Translation, Adaptation, and Validation of a Spanish Version of the Japanese Orthopaedic Association Cervical Myelopathy Questionnaire.

STUDY DESIGN: Translation and psychometric testing of a questionnaire. OBJECTIVE: Translation, adaptation, and validation of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) to the Spanish language. SUMMARY OF BACKGROUND DATA: Degenerative cervical myelopathy (DCM) has a clear impact on quality of life (QoL). The JOACMEQ is a self-administered questionnaire used to assess DCM-related disability and its impact on QoL. It is compound of five domains: Cervical Function, Upper Extremity Function, Lower Extremity Function, Blader Function, and QoL. Despite its increasing use, the JOACMEQ has not yet been translated and validated for Spanish-speaking patients. METHODS: A total of 180 patients completed the Spanish version. Of these, 145 (80%) had DCM (mean age: 62.53; SD: 9.92), while 35 had neck pain without DCM (age: 52.71; SD: 10.29). The psychometric properties measured were construct validity, internal consistency, reproducibility, concurrent validity, and discriminatory ability. RESULTS: We recruited 145 patients with DCM (mean age: 62.5) and 35 with cervical pain (mean age: 52.7). After factor analysis, our data showed very strong construct validity, with questions strongly loaded and clustered for five factors. Internal consistency proved high (Cronbach's α coefficient of 0.912). The intraclass correlation coefficient showed very good reproducibility for all domain (intraclass correlation coefficient range between 0.85 and 0.95). A high correlation between the JOACMEQ QoL domain and neck disability index was also found (Spearman's ρ=-0.847, P <0.01) confirming concurrent validity. The receiver operating characteristic curves proved to be significant in the upper (area under the curve=0.65, P =0.006) and lower (area under the curve=0.661, P =0.003) extremities, confirming discriminatory ability. CONCLUSIONS: Our proposed Spanish version of the JOACMEQ retains the psychometric characteristics of the original JOACMEQ and could prove useful for the evaluation of patients with DCM in Spanish-speaking countries.

Is routine blood typing and screening necessary for degenerative cervical spine surgery patients in specialty surgical hospitals?

BACKGROUND: Blood loss warranting transfusion is a relatively rare requirement for degenerative cervical spine surgery. Despite this rarity, pretransfusion testing (blood typing, screening, and cross-matching) has become routine in most parts of the world. We sought to determine if such routine testing is necessary for patients who undergo degenerative cervical spine surgery patients in specialty surgical hospitals by (1) measuring the current rate of intraoperative transfusions in degenerative cervical spine surgery and (2) identifying risk factors for transfusions. STUDY METHODS: Retrospective review was performed on patients who underwent degenerative cervical spine surgery in two institutions. Demographic and baseline clinical and laboratory data were collected and analyzed to identify predictors of transfusion. Bivariate and multivariate logistic regression analysis was performed to identify perioperative transfusion risk factors. RESULTS: Overall transfusion rate was 1.9% (7/372), with no emergent transfusions. Decreases between preoperative and postoperative hemoglobin and hematocrit were 1.4 (SD 1.1) g/dL and 7.2 (SD 4.1) %, respectively. Multivariate logistic regression identified preoperative Hgb lower than 12 gr/dl (OR 27.62; 95% CI 4.31-176.96; p < 0.001) as significant independent transfusion risk factor. The receiver operating characteristic (ROC) curve for the model showed a very good discriminatory power with an area under the curve of 0.91. DISCUSSION: Our study suggests that pretransfusion testing for all patients undergoing degenerative cervical spine surgery is unnecessary. We recommend that only patients with preoperative Hgb lower than 12 gr/dl would routinely need pretransfusion testing.

Randomized clinical trial: expanded autologous bone marrow mesenchymal cells combined with allogeneic bone tissue, compared with autologous iliac crest graft in lumbar fusion surgery.

BACKGROUND CONTEXT: Although autogenous iliac crest bone graft (AICBG) is considered the gold-standard graft material for spinal fusion, new bone substitutes are being developed to avoid associated complications and disadvantages. By combining autologous bone marrow mesenchymal stromal cells (MSCs) expanded ex vivo and allogenic cancellous bone graft, we obtain a tissue-engineered product that is osteoconductive and potentially more osteogenic and osteoinductive than AICBG, owing to the higher concentration of MSCs. PURPOSE: This study aimed to evaluate the feasibility and safety of implanting a tissue-engineered product consisting of expanded bone marrow MSCs loaded onto allograft bone (MSC+allograft) for spinal fusion in degenerative spine disease, as well as to assess its clinical and radiological efficacy. STUDY DESIGN/SETTING: A prospective, multicenter, open-label, blinded-reader, randomized, parallel, single-dose phase I-II clinical trial. PATIENT SAMPLE: A total of 73 adult patients from 5 hospitals, with Meyerding grade I-II L4-L5 degenerative spondylolisthesis and/or with L4-L5 degenerative disc disease who underwent spinal fusion through transforaminal lumbar interbody fusion (TLIF). OUTCOME MEASURES: Spinal fusion was assessed by plain X-ray at 3, 6, and 12 months and by computed tomography (CT) at 6 and 12 months post-treatment. An independent radiologist performed blinded assessments of all images. Clinical outcomes were measured as change from baseline value: visual analog scale for lumbar and sciatic pain at 12 days, 3, 6, and 12 months posttreatment, and Oswestry Disability Index and Short Form-36 at 3, 6, and 12 months posttreatment. METHODS: Patients who underwent L4-L5 TLIF were randomized for posterior graft type only, and received either MSC+allograft (the tissue-engineered product, group A) or AICBG (standard graft material, group B). Standard graft material was used for anterior fusion in all patients. Feasibility was measured primarily as the percentage of randomized patients who underwent surgery in each treatment group. Safety was assessed by analyzing treatment-emergent adverse events (AEs) for the full experimental phase and appraising their relationship to the experimental treatment. Outcome measures, both radiological and clinical, were compared between the groups. RESULTS: Seventy-three patients were randomized in this study, 36 from the MSC+allograft group and 37 from the AICBG group, and 65 were surgically treated (31 group A, 34 group B). Demographic and comorbidity data showed no difference between groups. Most patients were diagnosed with grade I or II degenerative spondylolisthesis. MSC+allograft was successfully implanted in 86.1% of randomized group A patients. Most patients suffered treatment-emergent AEs during the study (88.2% in group A and 97.1% in group B), none related to the experimental treatment. X-ray-based rates of posterior spinal fusion were significantly higher for the experimental group at 6 months (p=.012) and 12 months (p=.0003). CT-based posterior fusion rates were significantly higher for MSC+allograft at 6 months (92.3% vs 45.7%; p=.0001) and higher, but not significantly, at 12 months (76.5% vs 65.7%; p=.073). CT-based complete response (defined as the presence of both posterior intertransverse fusion and anterior interbody fusion) was significantly higher at 6 months for MSC+allograft than for AICBG (70.6% vs 40%; p=.0038), and remained so at 12 months (70.6% vs 51.4%; p=.023). Clinical results including patient-reported outcomes improved postsurgery, although there were no differences between groups. CONCLUSIONS: Compared with the current gold standard, our experimental treatment achieved a higher rate of posterior spinal fusion and radiographic complete response to treatment at 6 and 12 months after surgery. The treatment clearly improved patient quality of life and decreased pain and disability at rates similar to those for the control arm. The safety profile of the tissue-engineered product was also similar to that for the standard material, and no AEs were linked to the product. Procedural AEs did not increase as a result of BM aspiration. The use of expanded bone marrow MSCs combined with cancellous allograft is a feasible and effective technique for spinal fusion, with no product-related AEs found in our study.

Síndrome de la espalda inclinada: Presentación de cuatro casos y revisión de la bibliografía / Bent spine syndrome. Presentation of four cases and literature review

El síndrome de la espalda inclinada o camptocormia es una causa de desequilibrio sagital del tronco no estructurada de difícil manejo médico y quirúrgico. Puede ser secundario a enfermedades del sistema nervioso central o periférico, o de origen primario muscular, como la atrofia aislada de la musculatura paravertebral espinal. El diagnóstico se basa en la evaluación clínica, los estudios por imágenes, la electromiografía y la biopsia muscular. El síndrome de la espalda inclinada, cualquiera fuera su causa, tiene un pronóstico pobre, los síntomas suelen progresar hasta afectar la bipedestación de manera irreversible. Presentamos un análisis retrospectivo de cuatro casos de síndrome de la espalda inclinada tratados en nuestro centro y una revisión de la bibliografía. Nivel de Evidencia: IV

Objectives: Bent spine syndrome (BSS) or camptocormia is a cause of unstructured sagittal imbalance of difficult medical and surgical management. The purpose of this paper is to describe the causes of BSS and how to approach its treatment. Materials and Methods: Retrospective analysis of 4 cases of BSS treated at our center and review of the literature. Results: The 4 patients were women between 60 and 82 years of age. In 3 of them, BSS was due to an isolated atrophy of the paravertebral erector spinae muscles, and in 1 of them, it was due to an inflammatory myopathy. Conclusions: The prognosis of BSS is poor in all cases, so symptoms usually progress to an irreversible difficulty to stand upright. Level of Evidence: IV

30-Day unplanned surgery in cervical spondylotic myelopathy surgically treated: a single-center experience.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Analyze the rate and risk factors associated with Unplanned Surgeries (US) during the first 30 days in patients treated for cervical spondylotic myelopathy. BACKGROUND: US are often regarded as a potentially useful quality of care indicator. METHODS: We defined US as any, non-planned, surgical procedure as a complication after "index" surgery. Demographic data, comorbidities, ASA, smoking status, surgical details and postoperative complications were collected. We conducted a subjective outcome test using the Global Outcome Score (GOS). To assess risk factors, a bivariate analysis was performed using T Student or Chi-square. Risk is shown as odds ratio (OR) with 95% confidence interval (CI). Multivariable logistic regression models with bootstrap resampling procedure were performed. RESULTS: The study included 303 patients (200 men) with mean age of 57.7 years (27-86) and mean follow-up of 75.35 months (16-126 m). 63.3% patients were ASA 1 or 2 and 41.9% were smokers. 77.9% of patients had some comorbidity. Anterior approach surgeries were 65.7%. Perioperative complications: 29% medical, 8.9% intraoperative and 3% implant related. US rate was 2.6%. Causes for revision were postoperative infection or deep hematomas. After bivariate analysis, the risk factors associated were diabetes mellitus (OR 2.6; 95% CI 1-5.5) and intraoperative complications (OR 6.5, 95% CI 1-40). The presence of US does not have influence in satisfaction using GOS score. CONCLUSIONS: Our US rate was 2.6%, similar to the literature. Diabetics and patients suffering an intraoperative complication are more likely to need an early reinterventions (OR 2.2 and 6.5, respectively). US did not alter the patient's outcomes. These slides can be retrieved under Electronic Supplementary Material.

The visual analog scale and a five-item verbal rating scale are not interchangeable for back pain assessment in lumbar spine disorders.

STUDY DESIGN: Prospective study of patients with chronic back pain from lumbar spine disorders. OBJECTIVE: To evaluate the degree of interchangeability of a 100-mm visual analog scale (VAS) and a 5-point verbal rating scale (VRS) for the assessment of pain intensity. SUMMARY OF BACKGROUND DATA: The fact that VAS and Likert scales are highly intercorrelated does not mean that both types of scales can be used interchangeably. METHODS.: A total of 151 patients (mean age, 52 ± 14.6 years) undergoing elective spine surgery completed a 100-mm VAS and a discrete 5-category VRS corresponding to the first item question of the core set ("How severe was your back pain in the last week?"). Pain intensity on the VAS was rated using the same question than for the VRS. The level of order-consistency (monotonic agreement), disordered pairs (D), percentage of agreement, and systematic disagreement (relative position), and relative concentration ([RC]) were estimated. VAS assessments were transformed into a discrete 5-category, with the cut-off VAS positions being defined by quintiles and equidistantly. RESULTS: For VAS defined equidistantly, monotonic agreement was 0.840, D was 0.080, and the percentage of identical pairs was 53%. The corresponding figures for VAS defined by quintiles were 0.809, 0.096, and 27.8%. Inconsistencies between the VAS and the VRS scales were also demonstrated by the marginal distributions, with PR values of -0.005 (95% confidence interval [CI], -0.011 to -0.002) and RC values of 0.144 (95% CI, 0.137-0.152) for VAS defined equidistantly, and PR values of 0.391 (95% CI, 0.384-0.397) and RC values of 0.265 (95% CI, 0.255-0.275) for VAS defined by quintiles. CONCLUSION: The order-consistency level was low with overlapping of pain records between the 2 scales, indicating that VAS and VRS are not interchangeable and, therefore, a results obtained with the use of each scale cannot be compared.