The diagnostic value of cytokines for the discrimination of vertebral osteomyelitis and degenerative diseases of the spine.

Vertebral osteomyelitis (VO) is a primary infection of the endplates of the vertebral bodies with secondary infection of the adjacent intervertebral discs. Diagnosis is often delayed due to unspecific symptoms and a lack of specific infection markers. In this prospective study, we determined the suitability of 27 cytokines for the discrimination of VO and degenerative diseases of the spine and compared its diagnostic potential in relation to the C-reactive protein (CRP), which is widely used as a non-specific inflammation marker in clinical diagnostics. The patients included in this study underwent surgical stabilization of the lumbar and/or thoracic spine with removal of 1 or more affected intervertebral discs, as therapy for VO (n = 16) or for erosive osteochondrosis (EO, control group, n = 20). We evaluated the cytokine and CRP concentrations before (pre-OP = -20-0d where 0 means the day of surgery) and after surgery (post-OP) on days 3-5, 6-11, 40-56, and 63-142. Compared to the control patients pre-OP, a significantly higher elevation of the 4 cytokines IL-6, IL-8, IL-12 (p70), and VEGF as well as CRP were found in the VO patients, showing an area under the curve > 0.80 pre-OP. No significant differences were observed between VO patients with high and low virulent bacteria with respect to all 5 elevated biomarkers. This is the first prospective study in which a broad spectrum of 27 cytokines was analysed via multiplex assay using sera from patients with and without VO. Our results show that, in addition to CRP, 4 different cytokines were significantly altered in VO but not control patients. The results implicate that these candidate cytokines may be used in a multiplex assay for discrimination between VO and degenerative diseases of the spine.

Biomechanical In Vitro and Finite Element Study on Different Sagittal Alignment Postures of the Lumbar Spine During Multiaxial Daily Motion.

Lumbar lordotic correction (LLC), the gold standard treatment for sagittal spinal malalignment (SMA), and its effect on sagittal balance have been critically discussed in recent studies. This paper assesses the biomechanical response of the spinal components to LLC as an additional factor for the evaluation of LLC. Human lumbar spines (L2L5) were loaded with combined bending moments in flexion (Flex)/extension (Ex) or lateral bending (LatBend) and axial rotation (AxRot) in a physiological environment. We examined the dependency of AxRot range of motion (RoM) on the applied bending moment. The results were used to validate a finite element (FE) model of the lumbar spine. With this model, the biomechanical response of the intervertebral discs (IVD) and facet joints under daily motion was studied for different sagittal alignment postures, simulated by a motion in Flex/Ex direction. Applied bending moments decreased AxRot RoM significantly (all P < 0.001). A stronger decline of AxRot RoM for Ex than for Flex direction was observed (all P < 0.0001). Our simulated results largely agreed with the experimental data (all R2 > 0.79). During the daily motion, the IVD was loaded higher with increasing lumbar lordosis (LL) for all evaluated values at L2L3 and L3L4 and posterior annulus stress (AS) at L4L5 (all P < 0.0476). The results of this study indicate that LLC with large extensions of LL may not always be advantageous regarding the biomechanical loading of the IVD. This finding may be used to improve the planning process of LLC treatments.

Quality of life and mortality after surgical treatment for vertebral osteomyelitis (VO): a prospective study.

PURPOSE: Vertebral osteomyelitis (VO) has a high mortality and leads to chronic pain and functional disability. Surgical treatment is often necessary. To date, little is known about the consequences of surgery on patient outcome. The aim of this study was to determine the quality of life (QoL) and mortality rates of surgically treated VO patients for a period of 2 years. METHODS: Patients with VO undergoing surgical treatment in a tertiary referral hospital from 2008 to 2015 were included prospectively. Data were collected before (T0) as well as 1 year (T1) and 2 years (T2) post-surgery. Within the European Spine Tango registry, prospective patient and QoL data were collected using validated outcome scores: Oswestry Disability Index, Short Form 36/EuroQol, Visual Analog Scale, and Core Outcome Measures Index. RESULTS: From 195 patients surgically treated for VO, QoL data were available from 136 patients at T0, 100 patients at T1, and 82 patients at T2, respectively. The 1- and 2-year mortality rates were 20% and 23%. Mainly all QoL outcome scores showed significant improvement at T1 and did not change significantly from T1 to T2. CONCLUSION: Surgical treatment of VO patients leads to significantly improved QoL. Nevertheless, QoL levels were below those of the general population. Our results underscore that spine disability questionnaires measuring QoL are mandatory to demonstrate comprehensively the severity of this entity. Our study confirms a high mortality and points out the role of VO as a potentially life-threatening condition.

Biomechanical In Vitro Test of a Novel Dynamic Spinal Stabilization System Incorporating Polycarbonate Urethane Material Under Physiological Conditions.

Posterior dynamic stabilization systems (PDSS) were developed to provide stabilization to pathologic or hypermobile spinal segments while maintaining the healthy biomechanics of the spine. Numerous novel dynamic devices incorporate the temperature and moisture dependent material polycarbonate urethane (PCU) due to its mechanical properties and biocompatibility. In this study, standardized pure moment in vitro tests were carried out on human lumbar spines to evaluate the performance of a device containing PCU. An environmental chamber with controlled moisture and temperature was included in the setup to meet the requirements of testing under physiological conditions. Three test conditions were compared: (1) native spine, (2) dynamic instrumentation, and (3) dynamic instrumentation with decompression. The ranges of motion, centers of rotation, and relative pedicle screw motions were evaluated. The device displayed significant stiffening in flexion-extension, lateral bending, and axial rotation load directions. A reduction of the native range of motion diminished the stiffening effect along the spinal column and has the potential to reduce the risk of the onset of degeneration of an adjacent segment. In combination with decompression, the implant decreased the native range of motion for flexion-extension and skew bending, but not for lateral bending and axial rotation. Curve fittings using the sigmoid function were performed to parameterize all load-deflection curves in order to enhance accurate numerical model calibrations and comparisons. The device caused a shift of the center of rotation (COR) in the posterior and caudal direction during flexion-extension loading.

The sacral screw placement depending on morphological and anatomical peculiarities.

PURPOSE: Various pathologies of the lumbosacral junction require fusion of the L5/S1 segment. However, pseudarthroses, which often come along with sacral screw loosening, are problematic. The aim of the present investigation was to elaborate the morphological features of the L5/S1 segment to define a so-called "safe zone" for bi- or tricortical screw placement without risking a damage of the iliac vessels. METHODS: A total of one hundred computed tomographies of the pelvis were included in this investigation. On axial and sagittal slices, pedicle morphologies, the prevertebral position of the iliac vessels, the spinal canal and the area with the largest bone density were analyzed. RESULTS: Beginning from the entry point of S1-srews iliac vessels were located at an average angle of 7° convergence, the spinal canal at 38°. Bone density was significantly higher centrally with a mean value of 276 Hounsfield Units compared to the area of the Ala ossis sacri. The largest intraosseous screw length could be achieved at an angle of 25°. The average pedicle width was 20 mm and the pedicle height 13 mm. CONCLUSIONS: A "safe-zone" for bicortical screw placement at S1 with regard to the course of the iliac vessels could be defined between 7° and 38° convergence. Regarding the area offering the largest bone density and the maximal possible screw length, a convergence of 25° is recommended at S1 to reduce the incidence of screw loosening. Screw diameter, as a further influence factor on screw holding, is limited by pedicle height not pedicle width.

[Reduction of needlestick injuries by 48 % in 1 year : Effects of improvement of the safety concept according to the European Union Council directive 2010/32/EU at a large regional hospital]. / Reduktion von Nadelstichverletzungen um 48 % in einem Jahr : Auswirkungen einer Verbesserung des Sicherheitskonzeptes nach der EU-Direktive 2010/32/EU an einem großen regionalen Krankenhaus.

BACKGROUND: Needlestick injuries (NSI) are potentially infectious injuries from sharp or pointed medical instruments and through contact with blood on mucous membranes or nonintact skin. Although the European Union (EU) Council directive 2010/32/EU on the prevention of NSI was implemented in EU countries in 2013, information on the effectiveness of the measures is limited. OBJECTIVE: The aim of this study was to evaluate the effectiveness of a safety concept according to the EU Council Directive 2010/32/EU on prevention of NSI. MATERIAL AND METHODS: In 2016 the NSI safety concept at a large regional hospital was improved according to 2010/32/EU, specifically by an update of blood screening profiles and standard operating procedures (SOP), better dissemination of information to employees and complete conversion to safety cannulas and scalpels. The medical records of all NSIs from 2015-2017 were retrospectively anonymized and evaluated and a cost analysis was performed. RESULTS: The number of NSIs in 2017 was significantly reduced by 48.4% as compared to 2016 and NSIs with scalpels were completely prevented. The proportion of employees with NSIs who were adequately immunized against hepatitis B was significantly increased to 84.1% in 2017. Furthermore, identification of the index patient was significantly increased to 82.5% in 2017. The cost of avoiding NSIs increased by a total of 24.1% in 2017 as compared to 2015 before introduction of the safety concept. CONCLUSION: Implementation of the EU Council directive 2010/32/EU, resulted in an almost 50% reduction in NSIs over 1 year, including the complete prevention of NSIs due to scalpels. In addition, the anamnestic presence of immunization against hepatitis B and index patient identification were significantly increased.

Material failure in dynamic spine implants: are the standardized implant tests before market launch sufficient?

PURPOSE: International Standards Organization (ISO) 12189 and American Society for Testing and Materials F2624 are two standard material specification and test methods for spinal implant devices. The aim of this study was to assess whether the existing and required tests before market launch are sufficient. METHODS: In three prospective studies, patients were treated due to degenerative disease of the lumbar spine or spondylolisthesis with lumbar interbody fusion and dynamic stabilization of the cranial adjacent level. The CD HORIZON BalanC rod and S4 Dynamic rod were implanted in 45 and 11 patients, respectively. RESULTS: A fatigue fracture of the material of the topping off system has been found in five cases (11%) for the group fitted with the CD HORIZON BalanC rod. In the group using the S4 Dynamic rod group, a material failure of the dynamic part was demonstrated in seven patients (64%). All three studies were interrupted due to these results, and a report to the Federal Institute for Drugs and Medical Devices was generated. CONCLUSION: Spinal implants have to be checked by a notified body before market launch. The notified body verifies whether the implants fulfil the requirements of the current standards. These declared studies suggest that the current standards for the testing of load bearing capacity and stand ability of dynamic spine implants might be insufficient. Revised standards depicting sufficient deformation and load pattern have to be developed and counted as a requirement for the market launch of an implant. These slides can be retrieved under Electronic Supplementary Material.

To fuse or not to fuse: a survey among members of the German Spine Society (DWG) regarding lumbar degenerative spondylolisthesis and spinal stenosis.

INTRODUCTION: Surgical treatment methods for degenerative spondylolisthesis (decompression versus decompression and fusion) have been critically debated. The medical care situation is almost unknown for either treatment. Therefore, the aim of the present study was to provide information regarding the use of parameters for decision-making and the employment of surgical techniques. MATERIALS AND METHODS: A web-based survey was performed among members of the German-Spine-Society (DWG). Information regarding participant characteristics (specialty, age, DWG certification status, number of spine surgeries performed at the participant's institution each year, institutional status), estimates of the use of both treatment options, clinical and morphological decision-making criteria for additive fusion, and the surgical technique used was queried. RESULTS: 305 members (45% neurosurgeons/ 55% orthopedic or trauma surgeons) participated in the present study. The participants estimated that in 41.7% of the cases, decompression only was required, while 55.6% would benefit from additional fusion. Among the participants, 74% reported that low back pain was an important indicator of the need for fusion if the numerical rating scale for back pain was at least 6/10. The most commonly used decompression technique was minimally invasive unilateral laminotomy, whereas open approach-based interbody fusion with transpedicular fixation and laminotomy was the most frequently used fusion technique. Specialty, age, certification status, and institutional status had a partial effect on the responses regarding indications, treatment and surgical technique. CONCLUSIONS: The present survey depicts the diversity of approaches to surgery for degenerative spondylolistheses in Germany. Considerable differences in treatment selection were observed in relation to the participants' educational level and specialty.

The use of the DTO™ hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial.

BACKGROUND: The purpose of this study was to assess the radiological and clinical outcome parameters following lumbar hybrid dynamic instrumentation with the focus on the adjacent segment degeneration (ASD) and adjacent segment disease (ASDi). METHODS: In this prospective trial all patients presenting with degenerative changes to the lumbar spine have been included. Precondition was a stable adjacent level with/without degenerative alteration. The elected patients underwent a standardised fusion procedure with hybrid instrumentation (DTO™, Zimmer Spine Inc., Denver, USA). Patients' demographics have been documented and the follow-up visits were conducted after 6 weeks, and then stepwise after 6 up to 48 months. Each follow-up visit included assessment of quality of life and pain using specific questionnaires (COMI, SF-36, ODI) and the radiological evaluation with focus on the adjacent level alterations. RESULTS: At a mean follow up of 24 months an incidence of ASD with 10.91% and for ASDi with 18.18% has been observed. In 9% a conversion to standardised fusion was needed. There was a high rate of mechanical complication: (1) screw loosening (52.73%), (2) pedicle screw breakage (10.91%), and (3) rod breakage (3.64%) after a follow up of a maximum of 60 months. There were no significant difference of COMI, ODI and SF-36(v2) in comparison to all groups but all 55 patients showed a clinical improvement over the time. CONCLUSION: The dynamic hybrid DTO™ device is comparable to the long-term results after standardised fusion procedure, while a high rate of mechanical complication decreased the initial benefit. TRIAL REGISTRATION: This trial was registered at the ClinicalTrials Register ( #NCT03404232 , 2018/01/18, registered retrospectively).

Computer tomography-based morphometric analysis of the cervical spine pedicles C3-C7.

BACKGROUND: Our aim was to examine the specific dimensions of cervical pedicles in a large Caucasian cohort on high dissolving CT scans. METHODS: A retrospective analysis of 100 cervical spine CT scans with a maximum slice thickness of 1 mm in axial, sagittal, and coronal reconstructions was performed. The pedicle axial length (PAL), inner and outer pedicle diameter (IPD/OPD), pedicle sagittal and transverse angle (PSA/PTA), pedicle height (PH), pedicle width (PW), and the cortical thickness (COT) at different margins were measured by two independent observers. A total of 1000 cervical pedicles (C3-C7) of 52 male (age 58 ± 17.47 years, height 177.97 ± 8.17 cm) and 48 female patients (age 57 ± 19.07 years, height 165.50 ± 7.44) were measured. RESULTS: Cortical thickness at the medial limitation of the pedicle was 1.77 ± 0.43 and 0.90 ± 0.36 mm at the lateral limitation (p < 0.001). The mean PAL ranged from 30.5 mm at C4 level to 35.3 mm at C6 level. PW and PAL were smaller in the female than in the male patients. The smallest values for PW were at C3 with 29.17% of males and 52.88% of females < 4.5 mm. The percentage of patients with PW < 4.5 mm decreased caudally with less than 10% of pedicles below C4 in male participants and below C6 in female participants. Mean PTA ranged from 34.6° to 48.02° peaking at C4 and C5 levels. No gender-specific difference was found for PTA and PSA (p ≥ 0.13). IPD and OPD were larger in males (p < 0.001), and body height correlated significantly with IPW (p ≤ 0.019) and OPW (p ≤ 0.003). The interrater reliability was very good for PW, PH, and IPD (0.84-0.86), good for OPD, PTA, and PSA (0.64-0.79), and moderate for PAL (0.54) and cortical thickness (0.44). CONCLUSIONS: Peculiarities of pedicle dimension of this central European cohort are comparable to morphometric studies in other ethnicities. Preoperative planning before cervical pedicle screw insertion on fine-cut CT scans demonstrates good interrater reliability for all important dimensions and angulations. More than half of female patients and almost a third of male patients had a PW of less than 4.5 mm at C3 level. Even though this percentage decreases caudally, pedicle screws might not be safe to insert in a noteworthy percentage of patients.

Predictors of improvement in quality of life and pain relief in lumbar spinal stenosis relative to patient age: a study based on the Spine Tango registry.

BACKGROUND: An open decompression is the most common treatment for lumbar spinal canal stenosis (LSS), even in the elderly. However, it is not clear whether the treatment outcome is age dependent. The main purpose of this study was to evaluate the improvement in quality of life (QoL) and pain relief, after open decompression for LSS in relation to patient age. METHODS: The study was performed on the basis of Spine Tango registry data. The database query resulted in 4768 patients from 40 international Spine Tango centres. The patients were subdivided into three age groups: (1) 20-64, (2) 65-74, and (3) ≥75 years. In multivariate logistic regression models, predictors for improvement in QoL and achievement of the minimum clinically relevant change in pain of two points were analysed. RESULTS: All groups benefited from significant improvement in QoL and back and leg pain relief. Age group had no significant influence on the outcomes. The preoperative status of each outcome was a predictor for its own postoperative outcome. Fewer previous surgeries, rigid or dynamic stabilization, and lower patient comorbidity also had a partially predictive influence for one or the other outcome. CONCLUSIONS: Our results confirm that all age groups significantly benefit from the open decompressive treatment of LSS. Age group had no significant influence on any outcome.

Incidental durotomy in decompression for lumbar spinal stenosis: incidence, risk factors and effect on outcomes in the Spine Tango registry.

PURPOSE: The three aims of this Spine Tango registry study of patients undergoing decompression for spinal stenosis were to: report the rate of dural tear (DT) stratified by treatment centre; find factors associated with an increased likelihood of incurring a DT; and compare treatment outcomes in relation to DT (none vs. repaired vs. unrepaired DT). METHODS: Multivariate logistic regression was used to assess the association between DT and patient and treatment characteristics. Patient-rated and surgical outcomes were compared in patients with no DT, repaired DT, and unrepaired DT, while adjusting for case-mix. RESULTS: DT occurred in 328/3254 (10.1%) of included patients. The rate for all 29 contributing hospitals was within 95% confidence intervals of the average. The likelihood of DT increased by 2% per year of age, 1.78 times with previous spine surgery, 1.67 for a minimally/less invasive surgery, 1.58 times with laminectomy, and 1.40, and 2.12 times for BMI 31-35, and >35 in comparison with BMI 26-30, respectively. The majority of DTs (272/328; 82.9%) were repaired. Repairing the DT was associated with a longer duration of surgery (p < 0.001). More patients with repaired than with unrepaired DTs were satisfied with treatment, but the difference was not statistically significant. There was no association between DT and patient-reported outcomes. CONCLUSION: The unadjusted rate of incidental DT during decompression for LSS was homogeneous across the participating centres and was associated with age, BMI, previous surgery at the same spinal level, minimally/less invasive surgery, and laminectomy. Non-repair of DTs had no negative association with treatment outcome; however, the unrepaired DTs may have been those that were smaller in size.

In vivo analysis of coracoid and subacromial shoulder impingement mechanism during clinical examination.

BACKGROUND: Understanding the mechanisms of shoulder impingement created by clinical tests is crucial to accurately evaluate the condition. The objective of this study was to relate mechanisms of subacromial and coracoid impingement occurring in positions of the shoulder during clinical examination, in quantitative and qualitative terms. METHODS: A 1.0T open magnetic resonance imaging system was used in 18 female and 19 male subjects, to determine the distances between the humeral head and the acromion or coracoid, and contact with the rotator cuff (RC). Measurements were taken with the shoulder in neutral, "Hawkins", "Neer", and 90° abduction/15° internal rotation (horizontal impingement test) positions. Additionally, impingement was classified based on the grade of RC contact with the acromion or coracoid. RESULTS: In the Hawkins position, distance between the supraspinatus and the coracoid was closest (14.5 ± 4.5 mm), while the coracohumeral distance (CHD) narrowed (p < 0.001). In the horizontal impingement test position, the minimum distance between the subscapularis and coracoid was found, whereas the CHD increased (27.4 ± 5.7 mm). In the Neer and Hawkins positions, the space between the greater tuberosity and acromion was significantly narrowed, which was also the case in the horizontal impingement test position compared to neutral position (p < 0.001). CONCLUSION: Shoulder movements of forward flexion and internal rotation (Hawkins test) and abduction and internal rotation (horizontal impingement test) can lead to different coracoid impingement mechanisms during clinical examination. The Hawkins, Neer, and horizontal impingement tests lead to comparable narrowed acromiohumeral distances and subacromial contact of the RC. LEVEL OF EVIDENCE: Therapeutic level III.

Is the use of modern versus conventional wound dressings warranted after primary knee and hip arthroplasty? Results of a Prospective Comparative Study.

PURPOSE OF THE STUDY: This prospective, open, non-controlled clinical investigation evaluated the performance of a modern post-operative wound dressing versus conventional dressings used on wounds of patients after undergoing hip or knee replacement. METHODS: The clinical investigation started with a two-week observation phase of conventional wound dressings, followed by an intervention phase where patients were treated with Mepilex® Border Post-Op dressings. The primary objective was to evaluate the occurrence of blisters. RESULTS: There was no blistering in any of the patients in the Mepilex group (n = 49), whereas blistering occurred in 27.3% (n = 3) of patients in the conventional group (n =  11, p < 0.01). The Mepilex dressing was left on for seven days in 70% of patients. There was a significant reduction in the total cost for dressing changes with the Mepilex dressings (p = 0.006). CONCLUSION: By using Mepilex dressings, the risk of blistering was negated and the reduced frequency of dressing changes was associated with the reduced overall cost. Therefore, we recommend the use of Mepilex Border Post-Op dressings.

Clinical benefit and improvement of activity level after reconstruction surgery of Charcot feet using external fixation: 24-months results of 292 feet.

BACKGROUND: Reconstruction of Charcot feet remains a surgical challenge. The goal of this study was to investigate safety and clinical benefit from reconstruction of Charcot feet using an external fixator. There is limited valid data regarding long-term outcomes for Charcot foot procedures. METHODS: In a retrospective study, 292 Charcot feet (282 patients) undergoing reconstructive procedures in our clinic from 1996-2010 were included (93 female, 189 male, mean age 57.9 years). Average follow-up was 24.1 months. Exclusion criteria were previous major amputation on the same side. All patients underwent surgery using a Hoffmann II external fixator for six to eight weeks with offloading. The fixator was then removed, and a customized AFO with full weight bearing was applied for another 11 months. After one year, patients received customized orthopedic shoes. RESULTS: Initial amputations were avoided. Patient activity improved significantly by more than 1 level (SD 0.67, p < .001) according to the Hoffer activity score for lower limb amputees. The most common minor complication was persistent or recurrent ulceration in 67 feet (23%). Secondary amputation (after failure of external fixation) was required in only 12 patients (6.2%). Orthopedic shoes were used by approximately 34% of patients 18 months after surgery. CONCLUSIONS: Reconstructive surgery of Charcot feet using external fixation is a safe and economically feasible procedure. Activity levels improved significantly by more than 1 level (p < 0.01), severe complications were rare, and secondary amputation was required in only 12 patients (6.2%) of a high-risk patient population. Use of an external fixator offers the advantage that all extraneous material is removed after six weeks; thus, there is no risk of broken screws or plates and the associated potential complications.

Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial.

BACKGROUND: The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, "topping off"). However, its clinical significance is still uncertain due to the lack of conclusive data. METHODS/DESIGN: The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + "topping off"), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year.Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. DISCUSSION: New hybrid "topping off" systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. TRIAL REGISTRATION: NCT01852526.

Diagnosis and treatment of spondylodiscitis in HIV-positive patients.

With an incidence between 1:100,000 and 1:250,000, spondylodiscitis is rare, but is increasingly reported due to longer life expectancy, risk factors, and comorbidities, with HIV+ patients being at greater risk. We reviewed the literature on the diagnostic tools, and on the benefits and drawbacks of different treatments of spondylodiscitis in HIV- positive patients. We discuss basic strategies and indications for surgery. Recently, the trend was toward early mobilization of patients after surgical treatment. Modern surgical and antibiotic treatment can prevent a recurrence in these patients. The decision to opt for conservative or surgical treatment should be made depending on the extent of infection and the responsible pathogen, without regard to HIV. However, these patients should be treated in a specialized hospital by an experienced interdisciplinary team of consultants.

Epidemiology of Surgically Treated Spinal Tumors: A Multicenter Surveillance Study of 9686 Patients from the German Spine Registry (DWG Register).

Tumors of the spine are challenging in terms of diagnoses and interdisciplinary treatment. This study was conducted to evaluate and characterize a large multicenter cohort of surgically treated spine tumor patients.Data of the German Spine Society (DWG) were used to characterize a cohort of all surgically treated spine tumor cases that were registered between 2017 and 2021. Subgroup analysis was performed for tumor entity, tumor localization, height of most severely affected segments, surgical treatment, and demographic parameters.In total, there were 9686 cases, of which 6747 were "malignant", 1942 were "primary benign", 180 were "tumor-like lesions", and 488 were "other" spinal tumors. Subgroups showed differences in number of affected segments as well as localization. There were further significant differences in surgical complication rates (p = 0.003), age (p < 0.001), morbidity (p < 0.001), and duration of surgery (p = 0.004).This is a representative study on spinal tumors from a large spine registry and allows for the epidemiological characterization of surgically treated tumor subgroups and quality control of registry data.

Complications of vertebroplasty and kyphoplasty in the treatment of vertebral fractures: results of a questionnaire study.

Percutaneous vertebroplasty (VP) and balloon kyphoplasty (BKP) are minimally invasive procedures performed to stabilize vertebral fractures. With continuing expansion in clinical use, a broad spectrum of complications has been reported for both interventions. The goal of the current study was to compare the safety of these procedures using a questionnaire completed by practitioners. A questionnaire was developed with multiple choice and open questions. General data as well as information regarding complications which occurred during the year 2007 were requested. The incidence and odds ratios (OR) of complications for both procedures were analysed. One hundred and sixteen questionnaires detailing 3216 VP and 5139 BKP procedures were included for evaluation. The risk of cement extrusion from the vertebra (OR 2.64, p <0.01) and into the spinal canal (OR 435, p <0.01) was markedly increased for VP. The odds ratio for neurologic complications (OR 2.56, p = 0.1) and secondary fracture (OR = 0.99, p = 0.96) did not indicate significant predisposition for either procedure. Secondary fracture occurred in 5% of VP and 5.1% of BKP procedures. Overall, 80% of practitioners subjectively considered BKP the safer procedure. Overall, BKP appears safer than VP. Symptomatic complications are rare with both procedures. Additional prospective data is necessary to reach more definitive conclusions.

Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial.

BACKGROUND: Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits. METHODS/DESIGN: The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off").Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually.Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided. DISCUSSION: New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the benefits and drawbacks of topping off devices. If only because these devices are quite expensive compared to conventional fusion implants, nonessential use should be avoided. In fact, these high costs necessitate efforts by health care providers to evaluate the effects of these implants. Randomized clinical trials are highly recommended to evaluate the benefits or harm to the patient. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01224379.