The projected increase of vertebral osteomyelitis in Germany implies a demanding challenge for future healthcare management of aging populations.

PURPOSE: Since an increase in the occurrence of native vertebral osteomyelitis (VO) is expected and reliable projections are missing, it is urgent to provide a reliable forecast model and make it a part of future health care considerations. METHODS: Comprehensive nationwide data provided by the Federal Statistical Office of Germany were used to forecast total numbers and incidence rates (IR) of VO as a function of age and gender until 2040. Projections were done using autoregressive integrated moving average model on historical data from 2005 to 2019 in relation to official population projections from 2020 to 2040. RESULTS: The IR of VO is expected to increase from 12.4 in 2019 to 21.5 per 100,000 inhabitants [95% CI 20.9-22.1] in 2040. The highest increase is predicted in patients over 75 years of age for both men and women leading to a steep increase in absolute numbers, which is fourfold higher compared to patients younger than 75 years. While the IR per age group will not increase any further after 2035, the subsequent increase is due to a higher number of individuals aged 75 years or older. CONCLUSIONS: Our data suggest that increasing IR of VO will seriously challenge healthcare systems, particularly due to demographic change and increasing proportions of populations turning 75 years and older. With respect to globally fast aging populations, future health care policies need to address this burden by anticipating limitations in financial and human resources and developing high-level evidence-based guidelines for prevention and interdisciplinary treatment.

Cervical spine fractures in ankylosing spondylitis patients: an analysis of the presentation and clinical results of 110 surgically managed patients in two spine centers.

PURPOSE: In this work, a two-center study was performed to study the clinical presentation of cervical spine fractures in ankylosing spondylitis (AS) patients and assess the surgical management of these fractures. METHODS: A retrospective analysis of prospectively collected data in two level-1 spine surgery centers was performed. Both spine centers have a standard database for all admitted patients. Inclusion criteria were surgically treated AS with cervical spine fracture diagnosis (from C1 to Th3) and postoperative follow-up minimum of 12 months. RESULTS: One hundred ten patients (105 male/5 female) were included. The mean age was 62 ± 10 years. The mean time between trauma and surgery was 49 ± 42 days. There was a history of mild trauma in 72 patients (65.4%). The clinical presentation was a pain in all patients. Twenty-seven (24.6%) had a neurological deficit at admission. The most common fracture level was C6/7 in 63 patients (57.23%). The VAS was 7 ± 1, and NDI was 34 ± 8 in the preoperative assessment. The mean preoperative kyphosis angle was 48 ± 26° between C2 and C7. Positioning and preparing of the patients on the operation table took a mean of 57 ± 28 min. The surgical approach was dorsal in 59 patients (53.6%), combined in 45 patients (40.9%), and ventral in 6 patients (6,5%). The mean number of the fixed levels was 6 ± 2 levels. Intraoperative complications occurred in 9 patients (8.2%). Postoperative Cobb angle improved to a mean of 17 ± 9 degrees. Neurological improvement occurred in 20/27 patients. In 12 patients, the recovery was complete. The mean postoperative follow-up was 46 ± 18 months. VAS improved to 3 ± 1, and NDI improved to 14 ± 6 at the last postoperative visit. The improvement was clinically significant (p = 0.01 and 0.00, respectively). CONCLUSION: High suspicion of cervical spine fractures is necessary for patients with AS. CT and MRI images are necessary to rule out cervical spine fractures in AS patients, especially to detect occult fractures. Surgical treatment is safe, and the posterior approach with long-segment fusion is the approach of choice in this group of patients.

Spondylodiscitis due to transmitted mycotic aortic aneurysm or infected grafts after endovascular aortic aneurysm repair (EVAR): A retrospective single-centre experience with short-term outcomes.

PURPOSE: To report the challenging therapeutic approach and the clinical outcome of patients with pyogenic spondylodiscitis transmitted due to infected retroperitoneal regions of primary infected mycotic aortic aneurysms (MAAs) or secondary infected aortic stent grafts after endovascular aneurysm repair (EVAR). METHODS: Between 2012 and 2019, all patients suffering from spondylodiscitis based on a transmitted infection after the EVAR procedure were retrospectively identified. Patient data were analysed regarding the time between primary and secondary EVAR infection and spondylodiscitis detection, potential source of infection, pathogens, antibiotic treatment, complications, recovery from infection, mortality, numeric rating scale (NRS), COBB angle and cage subsidence. RESULTS: Fifteen patients with spondylodiscitis transmitted from primary or secondary infected aortic aneurysms after EVAR were included. The median follow-up time was 8 months (range 1-47). Surgery for spondylodiscitis was performed in 12 patients. In 9 patients, the infected graft was treated conservatively. MAAs were treated in 4 patients first with percutaneous aortic stent graft implantation followed by posterior surgery of the infected spinal region in a two-step procedure. Infection recovery was recorded in 11 patients during follow-up. The overall mortality rate was 27% (n = 4). The mean pain intensity improved from an NRS score of 8.4 (3.2-8.3) to 3.1 (1.3-6.7) at the last follow-up. CONCLUSION: EVAR was used predominantly to treat primary infected MAAs. Secondary infected grafts were treated conservatively. Independent of vascular therapy, surgery of the spine led to recovery in most cases. Thus, surgery should be considered for the treatment of EVAR- and MAA-related spondylodiscitis.

[Etiology, epidemiology, prognosis and biomechanical principles of neuromuscular scoliosis]. / Ätiologie, Epidemiologie, Prognose und biomechanische Besonderheiten neuromuskulärer Skoliosen.

Deformity due to neuromuscular disease is often progressive and associated with reduced vital capacity. In general, all treatment should be performed in specialized centers, since invasive measures are associated with an increased morbidity compared to adolescent scoliosis. Derived from the etiology and the resulting biomechanical basis (characteristics), important aspects and considerations arise for all healthcare institutions from the examination interval to the duration of conservative therapy and initiation of surgical therapy. Proper monitoring and assessment are key components to identify curve progression and to achieve preservation or improvement of basic functions.

Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients.

PURPOSE: To evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone metastases. MATERIALS AND METHODS: One hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects' pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected. RESULTS: Eighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n = 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P < .0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure. CONCLUSIONS: Results from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.

Magnetic resonance tomography for the early detection of occult fractures of the spinal column in patients with ankylosing spondylitis.

PURPOSE: The purpose of this study was to determine the extent to which magnetic resonance imaging (MRI) performed in patients with ankylosing spondylitis (AS) after low- and no-energy trauma leads to an improved diagnosis and, as a result, to a change in the therapeutic strategy. METHODS: All patients with AS, who underwent surgery after minor traumas (low-energy traumas, LETs) and patients without trauma history (NET: no-energy trauma), were retrospectively analysed. The diagnostic and planned surgical procedure was examined initially and again after total spine MRI in patients with persistent and/or new complaints. RESULTS: One hundred and thirty-six patients with AS after trauma were surgically treated. A total of 92 patients with LETs and 12 patients with NETs were included. After initial diagnostics (CT and X-ray) were performed in 15.4% of the patients with LET or NET (n = 16), we found occult fractures on MRI scans. In ten of these patients (6 LET, 4 NET) in which a previous decision was made to follow conservative therapy, no fracture indication was found on CT or X-ray. Two fracture heights were observed in six patients who experienced LET. However, on X-ray and CT, the fractures were only visible at one height. All fractures were treated surgically with stabilization and decompression if indicated. CONCLUSION: Considering the high percentage of our patient population with occult fractures, we recommend supplementing the basic diagnostic procedures with an MRI of the entire spinal column in patients with painful spinal column findings after minor trauma and for those with persistent pain without trauma. These slides can be retrieved under Electronic Supplementary Material.

Paget's disease of the lumbar spine: decompressive surgery following 17 years of bisphosphonate treatment.

BACKGROUND: We present a rare case of Paget's disease (PD) with involvement of the lumbar spine over a period of 19 years. We discuss the diagnostic process to rule out alternative diagnoses and medical and surgical treatment strategies. CASE DESCRIPTION: A 58-year-old man first diagnosed with PD in 1998 with solid involvement of the 4th lumbar vertebra has been undergoing periodic examinations over a period of 18 years. Since then, the patient has been treated conservatively with bisphosphonates. When conservative treatment options have been exhausted, surgery was indicated due to a progressively reduced ability to walk. Surgery with undercutting decompression via laminotomy was performed. PD was confirmed by biopsy. Bisphosphonate treatment was continued pre- and postoperatively. Follow-up examinations showed an improvement in clinical outcome measures. CONCLUSIONS: Conservative treatment remains the gold standard for PD with spinal involvement. This patient had been asymptomatic on bisphosphonate therapy for almost 17 years, but presented with new onset back pain. In such cases, fracture and rare conversion into sarcoma must be ruled out, and biopsy should be performed even in the absence of signs of malignancy. Currently, there are no clear treatment recommendations available in the literature regarding cases of PD with expansive growth and involvement of the spinal canal causing neurologic deficits. Furthermore, laminectomy has been shown to cause complications in up to 27% of cases with the risk of early postoperative death. In contrast, extended laminotomy and undercutting decompression should be considered.

Side specific differences of Hounsfield-Units in the osteoporotic lumbar spine.

Background: Gold standard for determining bone density as a surrogate parameter of bone quality is measurement of bone mineral density (BMD) by dual energy X-ray absorptiometry (DXA), most commonly performed on the lumbar spine (L1-L4). Computed tomography (CT) data are often available for surgical planning prior to spine procedures, but currently this information is not standardized for bone quality assessment. Besides, measuring the Hounsfield-Units (HU) is also of great importance in the context of biomechanical studies. This in vitro study aims in comparing BMD from DXA and HU based on diagnostic CT scans. In addition, methods are presented to quantify local density variations within bones. Methods: One hundred and seventy-six vertebrae (L1-L4) from 44 body donors (age 84.0±8.7 years) were studied. DXA measurements were obtained on the complete vertebrae to determine BMD, as well as axial CT scans with a slice thickness of 1 mm. Using Mimics Innovation Suite image processing software (Materialise NV, Leuven, Belgium), two volumes (whole vertebra vs. spongious bone) were formed for each vertebra, which in turn were divided in their left and right sides. From these total of six volumes, the respective mean HU was determined. HU of the whole vertebra and just spongious HU were compared with the BMD of the corresponding vertebrae. Side specific differences were calculated as relative values. Results: Whole bone and spongious HU correlated significantly (P>0.001; α=0.01) with BMD. A positive linear correlation was found, which was more pronounced for whole bone HU (R=0.72) than for spongious HU (R=0.62). When comparing the left and right sides within each vertebra, the HU was found to be 10% larger on average on one side compared to the opposite side. In some cases, the difference of left and right spongious bone can be up to 170%. There is a tendency for the side comparison to be larger for the spongious HU than for the whole vertebra. Conclusions: Determination of HU from clinical CT scans is an important tool for assessing bone quality, primarily by including the cortical portion in the calculation of HU. Unlike BMD, HU can be used to distinguish precisely between individual regions. Some of the very large side-specific gradients of the HU indicate an enormous application potential for preoperative patient-specific planning.

Spinal Orthoses in the Treatment of Osteoporotic Thoracolumbar Vertebral Fractures in the Elderly: A Systematic Review With Quantitative Quality Assessment.

STUDY DESIGN: Systematic review. OBJECTIVES: Spinal orthoses are frequently used to non-operatively treat osteoporotic vertebral fractures (OVF), despite the available evidence is rare. Previously systematic reviews were carried out, presenting controversial recommendations. The present study aimed to systematic review the recent and current literature on available evidence for the use of orthoses in OVF. METHODS: A systematic review was conducted using PubMed, Medline, EMBASE and CENTRAL databases. Identified articles including previous systematic reviews were screened and selected by three authors. The results of retrieved articles were presented in a narrative form, quality assessment was performed by two authors using scores according to the study type. RESULTS: Thirteen studies (n = 5 randomized controlled trials, n = 3 non- randomized controlled trials and n = 5 prospective studies without control group) and eight systematic reviews were analyzed. Studies without comparison group reported improvements in pain, function and quality of life during the follow-up. Studies comparing different types of orthoses favor non-rigid orthoses. In comparison to patients not wearing an orthosis three studies were unable to detect beneficial effects and two studies reported about a significant improvement using an orthosis. In the obtained quality assessment, three studies yielded good to excellent results. Previous reviews detected the low evidence for spinal orthoses but recommended them. CONCLUSION: Based on the study quality and the affection of included studies in previous systematic reviews a general recommendation for the use of a spinal orthosis when treating OVF is not possible. Currently, no superiority for spinal orthoses in OVF treatment was found.

Mediating Medical Comorbidities in Geriatric Patients Undergoing Surgery for OVCF: From Preoperative Screening to Risk and Outcomes Optimization.

OBJECTIVES: Osteoporotic vertebral compression fractures (OVCF) are a common increasing entity in elderly patients and represent a tremendous economic burden. Surgical treatment is related to high complication rates and little is known about patient-specific and internal risk factors associated with poor clinical results. METHODS: We carried out a comprehensive, systematic literature search according to the PRISMA checklist and algorithm. Risk factors for perioperative complications, for early inpatient readmission, for the duration of the hospital stay, the hospital mortality, the total mortality and the clinical result were analyzed. RESULTS: A total of 739 potentially usable studies were identified. After considering all inclusion and exclusion criteria, 15 studies with 15,515 patients were included. Non-adjustable risk factors were age >90 years (OR 3.27), male gender (OR 1.41), BMI less than 18.5 kg/m2 (OR 3.97), ASA score >3 (OR 2.7), activity of daily live (ADL) (OR 1.52), dependence (OR 5.68), inpatient admission status (OR 3.22), Parkinson disease (OR 3.63) and disseminated cancer (OR 2.98). Adjustable factors were insufficient kidney function (GFR <60 mL/min, and Creatinine Clearance below 60 mg/dl) (OR 4.4), nutrition status (hypalbuminemia (<3.5 g/dl)), liver function (OR 8.9) and further cardiac and pulmonary comorbidities. DISCUSSION: We identified a couple of non-adjustable risk factors, which should be considered preoperatively in terms of risk assessment. However, even more important were adjustable factors that can be influenced preoperatively. In conclusion, we recommend a perioperative interdisciplinary cooperation, especially with geriatricians, to achieve the best possible clinical results in geriatric patients undergoing surgery for OVCF.

Radiofrequency Ablation Provides Rapid and Durable Pain Relief for the Palliative Treatment of Lytic Bone Metastases Independent of Radiation Therapy: Final Results from the OsteoCool Tumor Ablation Post-Market Study.

PURPOSE: The OsteoCool Tumor Ablation Post-Market Study (OPuS One) was a prospective, multi-national, single-arm study to investigate safety and effectiveness of radiofrequency ablation (RFA) for palliation of painful lytic bone metastases with 12 months of follow-up. RFA has demonstrated effective palliation of osseous metastases in small clinical studies with short-term follow-up; however, a long-term assessment with robust subject numbers is lacking. MATERIALS AND METHODS: Prospective assessments were conducted at Baseline, 3 days, 1 week, and 1, 3, 6, and 12-months. Pain and quality of life were measured prior to RFA and postoperatively using the Brief Pain Inventory, European Quality of Life-5 Dimension, and European Organization for Research and Treatment of Cancer Care Quality of Life Questionnaire for palliative care. Radiation, chemotherapy and opioid usage, and related adverse events were collected. RESULTS: 206 subjects were treated with RFA at 15 institutions in OPuS One. Worst pain, average pain, pain interference and quality of life significantly improved at all visits starting 3 days post-RFA and sustained to 12 months (P < 0.0001). Post hoc analysis found neither systemic chemotherapy nor local radiation therapy at the index site of RFA influenced worst pain, average pain, or pain interference. Six subjects had device/procedure-related adverse events. CONCLUSION: RFA for lytic metastases provides rapid (within 3 days) and statistically significant pain and quality of life improvements with sustained long-term relief through 12 months and a high degree of safety, independent of radiation. LEVEL OF EVIDENCE: 2B, PROSPECTIVE, NON-RANDOMIZED, POST-MARKET STUDY: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Spinal Tuberculosis. / Tuberkulose der Wirbelsäule.

Tuberculosis is one of the most common infectious diseases worldwide. The frequency in Germany is low, however, an increase has been observed in the past few years. The incidence of extrapulmonary manifestation accounts for up to 10 to 20%. In 50% of these cases the spinal column is affected. Although literature reveals worldwide experiences in the treatment, in Germany spinal tuberculosis remains a rarity. Different pitfalls and specific characteristics regarding diagnosis and therapy are to consider. Therefore, a presentation of these specifics and their discussion based on the available literature will be presented. The purpose is to achieve an increase in awareness regarding this, in our latitudes, rare disease.

Surgical Treatment Strategies for Pyogenic Spondylodiscitis of the Thoracolumbar Spine. / Operative Behandlungsstrategien der pyogenen Spondylodiszitis der thorakolumbalen Wirbelsäule.

BACKGROUND: Despite advances, the morbidity and mortality rates of patients with spondylodiscitis remains high, with an increasing incidence worldwide. Although conservative therapy has progressed, several cases require surgical intervention. However, the indication and opportunities for surgical treatment are still disputable. METHODS: In a joint consensus, the members of the 'Spondylodiscitis' working group of the Spine Section of the German Society for Orthopaedics and Trauma Surgery considered current literature, particularly the newly published S2k guideline of the AWMF, and examined the surgical indications and treatment strategies for thoracolumbar spondylodiscitis. RESULTS: Surgical intervention for spondylodiscitis is only required in a small percentage of patients. In studies comparing conservative and surgical therapies, most patients benefitted from surgery, regardless of the surgical technique selected. Presently, the standard procedure is a combined dorsoventral approach, in which a monolateral attempt should always be made. The choice of material (PEEK, titanium) for ventral support does not influence the clinical result.

A Rare Case of Wear Induced Complications after Cervical Disc Replacement. / Der seltene Fall einer abriebinduzierten Spätinfektion nach zervikaler Bandscheibenendoprothesenimplantation.

Wear-induced complications after cervical disc replacement (CDR) are rare. A literature review on this topic found only a few case reports. We present a case of late complications after implantation of two cervical disc replacements, which resulted in infectious/abrasion-induced mixed-type inflammation with extensive osteolysis. The diagnostic workup, surgical therapy and outcome are presented and discussed with a review of the recent literature.

Halo Fixator and Halo Traction - Value for the Treatment of Spinal Disorders in Childhood. / Halofixateur und Halotraktion ­ Stellenwert bei Erkrankungen und Verletzungen der Wirbelsäule im Kindesalter.

The application of the Halo fixateur in case of spinal pathologies in childhood is a standardized technique. The halo fixateur may be used for treatment of injuries of the cervical spine, for additional stabilization following extended surgery at the cervical spine and their transitional regions as well as to achieve preoperative reduction in case of severe and rigid deformity. These indications are, referred to the early age, rare. However, the successful use of the Halo fixateur presumes a certain familiarity with the device and experiences regarding the underlying diseases to minimize related risks and to avoid possible complications. In this article the use and specific features regarding the application of the halo fixateur in childhood based on presented cases and the literature will be discussed.

Spontaneous intraoperative lumbar fracture leading to an unexpected correction in ankylosing spondylitis corrective surgery - a case report.

Severe kyphotic deformity in patients with ankylosing spondylitis can be corrected surgically to achieve a better spinal alignment and an improved visual axis. Different surgical techniques are used today depending on the extent of ossification and the degree of kyphosis. It is well known that the underlying disease leads to distinct biomechanical changes of the spinal column causing an increased fracture risk especially in case of minor trauma. This includes manipulations during surgical procedures as well as during the required perioperative measures. We present the case of a 45-year-old patient with severe global kyphotic deformity due to ankylosing spondylitis. During the elective corrective surgery (pedicle subtraction osteotomy at the level of L3) the patient sustained a spontaneous fracture at L2/3. This fortunately nondisplaced wedge-shaped fracture in the sense of a Smith-Peterson osteotomy led to a spontaneous correction of the kyphosis. The described unexpected event required a change in the surgical strategy. Correction could be achieved using a two-stage surgical procedure without further drawbacks for the patient. This case report stresses the need of particular attention regarding the increased susceptibility of the spinal column in case of ankylosing spondylitis.

Treatment of Severe Kyphoscoliosis in Children with Mucopolysaccharidosis Type I (Pfaundler-Hurler Syndrome) Using the Growing Rod Technique: A Case Series with Mid-Term Results.

BACKGROUND: Patients with mucopolysaccharidosis type I (MPS I) have a good life expectancy due to early therapeutic options, such as stem cell therapy. Stem cell therapy can prevent the progression of some skeletal malformations. In contrast, the progression of thoracolumbar kyphoscoliosis, genua vara, and hip dysplasia cannot be influenced. We present 3 cases of children with MPS I with thoracolumbar kyphosis/kyphoscoliosis treated with a growing rod system. CASE DESCRIPTION: The medical records and radiologic imaging of 3 children with a diagnosis of MPS I and kyphosis/kyphoscoliosis of the lumbar spine treated between 2007 and 2019 were retrospectively analyzed. Two children presented with a kyphoscoliosis, and 1 child had a combination of severe anterolisthesis and kyphoscoliosis. Surgery to correct the kyphosis and dorsal stabilization was performed in all patients after exhausted conservative treatment. There were no neurologic complications. Postoperative treatment and aftercare included a corset for 4 months and physical therapy. In all 3 patients, distraction surgery of the lumbar stabilization was done twice at a mean interval of 1 year. CONCLUSIONS: If conservative treatment fails and surgery is necessary, an individual approach is needed. Dorsal stabilization with pedicle screws using a growing rod technique is an option for the correction of thoracolumbar/lumbar kyphosis in children with MPS I. However, fusion should be prevented initially or should be kept as short as possible. We achieved acceptable correction of the spinal deformity using the growing rod technique. Finally, surgery with correction and fusion is necessary after exhausted correction potential.

Traumatic pneumorrhachis.

INTRODUCTION: Traumatic pneumorrhachis (PR) is a rare entity. There are only a few single cases published in English literature. In most of these cases PR was accidentally found during CT-diagnostics and remained asymptomatic. The exact pathogenesis of traumatic PR has not been conclusively clarified. It is assumed, that a sudden increase in thoracic pressure causes air to escape the alveoli and migrates along the fasciae towards the spinal canal. In this study we reviewed the patients of our clinic for 13 years. Eight Patients with traumatic PR could be detected. This study represents the biggest account of traumatic PR in literature and gives a hint for the diagnostic and therapeutical regimen. METHODS: We reviewed the radiological findings of our patients with thoracic trauma in the period from 2004 to 2016. We could detect eight patients with traumatic epidural PR and recorded any further injuries, therapies and outcome. Furthermore, a systematic literature review was carried out. RESULTS: We found a total of eight patients suffering from traumatic PR. One of them hat a combination of epidural and subarachnoidal PR due to an open skull injury. Another of these patients got spondylodiscites nine months later at the level of the PR. In one Patient we could show the spontaneous reabsorption of the air in a CT-scan 4 days after trauma. DISCUSSION: Traumatic PR remains a rare entity. It can be diagnosed with CT an MRT-scans. It needs no specific initial therapy besides the therapy of the underlying injuries. The prognosis of traumatic epidural PR is good and determined by the accompanying injuries. In cases of elevated paraclinical infection parameters one has to consider the development of spondylodiscitis in areas of PR.

Is the radiographic subsidence of stand-alone cages associated with adverse clinical outcomes after cervical spine fusion? An observational cohort study with 2-year follow-up outcome scoring.

BACKGROUND: The stand-alone treatment of degenerative cervical spine pathologies is a proven method in clinical practice. However, its impact on subsidence, the resulting changes to the profile of the cervical spine and the possible influence of clinical results compared to treatment with additive plate osteosynthesis remain under discussion until present. METHODS: This study was designed as a retrospective observational cohort study to test the hypothesis that radiographic subsidence of cervical cages is not associated with adverse clinical outcomes. 33 cervical segments were treated surgically by ACDF with stand-alone cage in 17 patients (11 female, 6 male), mean age 56 years (33-82 years), and re-examined after eight and twenty-six months (mean) by means of radiology and score assessment (Medical Outcomes Study Short Form (MOS-SF 36), Oswestry Neck Disability Index (ONDI), painDETECT questionnaire and the visual analogue scale (VAS)). RESULTS: Subsidence was observed in 50.5% of segments (18/33) and 70.6% of patients (12/17). 36.3% of cases of subsidence (12/33) were observed after eight months during mean time of follow-up 1. After 26 months during mean time of follow-up 2, full radiographic fusion was seen in 100%. MOS-SF 36, ONDI and VAS did not show any significant difference between cases with and without subsidence in the two-sample t-test. Only in one type of scoring (painDETECT questionnaire) did a statistically significant difference in t-Test emerge between the two groups (p = 0.03; α = 0.05). However, preoperative painDETECT score differ significantly between patients with subsidence (13.3 falling to 12.6) and patients without subsidence (7.8 dropped to 6.3). CONCLUSIONS: The radiological findings indicated 100% healing after stand-alone treatment with ACDF. Subsidence occurred in 50% of the segments treated. No impact on the clinical results was detected in the medium-term study period.

Single- and multiple-dose pharmacokinetics of linezolid and co-amoxiclav in healthy human volunteers.

In an open, randomized, two-period crossover study the pharmacokinetics of linezolid and co-amoxiclav were investigated after single- and multiple-dose administration in 12 healthy volunteers (six females and six males). Linezolid was given in tablets of 600 mg twice a day for 7 days and co-amoxiclav in tablets of 1000 mg (875 + 125 mg) once a day for 7 days. The wash-out period was 4 weeks between the administration of the two antibacterial agents. Blood and urine samples were collected on days 1 and 7 before and at different time points up to 24 h after medication. The concentrations of the antibiotics in serum and urine were measured by validated high-performance liquid chromatography methods. Linezolid exhibited a mean C(max) of 14.5 +/- 4.6 mg/L after T(max) of 47.5 +/- 20.1 min on day 1, with a significant increase to 24.0 +/- 6.9 mg/L on day 7 (P < 0.01). The AUD(tot) (total area under the data) revealed a significant increase from 140.5 +/- 28.3 mg.h/L on day 1 to 220.2 +/- 42.6 mg.h/L on day 7 (P < 0.01). There were no significant differences in terminal elimination half-life between days 1 and 7 (9.53 +/- 2.87 versus 7.97 +/- 3.08 h) or in total clearance (71.6 +/- 17.6 versus 81.5 +/- 14.7 ml/min.1.73 m(2)). Results are in agreement with the assumption of a limited accumulation of linezolid under the dosage regimen given. Serum linezolid concentrations in females were always higher than those in males. The volume of distribution V(ss)/f differed significantly between females and males (41.6 +/- 4.2 versus 52.2 +/- 3.3 L/70 kg; P < 0.01). Pharmacokinetic parameters of amoxicillin and clavulanic acid found in this study were similar to previously published data. No accumulation was found with co-amoxiclav. No serious adverse event was observed with the study drugs.