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The aim of this systematic review is to describe the epidemiology of chordoma and to provide a clear overview of clinical prognostic factors predicting progression-free and overall survival. Four databases of medical literature were searched. Separate searches were performed for each of the two objectives. Reference and citation tracking was performed. Papers were processed by two independent reviewers according to a protocol that included risk of bias analysis. Disagreement was resolved by discussion. Pooled analyses were planned if homogeneity of data would allow. Incidence—incidence rates ranged between 0.18 and 0.84 per million persons per year and varied between countries and presumably between races. On average patients were diagnosed in their late fifties and gender data indicate clear male predominance. Two of the largest studies (n = 400 and n = 544) reported different anatomical distributions: one reporting the skull base and sacrococcygeal area affected in 32% and 29% of cases, whereas the other reporting that they were affected in 26% and 45% of cases, respectively. Statistically significant adverse prognostic factors predicting progression-free and overall survival include female sex, older age, bigger tumour size, increasing extent of tumour invasion, non-total resection, presence of metastasis, local recurrence, and dedifferentiated histological subtype. Incidence rate and anatomical distribution vary between countries and presumably between races. Most chordomas arise in the skull base and sacrococcygeal spine, and the tumour shows clear male predominance. Multiple adverse prognostic factors predicting progression-free and overall survival were identified in subgroups of patients. These slides can be retrieved under Electronic Supplementary Material.

Study Design: Observational study of prospectively collected data. Objectives: Patients with chronic low back pain resistant to nonoperative treatment often face a poor prognosis for recovery. The aim of the current study was to compare the variation and outcome of surgical treatment of degenerative disc disease in the Scandinavian countries based on The International Consortium for Health Outcomes Measurement core spine data sets. Methods: Anonymized individual level data from 3 national registers were pooled into 1 database. At the time of surgery, the patient reports data on demographics, lifestyle topics, comorbidity, and data on health-related quality of life such as Oswestry Disability Index, Euro-Qol-5D, and back and leg pain scores. The surgeon records diagnosis, type of surgery performed, and complications. One-year follow-ups are obtained with questionnaires. Baseline and 1-year follow-up data were analyzed to expose any differences between the countries. Results: A total of 1893 patients were included. At 1-year follow-up, 1315 (72%) patients responded. There were statistically significant baseline differences in age, smoking, comorbidity, frequency of previous surgery and intensity of back and leg pain. Isolated fusion was the primary procedure in all the countries ranging from 84% in Denmark to 76% in Sweden. There was clinically relevant improvement in all outcome measures except leg pain. Conclusions: In homogenous populations with similar health care systems the treatment traditions can vary considerably. Despite variations in preoperative variables, patient reported outcomes improve significantly and clinically relevant with surgical treatment.

This is the protocol for a review and there is no abstract. The objectives are as follows: To identify and summarise the evidence from randomised controlled trials assessing the clinical efficacy and safety of resurfacing the patella versus not resurfacing the patella in total knee arthroplasty. The following null hypotheses will be tested: 1.There is no difference in outcome between resurfacing the patella and not resurfacing the patella in patients with osteoarthritis of the knee. 2.There is no difference in outcome between resurfacing the patella and not resurfacing the patella in patients with inflammatory arthritis of the knee. 3.There is no difference in outcome between not resurfacing the patella and resurfacing the patella with different prosthetic designs. 4.There is no difference in outcome between resurfacing the patella and not resurfacing the patella in patients with grade varying grades of patellofemoral arthritis, and varus or valgus deformity of the knee

Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression ( n = 55) or conventional surgery ( n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs.

BACKGROUND: Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation.PURPOSE: To evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness.STUDY DESIGN: An observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark.PATIENT SAMPLE: Patients aged 50 and higher operated 2011-2013 for LSS were included.OUTCOME MEASURES: Patient-reported outcome measures (PROMs) Oswestry disability index (ODI) (primary outcome), numeric rating scale (NRS) for leg pain and back pain, and health-related quality of life (EQ-5D). Analysis included case-mix adjustment. In addition, we report differences in hospital stay.METHODS: Analyses of baseline data were done by analysis of variance (ANOVA), Chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at one-year follow-up between the countries were done by ANOVA (crude) and analyses of covariance (ANCOVA, case mix adjustment). There are no conflicts of interest. Funding was received from the Danish Society of Spinal Surgery ($5,925), the Northern Norway Regional Health Authority ($5,925) and from Swedish Association of Local Authorities and Regions ($11,885). The sponsor had no role in the acquisition of data, analysis, or preparation of the manuscript.RESULTS: Out of 14,223 included patients, 10,890 (77%) responded at one-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without, with spondylolisthesis) was: Norway 11% (4%, 47%), Sweden 21% (9%, 56%) and Denmark 28% (15%, 88%). At one-year follow-up the mean improvement for ODI (95%CI) was: Norway 18 (17 to 18), Sweden 17 (17 to 18), and Denmark 18 (17 to 19). Patients operated with arthrodesis had prolonged hospital stay.CONCLUSIONS: Real life data from three national spine registers showed similar indications for decompression surgery, but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness.

Purpose: Yearly incidence of surgery for symptomatic lumbar disc herniation varies and is 29/100,000 in Sweden, 46/100,000 in Denmark and 58/100,000 in Norway. This variation was used to study whether differences in surgical incidence were associated with differences in preoperative patient characteristics as well as patient-reported outcomes. Methods: Data from the national spine registers in Sweden, Denmark and Norway during 2011–2013 were pooled, and 9965 individuals, aged 18–65 years, of which 6468 had one-year follow-up data, were included in the study. Both absolute and case-mix-adjusted comparisons of the primary outcome Oswestry Disability Index (ODI) and the secondary outcomes EQ-5D-3L, and Numerical Rating Scale (NRS) for leg and back pain were performed. Case-mix adjustment was done for baseline age, sex, BMI, smoking, co-morbidity, duration of leg pain and preoperative value of the dependent variable. Results: Mean improvement in the outcome variables exceeded previously described minimal clinical important change in all countries. Mean (95% CI) final scores of ODI were 18 (17–18), 19 (18–20) and 15 (15–16) in Sweden, Denmark and Norway, respectively. Corresponding results of EQ-5D-3L were 0.74 (0.73–0.75), 0.73 (0.72–0.75) and 0.75 (0.74–0.76). Results of NRS leg and back pain behaved similarly. Case-mix adjustment did not alter the findings substantially. Conclusion: We found no clear association between incidence of surgery for lumbar disc herniation and preoperative patient characteristics as well as outcome, and the differences between the countries were lower than the minimal clinical important difference in all outcomes. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.].

Sciatica due to lumbar disc herniation refractory to conservative treatment is effectively treated by surgery. The primary goal of surgery is retrieval of herniated disc fragments and decompression of the nerve root. After the historical publication of Mixter and Barr [1], who performed extensive laminectomy with transdural excision of the herniated disc, lumbar disc surgery became one of the most frequently performed surgical procedures worldwide. With the introduction of the microscope in the late 1960s, Yasargil and Caspar launched the unilateral microdiscectomy [2]. Presently, unilateral transflaval microdiscectomy by using the microscope or headlight with loupe magnification, is regarded as the golden standard. However, a shift towards minimally invasive approaches to the spine has started. The rationale behind minimally invasive spine surgery is less tissue damage, shorter hospitalisation, and faster recovery while achieving a good clinical outcome comparable with that of open conventional surgery. Minimally invasive spine surgery has adopted several techniques from other fields and has been influenced by endoscopy, biochemical advances, lasers, and image guidance systems. Intradiscal chymopapaine has been used more than 30 years but has been abandoned since it is less effective than surgical nerve root decompression [3]. Hijikata and Kambin are credited for their first report of percutaneous nucleotomy by inserting a 7 mm diameter tube under local anaesthesia with partial resection of disc material [4]. Choi and Ascher reviewed the first results of percutaneous laser disc decompression aiming at decreasing intradiscal pressure and subsequent nerve root relief [5]. The concept of posterolateral endoscopic discectomy changed from central nucleotomy to transforaminal nerve root decompression, which was launched by Hoogland [6] A few years later, Foley and Smith introduced the transmuscular approach of microendoscopic tubular discectomy with advanced optics and instruments applicated in laparoscopic surgery [7], which was later modified with the operative microscope.

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.

For the selection of treatment in patients with spinal bone metastases (SBM), survival estimation plays a crucial role to avoid over- and under-treatment. To aid clinicians in this difficult task, several prediction models have been developed, consisting of many different risk factors. The aim of this systematic review was to identify prognostic factors that are associated with survival in patients with SBM to support development of predictive models. A systematic review was performed with focus on prognostic factors associated with survival in patients with SBM. Two reviewers independently selected studies for inclusion and assessed the risk of bias. A level of evidence synthesis was performed for each prognostic factor. Inter-observer agreement for the risk of bias assessment was determined by the kappa-statistic. After screening, 142 full-text articles were obtained, of which 22 met the eligibility criteria. A total of 43 different prognostic factors were investigated in the included studies, of which 17 were relevant to pre-treatment survival estimation. The prognostic factors most frequently associated with survival were the primary tumor and the performance status. The prognostic factors most frequently not associated with survival were age, gender, number and location of the SBM and the presence of a pathologic fracture. Prognostication for patients with SBM should be based on an accurate primary tumor classification, combined with a performance score. The benefit of adding other prognostic factors is doubtful.

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

BACKGROUND CONTEXT: Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. PURPOSE: In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. STUDY DESIGN/SETTING: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. PATIENT SAMPLE: One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. OUTCOME MEASURES: The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. METHODS: Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. RESULTS: The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. CONCLUSIONS: At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery. (C) 2015 Elsevier Inc. All rights reserved.

STUDY DESIGN A cross-sectional study on baseline data. OBJECTIVE To translate the Oswestry Disability Index (ODI) version 2.1a into the Dutch language and to validate its use in a cohort of patients with chronic low back pain in secondary spine care. SUMMARY OF BACKGROUND DATA Patient-reported outcome measures (PROMs) are commonly accepted to evaluate the outcome of spine interventions. Functional status is an important outcome in spine research. The ODI is a recommended condition-specific patient-reported outcome measure used to evaluate functional status in patients with back pain. As yet, no formal translated Dutch version exists. METHODS The ODI was translated according to established guidelines. The final version was built into the electronic web-based system in addition with the Roland Morris Disability Questionnaire, the numeric rating scale for pain severity, 36-Item Short Form Health Survey Questionnaire for quality of life, and the hospital anxiety and depression scale. Baseline data were used of 244 patients with chronic low back pain who participated in a combined physical and psychological program. Floor and ceiling effects, internal consistency, and the construct validity were evaluated using quality criteria. RESULTS The mean ODI (standard deviation) was 39.6 (12.3); minimum 6, maximum 70. Most of the participants (88%) were moderately to severely disabled. Factor analysis determined a 1-factor structure (36% explained variance) and the homogeneity of ODI items is shown (Cronbach α = 0.79). The construct validity is supported as all (6:6) the a priori hypotheses were confirmed. Moreover, the ODI and Roland Morris Disability Questionnaire, showed a strong significant correlation (r = 0.68, P < 0.001) and an overlap: mean difference of -18 (95% limits of agreement: -44 to 8). CONCLUSION The Dutch ODI version 2.1a is a valid and valuable tool for the measurement of functional status and disability among Dutch patients with chronic low back pain. This translated condition-specific patient-reported outcome measure version is recommended for use in future back pain research and to evaluate outcome of back care in the Netherlands.

The choice of a specific surgical technique should be based on its benefits and harms. Previous reviews have shown that the benefit of surgery over conservative care is not clearly demonstrated in patients with disorders of the cervical spine. Also, no additional benefit of fusion upon anterior decompression techniques could be found. A clear overview of other surgical techniques is lacking. We therefore aimed to assess the benefits and harms of cervical spinal surgery in patients with cervical disorders. We searched MEDLINE, EMBASE, CINAHL, and CENTRAL up to June 2012. Randomized controlled trials (RCTs) were selected which included adults with cervical disorders receiving a surgical intervention and that reported at least 1 clinically relevant outcome measure (eg, pain, function, recovery). Two authors independently assessed the risk of bias using the criteria recommended by the Cochrane Back Review Group and extracted the data. The quality of the evidence was rated using the GRADE method. We included 39 RCTs comparing different surgical interventions. We found low-quality evidence for no difference in effectiveness between various surgical techniques used for anterior discectomy. There is a small, clinically irrelevant benefit on recovery and pain in favour of prosthetic disc surgery when compared with fusion techniques. Unfortunately, in these studies the authors had a clear conflict of interest. The differences in benefits and harms between the various surgical techniques are small. The surgeon, patient, and health care provider can therefore make the choice of any surgical technique based on experience, preferences, or costs. © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Identification of prognostic factors for surgery in patients with sciatica is important to be able to predict surgery in an early stage. Identification of prognostic factors predicting persistent pain, disability and recovery are important for better understanding of the clinical course, to inform patient and physician and support decision making. Consequently, we aimed to systematically review prognostic factors predicting outcome in non-surgically treated patients with sciatica. A search of Medline, Embase, Web of Science and Cinahl, up to March 2012 was performed for prospective cohort studies on prognostic factors for non-surgically treated sciatica. Two reviewers independently selected studies for inclusion and assessed the risk of bias. Outcomes were pain, disability, recovery and surgery. A best evidence synthesis was carried out in order to assess and summarize the data. The initial search yielded 4392 articles of which 23 articles reporting on 14 original cohorts met the inclusion criteria. High clinical, methodological and statistical heterogeneity among studies was found. Reported evidence regarding prognostic factors predicting the outcome in sciatica is limited. The majority of factors that have been evaluated, e.g., age, body mass index, smoking and sensory disturbance, showed no association with outcome. The only positive association with strong evidence was found for leg pain intensity at baseline as prognostic factor for subsequent surgery.

Objective: Odontoid fractures are the most common cervical spine fractures in elderly patients. The optimal treatment in this age group remains controversial. The goal of this study was to compare outcomes of surgical and conservative treatments. Methods: A retrospective cohort study was conducted in three tertiary referral centers in the Netherlands. Patient records were reviewed for patients who met the selection criteria (i.a. age ≥55 years, type II/III odontoid fractures). Fracture healing (union/stability) and clinical outcomes (Likert scale) were assessed. The influence of age, applied treatment, and treatment strategy (‘fracture based approach’ or ‘primarily conservative’) was studied. Results: A total of 105 patients were included (18 treated surgically, 87 treated conservatively; 52 treated with ‘fracture based approach’, 53 treated ‘primarily conservative’). No difference was found in fracture union (68% overall) and fracture stability (88% overall). Data on clinical outcome were scarce, but did not differ between treatment groups. Patients ≥80 years had worse outcomes in both applied treatment- and treatment strategy arms. Conclusion: No radiological differences in outcome between surgical or conservative treatment (strategies) were observed. The majority of patients achieved fracture healing. The exact correlation between the quality of fracture healing (union or stability) and clinical outcome remains unclear. Advanced age (>80 years) negatively influenced outcome.

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.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.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).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.).

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. (C) 2016 Elsevier Inc. All rights reserved.

Item does not contain fulltext STUDY DESIGN: A systematic review of randomized controlled trials. OBJECTIVE: To determine which technique of anterior cervical interbody fusion (ACIF) gives the best outcome in patients with cervical degenerative disc disease. SUMMARY OF BACKGROUND DATA: The number of surgical techniques for decompression and ACIF as treatment for cervical degenerative disc disease has increased rapidly, but the rationale for the choice between different techniques remains unclear. METHODS: From a comprehensive search, we selected randomized studies that compared anterior cervical decompression and ACIF techniques, in patients with chronic single- or double-level degenerative disc disease or disc herniation. Risk of bias was assessed using the criteria of the Cochrane back review group. RESULTS: Thirty-three studies with 2267 patients were included. The major treatments were discectomy alone and addition of an ACIF procedure (graft, cement, cage, and plates). At best, there was very low-quality evidence of little or no difference in pain relief between the techniques. We found moderate quality evidence for few secondary outcomes. Odom's criteria were not different between iliac crest autograft and a metal cage (risk ratio [RR]: 1.11; 95% confidence interval [CI]: 0.99-1.24). Bone graft produced more fusion than discectomy (RR: 0.22; 95% CI: 0.17-0.48). Complication rates were not different between discectomy and iliac crest autograft (RR: 1.56; 95% CI: 0.71-3.43). Low-quality evidence was found that iliac crest autograft results in better fusion than a cage (RR: 1.87; 95% CI: 1.10-3.17); but more complications (RR: 0.33; 95% CI: 0.12-0.92). CONCLUSION: When fusion of the motion segment is considered to be the working mechanism for pain relief and functional improvement, iliac crest autograft appears to be the golden standard. When ignoring fusion rates and looking at complication rates, a cage as a golden standard has a weak evidence base over iliac crest autograft, but not over discectomy.

This chapter discusses key aspects in the diagnosis, prognosis, and surgical treatment of lumbar disc herniation with persistent complaints. The importance of natural history, clinical assessments, and imaging with MRI is viewed with regard to decision for surgery. The appropriate wait and see time before indicating surgery is regarded in relation to the comparison of conservative treatment with surgery. Existing evidence shows that short-term improved outcome should be balanced against the surgical burden and associated risks. Further, comparative evidence between different surgical techniques shows no clear advantage of different techniques.

Patella position can be measured on axial radiographs and many measurement techniques have been described in literature. The goal of this study was to evaluate the inter- and intraobserver reproducibility of measurement techniques available in the literature for patients with a knee prosthesis. Fifty axial patella radiographs from knee prostheses were used to measure the reproducibility of five measurement techniques. Reproducibility was calculated using the Bland and Altman method. The Patellar Displacement (>or=4 mm) and the Lateral Patellar Tilt (>10 degrees) were found to be useful and clinically relevant. Based on our study we recommend that the most reproducible method to use for measurement of tilt, is Lateral Patellar Tilt; to measure displacement, the surgeon should use the Patellar Displacement technique.

Goal of this study is to determine the anterior-posterior laxity in 30 degrees of knee flexion for a posterior cruciate retaining total knee arthroplasty with a relative dished insert and implanted with a ligament tensor. Furthermore, the correlation between these AP laxities and the postoperative range of motion (ROM) and postoperative Knee Society Score (KSS) is analysed. Fifty-one balanSys total knee arthroplasties were performed in 49 patients between 1998 and 2000. These arthroplasties are analysed with respect to AP laxity (Rolimeter), ROM and KSS with a mean follow-up of 4.6 years. The mean anterior laxity is 2.8 mm with no posterior laxities at all. The average postoperative ROM is 110 degrees with an average KSS of 142. No correlations between AP-laxity and postoperative ROM or between AP-laxity and postoperative KSS are found. A posterior cruciate retaining TKA with a relative dished insert and implanted with a tensor is very stable in the anterior-posterior direction in 30 degrees of knee flexion. This limited laxity does not seem to disadvantage the mean postoperative ROM and KSS, when compared to other TKA studies.

Background It is unclear whether there are differences in benefits and harms between mobile and fixed prostheses for total knee arthroplasty (TKA). The previous Cochrane review published in 2004 included two articles. Many more trials have been performed since then; therefore an update is needed. Objectives To assess the benefits and harms of mobile bearing compared with fixed bearing cruciate retaining total knee arthroplasty for functional and clinical outcomes in patients with osteoarthritis (OA) or rheumatoid arthritis (RA). Search methods We searched The Cochrane Library, PubMed, EMBASE, CINAHL and Web of Science up to 27 February 2014, and the trial registers ClinicalTrials.gov, Multiregister, Current Controlled Trials and the World Health Organization (WHO) International Clinical Trials Registry Platform for data from unpublished trials, up to 11 February 2014. We also screened the reference lists of selected articles. Selection criteria We selected randomised controlled trials comparing mobile bearing with fixed bearing prostheses in cruciate retaining TKA among patients with osteoarthritis or rheumatoid arthritis, using functional or clinical outcome measures and follow-up of at least six months. Data collection and analysis We used standard methodological procedures as expected by The Cochrane Collaboration. Main results We found 19 studies with 1641 participants (1616 with OA (98.5%) and 25 with RA (1.5%)) and 2247 knees. Seventeen new studies were included in this update. Quality of the evidence ranged from moderate (knee pain) to low (other outcomes). Most studies had unclear risk of bias for allocation concealment, blinding of participants and personnel, blinding of outcome assessment and selective reporting, and high risk of bias for incomplete outcome data and other bias. Knee pain We calculated the standardised mean difference (SMD) for pain, using the Knee Society Score (KSS) and visual analogue scale (VAS) in 11 studies (58%) and 1531 knees (68%). No statistically significant differences between groups were reported (SMD 0.09, 95% confidence interval (CI) -0.03 to 0.22, P value 0.15). This represents an absolute risk difference of 2.4% points higher (95% CI 0.8% lower to 5.9% higher) on the KSS pain scale and a relative percent change of 0.22% (95% CI 0.07% lower to 0.53% higher). The results were homogeneous. Clinical and functional scores The KSS clinical score did not differ statistically significantly between groups (14 studies (74%) and 1845 knees (82%)) with a mean difference (MD) of -1.06 points (95% CI -2.87 to 0.74, P value 0.25) and heterogeneous results. KSS function was reported in 14 studies (74%) with 1845 knees (82%) as an MD of -0.10 point (95% CI -1.93 to 1.73, P value 0.91) and homogeneous results. In two studies (11%), the KSS total score was favourable for mobile bearing (159 vs 132 for fixed bearing), with MD of -26.52 points (95% CI -45.03 to -8.01, P value 0.005), but with a wide 95% confidence interval indicating uncertainty about the estimate. Other reported scoring systems did not show statistically significant differences: Hospital for Special Surgery (HSS) score (seven studies (37%) in 1021 knees (45%)) with an MD of -1.36 (95% CI -4.18 to 1.46, P value 0.35); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (two studies (11%), 167 knees (7%)) with an MD of -4.46 (95% CI -16.26 to 7.34, P value 0.46); and Oxford total (five studies (26%), 647 knees (29%) with an MD of -0.25 (95% CI -1.41 to 0.91, P value 0.67). Health-related quality of life Three studies (16%) with 498 knees (22%) reported on health-related quality of life, and no statistically significant differences were noted between the mobile bearing and fixed bearing groups. The Short Form (SF)-12 Physical Component Summary had an MD of -1.96 (95% CI -4.55 to 0.63, P value 0.14) and heterogeneous results. Revision surgery Twenty seven revisions (1.3%) were performed in 17 studies (89%) with 2065 knees (92%). In all, 13 knees were revised in the fixed bearing group and 14 knees in the mobile bearing group. No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.58), and homogeneous results were reported. Mortality In seven out of 19 studies, 13 participants (37%) died. Two of these participants had undergone bilateral surgery, and for seven participants, it was unclear which prosthesis they had received; therefore they were excluded from the analyses. Thus our analysis included four out of 191 participants (2.1%) who had died: one in the fixed bearing group and three in the mobile bearing group. No statistically significant differences were found. The risk difference was -0.02 (95% CI -0.06 to 0.03, P value 0.49) and results were homogeneous. Reoperation rates Thirty reoperations were performed in 17 studies (89%) with 2065 knees (92%): 18 knees in the fixed bearing group (of the 1031 knees) and 12 knees in the mobile group (of the 1034 knees). No statistically significant differences were found. The risk difference was -0.01 (95% CI -0.01 to 0.01, P value 0.99) with homogeneous results. Other serious adverse events Sixteen studies (84%) reported nine other serious adverse events in 1735 knees (77%): four in the fixed bearing group (of the 862 knees) and five in the mobile bearing group (of the 873 knees). No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.88), and results were homogeneous. Authors' conclusions Moderate- to low-quality evidence suggests that mobile bearing prostheses may have similar effects on knee pain, clinical and functional scores, health-related quality of life, revision surgery, mortality, reoperation rate and other serious adverse events compared with fixed bearing prostheses in posterior cruciate retaining TKA. Therefore we cannot draw firm conclusions. Most (98.5%) participants had OA, so the findings primarily reflect results reported in participants with OA. Future studies should report in greater detail outcomes such as those presented in this systematic review, with sufficient follow-up time to allow gathering of high-quality evidence and to inform clinical practice. Large registry-based studies may have added value, but they are subject to treatment-by-indication bias. Therefore, this systematic review of RCTs can be viewed as the best available evidence.

Summary points 1. The group of patients with so-called ‘failed back surgery syndrome’ (FBSS) is very diverse. Published studies evaluating the outcome of surgical treatment vary widely in terms of surgical interventions that were performed. Results from these papers cannot be generally applied to all people who have persisting complaints after low back surgery. 2. The literature search that was performed demonstrated that the articles that scored as acceptable on assessment bias demonstrated a low to moderate patient-perceived recovery percentage. The only randomized controlled trial on this topic did not demonstrate a difference between instrumented fusion and cognitive intervention and exercise. 3. Current research does not show repeat surgery to be successful in ‘FBSS patients’, but clinical practice indicates that, in a small, carefully selected group, repeat surgery can yield rewarding results. However, parameters that make a patient prone to recover from a subsequent surgical intervention cannot be found in the literature. 4. The term ‘failed back surgery syndrome’ implies a causative role of surgery in a problem situation; failed back surgery syndrome is frequently regarded as failed back surgery. The literature does not, however, provide evidence for this. 5. It is important to inform the patient adequately to shape realistic expectations. Preoperative evaluation of parameters evaluating the psychological condition could help to better predict the outcome of surgery. 6. The term ‘failed back surgery syndrome’ has been demonstrated to be an ill-defined term, serving as a container for all kinds of back and leg problems, and wrongly implying a definite role for the surgical intervention in the aetiology. We suggest shifting the paradigm to ‘failed back syndrome’. With this term we suggest defining those patients with back and radicular leg pain without a structural deficit, or with a structural deficit that has a low a priori chance of benefiting from a surgical intervention.

Objectives Multi-item questionnaires are frequently used to measure outcomes in randomized controlled trials (RCTs) in patients with sciatica. Knowing the minimaly important change (MIC) values for these instruments will facilitate interpretation of change scores. MIC values have been shown to be dependent on baseline values. The question is whether they also depend on the type of intervention. To estimate the MIC of the Roland Morris Disability Questionnaire (modified 23 item version) (RMDQ) and of intensity of leg pain measured by a Visual Analogue Scale (VAS) in patients with sciatica and to assess to what extent MIC values depend on type of intervention and on baseline values. Study Design and Setting This is a secondary analysis of RCT data of the effects of early surgery vs. prolonged conservative treatment in patients with sciatica. Baseline and 8-week data were used to assess MIC of the RMDQ-23 and VAS leg pain. We used the receiver operator characteristic (ROC) method to assess the MIC. Global Perceived Recovery (rated 8 weeks after baseline) was used as anchor. Subgroups were created based on type of treatment and baseline severity. Results The MIC value of the RMDQ-23 for the total group of sciatica patients was 7.5. The values were 8.1 and 6.9 for surgery and conservative treatment, respectively. For high and low baseline values, the MICs were 9.0 and 4.9, respectively, irrespective of treatment received. The MIC values of the VAS leg pain were 34.4 for the total group. For surgery and conservative treatment, the MIC values were 38.5 and 30.4, respectively, whereas for groups with high and low baseline values, MIC values of 53.5 and 17.2 were found. Conclusion The MIC values of the RMDQ-23 and VAS leg pain were found to be highly dependent on their baseline values, although the type of intervention appeared to influence the MIC value only slightly.

In this retrospective cohort, the results of step-cut tibial tubercle osteotomy (TTO) in 39 revision total knee arthroplasty, using the Continuum Knee System (CKS), are determined. In 39 revision, total knee arthroplasties, adequate exposure was obtained after step-cut TTO. All knees were recently reviewed for clinical and radiological results. Symptomatic TTO-related complications occurred in three out of 39 patients. Two patients had proximal migration of the tibial tubercle due to an insufficient step-cut. Another patient had posttraumatic avulsion of the tibial tubercle. No TTO-related extensor lag or tibial fracture occurred We conclude that, when adequate exposure cannot be obtained, step-cut TTO is a safe and reproducible procedure if strict attention is paid to technique and fixation. It does not compromise the functional results of TKA.

There is no consensus as to whether to use a posterior cruciate ligament (PCL) retaining design or a posterior-stabilized design for total knee arthroplasty. The objective of this study was to establish the difference in functional, clinical, and radiological outcome between retention and removal of the PCL.We conducted a search in Medline, EMBASE, the Cochrane database, and Current Contents, along with reference checks and citation tracking. Randomized controlled trials were selected and methodological quality was assessed with the van Tulder and Jadad checklists by 2 independent reviewers.We found 8 randomized controlled trials. 2 treatment options were compared against PCL retention: PCL removal without post and cam mechanism (2 studies), and posterior-stabilized design (5 studies). 1 study included all 3 options. Range of motion was found to be 8 degrees higher (105 degrees vs. 113 degrees ) in the posterior-stabilized group compared to the PCL retention group (p = 0.01, 95% CI (1.7, 15)).These results should be interpreted with caution, as the methodological quality of the studies was highly variable. Suggestions are given to improve future research on this specific aspect of knee arthroplasty.

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.

Purpose: Literature is ambiguous on the incidence of deep venous thrombosis and pulmonary embolism by neurosurgical patients. The objective of this systematic review is to assess the incidence of thromboembolic complications associated with neurosurgical interventions, evaluate current prophylaxis methods and propose a prophylaxis strategy. Methods: PubMed, Embase and Cochrane Central were searched systematically and studies involving neurosurgical procedures describing postoperative complications DVT and PE. The risk of bias was assessed using (adjusted) Cowley criteria. Results: Twenty studies (14 case series, 3 comparative studies, 3 RCT’s) were included, describing 8905 neurosurgical patients. Without prophylaxis the incidence of DVT was reported in 28% of neurosurgical cases (range 21-34%). Studies that provided any kind of prophylaxis, in which clinical evaluation was used to diagnose DVT, reported a 2.5% incidence of DVT (range 0 to 5%), however, when systematically assessed with ultrasound the occurrence was 6.4% (range 0-17%). Pulmonary embolism was presented in 0 to 4% of all cases. Venous thromboembolic events were more frequent in intracranial procedures compared to spinal procedures. Patients, receiving a combination of low molecular weight heparins and compression stockings, showed a 50% lower incidence of DVT than patients receiving mechanical or chemical prophylaxis alone. Conclusion: Optimal antithrombotic prophylaxis regime in neurosurgical interventions lowers the incidence of DVT’s from 28% to about 3 to 6%. We recommend a combination of LMWH and compression stockings for intracranial procedures. For spinal procedures this same prophylactic regimen is indicated, however it is defendable to choose single treatment with LMWH or compression stockings alone.

Background and purpose - Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set.Patients and methods - An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions.Results - Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on preexisting tools.Interpretation - The outcome measures recommended here are structured around specific etiologies of LBP, span a patient's entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

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 supporttheseareoftenlacking,especiallyintermsoftheirrelative benefitandriskcomparedwithothertreatmentoptions.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 appliedin 12%of allsurgeryfor LSS.Mostsurgeonsconsidered 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.

We consider a re-analysis of the wait-and-see (control) arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery.

Key points Low back pain (LBP) ranks as the number one disorder in terms of years lived with disability; estimated global one year incidences range from 22% to 65%.1 Back pain as a symptom, not attributable to spinal instability caused by trauma, infection, progressive deformity, or tumour, and not associated with radicular symptoms, is labelled non-specific LBP (see box). Many of patients with non-specific LBP may have degenerative intervertebral disc and bony joint changes, including disc herniations and spinal stenosis on imaging, but these findings are not more common than in the general population, including people without LBP.2 Guidelines discourage surgery for non-specific back pain3; some recommend surgery only after two years of failed conservative treatments in carefully selected patients.4 However, despite these recommendations, the rate of back surgery is rising, with considerable geographical variation.5 The rates of spinal fusion, including use of surgical implants, for all degenerative disorders of the lumbar spine show an unexplained exponential increase,6 7 with a corresponding rise in serious perioperative complications, including stroke and cardiopulmonary events.7 These rises are unexpected, as the incidence of spinal diseases causing instability of vertebral elements has not risen, and nor has the incidence of surgery for herniated discs and stenosis. …

Contains fulltext : 137225.pdf (Publisher’s version ) (Open Access) BACKGROUND: Cervical radicular syndrome (CRS) due to a herniated disc can be safely treated by surgical decompression of the spinal root. In the vast majority of cases this relieves pain in the arm and restores function. However, conservative treatment also has a high chance on relieving symptoms. The objective of the present study is to evaluate the (cost-) effectiveness of surgery versus prolonged conservative care during one year of follow-up, and to evaluate the timing of surgery. Predisposing factors in favour of one of the two treatments will be evaluated. METHODS/DESIGN: Patients with disabling radicular arm pain, suffering for at least 2 months, and an MRI-proven herniated cervical disc will be randomised to receive either surgery or prolonged conservative care with surgery if needed. The surgical intervention will be an anterior discectomy or a posterior foraminotomy that is carried out according to usual care. Surgery will take place within 2-4 weeks after randomisation. Conservative care starts immediately after randomisation. The primary outcome measure is the VAS for pain or tingling sensations in the arm one year after randomisation. In addition, timing of surgery will be studied by correlating the primary outcome to the duration of symptoms. Secondary outcome measures encompass quality of life, costs and perceived recovery. Predefined prognostic factors will be evaluated. The total follow-up period will cover two years. A sample size of 400 patients is needed. Statistical analysis will be performed using a linear mixed model which will be based on the 'intention to treat' principle. In addition, a new CRS questionnaire for patients will be developed, the Leiden Cervical Radicular Syndrome Functioning (LCRSF) scale. DISCUSSION: The outcome will contribute to better decision making for the treatment of cervical radicular syndrome. TRIAL REGISTRATION: NTR3504.

The goal of this study was to evaluate the ability of Ray threaded fusion cages, when used in an anterior approach, to restore intervertebral height and to improve the functional and occupational performance of the patients. The present study was initiated because insertion of fusion cages through a posterior approach causes destruction of facet joints and violation of the spinal canal. The anterior approach for insertion of threaded fusion cages to accomplish lumbar interbody fusion was evaluated in a series of 13 patients suffering monosegmental disc disease. The patients’ functional and occupational performance was evaluated using the Prolo score. Radiological measurements were used to evaluate disc height and degree of penetration into the endplates, and to confirm fusion. Seven of the 13 patients were short-term failures and had to be revised within 2 years. The study found that revised patients had poorer Prolo scores than non-revised patients. Although for the non-revised patients, the mean Prolo scores remained relatively stable during the 1st year, they dropped after 3 years. We were not able to identify any further clinical or radiological differences between the groups. These results indicate that although the anterior approach seems technically suitable for insertion of threaded fusion cages, destruction of the anterior longitudinal ligament and the anterior part of the annulus fibrosis appears to result in destabilisation of the motion segment.

The goal of this systematic literature review was to determine, for patients with degenerative disc disease, which method of single-level anterior cervical interbody fusion using the anterior approach gives the best clinical and radiological outcome. The number of new techniques for obtaining a solid fusion has increased rapidly, but the rationale for choosing between different techniques is unclear. Randomised comparative studies on anterior cervical interbody fusions were identified in a sensitive Medline, Cochrane and Current Contents database search. Two independent reviewers evaluated the articles that met the selection criteria, using a checklist. The search yielded eight randomised, controlled trials for the systematic literature review. Three of these studies were judged to be of sufficient quality with regard to methodology and the information provided. In the three articles, five different treatment methods were investigated, four of which were interbody fusions. Fusion rates varied between 28% for an allograft method and 63% for a discectomy-alone method. In one study, kyphosis varied from 40% to 62% between treatments. Good clinical outcome (disability, pain and symptoms) ratings varied from 66% to 82%. A meta-analysis to determine the best method for an anterior interbody fusion could not be performed due to the heterogeneity of the methods reported and because no standard outcome parameter was used. From this systematic literature review, a gold standard for the treatment of degenerative disc disease could not be identified.

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 (

Background The functional and clinical basis on which to choose whether or not to retain the posterior cruciate ligament during total knee arthroplasty surgery remained unclear after a Cochrane systematic review and meta-analysis in 2005, which contained eight clinical trials. Several new trials have been conducted since then. Hence, an update of the review was performed. Objectives Our aim was to assess the benefits and harms of retention compared to sacrifice of the posterior cruciate ligament in total knee arthroplasty in patients with osteoarthritis of the knee. Search methods An extensive search was conducted in CENTRAL, MEDLINE (PubMed), EMBASE, Web of Science, CINAHL, Academic Search Premier, Current Contents Connect and Science Direct. All databases were searched, without any limitations, up to 6 December 2012. References of the articles were checked and citation tracking was performed. Selection criteria Randomised and quasi-randomised controlled trials comparing retention with sacrifice of the posterior cruciate ligament in primary total knee arthroplasty in patients with osteoarthritis of the knee. Data collection and analysis Data were collected with a pre-developed form. Risk of bias was assessed independently by two authors (WV, LB). The level of evidence was graded using the GRADE approach. Meta-analysis was performed by pooling the results of the selected studies, when possible. Subgroup analyses were performed for posterior cruciate ligament retention versus sacrifice using the same total knee arthroplasty design, and for studies using a posterior cruciate ligament retaining or posterior stabilised design, and when sufficient studies were available subgroup analyses were performed for the same brand. Main results Seventeen randomised controlled trials (with 1810 patients and 2206 knees) were found, described in 18 articles. Ten of these were new studies compared to the previous Cochrane Review. One study from the original Cochrane review was excluded. Most new studies compared a posterior cruciate ligament retaining design with a posterior stabilised design, in which the posterior cruciate ligament is sacrificed (a posterior stabilised design has an insert with a central post which can engage on a femoral cam during flexion). The quality of evidence (graded with the GRADE approach) and the risk of bias were highly variable, ranging from moderate to low quality evidence and with unclear or low risk of bias for most domains, respectively. The performance outcome 'range of motion' was 2.4 ° higher in favour of posterior cruciate ligament sacrifice (118.3 ° versus 115.9 °; 95% confidence interval (CI) of the difference 0.13 to 4.67; P = 0.04), however the results were heterogeneous. On the item 'knee pain' as experienced by patients, meta-analysis could be performed on the Knee Society knee pain score; this score was 48.3 in both groups, yielding no difference between the groups. Implant survival rate could not be meta-analysed adequately since randomised controlled trials lack the longer term follow-up in order to evaluate implant survival. A total of four revisions in the cruciate-retention and four revisions in the cruciate-sacrifice group were found. The well-validated Western Ontario and McMaster Universities osteoarthritis index (WOMAC) total score was not statistically significantly different between the groups (16.6 points for cruciate-retention versus 15.0 points for cruciate-sacrifice). One study reported a patient satisfaction grade (7.7 points for cruciate-retention versus 7.9 points for cruciate-sacrifice on a scale from 0 to 10, 10 being completely satisfied) which did not differ statistically significantly. Complications were distributed equally between both groups. Only one study reported several re-operations other than revision surgery; that is patella luxations, surgical manipulation because of impaired flexion. The mean functional Knee Society Score was 2.3 points higher (81.2 versus 79.0 points; 95% CI of the difference 0.37 to 4.26; P = 0.02) in the posterior cruciate ligament sacrificing group. Results from the outcome Knee Society functional score were homogeneous. All other outcome measures (extension angle, knee pain, adverse effects, clinical questionnaire scores, Knee Society clinical scores, radiological rollback, radiolucencies, femorotibial angle and tibial slope) showed no statistically significant differences between the groups. In the subgroup analyses that allowed pooling of the results of the different studies, no homogeneous statistically significant differences were identified. Authors' conclusions The methodological quality and the quality of reporting of the studies were highly variable. With respect to range of motion, pain, clinical, and radiological outcomes, no clinically relevant differences were found between total knee arthroplasty with retention or sacrifice of the posterior cruciate ligament. Two statistically significant differences were found; range of motion was 2.4 ° higher in the posterior cruciate ligament sacrificing group, however results were heterogeneous; and the mean functional Knee Society Score was 2.3 points higher in the posterior cruciate ligament sacrificing group. These differences are clinically not relevant.

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.

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). 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. 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. 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.

BACKGROUND CONTEXT: In patients with sciatica due to a lumbar disc herniation, it is generally recommended to reserve surgical treatment for those who suffer from intolerable pain or those who demonstrate persistent symptoms after conservative management. Controversy exists about the necessity of early surgical intervention for those patients that have an additional motor deficit. PURPOSE: The aim of this study was to compare the recovery of motor deficit among patients receiving early surgery to those receiving prolonged conservative treatment. STUDY DESIGN: Subgroup analysis of a randomized controlled trial. PATIENT SAMPLE: This subgroup analysis focuses on 150 (53%) of 283 patients with sciatica due to a lumbar disc herniation and whose symptoms at baseline (before randomization) were accompanied by a motor deficit. OUTCOME MEASURES: Motor deficit was assessed through manual muscle testing and graded according to the Medical Research Council (MRC) scale. METHODS: In total, 150 patients with 6 to 12 weeks of sciatica due to a lumbar disc herniation and whose symptoms were accompanied by a moderate (MRC Grade 4) or severe (MRC Grade 3) motor deficit were randomly allocated to early surgery or prolonged conservative treatment. Repeated standardized neurologic examinations were performed at baseline and at 8, 26, and 52 weeks after randomization. This study was supported by a grant from the Netherlands Organization for Health Research and Development (ZonMW) and the Hoelen Foundation The Hague. RESULTS: Sciatica recovered among seven (10%) of the 70 patients assigned to early surgery before surgery could be performed, and of the 80 patients assigned to conservative treatment, 32 patients (40%) were treated surgically because of intolerable pain. Baseline severity of motor deficit was graded moderate in 84% of patients and severe in 16% of patients. Motor deficit recovered significantly faster among patients allocated to early surgery (p = .01), but the difference was no longer significant at 26 (p = .21) or 52 weeks (p = .92). At 1 year, complete recovery of motor deficit was found in 81% of patients allocated to early surgery and in 80% of patients allocated to prolonged conservative treatment. Perceived overall recovery of sciatica was directly related to the presence of an accompanying motor deficit. Severe motor deficit at baseline (odds ratio, 5.4; confidence interval, 1.7-17.4) and a lumbar disc herniation encompassing >= 25% of the cross-sectional area of the spinal canal (odds ratio, 6.4; confidence interval, 1.3-31.8) were the most important risk factors for persistent deficit at 1 year. CONCLUSIONS: Early surgery resulted in a faster recovery of motor deficit accompanying sciatica compared with prolonged conservative treatment but the difference was no longer significant during the final follow-up examination at 1 year. (C) 2014 Elsevier Inc. All rights reserved.

We aimed to evaluate the available evidence on the effectiveness of surgical interventions for a number of conditions resulting in low back pain (LBP) or spine-related irradiating leg pain. We searched the Cochrane databases and PubMed up to June 2013. We included systematic reviews and randomised controlled trials (RCTs) on degenerative disc disease (DDD), herniated disc, spondylolisthesis and spinal stenosis due to degenerative osteoarthritis. We included comparisons between surgery and conservative care and between different techniques. The quality of the systematic reviews was evaluated using assessment of multiple systematic reviews (AMSTAR). Twenty systematic reviews were included which covered the following diagnoses: disc herniation (n = 9), spondylolisthesis (n = 2), spinal stenosis (n = 3), DDD (n = 4) and combinations (n = 2). For most of the comparisons, no significant and/or clinically relevant differences between interventions were identified. In general, surgery is only indicated for relief of leg pain in clear indications such as disc herniation, spondylolisthesis or spinal stenosis.

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

PURPOSE: Cauda equina syndrome (CES) is a rare complication of lumbar disk herniation. Although micturition, defecation and/or sexual function are by definition affected, little seems to be known about long-term outcome. Aim of this study is to review current literature on outcome of micturition, defecation and sexual function in CES due to lumbar disk herniation. METHODS: A literature search was done in Pubmed, Embase and Web of Science using a sensitive search string combination. Studies were selected by predefined selection criteria and risk of bias was assessed using a Cochrane checklist adjusted for this purpose. RESULTS: Fifteen studies were included. Risk of bias varied with six studies showing low risk. Mean minimal follow-up time was 17.0 months (range 3-24 months). All studies evaluated micturition and reported dysfunction at follow-up in 42.5 % (range 13.3-90.0 %). Defecation and sexual function were evaluated in eight and nine studies, respectively, and reported to be 49.6 (range 10.5-90.0 %) and 44.3 % (range 10.0-76.6 %), respectively. Only two studies assessed sexual function in all patients at follow-up. CONCLUSION: This review offers an insight into the extent of micturition dysfunction, defecation dysfunction and sexual dysfunction (SD) in CES after decompression. Our findings show that dysfunction is extremely common, even at long-term follow-up. A condition as invalidating as CES requires proper patient information and the outcomes presented here may help in providing those data. Bias in included studies, lack of universal definitions and incomplete follow-up results qualify these data as the best we momentarily have, but still subject to improvement. Since SD seems to be severely underreported, we recommend further research to explore the extent of this problem, as well as the use of questionnaires in future clinical (prospective) studies to accomplish a more patient-based approach.

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.

STUDY DESIGN.: Systematic literature review. OBJECTIVE.: To assess the effect of total disc replacement for chronic low back pain due to lumbar degenerative disc disease compared with fusion or other treatment options. SUMMARY OF BACKGROUND DATA.: There is an increasing use in disc replacement devices for degenerative disc disease, but their effectiveness compared with other interventions such as fusion of the motion segment or conservative treatment remains unclear. METHODS.: A comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and FDA trials register was conducted. Randomized controlled trials comparing total disc replacement with any other intervention for degenerative disc disease were included. Risk of bias was assessed using the criteria of the Cochrane Back Review Group. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies, assessed risk of bias, and extracted data. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences. RESULTS.: We included 7 randomized controlled trials with a follow-up of 24 months. There is risk of bias in the included studies due to sponsoring and absence of any kind of blinding. One study compared disc replacement with rehabilitation and found a significant advantage in favor of surgery, which, however, did not reach the predefined threshold. Six studies compared disc replacement with fusion and found that the mean improvement in visual analogue scale score of back pain was 5.2 mm higher (2 studies; 95% confidence interval 0.2-10.3) with a low quality of evidence. The improvement of Oswestry disability index score at 24 months in the disc replacement group was 4.3 points more than in the fusion group (5 studies; 95% confidence interval 1.85-6.68) with a low quality of evidence. Both upper bounds of the confidence intervals were below the predefined clinically relevant difference. CONCLUSION.: Although statistically significant, the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. Prevention of adjacent level disease and/or facet joint degeneration was not properly assessed. Therefore, because we think that harm and complications may occur after some years, the spine surgery community should be prudent to adopt this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low back pain in selected patients, and in the short term is at least equivalent to fusion surgery. © 2012, Lippincott Williams &Wilkins.

Background context Systematic reviews of the literature are powerful tools in evidence-based medicine. However, the design and report of systematic reviews in spinal surgery contain many aspects amenable to improvement. Purpose To discuss the issues especially relevant for systematic reviews in spinal surgery. Methods From our experience of systematic reviews and meta-analyses of clinical trials in spinal surgery, we infer guidance for the design and execution of systematic literature reviews. Results There are many difficulties associated with the design as well as conduct of clinical trials and consequently appraising evidence in spinal surgery. New treatments should be compared with the gold standard before other comparisons are investigated. Studies should present data as thoroughly as possible regarding all subgroups and follow-up moments, possibly in supplementary material. To provide the highest level of evidence, systematic reviews should be as rigorously designed as possible. Conclusions Gathering information on clinical effectiveness in spinal surgery can be improved both at the clinical study level and at the systematic review level. Alternatives to randomized controlled trials such as comparative studies can be valuable tools on the clinical effectiveness of treatments in spinal surgery. The experience reflected in this article can support the scientific efforts in this field.

Background context Methodological quality measures of trials in meta-analyses have been shown to influence the pooled effect sizes in several medical fields. However, for spinal surgery, influence of quality measures has not been assessed. Purpose The purpose of this study was to analyze the influence of quality measures in studies on effectiveness in spinal surgery. Study design A metaepidemiological study was performed on meta-analyses within spinal surgery. Methods A systematic search was performed in MEDLINE, Cochrane Database, and EMBASE in August 2009. The effect sizes, defined as risk of positive clinical outcome, of trials included in the meta-analyses were assessed. The differences in effect sizes were calculated as risk differences (RDs). Relation of the RDs to potential quality measures such as sponsoring, randomization, allocation concealment, blinding, and study size was assessed with metaregression adjusted for multiple testing. Results Seven reviews consisting of 118 studies were included. Data provided by the systematic reviews alone were insufficient to analyze the effect of quality measures. Metaregression analysis of 76 of the individual trials reporting clinical outcome, though, showed that sample size, strict randomization, and outcome blinding were significant quality measures influencing study effect. Risk difference of effect from validly randomized studies was higher compared with not validly randomized and comparative observational trials (5.4%; 95% confidence interval [CI], 1.2–9.6; p=.044). Studies with adequate observer blinding showed a 7.2% lower RD (95% CI, 0.8–13.7; p=.049). For each increase of 100 patients, the RD decreased 3.6% (95% CI, 0.5–6.8; p=.098). Conclusions Contrary to basic methodological assertions, formal and strict randomization appeared to produce a significantly higher RD in spinal surgery research. Sufficient sample size and observer blinding, on the other hand, led to a lower RD as expected. These findings imply that effect of quality measures assessed in metaepidemiological studies should not be too easily translated to research in spinal surgery.