Incidence and clinical relevance of cage subsidence in anterior cervical discectomy and fusion: a systematic review.

BACKGROUND: The placement of intervertebral cages in anterior cervical discectomy (ACDF) supposedly maintains foraminal height. The most commonly reported cage-related complication is subsidence, although it is unknown whether a correlation between subsidence and clinical outcome exists. AIM: To assess the incidence and relevance of subsidence. METHODS: Literature searches were performed in PubMed, MEDLINE, Embase, Web of Science, COCHRANE, and CENTRAL. The inclusion criteria were as follows: ≥ 20 patients, ADCF with cage, subsidence assessed, and primary data. Risk of bias was assessed using adjusted Cochrane checklists. RESULTS: Seventy-one studies, comprising 4784 patients, were included. Subsidence was generally defined as ≥ 3-mm loss of height comparing postoperative intervertebral heights with heights at last follow-up. Mean incidence of subsidence was 21% (range 0-83%). Of all patients, 46% of patients received polyether-ether-ketone (PEEK) cages, 31% received titanium cages, 18% received cage-screw-combinations, and 5% received polymethyl-methacrylate (PMMA) cages. Patients treated with cage-screw-combinations had significantly less subsidence than patients treated with PEEK, titanium, or PMMA cages (15.1% vs. 23.5% vs. 24.9% vs. 30.2%; p < 0.001). Thirteen studies assessed clinical outcome in relation to subsidence; the majority did not find a significant correlation. Only four studies correlated subsidence to cage size and/or height; no correlation was established. CONCLUSIONS: Subsidence in ACDF with cages occurs in 21% of patients. The risk for subsidence seems lower using PEEK or titanium cages or adding screws. Whether subsidence affects clinical outcome is not satisfactorily evaluated in the available literature. Future studies on this correlation are warranted in order to establish the additional value of the interposition of a cage in ACDF.

Magnetic resonance imaging in follow-up assessment of sciatica.

BACKGROUND: Magnetic resonance imaging (MRI) is frequently performed during follow-up in patients with known lumbar-disk herniation and persistent symptoms of sciatica. The association between findings on MRI and clinical outcome is controversial. METHODS: We studied 283 patients in a randomized trial comparing surgery and prolonged conservative care for sciatica and lumbar-disk herniation. Patients underwent MRI at baseline and after 1 year. We used a 4-point scale to assess disk herniation on MRI, ranging from 1 for "definitely present" to 4 for "definitely absent." A favorable clinical outcome was defined as complete or nearly complete disappearance of symptoms at 1 year. We compared proportions of patients with a favorable outcome among those with a definite absence of disk herniation and those with a definite, probable, or possible presence of disk herniation at 1 year. The area under the receiver-operating-characteristic (ROC) curve was used to assess the prognostic accuracy of the 4-point scores regarding a favorable or unfavorable outcome, with 1 indicating perfect discriminatory value and 0.5 or less indicating no discriminatory value. RESULTS: At 1 year, 84% of the patients reported having a favorable outcome. Disk herniation was visible in 35% with a favorable outcome and in 33% with an unfavorable outcome (P=0.70). A favorable outcome was reported in 85% of patients with disk herniation and 83% without disk herniation (P=0.70). MRI assessment of disk herniation did not distinguish between patients with a favorable outcome and those with an unfavorable outcome (area under ROC curve, 0.48). CONCLUSIONS: MRI performed at 1-year follow-up in patients who had been treated for sciatica and lumbar-disk herniation did not distinguish between those with a favorable outcome and those with an unfavorable outcome. (Funded by the Netherlands Organization for Health Research and Development and the Hoelen Foundation; Controlled Clinical Trials number, ISRCTN26872154.).

IPD without bony decompression versus conventional surgical decompression for lumbar spinal stenosis: 2-year results of a double-blind randomized controlled trial.

PURPOSE: Interspinous process devices (IPDs) are implanted to treat patients with intermittent neurogenic claudication (INC) based on lumbar spinal stenosis. It is hypothesized that patients with lumbar spinal stenosis treated with IPD have a faster short-term recovery, an equal outcome after 2 years and less back pain compared with bony decompression. METHODS: A randomized design with variable block sizes was used, with allocations stratified according to center. Allocations were stored in prepared opaque, coded and sealed envelopes, and patients and research nurses were blind throughout the follow-up. Five neurosurgical centers (including one academic and four secondary level care centers) included participants. 211 participants were referred to the Leiden-The Hague Spine Prognostic Study Group. 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were randomized into two groups. Patients and research nurses were blinded for the allocated treatment throughout the study period. 80 participants received an IPD and 79 participants underwent spinal bony decompression. The primary outcome at long-term (2-year) follow-up was the score for the Zurich Claudication Questionnaire. Repeated measurement analyses were applied to compare outcomes over time. RESULTS: At two years, the success rate according to the Zurich Claudication Questionnaire for the IPD group [69 % (95 % CI 57-78 %)] did not show a significant difference compared with standard bony decompression [60 % (95 % CI 48-71 %) p value 0.2]. Reoperations, because of absence of recovery, were indicated and performed in 23 cases (33 %) of the IPD group versus 6 (8 %) patients of the bony decompression group (p < 0.01). Furthermore, long-term VAS back pain was significantly higher [36 mm on a 100 mm scale (95 % CI 24-48)] in the IPD group compared to the bony decompression group [28 mm (95 % CI 23-34) p value 0.04]. CONCLUSIONS: This double-blinded study could not confirm the advantage of IPD without bony decompression over conventional 'simple' decompression, two years after surgery. Moreover, in the IPD treatment arm, the reoperation rate was higher and back pain was even slightly more intense compared to the decompression treatment arm.

Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomised controlled trial.

STUDY QUESTION: Is interspinous process device implantation more effective in the short term (eight weeks) than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis? SUMMARY ANSWER: The use of interspinous implants did not result in a better outcome than conventional decompression, but the reoperation rate was significantly higher. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Bony decompression and treatment with interspinous process devices are superior to conservative and non-surgical treatment for intermittent neurogenic claudication due to lumbar spinal stenosis. Interspinous implants surgery is not superior to bony decompression, and the reoperation rate is significantly higher.

Similar outcome after retention or sacrifice of the posterior cruciate ligament in total knee arthroplasty.

BACKGROUND AND PURPOSE: To retain or to sacrifice the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) remains a matter of discussion. In this systematic review, we wanted to find differences in functional and clinical outcome between the 2 methods. METHODS: We conducted a systematic review and meta-analysis including all randomized controlled trials (RCTs) and quasi-RCTs that have compared PCL retention with PCL sacrifice in TKA with a minimum of 1-year follow-up. Primary outcome was range of motion. Secondary outcomes were knee pain and clinical scoring systems that were preferably validated. Quality of evidence was graded using the GRADE approach. All outcomes available for data pooling were used for meta-analysis. RESULTS: 20 studies involving 1,877 patients and 2,347 knees were included. In meta-analysis, the postoperative flexion angle had a mean difference of 2 degrees (95% CI: 0.23-4.0; p = 0.03) and the KSS functional score was 2.4 points higher in favor of PCL sacrifice (95% CI: 0.41-4.3; p = 0.02). There were no statistically significant differences regarding other measured clinical outcomes such as WOMAC, KSS pain, clinical and overall score, HSS score, SF-12, radiolucencies, femoro-tibial angle, and tibial slope. The quality of the studies varied considerably. Risk of bias in most studies was unclear; 5 were judged to have a low risk of bias and 5 to have a high risk of bias. INTERPRETATION: We found no clinically relevant differences between retention and sacrifice of the PCL in TKA, in terms of functional and clinical outcomes. The quality of the studies ranged from moderate to low. Based on the current evidence, no recommendation can be made as to whether to retain or to sacrifice the PCL.

Evidence and practice in spine registries.

BACKGROUND AND PURPOSE: We performed a systematic review and a survey in order to (1) evaluate the evidence for the impact of spine registries on the quality of spine care, and with that, on patient-related outcomes, and (2) evaluate the methodology used to organize, analyze, and report the "quality of spine care" from spine registries. METHODS: To study the impact, the literature on all spinal disorders was searched. To study methodology, the search was restricted to degenerative spinal disorders. The risk of bias in the studies included was assessed with the Newcastle-Ottawa scale. Additionally, a survey among registry representatives was performed to acquire information about the methodology and practice of existing registries. RESULTS: 4,273 unique references up to May 2014 were identified, and 1,210 were eligible for screening and assessment. No studies on impact were identified, but 34 studies were identified to study the methodology. Half of these studies (17 of the 34) were judged to have a high risk of bias. The survey identified 25 spine registries, representing 14 countries. The organization of these registries, methods used, analytical approaches, and dissemination of results are presented. INTERPRETATION: We found a lack of evidence that registries have had an impact on the quality of spine care, regardless of whether intervention was non-surgical and/or surgical. To improve the quality of evidence published with registry data, we present several recommendations. Application of these recommendations could lead to registries showing trends, monitoring the quality of spine care given, and ultimately improving the value of the care given to patients with degenerative spinal disorders.

Rationale and design of the INNOVATE Trial: an international cooperative study on surgical versus conservative treatment for odontoid fractures in the elderly.

BACKGROUND: Fractures of the odontoid process of the axis are the most common fractures of the geriatric cervical spine. As the population ages, their incidence is expected to increase progressively, as is the number of very old patients (>80 years) with an odontoid fracture. No consensus exists on the optimal treatment (surgical or conservative) and the most relevant outcome parameter (osseous union, fracture stability or clinical outcome). The aim of the INNOVATE (INterNational study on Odontoid frActure Treatment in the Elderly) Trial is to prospectively assess fracture healing and clinical outcome after surgical and conservative treatment for odontoid fractures in the elderly patient, with a specific focus on the very old patient. METHODS/DESIGN: The trial is an observational study in which eleven centres in five European countries are involved. All patients admitted to one of these centres who meet the selection criteria (≥55 years, acute (

Management of lumbar spinal stenosis: a survey among Dutch spine surgeons.

BACKGROUND: Various surgical and non-surgical treatments for lumbar spinal stenosis (LSS) are widely adopted in clinical practice, but high quality randomised controlled trials to support these are often lacking, especially in terms of their relative benefit and risk compared with other treatment options. Therefore, an evaluation of agreement among clinicians regarding the indications and the choice for particular treatments seems appropriate. METHODS: One hundred and six Dutch neurosurgeons and orthopaedic spine surgeons completed a questionnaire, which evaluated treatment options for LSS and expectations regarding the effectiveness of surgical and non-surgical treatments. RESULTS: Responders accounted for 6,971 decompression operations and 831 spinal fusion procedures for LSS annually. Typical neurogenic claudication, severe pain/disability, and a pronounced constriction of the spinal canal were considered the most important indications for surgical treatment by the majority of responders. Non-surgical treatment was generally regarded as ineffective and believed to be less effective than surgical treatment. Interlaminar decompression was the preferred technique by 68% of neurosurgeons and 52% orthopaedic surgeons for the treatment of LSS. Concomitant fusion was applied in 12% of all surgery for LSS. Most surgeons considered spondylolisthesis as an indication and spinal instability as a definite indication for additional fusion. CONCLUSIONS: The current survey demonstrates a wide variety of preferred treatments of symptomatic LSS by Dutch spine surgeons. To minimise variety, national and international protocols based on high-quality randomised controlled trials and systematic reviews are necessary to give surgeons more tools to support everyday decision-making.

The optimal treatment of type II and III odontoid fractures in the elderly: a systematic review.

PURPOSE: Odontoid fractures are the most common cervical spine fractures in the elderly. As the population ages, their incidence is expected to increase progressively. The optimal treatment of this condition is still the subject of controversy. The objective of this review is to summarize and compare the outcome of surgical and conservative interventions in the elderly (≥ 65 years). METHODS: A comprehensive search was conducted in nine databases of medical literature, supplemented by reference and citation tracking. Clinical status was considered the primary outcome. Fracture union and stability rates were considered secondary outcomes. RESULTS: A total of nineteen studies met the inclusion criteria. All studies were performed retrospectively and were of limited quality. There was insufficient data, especially from direct comparisons, to determine the difference in clinical outcome between surgical and conservative interventions. Osseous union was achieved in 66-85 % of surgically treated patients and in 28-44 % of conservatively treated patients. Fracture stability was achieved in 82-97 % of surgically patients and in 53-79 % of conservatively treated patients. CONCLUSIONS: There was insufficient data to determine a potential difference in clinical outcome between different treatment groups. Surgically treated patients showed higher osseous union rates compared to conservatively treated patients, possibly because of different selection mechanisms. The majority of patients appears to achieve fracture stability regardless of the applied treatment. A prospective trial with appropriate sample size is needed to identify the optimal treatment of odontoid fractures in the elderly and predictors for the success of either one of the available treatments.

The evidence on surgical interventions for low back disorders, an overview of systematic reviews.

PURPOSE: Many systematic reviews have been published on surgical interventions for low back disorders. The objective of this overview was to evaluate the available evidence from systematic reviews on the effectiveness of surgical interventions for disc herniation, spondylolisthesis, stenosis, and degenerative disc disease (DDD). An earlier version of this review was published in 2006 and since then, many new, better quality reviews have been published. METHODS: A comprehensive search was performed in the Cochrane database of systematic reviews (CDSR), database of reviews of effectiveness (DARE) and Pubmed. Two reviewers independently performed the selection of studies, risk of bias assessment, and data extraction. Included are Cochrane reviews and non-Cochrane systematic reviews published in peer-reviewed journals. The following conditions were included: disc herniation, spondylolisthesis, and DDD with or without spinal stenosis. The following comparisons were evaluated: (1) surgery vs. conservative care, and (2) different surgical techniques compared to one another. The methodological quality of the systematic reviews was evaluated using AMSTAR. We report (pooled) analyses from the individual reviews. RESULTS: Thirteen systematic reviews on surgical interventions for low back disorders were included for disc herniation (n = 6), spondylolisthesis (n = 2), spinal stenosis (n = 4), and DDD (n = 4). Nine (69 %) were of high quality. Five reviews provided a meta-analysis of which two showed a significant difference. For the treatment of spinal stenosis, intervertebral process devices showed more favorable results compared to conservative treatment on the Zurich Claudication Questionnaire [mean difference (MD) 23.2 95 % CI 18.5-27.8]. For degenerative spondylolisthesis, fusion showed more favorable results compared to decompression for a mixed aggregation of clinical outcome measures (RR 1.40 95 % CI 1.04-1.89) and fusion rate favored instrumented fusion over non-instrumented fusion (RR 1.37 95 % CI 1.07-1.75). CONCLUSIONS: For most of the comparisons, the included reviews were not significant and/or clinically relevant differences between interventions were identified. Although the quality of the reviews was quite acceptable, the quality of the included studies was poor. Future studies are likely to influence our assessment of these interventions.

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.

Surgical techniques for sciatica due to herniated disc, a systematic review.

INTRODUCTION: Disc herniation with sciatica accounts for five percent of low-back disorders but is one of the most common reasons for spine surgery. The goal of this study was to update the Cochrane review on the effect of surgical techniques for sciatica due to disc herniation, which was last updated in 2007. MATERIALS AND METHODS: In April 2011, we conducted a comprehensive search in CENTRAL, MEDLINE, EMBASE, CINAHL, PEDRO, ICL, and trial registries. We also checked the reference lists and citation tracking results of each retrieved article. Only randomized controlled trials (RCT) of the surgical management of sciatica due to disc herniation were included. Comparisons including chemonucleolysis and prevention of scar tissue or comparisons against conservative treatment were excluded. Two review authors independently selected studies, assessed risk of bias of the studies and extracted data. Quality of evidence was graded according to the GRADE approach. RESULTS: Seven studies from the original Cochrane review were included and nine additional studies were found. In total, 16 studies were included, of which four had a low risk of bias. Studies showed that microscopic discectomy results in a significantly, but not clinically relevant longer operation time of 12 min (95% CI 2-22) and shorter incision of 24 mm (95% CI 7-40) compared with open discectomy, but did not find any clinically relevant superiority of either technique on clinical results. There were conflicting results regarding the comparison of tubular discectomy versus microscopic discectomy for back pain and surgical duration. CONCLUSIONS: Due to the limited amount and quality of evidence, no firm conclusions on effectiveness of the current surgical techniques being open discectomy, microscopic discectomy, and tubular discectomy compared with each other can be drawn. Those differences in leg or back pain scores, operation time, and incision length that were found are clinically insignificant. Large, high-quality studies are needed, which examine not only effectiveness but cost-effectiveness as well.

Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis.

INTRODUCTION: Despite an increasing implantation rate of interspinous process distraction (IPD) devices in the treatment of intermittent neurogenic claudication (INC), definitive evidence on the clinical effectiveness of implants is lacking. The main objective of this review was to perform a meta-analysis of all systematic reviews, randomized clinical trials and prospective cohort series to quantify the effectiveness of IPDs and to evaluate the potential side-effects. METHODS: Data from all studies prospectively describing clinical results based on validated outcome scales and reporting complications of treatment of patients with INC with IPD placement. We searched MEDLINE, EMBASE, Web of Science, Cochrane (CENTRAL), CINAHL, Academic Search Premier, Science Direct up to July 2010. Studies describing patients with INC caused by lumbar stenosis, reporting complication rate and reporting based on validated outcome scores, were eligible. Studies with only instrumented IPD results were excluded. RESULTS: Eleven studies eligible studies were identified. Two independently RCTs and eight prospective cohorts were available. In total 563 patients were treated with IPDs. All studies showed improvement in validated outcome scores after 6 weeks and 1 year. Pooled data based on the Zurich Claudication Questionnaire of the RCTs were more in favor of IPD treatment compared with conservative treatment (pooled estimate 23.2, SD 18.5-27.8). Statistical heterogeneity after pooled data was low (I-squared 0.0, p = 0.930). Overall complication rate was 7%. CONCLUSION: As the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced.

Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review.

The effectiveness of surgery in patients with sciatica due to lumbar disc herniations is not without dispute. The goal of this study was to assess the effects of surgery versus conservative therapy (including epidural injections) for patients with sciatica due to lumbar disc herniation. A comprehensive search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to October 2009. Randomised controlled trials of adults with lumbar radicular pain, which evaluated at least one clinically relevant outcome measure (pain, functional status, perceived recovery, lost days of work) were included. Two authors assessed risk of bias according to Cochrane criteria and extracted the data. In total, five studies were identified, two of which with a low risk of bias. One study compared early surgery with prolonged conservative care followed by surgery if needed; three studies compared surgery with usual conservative care, and one study compared surgery with epidural injections. Data were not pooled because of clinical heterogeneity and poor reporting of data. One large low-risk-of-bias trial demonstrated that early surgery in patients with 6-12 weeks of radicular pain leads to faster pain relief when compared with prolonged conservative treatment, but there were no differences after 1 and 2 years. Another large low-risk-of-bias trial between surgery and usual conservative care found no statistically significant differences on any of the primary outcome measures after 1 and 2 years. Future studies should evaluate who benefits more from surgery and who from conservative care.

Effects of the balanced gap technique on femoral component rotation in TKA.

UNLABELLED: Femoral component rotation from a total knee prosthesis can be determined by either a measured resection technique or a balanced gap technique. With the balanced gap implantation technique, femoral component rotation can vary freely within the restrictions produced by soft tissue structures. Because internal rotation might cause patella problems, the effect of ligament releases on femoral component rotation in a prospective clinical study was studied. Femoral component rotation was measured intraoperatively with a tensor applied in flexion at 150 N in 87 knees. Great interpatient variability was found; femoral component rotation, reference from the posterior condyles, ranged from -4 degrees to 13 degrees . There was no difference in femoral component rotation of knees with or without ligament releases in extension. However, knees with major medial release had less external femoral component rotation than knees with minor lateral releases. Preoperative alignment had no influence on femoral component rotation. The use of the balanced gap implantation technique theoretically will result in a balanced flexion gap, but the amount of femoral component rotation will be variable owing to patient variability and variation in ligament releases. LEVEL OF EVIDENCE: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Real-World Adverse Effects of Capecitabine Toxicity in an Elderly Population.

BACKGROUND: Few studies have assessed the safety and effectiveness of the numerous available chemotherapeutic therapies for geriatric oncology patients. Most safety studies are conducted in large trials, and there is some uncertainty surrounding whether the results would be the same in typical daily use. OBJECTIVE: This retrospective study aims to assess the adverse effects of real-world capecitabine use in elderly patients. METHODS: We reviewed the records of patients treated with capecitabine in an oncology department of a University Clinic in Nijmegen, The Netherlands. We scored adverse effects such as hand-foot syndrome and diarrhea, and dosage adjustments and the reasons for them. In total, 132 patients were included, 69 of whom were aged 70 years or below (mean age: 57 years), while 63 were aged older than 70 years (mean age: 74 years). RESULTS: Patients aged over 70 years experienced more serious adverse effects than younger patients. Grade 2 or 3 hand-foot syndrome toxicity was experienced by 20.2% of patients aged younger than 70 years and by 34.9% of patients older than 70 years (p = 0.059). Grade 2, 3, or 4 diarrhea was experienced by 17.4% of the patients aged younger than 70 years but by 31.7% of the patients aged older than 70 years (p = 0.044). Dosage was adjusted for 27/69 patients in the younger group and 52/63 patients in the older group (p = 0.001). CONCLUSION: The difference in observed adverse effects cannot be the sole explanation for the high incidence of observed dose adjustments. A prospective follow-up study of elderly patients using capecitabine outside clinical trials is needed to evaluate the optimum balance between adverse effects and efficacy.

Preoperative MRI in Patients With Intermittent Neurogenic Claudication: Relevance for Diagnosis and Prognosis.

STUDY DESIGN: We studied baseline magnetic resonance images of 155 patients with intermittent neurogenic claudication and lumbar spinal stenosis (LSS). Magnetic resonance imaging (MRI) and patient data were gathered from participants of a randomized trial. OBJECTIVE: It is believed that the narrowness of the lumbar spinal canal correlates to the severity of complaints and that it may be a good predictor of clinical outcome if treated. However, this hypothesis has never been (prospectively) tested. SUMMARY OF BACKGROUND DATA: MRI is an important tool to confirm the diagnosis of LSS as a cause for intermittent neurogenic claudication. METHODS: Three raters were asked to evaluate the magnetic resonance images (Schizas scale). Symptom severities at baseline and 1-year follow-up were quantified. The radiological scores were correlated with clinical baseline and outcome scores to assess diagnostic and prognostic value of MRI findings at baseline. RESULTS: There was good agreement on the clinically relevant level of LSS (kappa range 0.57-0.64). MRI assessment of grading of compression (kappa 0.33-0.46) did not correlate with baseline MRDQ nor with outcome based on postoperative change in MRDQ (P = 0.61). However, both absence of epidural fat and presence of tortuous caudal nerves on magnetic resonance images (kappa 0.53-0.72 and 0.67-0.70) in patients with LSS were relatively good predictors for satisfactory recovery after surgery (P = 0.03 and P < 0.01). CONCLUSION: The grading of compression on the preoperative MRI is neither ambiguous nor correlating to severity of clinical condition. It does, furthermore, not have the ability to predict the outcome after 1 year if surgically treated. LEVEL OF EVIDENCE: 2.

Toward the Development of a Universal Outcome Instrument for Spine Trauma: A Systematic Review and Content Comparison of Outcome Measures Used in Spine Trauma Research Using the ICF as Reference.

STUDY DESIGN: A systematic literature review. OBJECTIVE: The aim of this study was (1) to identify patient-reported and clinician-based outcome measures most frequently used to evaluate the function and health of spine trauma patients, (2) to identify and quantify the concepts of these measures using the International Classification of Functioning, Disability, and Health (ICF) as reference, and (3) to describe their clinimetric properties. SUMMARY OF BACKGROUND DATA: There is a real need for a disease-specific outcome instrument to measure the effect size of various treatment options in a variety of traumatic spinal column injuries. METHODS: A systematic literature search was conducted in several databases. From the included studies, outcome measures were extracted. The items and underlying concepts of the identified outcome measures were specified and linked to the ICF categories. Finally, as far as available in literature, the clinimetric properties of the obtained measures were analyzed. RESULTS: Out of 5117 screened references, 245 were included, and 17 different frequently used outcome measures were identified. Meaningful concepts of the items and response options of the retrieved outcome measures were linked to a total of 105 different ICF categories, aggregated to 57 first- or second-level categories. The categories were linked to the components activities and participation (n = 31), body functions (n = 17), environmental factors (n = 8), and body structures (n = 1). Overall, there is only limited evidence on the measurement properties, except for some disease-specific questionnaires, such as Oswestry Disability Index, Roland-Morris Disability Questionnaire, Neck Disability Index, and Cervical Spine Outcome Questionnaire. CONCLUSION: The current systematic literature review revealed great diversity in the use and content of outcome measures to evaluate the functioning and health of spine trauma patients, with 17 different outcome measures linked to 57 unique ICF categories. This study creates an evidence base for a consensus meeting during which a core set of ICF categories for outcome measurement in spine trauma will be decided. LEVEL OF EVIDENCE: 2.

The selection of core International Classification of Functioning, Disability, and Health (ICF) categories for patient-reported outcome measurement in spine trauma patients-results of an international consensus process.

BACKGROUND CONTEXT: There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. PURPOSE: The paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury. STUDY DESIGN/SETTING: The study used a formal decision-making and consensus process. PATIENT SAMPLE: The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients. OUTCOME MEASURES: The wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories. METHODS: A formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise. RESULTS: Combining the results of the preparatory studies, the list of ICF categories presented at the consensus conference included 159 different ICF categories. Based on voting and discussion, 11 experts from 6 countries selected a total of 25 ICF categories as core categories for patient-reported outcome measurement in adult traumatic spinal column injury patients (9 body functions, 14 activities and participation, and 2 environmental factors). The experts also agreed to use the Numeric Rating Scale 0-100 as response scale in the future universal outcome instrument. CONCLUSIONS: A formal consensus process integrating evidence and expert opinion led to a set of 25 core ICF categories for patient-reported outcome measurement in adult traumatic spinal column injury patients, as well as the response scale for use in the future universal disease-specific outcome instrument. The adopted core ICF categories could also serve as a benchmark for assessing the content validity of existing and future outcome instruments used in this specific patient population.