What level of symptoms are patients with adult spinal deformity prepared to live with? A cross-sectional analysis of the 12-month follow-up data from 1043 patients.

INTRODUCTION: Previous studies suggest that a meaningful and easily understood measure of treatment outcome may be the proportion of patients who are in a "patient acceptable symptom state" (PASS). We sought to quantify the score equivalent to PASS for different outcome instruments, in patients with adult spinal deformity (ASD). METHODS: We analysed the following 12-month questionnaire data from the European Spine Study Group (ESSG): Oswestry Disability Index (ODI; 0-100); Numeric Rating Scales (NRS; 0-10) for back/leg pain; Scoliosis Research Society (SRS) questionnaire; and an item "if you had to spend the rest of your life with the symptoms you have now, how would you feel about it?" (5-point scale, dichotomised with top 2 responses "somewhat satisfied/very satisfied" being considered PASS+, everything else PASS-). Receiver operating characteristics (ROC) analyses indicated the cut-off scores equivalent to PASS+. RESULTS: Out of 1043 patients (599 operative, 444 non-operative; 51 ± 19 years; 84% women), 42% reported being PASS+ at 12 months' follow-up. The ROC areas under the curve were 0.71-0.84 (highest for SRS subscore), suggesting the questionnaire scores discriminated well between PASS+ and PASS-. The scores corresponding to PASS+ were > 3.5 for the SRS subscore (> 3.3-3.8 for SRS subdomains); ≤ 18 for ODI; and ≤ 3 for NRS pain. There were slight differences in cut-offs for subgroups of age, treatment type, aetiology, baseline symptoms, and sex. CONCLUSION: Most interventions for ASD improve patients' complaints but do not totally eliminate them. Reporting the percentage achieving a score equivalent to an "acceptable state" may represent a more stringent and discerning target for denoting treatment success in ASD. These slides can be retrieved under Electronic Supplementary Material.

Factor analysis of the SRS-22 outcome assessment instrument in patients with adult spinal deformity.

PURPOSE: Designed for patients with adolescent idiopathic scoliosis, the SRS-22 is now widely used as an outcome instrument in patients with adult spinal deformity (ASD). No studies have confirmed the four-factor structure (pain, function, self-image, mental health) of the SRS-22 in ASD and under different contexts. Factorial invariance of an instrument over time and in different languages is essential to allow for precise interpretations of treatment success and comparisons across studies. This study sought to evaluate the invariance of the SRS-22 structure across different languages and sub-groups of ASD patients. METHODS: Confirmatory factor analysis was performed on the 20 non-management items of the SRS-22 with data from 245 American English-, 428 Spanish-, 229 Turkish-, 95 French-, and 195 German-speaking patients. Item loading invariance was compared across languages, age groups, etiologies, treatment groups, and assessment times. A separate sample of SRS-22 data from 772 American surgical patients with ASD was used for cross-validation. RESULTS: The factor structure fitted significantly better to the proposed four-factor solution than to a unifactorial solution. However, items 14 (personal relationships), 15 (financial difficulties), and 17 (days off work) consistently showed weak item loading within their factors across all language versions and in both baseline and follow-up datasets. A trimmed SRS (16 non-management items) that used the four least problematic items in each of the four domains yielded better-fitting models across all languages, but equivalence was still not reached. With this shorter version there was equivalence of item loading with respect to treatment (surgery vs conservative), time of assessment (baseline vs 12 months follow-up), and etiology (degenerative vs idiopathic), but not age (< vs ≥50 years). All findings were confirmed in the cross-validation sample. CONCLUSION: We recommend removal of the worst-fitting items from each of the four domains of the SRS-instrument (items 3, 14, 15, 17), together with adaptation and standardization of other items across language versions, to provide an improved version of the instrument with just 16 non-management items.

Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trial†.

Background: Perioperative tranexamic acid (TXA) use can reduce bleeding and transfusion requirements in several types of surgery, but level I evidence proving its effectiveness in major spine surgery is lacking. This study was designed to investigate the hypothesis that TXA reduces perioperative blood loss and transfusion requirements in patients undergoing major spine procedures. Methods: We conducted a multicentre, prospective, randomized double-blind clinical trial, comparing TXA with placebo in posterior instrumented spine surgery. Efficacy was determined based on the total number of blood units transfused and the perioperative blood loss. Other variables such as the characteristics of surgery, length of hospital stay, and complications were also analysed. Results: Ninety-five patients undergoing posterior instrumented spine surgery (fusion of >3 segments) were enrolled and randomized: 44 received TXA (TXA group) and 51 received placebo (controls). The groups were comparable for duration of surgery, number of levels fused, and length of hospitalization. Transfusion was not required in 48% of subjects receiving TXA compared with 33% of controls (P = 0.05). Mean number of blood units transfused was 0.85 in the TXA group and 1.42 with placebo (P = 0.06). TXA resulted in a significant decrease in intraoperative bleeding (P = 0.01) and total bleeding (P = 0.01) relative to placebo. The incidence of adverse events was similar in the two groups. Conclusions: TXA did not significantly reduce transfusion requirements, but significantly reduced perioperative blood loss in adults undergoing major spinal surgery. Clinical trial registration: NCT01136590.

The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity.

INTRODUCTION: The Core Outcome Measures Index for the back (COMI-back) is a very brief instrument for assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability). However, it might be expected to be less responsive than a disease-specific instrument when evaluating specific pathologies. In patients with adult spinal deformity, we compared the performance of COMI-back with the widely accepted SRS-22 questionnaire. METHODS: At baseline and 12 months after non-operative (N = 121) and surgical (N = 83) treatment, patients (175 F, 29 M) completed the following: COMI-back, SRS-22, Oswestry Disability Index (ODI) and SF-36 PCS. At 12 months' follow-up, patients also indicated on a 15-point Global Rating of Change Scale (GRCS) how their back problem had changed relative to 1 year ago. Construct validity for the COMI-back was assessed by the correlation between its scores and those of the comparator instruments; responsiveness was assessed with receiver operating characteristics (ROC) analysis of COMI-back change scores versus the criterion 'treatment success' (dichotomized GRCS). RESULTS: Baseline values for the COMI-back showed significant (p < 0.0001) correlations with SRS-22 (r = -0.85), ODI (r = 0.83), and SF-36 PCS (r = -0.82) scores; significantly worse scores for all measures were recorded in the surgical group. The correlation between the change scores (baseline to 12 months) for COMI and SRS-22 was 0.74, and between each of these change scores and the external criterion of treatment success were: COMI-back, r = 0.58; SRS-22, r = -0.58 (each p < 0.0001). The ROC areas under the curve for the COMI-back and SRS-22 change scores were 0.79 and 0.82, respectively. CONCLUSION: Both baseline and change scores for the COMI-back correlated strongly with those of the SRS-22, and differed significantly in surgical and non-operative patients, suggesting good construct validity. With the "change in the back problem" serving as external criterion, COMI-back showed similar external responsiveness to SRS-22. The COMI-back was well able to detect important change. Coupled with its brevity, which minimizes patient burden, these favourable psychometric properties suggest the COMI-back is a suitable instrument for use in registries and can serve as a valid instrument in clinical studies emerging from such data pools.

Shorter and sweeter: the 16-item version of the SRS questionnaire shows better structural validity than the 20-item version in young patients with spinal deformity.

PURPOSE: In patients with adult spinal deformity, it was previously shown that 16 of the non-management items of the SRS-instrument showed a better fit to the theoretical four-factor model (pain, function, self-image, mental health) than did all 20 items. Whether the same phenomenon is observed in data from younger (< 20y) patients, for whom the questionnaire was originally designed, is not currently known. METHODS: Confirmatory factor analysis was used to evaluate the factor structure of the 20 non-management items of the SRS-instrument completed by 3618 young patients with spinal deformity (75.5% female; mean age, 15.0 ± 2.0 years) and of its equivalence across language versions (2713 English-speaking, 270 Spanish, 264 German, 223 Italian, and 148 French). The root mean square error of approximation (RMSEA) and comparative fit index (CFI) indicated model fit. RESULTS: Compared with the 20-item version, the 16-item solution significantly increased the fit (p < 0.001) across all language versions, to achieve good model fit (CFI = 0.96, RMSEA = 0.06). For both 16-item and 20-item models, equivalence across languages was not reached, with some items showing weaker item-loading for some languages, in particular German and French. CONCLUSION: In patients with adolescent idiopathic scoliosis, the shorter 16-item version showed a better fit to the intended 4-factor structure of the SRS-instrument. The wording of some of the items, and/or their equivalence across language versions, may need to be addressed. Questionnaire completion can be a burden for patients; if a shorter, more structurally valid version is available, its use should be encouraged.

Individualized antibiotic prophylaxis reduces surgical site infections by gram-negative bacteria in instrumented spinal surgery.

PURPOSE: Surgical site infection (SSI) can be a challenging complication after posterior spinal fusion and instrumentation (PSFI). An increasing rate of SSI by gram-negative bacteria (GNB) has been observed. Current guideline recommendations have not been effective for preventing infection by these microorganisms. METHODS: Retrospective cohort study comparing two consecutive groups of patients undergoing PSFI at a single institution. Cohort A includes 236 patients, operated between January 2006 and March 2007, receiving standard preoperative antibiotic prophylaxis with cefazolin (clindamycin in allergic patients). Cohort B includes 223 patients operated between January and December 2009, receiving individualized antibiotic prophylaxis and treatment based on preoperative urine culture. Cultures were done 3-5 days before surgery in patients meeting one of the following risk criteria for urinary tract colonization: hospitalization longer than 7 days, indwelling catheter, neurogenic bladder, history of urinary incontinence, or history of recurrent urinary tract infection. RESULTS: Twenty-two (9.3%) patients in cohort A developed SSI, 68.2% due to GNB. 38 (17%) patients in cohort B were considered at risk for GNB colonization; preoperative urine culture was positive in 14 (36%). After adjusted antibiotic prophylaxis, 15 (6.27%) patients in cohort B developed SSI, 33.4% due to GNB. A statistically significant reduction in GNB SSI was seen in cohort B (Fisher's exact test, p = 0.039). CONCLUSION: Higher preoperative GNB colonization rates were found in patients with neurogenic bladder or indwelling catheters. Preoperative bacteriological screening, treatment for bacteriuria, and individualized antibiotic prophylaxis were effective for reducing GNB SSI.

Muscle dysfunction and exercise limitation in adolescent idiopathic scoliosis.

Adolescent idiopathic scoliosis (AIS) can lead to ventilatory restriction, respiratory muscle weakness and exercise limitation. However, both the causes and the extent of muscle dysfunction remain unclear. The aim of our study is to describe muscle weakness and its relationship to lung function and tolerance to exercise in AIS patients. Lung and muscle function, together with exercise capacity, were assessed in 60 patients with pronounced spinal deformity (>40 degrees) and in 25 healthy volunteers. Patients with AIS had only mild to moderate abnormal ventilatory patterns, the most frequent of which were restrictive abnormalities. The function of respiratory and limb muscles and exercise capacity were below normal limits in AIS patients, and were significantly lower than in controls. Exercise capacity was found to correlate with the function of inspiratory, expiratory, upper limb and lower limb muscles which, in addition, were reciprocally interrelated. Multivariate analysis showed that lower limb muscle function is the main contributor to exercise intolerance. There appeared to be no connection between spinal deformity and lung function, muscle function or exercise capacity. We conclude that AIS patients show generalised muscle dysfunction which contributes to the reduction in their exercise capacity, even in the absence of severe ventilatory impairment.

Human adipose tissue-derived mesenchymal stromal cells as vehicles for tumor bystander effect: a model based on bioluminescence imaging.

Human adipose tissue mesenchymal stromal cells (AMSCs) share common traits, including similar differentiation potential and cell surface markers, with their bone marrow counterparts. Owing to their general availability, higher abundance and ease of isolation AMSCs may be convenient autologous delivery vehicles for localized tumor therapy. We demonstrate a model for tumor therapy development based on the use of AMSCs expressing renilla luciferase and thymidine kinase, as cellular vehicles for ganciclovir-mediated bystander killing of firefly luciferase expressing tumors, and noninvasive bioluminescence imaging to continuously monitor both, tumor cells and AMSCs. We show that the therapy delivering AMSCs survive long time within tumors, optimize the ratio of AMSCs to tumor cells for therapy, and asses the therapeutic effect in real time. Treatment of mice bearing prostate tumors plus therapeutic AMSCs with the prodrug ganciclovir induced bystander killing effect, reducing the number of tumor cells to 1.5 % that of control tumors. Thus, AMSCs could be useful vehicles to deliver localized therapy, with potential for clinical application in inoperable tumors and surgical borders after tumor resection. This approach, useful to evaluate efficiency of therapeutic models, should facilitate the selection of cell types, dosages, therapeutic agents and treatment protocols for cell-based therapies of specific tumors.

Analysis of nutritional parameters in idiopathic scoliosis patients after major spinal surgery.

OBJECTIVE: The aim of the study is to investigate the evolution of nutritional parameters after major spinal surgery in patients with idiopathic scoliosis. METHODS: This retrospective study included 31 patients with a mean age of 18 y, diagnosed with idiopathic scoliosis. The following variables were analyzed: demographic, surgical (type, number of fused segments, duration, and blood loss), nutritional assessment (proteins, albumin, prealbumin, transferrin, lymphocytes, and body mass index), and duration of hospitalization at different time points. Statistical analyses were performed with the SPSS 6.1 software. RESULTS: Before surgery, nutritional status was normal in all patients. At 24-48 h after surgery, statistically significant decrease with respect to preoperative values was recorded for all the parameters studied: proteins (P < 0.001), albumin (P < 0.001), prealbumin (P < 0.01), transferrin (P < 0.001), and lymphocytes (P < 0.001). CONCLUSION: Our results showed a significant postoperative decrease in the nutritional parameters analyzed in a previously well-nourished population considered to be at low risk for nutritional depletion.

Lateral distraction injury to the lumbar spine. Report of spontaneous reduction.

STUDY DESIGN: A patient with a lateral distraction injury of the lumbar spine that reduced spontaneously and not associated with any thoracic or abdominal injury is reported. SUMMARY OF BACKGROUND DATA: A brief summary of the clinical presentation is given as is the surgical technique employed. Lateral distraction injuries of the thoracolumbar spine associate a distraction injury with lateral bending in the frontal plane, causing unilateral disruption of the ligamentous and osseous restraints. The have been associated with life-threatening thoracic and abdominal injuries. Closed reduction of this spine injury is not believed to be feasible. CONCLUSIONS: This case introduces interesting new features to this spine lesion. It is the first reported case with documented spontaneous reduction.

Traumatic lumbosacral dislocation.

STUDY DESIGN: Case report of a patient with lumbosacral dislocation. OBJECTIVES: To report a case of traumatic lumbosacral dislocation treated nonoperatively, with 10 years of follow-up. SUMMARY OF BACKGROUND DATA: Lumbosacral dislocation is rare, with only 48 cases reported in the literature. Surgical treatment by means of open reduction and fusion is advisable. However, the literature shows six cases of patients with complete lumbosacral dislocation treated nonoperatively with good results. METHODS: A 38-year-old man was involved in a highspeed vehicle accident. The lumbosacral dislocation (anterior displacement of L5 on S1, 44% slippage) was initially missed, and the patient was treated conservatively. RESULTS: Slippage did not progress, and the patient returned to full, normal activity. Ten years later he is asymptomatic and is able to work and play sports. CONCLUSIONS: This study reports a rare injury of the lumbosacral junction that was detected 3 months after injury. Satisfactory results were obtained with nonoperative treatment in this case. Although a surgical approach is advisable in acute cases to decompress the neurologic structures and to stabilize the lumbosacral junction, conservative management may be the treatment of choice in inveterate lesions.

Vertebral fracture in a fused spine for scoliosis. A case report.

STUDY DESIGN: A case report. OBJECTIVES: To document a fracture of the 11th thoracic vertebra after spine fusion for adult idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: Three cases of vertebral fractures associated with spine fusion for scoliosis were found in the literature. METHODS: Medical and radiologic records and related literature were reviewed. RESULTS: A 30-year-old woman had undergone anterior and posterior fusion with Cotrel-Dubousset instrumentation for progressive idiopathic scoliosis. Two years after surgery, she was in a car accident. A radiographic study and computer tomographic scanning depicted a fracture of T11 and bending of the rods. Observation was instituted and symptoms resolved. CONCLUSIONS: Fracture of a vertebra within an extensive spine fusion for scoliosis is rare. The 360 degrees solid fusion together with strong posterior instrumentation may have had some protective effect in this patient.

Isolated thrombosis of the external jugular vein.

Thrombosis of the external jugular vein (EJV) is an infrequent clinical condition that has been associated with central venous catheterization, head and neck infections, intravenous drug abuse, and compression at the affected site. The authors report a case of thrombotic obstruction of the EJV in the late postoperative period after laparoscopic anterior lumbar interbody fusion. A 40-year-old morbidly obese woman with a depressive syndrome was diagnosed with L5-S1 discopathy and was submitted to laparoscopic anterior isthmic fusion. The operation lasted approximately 6 hours, during which the patient remained in a supine decubitus and Trendelenburg position. The left radial artery, peripheral veins, and right internal jugular vein were canalized. The internal jugular vein catheter was electively withdrawn 24 hours after the intervention. The postoperative period was satisfactory, and the patient was started on prophylaxis with low-molecular-weight heparin. She sat up and began walking at 24 hours and was discharged to her home 4 days after the procedure. Eight days after discharge she returned, experiencing right cervical pain. Palpation revealed a painful induration and erythematous area under the anterior edge of the sternocleidomastoid muscle. Results of otoscopy and laryngoscopy were normal. Cervical echo-Doppler disclosed an image consistent with EJV thrombosis. The most frequent causes of jugular vein thrombosis are mentioned above. A higher incidence has been described after upper abdomen and pelvic surgery; other contributing factors are age, obesity, and associated illness. There are few references in the literature to position-induced EJV thrombosis in the late postoperative period. The authors' patient presented signs and symptoms of EJV thrombosis (probably because of various factors), which was confirmed by echo-Doppler study and treated with 10 days of calcic heparin.

Four radiological measures to estimate shoulder balance in scoliosis.

We studied four indirect radiological measures of shoulder balance, their correlation with true shoulder balance, and measurement error of each method. Thirty-three consecutive patients with idiopathic scoliosis requiring surgical treatment were selected. Actual shoulder level was determined from a line in the top margin of the acromion clearly visualized in the wide chart. Indirect references used to assess shoulder balance were tilting of cephalic end-plate of T1, inclination of a line through superior border of both first ribs, the level of top margin of coracoid processes, and the level of two specific points where the clavicle intersects the rib cage. All radiographs were assessed by three independent observers. Correlation coefficients between each measurement and true shoulder level were 0.54 for T1 tilting (p = 0.001), 0.63 for first rib inclination (p < 0.001), 0.96 for coracoid process (p = 0.0001), and 0.93 for clavicle-rib cage intersection (p = 0.0001).

[Total parenteral nutrition in major surgery of the spine]. / Nutrición parenteral total en la cirugía mayor del raquis.

This paper presents clinical experience with the use of total parenteral nutrition (TPN) in patients undergoing major spinal surgery, as well as the identification of possible risk factors involved in the extended duration of TPN. Although TPN is an expensive therapy, it may even represent a cost saving in patients with a high risk of developing malnutrition. Therefore, it is necessary to identify those patients with the greatest likelihood of presenting nutritional deterioration in order to select those who would benefit from post-operative TPN. During the period under analysis (1995-1998), 137 patients were operated on and could be analyzed retrospectively. The variable considered were: age, sex, weight, body mass index, height, diagnosis, type and time of surgery involved, bleeding, duration of TPN and number of days admitted. The statistical analysis was carried out using the SPSS 6.1 for Windows software package. It comprised a descriptive univariate study, a bivariate comparative means analysis using Student's t test and multi-variant analysis using multiple regression. In the bivariate analysis, a greater duration of TPN was found in those patients subjected to circumferential arthrodesis (p = 0.0001), as well as in patients diagnosed as having kyphoscoliosis following neuromuscular disease (p = 0.0041). The multi-variant analysis gave a correlation statistically significant duration of TPN and surgery time (p = 0.00001), intra-operative bleeding (p = 0.01) and weight (p = 0.0002). No link was found between the duration of TPN and age, nor with the number of days spent in hospital.

Double-level spinal injury resulting in "en bloc" dislocation of the lumbar spine. A case report.

We report the case of a 21-year-old man with a unilateral lumbosacral dislocation together with a fracture of L1 resulting in "en bloc" dislocation, which is difficult to classify from an anatomopathological and biomechanical point of view. Unilateral lumbosacral dislocation is likewise an infrequent injury with less than 10 cases previously reported. Its association results in an anterior displacement to the left of the whole lumbar spine. To our knowledge, this displacement "en bloc" of the lumbar spine represents a rotatory dislocation of the same, an injury which we have not seen described until now in the literature.

Tuberculosis of the knee. Surgical or conservative treatment?

This report presents the clinical histories and the radiological, histologic and bacteriological findings of nine patients with tuberculosis of the knee, diagnosed and treated between 1974 and 1980. The authors review the results of the medical and surgical treatments.

Relationship of gastric metaplasia and age, sex, smoking and Helicobacter pylori infection in patients with duodenal ulcer and duodenitis.

Gastric metaplasia is one of the factors in duodenal ulcer appearance. The aim of this study was to investigate the frequency of gastric metaplasia and its connection with age, sex, cigarette smoking and H. pylori infection. In the study 216 patients were included. There were 98 patients with duodenal ulcer, 60 with duodenitis, and 58 healthy control subjects. There was no statistically significant difference in gastric metaplasia frequency according to age and sex. Gastric metaplasia was statistically more significant in patients with duodenal ulcer (p < 0.01). In all the subjects cigarette smoking did not significantly influence gastric metaplasia. In smokers with duodenal ulcer, and those who besides duodenal ulcer and smoking had H. pylori infection gastric metaplasia was more frequent (p < 0.01). However, in patients with duodenal ulcer, there was no statistically significant difference of gastric metaplasia related to H. pylori presence. It may be suggested that H. pylori infection is not of indispensable significance for gastric metaplasia appearance.

Effect of Helicobacter pylori eradication on extent of duodenal gastric metaplasia and grade of gastritis.

The extent of the regression of duodenal gastric metaplasia (DGM) after the eradication of Helicobacter pylori infection is controversial. Therefore, we decided to assess the degree of DGM before, sex weeks and one year after H. pylori eradication. 105 consecutive Helicobacter pylori positive patients with endoscopically proven duodenal ulcer, with DGM and Helicobacter pylori infection were recruited for this study. The diagnosis of Helicobacter pylori infection was based on CLO-test and histology, and DGM was assessed on four bulb biopsies taken before, sex weeks and one year after Helicobacter pylori eradication. Histological assessment of Helicobacter pylori associated gastritis was performed according to the Sydney classification. Follow up study on 98 patients before, six weeks and one year after the eradication of Helicobacter pylori showed that the mean extent of DGM did not change significantly after eradication and did not differ when compared with 14 patients with persisting infection. Our results show that the inflammatory process related to Helicobacter pylori does not play the main role in the development of DGM.