Influence of the sagittal spinal profile type on the long-term outcome of patients with symptomatic lumbar spinal stenosis after microsurgical decompression.

OBJECTIVE: Microsurgical decompression for patients with symptomatic lumbar spinal stenosis (LSS) has demonstrated long-term improvement concerning pain and function. Nonetheless, a considerable proportion of these patients do not experience satisfactory alleviation of symptoms. Previous studies have not found a direct influence of single sagittal parameters on patient outcomes. However, recent research indicates that a composite of parameters, presented in specific sagittal profile types (SPTs) that were defined by Roussouly and colleagues, may affect these outcomes. This study aims to investigate the impact of SPT on long-term outcomes of patients with LSS following microsurgical decompression. METHODS: This study is a prospective clinical observation. Patients with symptomatic LSS, who underwent microsurgical treatment and had long-term follow-up data for at least 36 months, were included. Patients with spinal deformity, fractures, or significant instability were excluded. Outcomes were measured using the numeric rating scale for pain, 36-Item Short Form Health Survey for quality of life, walking distance, Oswestry Disability Index, Roland-Morris Disability Questionnaire, and Odom's criteria. SPT was determined in blinded fashion by using preoperative long standing radiographs. RESULTS: The initial population of this observational study consisted of 128 patients, with long-term results available for 87 individuals, including 24 patients with SPT1, 20 with SPT2, 27 with SPT3, and 16 with SPT4. The average age was 70 years, with a slight male majority (56.3%) and a mean BMI of 27.9 kg/m2. After a median follow-up of 48 months, all groups showed significant improvement in walking distance, leg pain, and disability. Overall, 75% reported satisfaction with the surgery. However, patients with SPT1, which is characterized by low sacral slope and specific spinal curvatures, experienced significantly less improvement in back pain (p = 0.018) and related disability (p = 0.030), and lower satisfaction compared to other SPT groups (p = 0.008). CONCLUSIONS: The sagittal spinal type is influencing the long-term outcome of patients suffering from symptomatic LSS. Patients with a combination of a flat sacral slope and a low overall lumbar lordosis with a high lordosis in the lower lumbar spine (i.e., spinal SPT1) showed worse outcome concerning back pain and had decreased satisfaction with surgery than comparable subjects from other SPT groups. Consequently, the authors recommend the assessment of sagittal spinal types in patients diagnosed with symptomatic spinal stenosis prior to decompression surgery. Inclusion of SPT in the preoperative consultation process can provide valuable insights, potentially guiding practitioners to more tailored patient counseling.

High-Precision Visual Servoing for the Neutron Diffractometer STRESS-SPEC at MLZ.

With neutron diffraction, the local stress and texture of metallic components can be analyzed non-destructively. For both, highly accurate positioning of the sample is essential, requiring the measurement at the same sample location from different directions. Current sample-positioning systems in neutron diffraction instruments combine XYZ tables and Eulerian cradles to enable the accurate six-degree-of-freedom (6DoF) handling of samples. However, these systems are not flexible enough. The choice of the rotation center and their range of motion are limited. Industrial six-axis robots have the necessary flexibility, but they lack the required absolute accuracy. This paper proposes a visual servoing system consisting of an industrial six-axis robot enhanced with a high-precision multi-camera tracking system. Its goal is to achieve an absolute positioning accuracy of better than 50µm. A digital twin integrates various data sources from the instrument and the sample in order to enable a fully automatic measurement procedure. This system is also highly relevant for other kinds of processes that require the accurate and flexible handling of objects and tools, e.g., robotic surgery or industrial printing on 3D surfaces.

Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial.

BACKGROUND: The optimal configuration for spinopelvic fixation during multilevel spine fusion surgery for adult spine deformity remains unclear. Postoperative sacroiliac (SI) joint pain, S2AI screw loosening and implant breakage could be related to continued motion of the SI joint with use of only a single point of fixation across the SI joint. METHODS: Prospective, international, multicenter randomized controlled trial of 222 patients with adult spine deformity scheduled for multilevel (4 or more levels) spine fusion surgery with pelvic fixation. Subjects were randomized to sacroalar (S2) iliac (S2AI) screws alone for pelvic fixation or S2AI + triangular titanium implants placed cephalad to S2AI screws. Quad rod techniques were not allowed or used. Baseline spinal deformity measures were read by an independent radiologist. Site-reported perioperative adverse events were reviewed by a clinical events committee. Quality of life questionnaires and other clinical outcomes are in process with planned 2-year follow-up. RESULTS: One hundred thirteen participants were assigned to S2AI and 109 to S2AI + titanium triangular implants (TTI). 35/222 (16%) of all subjects had a history of SI joint pain or were diagnosed with SI joint pain during preoperative workup. Three-month follow-up was available in all but 4 subjects. TTI placement was successful in 106 of 109 (98%) subjects assigned to TTI. In 2 cases, TTI could not be placed due to anatomical considerations. Three TTI ventral iliac breaches were observed, all of which were managed non-surgically. One TTI subject had a transverse sacral fracture and 1 TTI subject had malposition of the implant requiring removal. CONCLUSIONS: SI joint pain is common in patients with adult spinal deformity who are candidates for multilevel spine fusion surgery. Concurrent placement of TTI parallel to S2AI screws during multilevel spine fusion surgery is feasible and safe. Further follow-up will help to determine the clinical value of this approach to augment pelvic fixation.

SPINE20 recommendations 2023: One Earth, one family, one future WITHOUT spine DISABILITY.

Introduction: The purpose is to report on the fourth set of recommendations developed by SPINE20 to advocate for evidence-based spine care globally under the theme of "One Earth, One Family, One Future WITHOUT Spine DISABILITY". Research question: Not applicable. Material and methods: Recommendations were developed and refined through two modified Delphi processes with international, multi-professional panels. Results: Seven recommendations were delivered to the G20 countries calling them to:-establish, prioritize and implement accessible National Spine Care Programs to improve spine care and health outcomes.-eliminate structural barriers to accessing timely rehabilitation for spinal disorders to reduce poverty.-implement cost-effective, evidence-based practice for digital transformation in spine care, to deliver self-management and prevention, evaluate practice and measure outcomes.-monitor and reduce safety lapses in primary care including missed diagnoses of serious spine pathologies and risk factors for spinal disability and chronicity.-develop, implement and evaluate standardization processes for spine care delivery systems tailored to individual and population health needs.-ensure accessible and affordable quality care to persons with spine disorders, injuries and related disabilities throughout the lifespan.-promote and facilitate healthy lifestyle choices (including physical activity, nutrition, smoking cessation) to improve spine wellness and health. Discussion and conclusion: SPINE20 proposes that focusing on the recommendations would facilitate equitable access to health systems, affordable spine care delivered by a competent healthcare workforce, and education of persons with spine disorders, which will contribute to reducing spine disability, associated poverty, and increase productivity of the G20 nations.

Anterolateral versus posterior minimally invasive lumbar interbody fusion surgery for spondylolisthesis: comparison of outcomes from a global, multicenter study at 12-months follow-up.

BACKGROUND CONTEXT: Several minimally invasive lumbar interbody fusion techniques may be used as a treatment for spondylolisthesis to alleviate back and leg pain, improve function and provide stability to the spine. Surgeons may choose an anterolateral or posterior approach for the surgery however, there remains a lack of real-world evidence from comparative, prospective studies on effectiveness and safety with relatively large, geographically diverse samples and involving multiple surgical approaches. PURPOSE: To test the hypothesis that anterolateral and posterior minimally invasive approaches are equally effective in treating patients with spondylolisthesis affecting one or two segments at 3-months follow-up and to report and compare patient reported outcomes and safety profiles between patients at 12-months post-surgery. DESIGN: Prospective, multicenter, international, observational cohort study. PATIENT SAMPLE: Patients with degenerative or isthmic spondylolisthesis who underwent 1- or 2-level minimally invasive lumbar interbody fusion. OUTCOME MEASURES: Patient reported outcomes assessing disability (ODI), back pain (VAS), leg pain (VAS) and quality of life (EuroQol 5D-3L) at 4-weeks, 3-months and 12-months follow-up; adverse events up to 12-months; and fusion status at 12-months post-surgery using X-ray and/or CT-scan. The primary study outcome is improvement in ODI score at 3-months. METHODS: Eligible patients from 26 sites across Europe, Latin America and Asia were consecutively enrolled. Surgeons with experience in minimally invasive lumbar interbody fusion procedures used, according to clinical judgement, either an anterolateral (ie, ALIF, DLIF, OLIF) or posterior (MIDLF, PLIF, TLIF) approach. Mean improvement in disability (ODI) was compared between groups using ANCOVA with baseline ODI score used as a covariate. Paired t-tests were used to examine change from baseline in PRO for both surgical approaches at each timepoint after surgery. A secondary ANCOVA using a propensity score as a covariate was used to test the robustness of conclusions drawn from the between group comparison. RESULTS: Participants receiving an anterolateral approach (n=114) compared to those receiving a posterior approach (n=112) were younger (56.9 vs 62.0 years, p <.001), more likely to be employed (49.1% vs 25.0%, p<.001), have isthmic spondylolisthesis (38.6% vs 16.1%, p<.001) and less likely to only have central or lateral recess stenosis (44.9% vs 68.4%, p=.004). There were no statistically significant differences between the groups for gender, BMI, tobacco use, duration of conservative care, grade of spondylolisthesis, or the presence of stenosis. At 3-months follow-up there was no difference in the amount of improvement in ODI between the anterolateral and posterior groups (23.2 ± 21.3 vs 25.8 ± 19.5, p=.521). There were no clinically meaningful differences between the groups on mean improvement for back- and leg-pain, disability, or quality of life until the 12-months follow-up. Fusion rates of those assessed (n=158; 70% of the sample), were equivalent between groups (anterolateral, 72/88 [81.8%] fused vs posterior, 61/70 [87.1%] fused; p=.390). CONCLUSIONS: Patients with degenerative lumbar disease and spondylolisthesis who underwent minimally invasive lumbar interbody fusion presented statistically significant and clinically meaningful improvements from baseline up to 12-months follow-up. There were no clinically relevant differences between patients operated on using an anterolateral or posterior approach.

Nonsteroidal anti-inflammatory drugs (NSAID) do not increase blood loss or the incidence of postoperative epidural hematomas when using minimally invasive fusion techniques in the degenerative lumbar spine.

Objective: Nonsteroidal anti-inflammatory drugs (NSAID) are essential in surgeons' armamentarium for pain relief and antiphlogistic effects. However, spine surgeons are concerned about the drugs' impact on coagulation, fearing hemodynamic instability due to blood loss and neurological complications due to postoperative hematoma. Furthermore, there are no clear guidelines for the use of these drugs. Materials and methods: In this retrospective subgroup analysis of a prospective observational study, we investigated 181 patients who underwent minimally invasive spinal fusions in degenerative lumbar spine pathologies. 83 patients were given NSAID perioperatively, 54 of which were female and 29 male. Of these patients who took NSAID, 39 were on NSAID until at least one day before surgery or perioperatively, whilst the others discontinued their NSAID medication at least three days before surgery. Differences in perioperative blood loss, as well as complication rates between patients with and without NSAID treatment, were investigated. Results: A significantly higher amount of blood loss during surgery and the monitoring period was encountered in patients whose spine was fused in more than one level, regardless of whether NSAID medication was taken or not and up until what point. Furthermore, it was found that taking NSAID medication had no effect on the incidence of postoperative epidural hematomas. Conclusion: Perioperatively taking NSAID medication does not increase blood loss or the incidence of postoperative hematoma in patients undergoing minimally invasive lumbar spinal fusion surgery.

Advancements in osteoporotic spine fixation.

With the global rise in the population of elderly along with other risk factors, spine surgeons have to encounter osteoporotic spine more often. Osteoporotic spine, however, causes problems in management, particularly where instrumentation is involved, resulting in screw loosening, pull out, pseudoarthroses or adjacent segment kyphosis. Osteoporosis alters the bio mechanics at the bone implant interface resulting in various degrees of fixation failure. Various advancements have been made in this field to deal with such issues in addition to modification of basic surgical techniques such as increasing the diameter and length of the screw, smaller pilot hole, under tapping, longer constructs, supplemental anterior fixation, sublaminar wires or laminar hooks, use of transverse connectors and triangulation techniques, among others. They include novel surgical techniques such as cortical bone trajectory, superior cortical trajectory, double screw technique, cross trajectory technique, bicortical screw technique or prophylactic vertebroplasty. Advances in the screw design include expandable screws, fenestrated screws, conical screws and coated screws. In addition to PMMA cement augmentation, other biodegradable cements have been introduced to mitigate the side effects of PMMA such as calcium phosphate, calcium apatite and hydroxyapatite. Pharmacotherapy with teriparatide can aid fusion and lower the rate of pedicle screw loosening. Many of these strategies have only bio mechanical evidence and require well designed clinical trials to establish their clinical efficacy. Though no single technique is fool proof, little modifications in the existing techniques or utilizing a combination of techniques without adding to the cost of the surgery may help to achieve a near-ideal result. Surgeons have to equip their armamentarium with all the recent advances, and should be open to novel thoughts and techniques.

Design and fabrication of a generic 3D-printed silicone unilateral cleft lip and palate model.

The complexity of plastic surgery procedures often requires visualization of the anatomy in three dimensions and therefore demands the development of new and innovative teaching methods. This work describes the development and manufacture of a 3D silicone cleft lip and palate (CLP) model evaluated by surgical residents on its similarity to the biological model. Thirty unilateral CLP models were created and distributed to residents at two different institutions. The model was based on an adult CT scan that was manipulated to resemble an infant with a complete unilateral CLP. This digital model was directly printed in silicone elastomer pieces and later assembled. The residents rated the model based on its realistic value as well as whether or not they felt it improved their surgical technique. Twenty residents used the model to simulate a CLP repair. The structure of the model was rated as fairly realistic while both the material and assembly of the model require improvement in subsequent manufacturing. Post simulation, residents rated the model highly for how accurately it simulated the surgical procedure. An accurate 3D silicone unilateral cleft lip and palate replica was successfully created for educational purposes. This new approach combines a flexible generic design with automated manufacture.

[Radiation exposure caused by the OrthoScan mini C-arm in hand surgery: a one-year case series]. / Röntgenstrahlenexposition in der Handchirurgie durch den OrthoScan Mini-C-Arm: eine 1-Jahres Fallserie.

BACKGROUND: Mobile X-ray imaging systems are standard in the operating theatre. Mini-C-arms are the prevailing technology in hand surgery. Unfortunately, the exposure to Mini-C-arm radiation is often underestimated. METHODS: For one year, the intraoperative radiation dose delivered by an OrthoScan High Definition Mini-C-arm with a flat panel detector was measured using headband and finger ring dosimeters in all hand and wrist surgeries performed by three experienced hand surgeons. RESULTS: Two hundred and thirteen patients underwent surgical treatment involving the use of an OrthoScan High Definition Mini-C-arm. The total radiation dose administered by all three hand surgeons over 12 months was 9033.39 mGy with a total irradiation time of 376:38 min. A radiation exposure of 2.0 mSv was detected on both finger ring dosimeters of one surgeon during one month. For all other dosimeters, the monthly radiation exposure was below the detection limit of < 0.3 mSv. CONCLUSION: The radiation exposure reached during about 100 surgeries/surgeon/year involving the use of an OrthoScan Mini-C-arm does not exceed the annual occupational exposure limits of 50 mSv for the hand and 20 mSv for the lens of the eye. Only at an X-ray exposure of 800-1000 mGy/month can radiation exposure be detected with a finger ring dosimeter (measuring range 0.3 mSv-10 Sv) in a hand surgeon. Due to the potential health risk posed by stochastic radiation effects, all possible safeguards including behavioural measures should be observed.

Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study.

BACKGROUND: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up. METHODS: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. RESULTS: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients. CONCLUSIONS: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.

From Detection of Individual Metastases to Classification of Lymph Node Status at the Patient Level: The CAMELYON17 Challenge.

Automated detection of cancer metastases in lymph nodes has the potential to improve the assessment of prognosis for patients. To enable fair comparison between the algorithms for this purpose, we set up the CAMELYON17 challenge in conjunction with the IEEE International Symposium on Biomedical Imaging 2017 Conference in Melbourne. Over 300 participants registered on the challenge website, of which 23 teams submitted a total of 37 algorithms before the initial deadline. Participants were provided with 899 whole-slide images (WSIs) for developing their algorithms. The developed algorithms were evaluated based on the test set encompassing 100 patients and 500 WSIs. The evaluation metric used was a quadratic weighted Cohen's kappa. We discuss the algorithmic details of the 10 best pre-conference and two post-conference submissions. All these participants used convolutional neural networks in combination with pre- and postprocessing steps. Algorithms differed mostly in neural network architecture, training strategy, and pre- and postprocessing methodology. Overall, the kappa metric ranged from 0.89 to -0.13 across all submissions. The best results were obtained with pre-trained architectures such as ResNet. Confusion matrix analysis revealed that all participants struggled with reliably identifying isolated tumor cells, the smallest type of metastasis, with detection rates below 40%. Qualitative inspection of the results of the top participants showed categories of false positives, such as nerves or contamination, which could be targeted for further optimization. Last, we show that simple combinations of the top algorithms result in higher kappa metric values than any algorithm individually, with 0.93 for the best combination.

The appropriate management of persisting pain after spine surgery: a European panel study with recommendations based on the RAND/UCLA method.

PURPOSE: Management of patients with persisting pain after spine surgery (PPSS) shows significant variability, and there is limited evidence from clinical studies to support treatment choice in daily practice. This study aimed to develop patient-specific recommendations on the management of PPSS. METHODS: Using the RAND/UCLA appropriateness method (RUAM), an international panel of 6 neurosurgeons, 6 pain specialists, and 6 orthopaedic surgeons assessed the appropriateness of 4 treatment options (conservative, minimally invasive, neurostimulation, and re-operation) for 210 clinical scenarios. These scenarios were unique combinations of patient characteristics considered relevant to treatment choice. Appropriateness had to be expressed on a 9-point scale (1 = extremely inappropriate, 9 = extremely appropriate). A treatment was considered appropriate if the median score was ≥ 7 in the absence of disagreement (≥ 1/3 of ratings in each of the opposite sections 1-3 and 7-9). RESULTS: Appropriateness outcomes showed clear and specific patterns. In 48% of the scenarios, exclusively one of the 4 treatments was appropriate. Conservative treatment was usually considered appropriate for patients without clear anatomic abnormalities and for those with new pain differing from the original symptoms. Neurostimulation was considered appropriate in the case of (predominant) neuropathic leg pain in the absence of conditions that may require surgical intervention. Re-operation could be considered for patients with recurrent disc, spinal/foraminal stenosis, or spinal instability. CONCLUSIONS: Using the RUAM, an international multidisciplinary panel established criteria for appropriate treatment choice in patients with PPSS. These may be helpful to educate physicians and to improve consistency and quality of care. These slides can be retrieved under Electronic Supplementary Material.

Importance of Mechanoreceptors and Other Neural Structures Within the Anterior Intermeniscal Ligament in the Etiology of Anterior Knee Pain After Tibial Nailing.

BACKGROUND: Anterior knee pain is the most common complication after intramedullary tibial nailing. The cause is often multifactorial and varies among individuals. Violation of the anterior intermeniscal ligament (AIL) during intramedullary tibial nailing might be a possible source of postsurgical anterior knee pain. Although there is a certain ambiguity regarding the importance and function of the AIL, neural structures in the AIL tissue might play a significant role with respect to functional purposes and pain perception. METHODS: We subjected 6 AIL specimens to histologic examination to identify the neural structures that are a mandatory requirement as a source of anterior knee pain. Specifically, we performed three-dimensional immunohistochemical investigation of subtyping, orientation, and detailed characterization of neural structures within the AIL tissue. RESULTS: Histologic and three-dimensional immunohistochemical examinations confirmed the presence of neural structures in all 6 AIL specimens. We identified myelinated and unmyelinated nerve fibers, as well as all types of mechanoreceptors. CONCLUSIONS: Free nerve endings are a mandatory requirement for pain perception as a result of AIL violation during tibial nailing. Our verification of all different types of mechanoreceptors in the AIL tissue makes a role of the ligament in knee joint function and proprioception highly probable. Further investigations are necessary to clarify possible correlations between neural supply and function of the AIL. Violation of the ligament during operative procedures should be avoided, although the significance of the AIL is still debated.

The sagittal spinal profile type: a principal precondition for surgical decision making in patients with lumbar spinal stenosis.

OBJECTIVE Microsurgical decompression (MD) in patients with lumbar spinal stenosis (LSS) shows good clinical results. Nevertheless, 30%-40% of patients do not have a significant benefit after surgery-probably due to different anatomical preconditions. The sagittal profile types (SPTs 1-4) defined by Roussouly based on different spinopelvic parameters have been shown to influence spinal degeneration and surgical results. The aim of this study was to investigate the influence of the SPT on the clinical outcome in patients with LSS who were treated with MD. METHODS The authors retrospectively investigated 100 patients with LSS who received MD. The patients were subdivided into 4 groups depending on their SPT, which was determined from preoperative lateral spinal radiographs. The authors analyzed pre- and postoperative outcome scales, including the visual analog scale (VAS), walking distance, Oswestry Disability Index, Roland-Morris Disability Questionnaire, Odom's criteria, and the 36-Item Short Form Health Survey score. RESULTS Patients with SPT 1 showed a significantly worse clinical outcome concerning their postoperative back pain (VASback-SPT 1 = 5.4 ± 2.8; VASback-SPT 2 = 2.6 ± 1.9; VASback-SPT 3 = 2.9 ± 2.6; VASback-SPT 4 = 1.5 ± 2.5) and back pain-related disability. Only 43% were satisfied with their surgical results, compared with 70%-80% in the other groups. CONCLUSIONS A small pelvic incidence with reduced compensation mechanisms, a distinct lordosis in the lower lumbar spine with a high load on dorsal structures, and a long thoracolumbar kyphosis with a high axial load might lead to worse back pain after MD. Therefore, the indication for MD should be provided carefully, fusion can be considered, and other possible reasons for back pain should be thoroughly evaluated and treated.

MASTERS-D Study: A Prospective, Multicenter, Pragmatic, Observational, Data-Monitored Trial of Minimally Invasive Fusion to Treat Degenerative Lumbar Disorders, One-Year Follow-Up.

UNLABELLED: The objective of the study is to assess effectiveness and safety of minimally invasive lumbar interbody fusion (MILIF) for degenerative lumbar disorders (DLD) in daily surgical practice and follow up with patients for one year after surgery. A prospective, multicenter, pragmatic, monitored, international outcome study in patients with DLD causing back/leg pain was conducted (19 centers). Two hundred fifty-two patients received standard of care available in the centers. Patients were included if they were aged >18 years, required one- or two-level lumbar fusion for DLD, and met the criteria for approved device indications. Primary endpoints: time to first ambulation (TFA) and time to surgery recovery (TSR). Secondary endpoints: patient-reported outcomes (PROs)--back and leg pain (visual analog scale), disability (Oswestry Disability Index (ODI)), health status (EQ-5D), fusion rates, reoperation rates, change in pain medication, rehabilitation, return to work, patient satisfaction, and adverse events (AEs). Experienced surgeons (≥30 surgeries pre-study) treated patients with DLD by one- or two-level MILIF and patients were evaluated for one year (NCT01143324). At one year, 92% (233/252) of patients remained in the study. PRIMARY OUTCOMES: TFA, 1.3 ±0.5 days and TSR, 3.2 ±2.0 days. SECONDARY OUTCOMES: Most patients (83.3%) received one level MILIF; one (two-level) MILIF mean surgery duration, 128 (182) min; fluoroscopy time, 115 (154) sec; blood loss, 164 (233) mL; at one year statistically significant (P<.0001) and clinically meaningful changes from baseline were reported in all PROs--reduced back pain (2.9 ±2.5 vs. 6.2 ±2.3 at intake), reduced leg pain (2.2 ±2.6 vs. 5.9 ±2.8), and ODI (22.4% ± 18.6 vs. 45.3% ± 15.3), as well as health-related quality of life (EQ-5D index: 0.71 ±0.28 vs. 0.34 ±0.32). More of the professional workers were working at one year than those prior to surgery (70.3% vs. 55.2%). Three AEs and one serious AE were considered procedure-related; there were no deep site infections or deaths. This is the first study evaluating MILIF for treatment of DLD in daily clinical practice. Clinically significant improvements were observed in all endpoints. Short-term post-surgery improvements (four weeks) were maintained through one year with minimal complications. Our results suggest that MILIF has good-to-excellent outcomes for the treatment of DLD in a broad patient population under different clinical conditions and healthcare delivery systems.

Burden of disease of reoperations in instrumental spinal surgeries in Germany.

PURPOSE: To estimate the incidence of instrumental spinal surgeries (ISS) and consecutive reoperations and to calculate the related resource utilization and costs. METHODS: ISS and subsequent reoperations were identified retrospectively using surgery codes in claims data. The study period included January 01, 2009 to December 31, 2011. The reoperation rate was calculated for 1 year after the primary ISS. Resource utilization and costs were analyzed by group comparison. RESULTS: A total of 3316 incident ISS patients were identified in 2010 with an annual reoperation rate of 9.98% (95% CI 8.98-11.02%). Mean costs per patient were €11,331 per ISS and €11,370 per reoperation, with €8432 directly attributed to the reoperation and €2938 to additional resources. CONCLUSIONS: Costs of ISS and subsequent reoperations have a significant impact on health insurances budgets. The annual cost of reoperations exceeds the direct cost of the primary surgery driven by the need for further inpatient and outpatient care.

Maverick total disc replacement in a real-world patient population: a prospective, multicentre, observational study.

PURPOSE: Controlled trials have shown that total disc replacement (TDR) can provide pain and disability relief to patients with degenerative disc disease; however, whether these outcomes can also be achieved for patients treated in normal surgical practice has not been well documented. METHODS: This prospective, international study observed changes in disability and back pain in 134 patients who were implanted with Maverick TDR within the framework of routine clinical practice and followed for 2 years post-surgery. Primary and secondary outcomes were the differences from baseline to 6 months post-surgery in the means of the Oswestry Disability Index and the change in back pain intensity assessed on a 10-cm visual analogue scale, respectively. Mean patient age at surgery was 43 years, but ranged up to 65 years. RESULTS: One hundred twenty-three patients had an implant at one level, 10 patients at two levels, and one patient at three levels. Statistically significant improvements in mean disability (-25.4) and low back pain intensity (-4.0) scores were observed at 6 months postoperatively (P < 0.0001 for both) in the hands of experienced surgeons (>10 TDRs per centre). During the study, 56 patients (42 %) experienced a complication or adverse event. CONCLUSIONS: This is the first international observational study to report outcomes of TDR in real-world clinical settings. We showed statistically significant improvements in disability and pain scores at 6 months following Maverick TDR, which were maintained for 2 years alongside an acceptable rate of perioperative complications. The safety and tolerability shown in this observational study were comparable to those from controlled trials.

The Sagittal Balance Does not Influence the 1 Year Clinical Outcome of Patients With Lumbar Spinal Stenosis Without Obvious Instability After Microsurgical Decompression.

STUDY DESIGN: A retrospective study with retrospective and prospective inclusion of 100 patients. OBJECTIVE: To determine whether the sagittal balance (SB) influences the clinical outcome of patients with degenerative lumbar spinal stenosis, who underwent microsurgical decompression. SUMMARY OF BACKGROUND DATA: The SB has become a critical factor for clinical decision making in the surgical treatment of spinal degenerative diseases. However, a frequently recommended sagittal realignment of elderly, multimorbid patients is accompanied by a significant rate of complications. The influence of SB on the clinical outcome of patients with degenerative spinal stenosis, who undergo decompressive surgery is not well understood. The aim of this study was to explore whether the clinical outcome of these patients is related to the SB and whether patients with spinal stenosis and degenerative sagittal imbalance necessitate restoration of the SB in addition to microsurgical decompression. METHODS: One hundred patients with lumbar spinal stenosis, who received microsurgical decompression, were retrospectively identified and classified according to the severity of sagittal imbalance: (1) normal balance group, (2) minor loss of balance group, and (3) major loss of balance group. Sagittal parameters were determined from preoperative lateral spinal radiographs. As outcome parameters, we analyzed pre- and postoperative visual analogue scales for leg and back pain, walking distance, Oswestry disability index, Roland and Morris disability questionnaire, Odom's criteria, and the SF-36 score. RESULTS: All groups significantly benefited from surgery concerning leg pain, back pain, and disability in every day's life. There was no difference in patients with decompensated sagittal imbalance compared to patients with normal SB regarding life quality 6 to 24 months after microsurgical decompression. CONCLUSIONS: Patients with symptomatic degenerative spinal stenosis and excluded major instability significantly benefit from microsurgical decompression regardless of their sagittal spinal balance. Thus, restoration of the SB for patients with symptomatic degenerative spinal stenosis cannot be recommended in addition to microsurgical decompression. LEVEL OF EVIDENCE: 3.