A decision analysis to identify the ideal treatment for adult spinal deformity: is surgery better than non-surgical treatment in improving health-related quality of life and decreasing the disease burden?

BACKGROUND: Adult spinal deformity (ASD) is a major public health problem. There are pros and cons of the available treatment alternatives (surgical or non-surgical) and it had been difficult to identify the best treatment modality. AIM: To construct a statistical DA model to identify the optimum overall treatment in ASD. METHODS: From an international multicentre database of ASD patients (968 pts), 535 who had completed 1 year follow-up (371 non-surgical-NS, 164 surgical-S), constitute the population of this study. DA was structured in two main steps of: (1) baseline analysis (assessing the probabilities of outcomes, assessing the values of preference-utilities-, combining information on probability and utility and assigning the quality adjusted life expectancy (QALE) for each treatment) and (2) sensitivity analysis. RESULTS: Four hundred and thirty-two patients (309 NS, 123 S) had baseline and 1 year follow-up ODI measurements. Overall, 104 (24.1 %) were found to be improved (a decrease in ODI > 8 points), 225 (52.1 %) unchanged (-8 > ODI > 8) and 65 deteriorated. Surgery presented with a higher chance of improvement (54.2 %) versus NS (9.7 %). The overall QALE ranged from 56 to 69 (of 100 years) and demonstrated better final QALE in the NS group (60 vs. 65, P = 0.0038), this group having started with higher QALE as well (56 vs. 65 years, P < 0.0001). There were improvements in overall QALE in both groups but this was significant only in the surgical group (S from 56 to 60 years, P < 0.0001; NS from 65 to 65 years, P = 0.27). In addition, in the subgroup of patients with significant baseline disability (ODI > 25) surgery appeared to yield marginally better final QALE (58 vs. 56 years, P = 0.1) despite very a similar baseline (54 vs. 54 years, P = 0.93). DISCUSSION AND CONCLUSIONS: This study demonstrated that a single best treatment modality for ASD may not exist. Conservative treatment appears to yield higher (up to 6 %) QALE compared to surgery, most probably secondary to a higher baseline QALE. On the other hand, surgery provides a significantly higher increase in QALE. Especially in patients with significant disability at baseline, the final QALE tended higher in the S group (although not significant). Finally, chances of a relevant improvement at first year turned out to be significantly lower with NS treatment.

Safety and efficacy of osteotomies in adult spinal deformity: what happens in the first year?

PURPOSE: Spinal surgery for adult spinal deformity (ASD) may require the use of osteotomies, which may have high complication rates (up to 80 %). These may be expected to affect health-related quality of life (HRQOL) in the early postoperative phase but little is known about the clinical course of these patients in the first year following surgery. The aim of the study is to evaluate the radiological results and HRQOL in patients undergoing a spinal osteotomy for ASD within the first year following surgery with special reference to the effect of complications. METHODS: From a prospective multicenter ASD database, patients who had undergone a Smith-Petersen osteotomy (SPO), pedicle substraction osteotomy (PSO), vertebral column resection (VCR) or any combination of these were reviewed for radiological sagittal alignment parameters [sagittal vertical axis (SVA), global tilt, lumbar lordosis, T2-sagittal tilt (ST)] as well as HRQOL [Oswestry Disability Index (ODI), short form-36 items (SF-36) Physical Component Score (PCS), SF-36 mental CS (MCS), Scoliosis Research Society (SRS)-22 questionnaire (SRS-22) subtotal] preoperatively and at the 6th- and 12th-month follow-ups with special reference to complications classified as major (life threatening or requiring additional surgery) and minor and their effects on HRQOL. RESULTS: 121 patients (85 F, 36 M) with a total of 71 SPOs, 45 PSOs and 13 VCRs were evaluated. Osteotomy resulted in correction of the major coronal Cobb angle from 43.0 ± 3.7° to 24.8 ± 2.8° (p < 0.001) and the SVA from 69.0 ± 10.3 to 52.4 ± 6.6 mm (p = 0.001). Other radiological parameters showed no significant changes. Remarkable improvements in HRQOL scores with a strong age effect (p ≤ 0.01), for all instruments except SF-36 MCS, were found. Most of these HRQOL improvements have been achieved within the first 6 months. A total of 114 complications (59 major, 55 minor) that had a lesser effect on the age-adjusted HRQOL scores (p < 0.05) (except for the SF-36 PCS) and 1 death were observed. CONCLUSIONS: Osteotomies were moderately effective in radiological improvement but resulted in a significant increase in HRQOL. They were associated with a high rate of complications but these had no/minimal effect on the clinical outcome. Contrary to the general perception, the greatest improvements in HRQOL were seen to take place during the first 6 months after surgery, even in the presence of complications.

Analysis of the reliability of surgeons' ability to differentiate between idiopathic and degenerative spinal deformity in adults radiologically. What descriptive parameters help them decide?

PURPOSE: Adult spinal deformity (ASD) may be classified as idiopathic (ID) or degenerative (DD) (or other) based on classifier's perception, the reliability of and factors inherent to which remain unknown. The aim of this study is to evaluate the inter- and intra-observer reliability of surgeons' perception in differentiating ID from DD and to identify the determinants of this differentiation. METHODS: From a multicentric prospective database of ASD, 179 patients were identified with the diagnosis of ID (n = 103) or DD (n = 76); without previous surgery; and a lumbar coronal curve larger than 20°. Standing antero-posterior and lateral X-rays of these patients were sent to five experienced spine surgeons to be identified as DD or ID (or other); followed by a second round after reshuffling. Weighted kappa statistics were used, the strength of agreement for the kappa coefficient was considered as; 0.81-1 = almost perfect, 0.61-0.8 = substantial, 0.41-0.60 = moderate, 0.21-0.40 = fair, 0.01-0.20 = slight, and ≤0 = poor. Patients were then stratified based on the number of agreements on a total of 10 rounds as excellent (10 out of 10), good (more than 7 out of 10) and fair/poor (7 and less). These excellent and good agreements were further compared for additional radiological parameters. RESULTS: Agreement levels were moderate to substantial for intra but mostly fair for inter-observer comparisons. For ID patients, there were 42 cases with excellent and 38 with very good agreement whereas for DD, there were no excellent and only 17 cases with very good agreement. Upon comparison of these (ID vs DD for at least very good cases), it was seen that they were different for some coronal parameters such as lumbar Cobb angle (larger in ID, p < 0.001), central sacral vertical line (CSVL) modifier (C more common in ID, p = 0.007) and presence of rotatory subluxation (less common in DD, p = 0.017), but very different for sagittal parameters (lumbar lordosis, sagittal vertical axis, T2 sagittal tilt, pelvic tilt, sacral slope, and global tilt; increased sagittal imbalance in DD, all p ≤ 0.001). CONCLUSION: Surgeons in this study demonstrated reasonable (moderate to substantial) intra-observer agreement, but only fair agreement amongst them. Alarming as it may appear, we should be cautious in interpreting these results based on only radiology and no clinical information. In patients with good agreement, the most consistent radiologic determinant of degenerative ASD appeared to be the presence of sagittal imbalance.

Sacropelvic fixation in adult spinal deformity (ASD); a very high rate of mechanical failure.

BACKGROUND: Sacropelvic fixation (SPF) is an integral part of ASD surgery. Literature suggests that combination of S1 and iliac screws may be associated with lowest rate of complications. AIM: To analyze the rate and potential factors of mechanical failure associated with SPF in adult spinal deformity surgery. MATERIALS AND METHODS: Of 504 patients enrolled in a prospective multicentric database, 239 were treated conservatively and 265 were treated surgically. Forty-five of those who had sacroiliac fixations and with >6 months (or to failure) f/up constitute the population. Type of iliac fixation was S2 alar/iliac (S2AI) screws in 20 (44.4%) and iliac screws with lateral connectors (IwL) in 25 (55.6%). Diagnoses were degenerative in 20, failed back in 11 and other in 14. Average instrumentation length was 11.6 ± 4.0 levels. Cases with failure were compared to those without using Fisher's Exact and Mann-Whitney U tests. RESULTS: A total of 16 implant related complications were identified (35.6%). Failures were identified on an average of 224.1 days (8-709) following index surgery. Failure rate of S2AI screws was 35 vs. 12% for IwL screws (p > 0.05). All broken screws were associated with S2AI technique with polyaxial screws. Comparison of failed cases to others revealed that failed cases had inadequate restoration of Lumbar Lordosis but this was not statistically insignificant. Only age was a significantly different, patient with failure being older. DISCUSSION: Pelvic fixation is still associated with a very high rate of mechanical failure. Major risk factors appear to be age and type of fixation. Although could not be shown to be statistically significant, failure to restore the optimal sagittal balance may be a contributing factor as well. So in conclusion, in cases with suboptimal sagittal plane correction, S2AI with polyaxial screws seem to have higher risk of short-term acute failure compared to IwL.

Sagittal alignment of cervical spine in adult idiopathic scoliosis.

PURPOSE: Alignment of the cervical spine (CS) in adolescent idiopathic scoliosis (IS) as well as in asymptomatic adult populations has recently been studied and described as being less lordotic in the adolescent IS population. However, few studies have examined the sagittal alignment of the CS in adult IS or its association with other radiological variables and clinical relevance. The aim of this study is to analyse the sagittal alignment of CS in adult IS and its association with age, alignment of the thoracic, lumbar and global spinal column as well as health-related quality of life (HRQOL) parameters. METHODS: A retrospective review of prospectively collected data from a multicenter database was performed. Of 468 consecutive adult IS patients, 213 were included in the study; the remainder were excluded due to poor quality X-rays where the CS was not properly visible, or previous surgery. X-rays were measured for the following CS parameters: [Cranial base-C2 (C0-C2) lordosis, C2-C7 lordosis, thoracic (T1) slope, thoracic inlet angle (TIA) and odontoid (Od)-T1 offset using a measurement software]. These measurements were then evaluated for possible associations with patient age and with pre-existing alignment parameters and HRQOL scores using Pearson correlation tests. RESULTS: The average and standard deviations for CS alignment parameters were 32.3° ± 10.2° for C0-C2; 5.7° ± 14.1° for C2-C7; 23.9° ± 11.3° for T1 slope, 70.5° ± 14.7° for TIA and 20.8° ± 16.5° for Od-T1 offset. CS alignment showed a significant (p < 0.05) correlation with age, T kyphosis and several other sagittal alignment parameters such as sagittal vertical axis (SVA), global tilt and T1 sagittal tilt, but not with the HRQOL parameters. CONCLUSION: The sagittal alignment of the CS in adult IS is less lordotic than the normal average while less kyphotic than that of IS of a younger age. It correlates with age, thoracic kyphosis and some global sagittal alignment parameters. These findings suggest that CS alignment is likely a component of the global sagittal alignment strongly affected by thoracic kyphosis, and most probably does not affect HRQOL by itself.

Comparison of efficacy of Oral versus Intra-articular Corticosteroid Application in the treatment of Frozen Shoulder: An experimental study in rats.

OBJECTIVE: The aim of this study was to compare clinical and histopathological effects of oral versus intraarticular corticosteroid application in a rat model of frozen shoulder. METHODS: In this study, eighty adult Sprague-Dawley rats were used. The animals were divided into 5 equal groups. The frozen shoulder model was created by immobilizing animals' shoulders with internal fixation with sutures for 8 weeks. At the 8th week, sham (n: 16) and control (n: 16) groups were sacrificed to collect data for healthy and affected shoulders. Also, at the 8th week, 50 mg/ kg methylprednisolone was started for the oral treatment group, and a single dose of 0.5 mg/kg triamcinolone acetonide was injected for the intraarticular treatment group. The effect of additional steroid treatment was expected for 2 weeks, then all remaining treatment and natural course groups were sacrificed on the 10th week. RESULTS: After sacrification, specimens taken as "en bloc" scapulothoracic disarticulation were randomly divided into two groups for a range of motion measurement and histopathological examination. The control (frozen shoulder model) group's shoulder range of motion in all directions was lower than the sham (healthy) group (P < 0.01). Natural course and intraarticular steroid groups, compared to the frozen shoulder model showed a significant increase in the direction of abduction (P < 0.05). Also, it was found for treatment groups that in all directions the range of motion was not as good as the healthy values (P < 0.01). The intraarticular treatment group showed higher degrees of abduction compared to the natural course and oral steroid treatment groups (P < 0.01). Oral steroid treatment group's range of motion was not significantly better than the disease model and had no superiority to the natural course group (P > 0.05). Histopathologically, no statistically significant difference was observed between the groups for signs of frozen shoulder which was found in the immobilized group (P > 0.05). Histopathologically, immobilization was found to cause thickening of the capsule that cannot be resolved by treatment. (P < 0.05). CONCLUSION: In frozen shoulder disease, intraarticular steroid injection seems to be superior in increasing the range of motion than oral steroid treatment.

Biomechanical Comparison of Polymethylmethacrylate Augmentation Methods in Failed Pedicle Screw Revision.

AIM: To compare biomechanical results between different polymethylmethacrylate (PMMA) augmentation methods on failed lumbar pedicle screw models of animal vertebrae. MATERIAL AND METHODS: Thirty lumbar vertebrae were harvested from six calves, and their bone mineral density was measured. 60 Polyaxial pedicle screws were inserted to all vertebrae. Pull-out tests were performed to all specimens on an Instron machine. The specimens were randomly divided into four groups. The same screws used in primary screwing process were labeled and used in revision. Screws in the first group were augmented by injecting PMMA into the failed screw hole with a syringe; screws in the second group by inserting bone graft and roll-shaped PMMA, screws in the third group by inserting bone graft and injecting PMMA with a syringe; and the fourth group by inserting bone graft and injecting PMMA through a fenestrated pedicle screw. The pull-out strength (POS) results of all specimens were recorded and compared with statistical analyses. RESULTS: The mean BMD of the vertebrae was 1.31 ± 0.225 g/cm < sup > 2 < /sup > and no significant difference was found between the groups (p > 0.05). The mean POS of the primary screws in the first, second, third, and fourth groups were 2166,5 N/m < sup > 2 < /sup > , 2183,5 N/m2, 2508,5 N/m < sup > 2 < /sup > , and 2005c N/m < sup > 2 < /sup > respectively. After the augmentation, the mean POS in the first, second, third and fourth groups were 3839 N/m < sup > 2 < /sup > , 2874 N/m < sup > 2 < /sup > , 2929 N/m < sup > 2 < /sup > and 3826 N/m < sup > 2 < /sup > respectively. No statistical difference was found between the groups in post-revision POS values (p > 0.05). CONCLUSION: There was no significant statistical difference found in POS between the augmentation methods.

Supramalleolar osteotomy with a hexapod type external fixator for the treatment of ankle joint three planar deformity: Case report.

The varus ankle deformity can lead to osteoarthritis; therefore, numerous supramalleolar tibia osteotomy techniques are described to correct this deformity. Many of these techniques are more suitable for uniplanar ankle deformity. Particularly, if there are multiplane ankle deformities, the use of the six-axis deformity correction system may be successful in solving the problems which may occur during the correction. In this article, we report two cases of three plane deformities of ankle joint due to trauma sequelae, which were treated with supramalleolar osteotomy using a hexapod fixator which is called the Smart Correction Frame®.

Factors affecting lifespan following below-knee amputation in diabetic patients.

INTRODUCTION: Untreatable foot problems in diabetics may require lower extremity amputation, which has a high level of patient mortality. This high mortality rate is worse than most malignancies. The present study aimed to identify parameters that can be used to estimate survival in DM patients undergoing below-knee amputations for diabetic foot problems. MATERIALS AND METHODS: A total of 470 patients (299 males, 171 females) with a mean age of 64.32 years who underwent below-knee amputation for diabetic foot problems between 2004 and 2014 were enrolled in the study. The length of time from the operation to time of death was recorded in days. Patient details were obtained, including age during surgery, BMI, oral antidiabetic and insulin usage, dialysis therapy history, lower extremity endovascular intervention, previous amputation at the same extremity, the need for stump revision surgery during follow-up, and above-knee amputation at the same site. Biochemical test results of pre-operative HbA1c, ESR, and levels of CRP, BUN, and creatinine were also obtained. RESULTS: A total of 333 patients (70.9%) died and 137 (29.1%) survived post-surgery. Survival rates were 90% in the first 7 days, 84% in the first 30 days, and 64% after the first year. Patient median life expectancy post-surgery was 930 ± 106 days. Hemodialysis treatment (p = 0.001), endovascular intervention (p = 0.04), sex (p = 0.004), age (p = 0.001), BUN level (p = 0.001), and duration of insulin use (p = 0.003) were shown to be effective predictors of mortality. CONCLUSIONS: Life expectancy is low (<3 years) in DM patients requiring below-knee amputations for untreatable foot problems. Survival could be predicted by duration of insulin use, age, sex, and renal insufficiency. LEVEL OF EVIDENCE: Level IV, Therapeutic study.

Decision analysis to identify the ideal treatment for adult spinal deformity: What is the impact of complications on treatment outcomes?

OBJECTIVE: The aim of this study was to analyze the impact of treatment complications on outcomes in adult spinal deformity (ASD) using a decision analysis (DA) model. METHODS: The study included 535 ASD patients (371 with non-surgical (NS) and 164 with surgical (S) treatment) from an international multicentre database of ASD patients. DA was structured in two main steps; 1) Baseline analysis (Assessing the probabilities of outcomes, Assessing the values of preference -utilities-, Combining information on probability and utility and assigning the quality adjusted life expectancy (QALE) for each treatment) and 2) Sensitivity analysis. Complications were analyzed as life threatening (LT) and nonlife threatening (NLT) and their probabilities were calculated from the database as well as a thorough literature review. Outcomes were analyzed as improvement, no change and deterioration. Death/complete paralysis was considered as a separate category. RESULTS: All 535 patients were analyzed in regard to complications. Overall, there were 78 NLT and 12 LT complications and 3 death/paralysis. Surgical treatment offered significantly higher chances of clinical improvement but also was significantly more prone to complications (31.7% vs. 11.1%, p < 0.001). CONCLUSION: Surgical treatment of ASD is more likely to cause complications compared to NS treatment. On the other hand, surgery has been shown to provide a higher likelihood of improvement in HRQoL scores. So, the decision on the type of treatment in ASD needs to take both chances of improvement and burden associated with S or NS treatments and better be arrived by the active participation of patients and physicians equipped with the present information. LEVEL OF EVIDENCE: Level II, Decision analysis.

Evaluation of the Effect of Fixation Angle between Polyaxial Pedicle Screw Head and Rod on the Failure of Screw-Rod Connection.

Introduction. Polyaxial screws had been only tested according to the ASTM standards (when they were perpendicularly positioned to the rod). In this study, effects of the pedicle screws angled fixation to the rod on the mechanical properties of fixation were investigated. Materials and Method. 30 vertically fixed screws and 30 screws fixed with angle were used in the study. Screws were used in three different diameters which were 6.5 mm, 7.0 mm, and 7.5 mm, in equal numbers. Axial pull-out and flexion moment tests were performed. Test results compared with each other using appropriate statistical methods. Results. In pull-out test, vertically fixed screws, in 6.5 mm and 7.0 mm diameter, had significantly higher maximum load values than angled fixed screws with the same diameters (P < 0.01). Additionally, vertically fixed screws, in all diameters, had significantly greater stiffness according to corresponding size fixed with angle (P < 0.005). Conclusion. Fixing the pedicle screw to the rod with angle significantly decreased the pull-out stiffness in all diameters. Similarly, pedicle screw instrumentation fixed with angle decreased the minimum sagittal angle between the rod and the screw in all diameters for flexion moment test but the differences were not significant.

Restoration of pull-out strength of the failed pedicle screw: biomechanical comparison of calcium sulfate vs polymethylmethacrylate augmentation.

OBJECTIVE: The aim of the present study was to compare calcium sulfate (CAS) and polymethylmethacrylate (PMMA) bone cements used for the augmentation of a failed pedicle screw with biomechanical pull-out strength (POS) testing. METHODS: Thirty lumbar vertebrae were harvested from 6 calves and bone mineral densities (BMD) were measured. Primary polyaxial pedicle screws were randomly inserted and pulled out and the POSs of the specimen were recorded. For revision, specimens were randomly assigned to the CAS-augmented pedicle screws group (Group 1) or PMMA-augmented pedicle screw group (Group 2). Pull-out tests were repeated to compare both groups. RESULTS: Mean BMD of the specimens was 1.006 ± 0.116 g/cm(2). There were no statistically significant differences between BMD results of the two groups (p=0.116). For Group 1, mean POS of primary screws was 2,441.3 ± 936.4 N and was 2,499.5 ± 1,425.1 N after CAS augmentation, demonstrating no statistically significant difference (p=0.865). In Group 2, mean POS of the primary screws was 2,876.6 ± 926.6 N and significantly increased to 3,745.5 ± 1,299.2 N after PMMA augmentation (p=0.047). There was also a significant difference in mean POS between the CAS and PMMA groups (p=0.026). CONCLUSION: Although CAS augmentation facilitates a revision screw POS as strong as that of primary screws, it is not as strong as PMMA augmentation.

Primary extracranial meningioma of the lower limb.

This paper is about a primary extracranial meningioma case of a 40-year-old male patient who presented with a complaint of a rapidly growing painless stiff mass located in his left thigh. The magnetic resonance imaging examination revealed that the lesion was well-circumscribed and with isosignal intensity to muscle on T1-weighted images and with a relatively hiperintense on T2-weighted images. The histopathological analysis of the specimens both from the incisional biopsy and the excisional surgery were typical of meningioma showing spindle cell proliferation with a whirling pattern. Although extracranial meningiomas are very rare, it should be considered in the differential diagnosis of a spindle cell neoplasm.

A glomus tumor anterior to the patellar tendon: a case report.

Glomus tumors are benign neoplasms originating from the glomus body. They are most frequently found in the nail bed of the hands, and their occurrence in other parts of the body is rare. A 75-year-old man presented with left anterior knee pain of 30-year history, that became more intense with light touch or clothing and increased in severity despite medical treatment. Physical examination showed a painful, soft, mobile, red-purple colored mass, 2 x 2 cm in size, at the inferior border of the patella. Plain radiographs showed no pathology other than mild degenerative changes. Magnetic resonance imaging revealed a mass lesion, 1.5 x 1.1 x 2 cm in size, located at the anterior border of the patellar tendon, which showed hypointensity on T1A-weighted sequences and hyperintensity on T2-weighted sequences and T2-weighted sequences with fat saturation. The mass was excised and the histopathological diagnosis was reported as glomangioma. Postoperatively, the patient had no complaint of pain and no recurrence was observed during a two-year follow-up.