in the stenosis group. The satisfaction percentage was comparable in the stenosis and the spondylolisthesis group two months after surgery (80 vs. 74%). Of the 253 spondylolisthesis patients, 1% initially received instrumented spondylodesis and 6% in a second operation. CONCLUSION: Lumbar stenosis with and without (low-grade) degenerative spondylolisthesis can usually effectively be treated with mere decompression. Instrumented surgery in a second surgical procedure does not lead to less satisfaction with surgical outcomes.

Cost effectiveness of implanting a prosthesis after anterior cervical discectomy for radiculopathy: results of the NECK randomized controlled trial.

BACKGROUND CONTEXT: In the treatment of cervical radiculopathy due to a herniated disc, potential surgical treatments include: anterior cervical discectomy (ACD), ACD and fusion using a cage (ACDF), and anterior cervical disc arthroplasty (ACDA). Previous publications yielded comparable clinical and radiological outcome data for the various implants, but research on their comparative costutility has been inconclusive. PURPOSE: To evaluate the cost utility of ACD, ACDF, and ACDA. STUDY DESIGN: Cost-utility analysis. PATIENT SAMPLE: About 109 patients with cervical radiculopathy randomized to undergo ACD, ACDF, or ACDA as part of the NEtherlands Cervical Kinetics trial. OUTCOME MEASURES: Quality-adjusted life-years (QALYs) estimated from patient-reported utilities using the EuroQol-5D questionnaire and EuroQol Visual Analogue Scale (EQ VAS), measured at baseline, 2, 4, 8, 12, 26, 52, and 104 weeks postprocedure. Societal costs including admissions to hospital (related and otherwise), GP visits, specialist visits, physical therapy, medications, home care, aids, informal care, productivity losses, and out of pocket condition-related expenses. METHODS: The cost utility of the competing strategies over 1 and 2 years was assessed following a net benefit (NB) approach, whereby the intervention with the highest NB among competing strategies is preferred. Cost effectiveness acceptability curves were produced to reflect the probability of each strategy being the most cost effective across various willingness-to-pay (WTP) thresholds. Five sensitivity analyses were conducted to assess the robustness of results. RESULTS: ACDF was more likely to be the most cost-effective strategy at WTP thresholds of €20,000 to 50,000/QALY in all but one of the analyses. The mean QALYs during the first year were 0.750, 0.817, and 0.807 for ACD, ACDF, and ACDA, respectively, with no significant differences between groups. Total healthcare costs over the first year were significantly higher for ACDA, largely due to the higher surgery and implant costs. The total societal costs of the three strategies were €12,173 for ACD, €11,195 for ACDF, and €13,746 for ACDA, with no significant differences between groups. CONCLUSION: Our findings demonstrate that ACDF is likely to be more cost-effective than ACDA or ACD at most WTP thresholds, and this conclusion is robust to most sensitivity analyses conducted. It is demonstrated that the difference in costs is mainly caused by the initial surgical costs and that there are only minimal differences in other costs during follow-up. Since clinical data are comparable between the groups, it is to the judgment of the patient and surgeon which intervention is applied.

Clinical outcome in decompression alone versus decompression and instrumented fusion in patients with isthmic spondylolisthesis: a prospective cohort study.

OBJECTIVE: In the surgical treatment of isthmic spondylolisthesis, it is debatable whether instrumented fusion is mandatory in addition to decompression. The objective of this prospective cohort study was to assess the long-term effect of decompression alone compared with decompression and instrumented fusion in patients who underwent the intervention of their own preference. The results were compared with those in patients who underwent randomly assigned treatment. METHODS: The authors performed a prospective observational multicenter cohort study, including 91 patients with isthmic spondylolisthesis assigned to undergo either decompression alone (n = 44) or decompression and fusion (n = 47). The main outcomes were the Roland-Morris Disability Questionnaire (RDQ) scores and the patient's perceived recovery at the 2-year follow-up. Secondary outcomes were visual analog scale (VAS) leg pain and back pain scores and the reoperation rate. A meta-analysis was performed for data from this cohort study (n = 91) and from a randomized controlled trial (RCT) previously reported by the authors (n = 84). Subgroup analyses were performed on these combined data for age, sex, weight, smoking, and Meyerding grade. RESULTS: At the 12-week follow-up, improvements of RDQ scores were comparable for the two procedures (decompression alone [D group] 4.4, 95% CI 2.3-6.5; decompression and fusion [DF group] 5.8, 95% CI -4.3 to 1.4; p = 0.31). Likewise, VAS leg pain scores (D group 35.0, 95% CI 24.5-45.6; DF group 47.5, 95% CI 37.4-57.5; p = 0.09) and VAS back pain scores (D group 23.5, 95% CI 13.3-33.7; DF group 34.0, 95% CI 24.1-43.8; p = 0.15) were comparable. At the 2-year follow-up, there were no significant differences between the two groups in terms of scores for RDQ (difference -3.1, 95% CI -6.4 to 0.3, p = 0.07), VAS leg pain (difference -7.4, 95% CI -22.1 to 7.2, p = 0.31), and VAS back pain (difference -11.4, 95% CI -25.7 to 2.9, p = 0.12). In contrast, patient-perceived recovery from leg pain was significantly higher in the DF group (79% vs 51%, p = 0.02). Subgroup analyses did not demonstrate a superior outcome for decompression alone compared with decompression and fusion. Nine patients (20.5%) underwent reoperation in total, all in the D group. The meta-analysis including both the cohort and RCT populations yielded an estimated pooled mean difference in RDQ of -3.7 (95% CI -5.94 to -1.55, p = 0.0008) in favor of decompression and fusion at the 2-year follow-up. CONCLUSIONS: In patients with isthmic spondylolisthesis, at the 2-year follow-up, patients who underwent decompression and fusion showed superior functional outcome and perceived recovery compared with those who underwent decompression alone. No subgroups benefited from decompression alone. Therefore, decompression and fusion is recommended over decompression alone as a primary surgical treatment option in isthmic spondylolisthesis.

Long-term results of the NECK trial-implanting a disc prosthesis after cervical anterior discectomy cannot prevent adjacent segment disease: five-year clinical follow-up of a double-blinded randomised controlled trial.

BACKGROUND CONTEXT: Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment disease as compared to anterior cervical discectomy and fusion (ACDF). PURPOSE: To evaluate the long-term outcome in patients with cervical radiculopathy due to a herniated disc undergoing ACDA, ACDF or ACD (no cage, no plate) in terms of clinical outcome measured by the Neck Disability Index (NDI). Likewise, clinically relevant adjacent segment disease is assessed as a long-term result. STUDY DESIGN: Double-blinded randomized controlled trial. PATIENT SAMPLE: A total of 109 patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without cage. OUTCOME MEASURES: Clinical outcome was measured by patients' self-reported NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, perceived recovery and reoperation rate. Radiological outcome was assessed by radiographic cervical curvature and adjacent segment degeneration (ASD) parameters at baseline and up until five years after surgery. METHODS: To account for the correlation between repeated measurements of the same individual Generalized Estimated Equations (GEE) were used to calculate treatment effects, expressed in difference in marginal mean values for NDI per treatment group. RESULTS: Clinical outcome parameters were comparable in the ACDA and ACDF group, but significantly worse in the ACD group, though not reaching clinical relevance. Annual reoperation rate was 3.6% in the first two years after surgery, declined to 1.9% in the years thereafter. The number of reoperations for ASD was not lower in the ACDA group, while the number of reoperations at the index level was higher after ACD, when compared to ACDF and ACDA. CONCLUSIONS: A persisting absence of clinical superiority was demonstrated for the cervical disc prosthesis five years after surgery. Specifically, clinically relevant adjacent level disease was not prevented by implanting a prosthesis. Single level ACD without implanting an intervertebral device provided worse clinical outcome, which was hypothesized to be caused by delayed fusion. This stresses the need for focusing on timely fusion in future research.

The type of cervical disc herniation on MRI does not correlate to clinical outcomes.

AIMS: The aim of this study was to investigate whether the type of cervical disc herniation influences the severity of symptoms at the time of presentation, and the outcome after surgical treatment. METHODS: The type and extent of disc herniation at the time of presentation in 108 patients who underwent anterior discectomy for cervical radiculopathy were analyzed on MRI, using a four-point scale. These were dichotomized into disc bulge and disc herniation groups. Clinical outcomes were evaluated using the Neck Disability Index (NDI), 36-Item Short Form Survey (SF-36), and a visual analogue scale (VAS) for pain in the neck and arm at baseline and two years postoperatively. The perceived recovery was also assessed at this time. RESULTS: At baseline, 46 patients had a disc bulge and 62 had a herniation. There was no significant difference in the mean NDI and SF-36 between the two groups at baseline. Those in the disc bulge group had a mean NDI of 44.6 (SD 15.2) compared with 43.8 (SD 16.0) in the herniation group (p = 0.799), and a mean SF-36 of 59.2 (SD 6.9) compared with 59.4 (SD 7.7) (p = 0.895). Likewise, there was no significant difference in the incidence of disabling arm pain in the disc bulge and herniation groups (84% vs 73%; p = 0.163), and no significant difference in the incidence of disabling neck pain in the two groups (70.5% (n = 31) vs 63% (n = 39); p = 0.491). At two years after surgery, no significant difference was found in any of the clinical parameters between the two groups. CONCLUSION: In patients with cervical radiculopathy, the type and extent of disc herniation measured on MRI prior to surgery correlated neither to the severity of the symptoms at presentation, nor to clinical outcomes at two years postoperatively.Cite this article: Bone Joint J 2022;104-B(11):1242-1248.

The impact of mental health on outcome after anterior cervical discectomy: cohort study assessing the influence of mental health using predictive modelling.

BACKGROUND: Depression and anxiety are common mental disorders among patients with chronic pain. It is hypothesised that patients suffering from these disorders benefit less from cervical spine surgery than mentally healthy patients. Therefore, this study aimed to quantify the effect of mental health status on functional outcome after anterior cervical discectomy in a post hoc analysis on RCT data. METHODS: One hundred eight patients from the NECK trial, with radiculopathy due to a one-level herniated disc, underwent anterior cervical discectomy and were included into this analysis. Functional outcome was quantified using the Neck Disability Index (NDI), and mental health status was measured using the Hospital Anxiety and Depression Score (HADS) questionnaire. NDI differences were assessed using generalised estimated equations (GEE), crude means, a predictive linear mixed model (LMM) using baseline scores and over time with an explanatory LMM. RESULTS: At baseline, 24% and 32% of patients were respectively depressed and anxious and had statistically significant and clinically relevant higher NDI scores during follow-up. However, in those patients in which the HADS returned to normal during follow-up, NDI values decreased comparably to the non-depression or non-anxiety cases. Those patients that demonstrated persisting high HADS values had convincingly worse NDI scores. A predictive LMM showed that combining baseline NDI and HADS scores was highly predictive of NDI during follow-up. The R shiny application enabled the effective, visual communication of results from the predictive LMM. CONCLUSION: This study shows that mental health status and disability are strongly associated and provides insight into the size of the effect, as well as a way to use this relation to improve preoperative patient counselling. These findings give rise to the suggestion that incorporating mental health screening in the preoperative assessment of patients could help to adequately manage patients' expectations for functional recovery. TRIAL REGISTRATION: Dutch Trial Register Number: NTR1289.

Interspinous process device versus conventional decompression for lumbar spinal stenosis: 5-year results of a randomized controlled trial.

OBJECTIVE: Interspinous process distraction devices (IPDs) can be implanted to treat patients with intermittent neurogenic claudication (INC) due to lumbar spinal stenosis. Short-term results provided evidence that the outcomes of IPD implantation were comparable to those of decompressive surgery, although the reoperation rate was higher in patients who received an IPD. This study focuses on the long-term results. METHODS: Patients with INC and spinal stenosis at 1 or 2 levels randomly underwent either decompression or IPD implantation. Patients were blinded to the allocated treatment. The primary outcome was the Zurich Claudication Questionnaire (ZCQ) score at 5-year follow-up. Repeated measurement analysis was applied to compare outcomes over time. RESULTS: In total, 159 patients were included and randomly underwent treatment: 80 patients were randomly assigned to undergo IPD implantation, and 79 underwent spinal bony decompression. At 5 years, the success rates in terms of ZCQ score were similar (68% of patients who underwent IPD implantation had a successful recovery vs 56% of those who underwent bony decompression, p = 0.422). The reoperation rate at 2 years after surgery was substantial in the IPD group (29%), but no reoperations were performed thereafter. Long-term visual analog scale score for back pain was lower in the IPD group than the bony decompression group (p = 0.02). CONCLUSIONS: IPD implantation is a more expensive alternative to decompressive surgery for INC but has comparable functional outcome during follow-up. The risk of reoperation due to absence of recovery is substantial in the first 2 years after IPD implantation, but if surgery is successful this positive effect remains throughout long-term follow-up. The IPD group had less back pain during long-term follow-up, but the clinical relevance of this finding is debatable.

The Clinical Relevance of the Cervical Disc Prosthesis: Combining Clinical Results of Two RCTs.

STUDY DESIGN: Retrospective analysis was performed on data from 251 patients that were included in two randomized, double-blinded clinical trials comparing clinical results of anterior cervical discectomy and arthroplasty (ACDA) to anterior cervical discectomy and fusion (ACDF), and anterior cervical discectomy (ACD), for single-level disc herniation. OBJECTIVE: This study aimed to investigate whether the ACDA procedure offers superior clinical results 2 years after surgery, to either ACDF or ACD without instrumentation, in the entire group of patients or in a particular subgroup of patients. SUMMARY OF BACKGROUND DATA: The cervical disc prosthesis was introduced to provide superior clinical outcomes after ACD. METHODS: Neck Disability Index (NDI), and subscales of the 36-item short-form health survey (SF-36) and McGill pain score were collected at baseline, 1 year and 2 years after surgery. Reoperations and complications were also evaluated. A preliminary subgroup analysis was performed for age, disc height, body mass index (BMI), smoking, and sex. RESULTS: The NDI decreased comparably in all treatment arms to circa 50% of the baseline value and marginal mean NDI differences varied from 0.4 to 1.1 on a 100 point NDI scale, with confidence intervals never exceeding the 20-point minimal clinical important difference (MCID). Secondary outcome parameters showed comparable results. Preliminary subgroup analysis could not demonstrate clinically relevant differences in NDI between treatments after 2 years. CONCLUSION: After combining data from two Randomized Controlled Trials it can be concluded that there is no clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. Preliminary subgroup analysis indicated outcomes were similar between treatment groups, and that no subgroup could be appointed that benefited more from either ACD, ACDF, or ACDA.Level of Evidence: 1.

Deep Learning for Adjacent Segment Disease at Preoperative MRI for Cervical Radiculopathy.

Background Patients who undergo surgery for cervical radiculopathy are at risk for developing adjacent segment disease (ASD). Identifying patients who will develop ASD remains challenging for clinicians. Purpose To develop and validate a deep learning algorithm capable of predicting ASD by using only preoperative cervical MRI in patients undergoing single-level anterior cervical diskectomy and fusion (ACDF). Materials and Methods In this Health Insurance Portability and Accountability Act-compliant study, retrospective chart review was performed for 1244 patients undergoing single-level ACDF in two tertiary care centers. After application of inclusion and exclusion criteria, 344 patients were included, of whom 60% (n = 208) were used for training and 40% for validation (n = 43) and testing (n = 93). A deep learning-based prediction model with 48 convolutional layers was designed and trained by using preoperative T2-sagittal cervical MRI. To validate model performance, a neuroradiologist and neurosurgeon independently provided ASD predictions for the test set. Validation metrics included accuracy, areas under the curve, and F1 scores. The difference in proportion of wrongful predictions between the model and clinician was statistically tested by using the McNemar test. Results A total of 344 patients (median age, 48 years; interquartile range, 41-58 years; 182 women) were evaluated. The model predicted ASD on the 93 test images with an accuracy of 88 of 93 (95%; 95% CI: 90, 99), sensitivity of 12 of 15 (80%; 95% CI: 60, 100), and specificity of 76 of 78 (97%; 95% CI: 94, 100). The neuroradiologist and neurosurgeon provided predictions with lower accuracy (54 of 93; 58%; 95% CI: 48, 68), sensitivity (nine of 15; 60%; 95% CI: 35, 85), and specificity (45 of 78; 58%; 95% CI: 56, 77) compared with the algorithm. The McNemar test on the contingency table demonstrated that the proportion of wrongful predictions was significantly lower by the model (test statistic, 2.000; P < .001). Conclusion A deep learning algorithm that used only preoperative cervical T2-weighted MRI outperformed clinical experts at predicting adjacent segment disease in patients undergoing surgery for cervical radiculopathy. © RSNA, 2021 An earlier incorrect version appeared online. This article was corrected on September 22, 2021.

Study protocol: effect of infection, Modic and inflammation on clinical outcomes in surgery for radiculopathy (EIMICOR).

BACKGROUND: Evidence indicates that inflammatory processes are involved in radicular pain as well as in resorption of herniated disc tissue. Furthermore there are indications that the presence of vertebral end plate pathology (Modic changes; MC) is associated with a negative effect on inflammation. It is hypothesized that in patients with MC, the (possibly bacterial induced) inflammation will be accompanied by pro inflammatory cytokines that worsen the outcome, and that in patients without MC, the inflammation is accompanied by cytokines that induce a resorption process to accelerate recovery. METHODS: This prospective cohort study will include 160 lumbar and 160 cervical patients (total of 320), which are scheduled for surgery for either a lumbar or cervical herniated disc with ages between 18 and 75. The main and interaction effects of local bacterial infection (culture), inflammatory cells in disc material (immunohistology), MC (MRI), and blood biomarkers indicating inflammation or infection (blood sample evaluation) will be evaluated. Clinical parameters to be evaluated are leg pain on the 11 point NRS pain scale, Oswestry (lumbar spine) or Neck (cervical spine) Disability Index, Global Perceived Recovery, Womac Questionnaire, and medication status, at baseline, and after 6, 16, 26 and 52 weeks. DISCUSSION: Gaining insight in the aetiology of pain and discomfort in radiculopathy caused by a herniated disc could lead to more effective management of patients. If the type of inflammatory cells shows to be of major influence on the rate of recovery, new immunomodulating treatment strategies can be developed to decrease the duration and intensity of symptoms. Moreover, identifying a beneficial inflammatory response in the disc through a biomarker in blood could lead to early identification of patients whose herniations will resorb spontaneously versus those that require surgery. TRIAL REGISTRATION: prospectively enrolled at trialregister.nl, ID: NL8464 .

Decompression alone versus decompression and instrumented fusion for the treatment of isthmic spondylolisthesis: a randomized controlled trial.

OBJECTIVE: The most advocated surgical technique to treat symptoms of isthmic spondylolisthesis is decompression with instrumented fusion. A less-invasive classical approach has also been reported, which consists of decompression only. In this study the authors compared the clinical outcomes of decompression only with those of decompression with instrumented fusion in patients with isthmic spondylolisthesis. METHODS: Eighty-four patients with lumbar radiculopathy or neurogenic claudication secondary to low-grade isthmic spondylolisthesis were randomly assigned to decompression only (n = 43) or decompression with instrumented fusion (n = 41). Primary outcome parameters were scores on the Roland Disability Questionnaire (RDQ), separate visual analog scales (VASs) for back pain and leg pain, and patient report of perceived recovery at 12-week and 2-year follow-ups. The proportion of reoperations was scored as a secondary outcome measure. Repeated measures ANOVA according to the intention-to-treat principle was performed. RESULTS: Decompression alone did not show superiority in terms of disability scores at 12-week follow-up (p = 0.32, 95% CI -4.02 to 1.34), nor in any other outcome measure. At 2-year follow-up, RDQ disability scores improved more in the fusion group (10.3, 95% CI 3.9-8.2, vs 6.0, 95% CI 8.2-12.4; p = 0.006, 95% CI -7.3 to -1.3). Likewise, back pain decreased more in the fusion group (difference: -18.3 mm, CI -32.1 to -4.4, p = 0.01) on a 100-mm VAS scale, and a higher proportion of patients perceived recovery as showing "good results" (44% vs 74%, p = 0.01). Cumulative probabilities for reoperation were 47% in the decompression and 13% in the fusion group (p < 0.001) at the 2-year follow-up. CONCLUSIONS: In patients with isthmic spondylolisthesis, decompression with instrumented fusion resulted in comparable short-term results, significantly better long-term outcomes, and fewer reoperations than decompression alone. Decompression with instrumented fusion is a superior surgical technique that should in general be offered as a first treatment option for isthmic spondylolisthesis, but not for degenerative spondylolisthesis, which has a different etiology.

The Outcome of Epidural Injections in Lumbar Radiculopathy Is Not Dependent on the Presence of Disc Herniation on Magnetic Resonance Imaging: Assessment of Short-Term and Long-Term Efficacy.

OBJECTIVE: Lumbar radiculopathy is a condition with major physical, social, and economic consequences. Despite its favorable prognosis, the burden can be significant. In this study, we aimed to determine the value of magnetic resonance imaging (MRI) and the efficacy of transforaminal epidural injections (TEIs) in patients with lumbar radiculopathy secondary to lumbar disc herniation (LDH) and other causes (non-LDH). METHODS: Patients with lumbar radiculopathy were reviewed for radiologic diagnosis based on MRI. For patients receiving TEI therapy, response after 6-8 weeks (short-term) and 16 weeks (long-term), number of injections, subsequent surgery, and patient outcome were evaluated. Treatment response was assessed by patient-reported symptom relief and numeric rating scale pain scores. RESULTS: Overall, 66% of MRI examinations showed a clinically relevant LDH. A total of 486 of 1824 patients received TEI, of whom one third did not show LDH. Of patients, 70% reported a short-term effect with significant pain reduction and 44% reported a long-term effect. No significant differences were observed between the LDH and non-LDH groups. Of patients, 59% required multiple injections and reported similar efficacy compared with patients treated with a single injection. CONCLUSIONS: A considerable part of MRI examinations in patients with lumbar radiculopathy do not show a clinically relevant LDH. Regardless of the radiologic diagnosis, most patients treated with TEI benefit in both the short-term and the long-term after a single-injection or multiple-injection regime. Subsequent injections are advisable if the effect from the first injection is unsatisfactory or wears off. MRI examination before TEI therapy may be redundant, which allows for expedition of this treatment.

Prosthesis in Anterior Cervical Herniated Disc Approach Does Not Prevent Radiologic Adjacent Segment Degeneration.

STUDY DESIGN: Retrospective analysis using data from RCTs. OBJECTIVE: This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis. SUMMARY OF BACKGROUND DATA: Cervical disc prostheses were introduced to prevent ASD in the postsurgical follow-up. However, it is still a controversial issue. METHODS: Two hundred fifty-three patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level. RESULTS: Radiological ASD was present in 34% of patients at baseline and increased to 59% at 2-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up. CONCLUSIONS: Radiological ASD occurs in a similar manner in patients who were subjected to arthrodesis in cervical radiculopathy and in patients who received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent. LEVEL OF EVIDENCE: 2.

Surgery for extraforaminal lumbar disc herniation: a single center comparative observational study.

BACKGROUND: Surgery on extraforaminal lumbar disc herniation (ELDH) is a commonly performed procedure. Operating on this type of herniation is known to come with more difficulties than on the frequently seen paramedian lumbar disc herniation (PLDH). However, no comparative data are available on the effectiveness and safety of this operation. We sought out to compare clinical outcomes at 1 year following surgery for ELDH and PLDH. METHODS: Data were collected through the Norwegian Registry for Spine Surgery (NORspine). The primary outcome measure was change at 1 year in the Oswestry Disability Index (ODI). Secondary outcome measures were quality of life measured with EuroQol 5 dimensions (EQ-5D); and numeric rating scales (NRSs). RESULTS: Data of a total of 1750 patients were evaluated in this study, including 72 ELDH patients (4.1%). One year after surgery, there were no differences in any of the patient reported outcome measurements (PROMs) between the two groups. PLDH and ELDH patients experienced similar changes in ODI (- 30.92 vs. - 34.00, P = 0.325); EQ-5D (0.50 vs. 0.51, P = 0.859); NRS back (- 3.69 vs. - 3.83, P = 0.745); and NRS leg (- 4.69 vs. - 4.46, P = 0.607) after 1 year. The proportion of patients achieving a clinical success (defined as an ODI score of less than 20 points) at 1 year was similar in both groups (61.5% vs. 52.7%, P = 0.204). CONCLUSIONS: Patients operated for ELDH reported similar improvement after 1 year compared with patients operated for PLDH.

Nadroparin Plus Compression Stockings versus Nadroparin Alone for Prevention of Venous Thromboembolism in Cerebellopontine Angle Tumour Excisions: A Cohort Study.

BACKGROUND: Both compression stockings and low molecular weight heparin (LMWH) are used for the prevention of post-operative venous thromboembolism (VTE) in cerebellopontine angle (CPA) tumour excisions. OBJECTIVE: In an attempt to optimise the prophylactic treatment in these patients, we compared LMWH (nadroparin) plus compression stockings to nadroparin as single therapy. METHODS: Patients undergoing CPA tumour excision in the period between January 2014 and November 2015 received nadroparin as a single therapy. Patients treated since November 2015 received, in addition to this therapy, peri-operative compression stockings as VTE prophylaxis due to a change in protocol. VTE was defined as symptomatic deep vein thrombosis or pulmonary embolism and was confirmed via radiological imaging or autopsy. RESULTS: A total of 146 consecutive patients were reviewed. Treatment groups were comparable with respect to demographics and risk factors. Six of the 60 patients (10.0%; 95% confidence interval [CI] 3.8-20.5) receiving nadroparin single therapy developed symptomatic VTE. One out of 86 patients (1.2%; 95% CI 0-6.3) treated with combination therapy developed VTE (p = 0.019) with a risk difference of 8.8% (95% CI 1.43-19.0). In comparison to combination therapy, nadroparin single therapy showed a relative risk of 8.6 (95% CI 1.1-69.6). CONCLUSION: Adding compression stockings to peri-operative nadroparin, as a prophylactic strategy for thromboembolic complications in patients undergoing surgical intervention for CPA tumours, was associated with a significant reduction in the occurrence of VTE.