Miniaturized V-band circularly polarized leaky-wave antenna with continuous radiation coverage using modified waveguide and metasurface CSRRs.

A miniaturized V-band leaky-wave antenna (LWA) with circular polarization and backward-broadside-forward radiation based on a modified half-mode substrate integrated waveguide (M-HMSIW) is presented. The proposed M-HMSIW structure employs broadside coupled complementary split ring resonators to replace metallic vias, resulting in low-cost and fully-planar fabrication advantages over conventional HMSIWs. Each unit cell of the proposed LWA consists of an M-HMSIW in combination with two horizontal stubs and a cross-shaped complementary electric LC slot to provide a proper circular polarization with a composite right/left-handed property. Using this structure, the balanced condition can be obtained for the unit cell; hence a continuous backward-to-forward scanning, including broadside, is achieved. As a result, the proposed LWA with a radiator length of only 3.8 λ0 provides wide-angle beam scanning from - 53° to + 54° over the frequency range of 61.2 GHz to 73.4 GHz, while maintaining an excellent circular polarization between - 25° and 25°. The maximum gain of the LWA is 11.1 dB which is satisfactory, considering its compactness. The antenna's performance is experimentally verified, and close agreement between the simulations and measurements is observed.

Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results.

BACKGROUND: Reherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone. OBJECTIVE: The objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States. METHODS: In this post-market study, all patients (N = 55) received discectomy surgery with a bone-anchored ACD. The comparison population was patients enrolled in the RCT study who had discectomy with an ACD (N = 262) or discectomy alone (N = 272). All other eligibility criteria, surgical technique, device characteristics, and follow-up methodology were comparable between studies. Endpoints included rate of symptomatic reherniation or reoperation, SAEs, and patient-reported measures of disability, pain, and quality of life. RESULTS: Fifty-five patients received ACD implants at 12 sites between May 2020 and February 2021. In the previous RCT, 272 control patients had discectomy surgery alone (RCT-Control), and 262 patients had discectomy surgery with an ACD implant (RCT-ACD). Baseline characteristics across groups were typical of the overall population undergoing lumbar discectomy. The proportion of patients who experienced reherniation and/or reoperation was significantly lower in the ACD group compared to RCT-ACD and RCT-Control groups (p < 0.05). In the ACD study, the one-year rate of symptomatic reherniation was 3.7%, compared to 8.5% in the RCT-ACD group and 17.0% in the RCT-Control group. In the ACD group, the risk of reoperation was 5.5%, compared to 6.5% in the RCT-ACD group and 12.5% in the RCT-Control group. There were no device-related SAEs or device integrity failures in the ACD, and there were clinically meaningful improvements in patient-reported measures of disability, pain, and quality of life. CONCLUSION: In this post-market study of bone-anchored ACD in patients with large annular defects, rates of symptomatic reherniation, reoperation, and SAEs were all low. Compared to the RCT, the post-market ACD study demonstrated lower rates of reherniation and/or reoperation and measures of back pain one-year post-surgery.

Guided-wave manipulation in SIW H-plane horn antenna by combining phase correction and holographic-based leakage.

A hybrid technique is proposed to manipulate the field distribution in a substrate integrated waveguide (SIW) H-plane horn to enhance its radiation characteristics. The technique comprises two cascaded steps to govern the guided waves in the structure. The first step is to correct the phase of fields and form a quasi-uniform distribution in the flare section so that the gain increases and side-lobe-level (SLL) decreases. This is obtained by loading the structure with a novel modulated metal-via lens. Field expansion on the radiating aperture of the SIW H-plane horn generates backward surface waves on both broad walls which increases the backlobe. In the second step, these backward surface waves are recycled and directed forward with the aid of holography theory. This is achieved by adding a couple of dielectric slabs with holographic-based patterns of metallic strips on both broad walls. With this step, the backlobe is reduced and the endfire gain is further increased. Using the proposed technique, the structure is designed and fabricated to operate at [Formula: see text] GHz which simultaneously improves the measured values of gain to 11.65 dBi, H-plane SLL to [Formula: see text] dB, and front-to-back ratio to 17.02 dB.

Clinical Outcomes Following Minimally Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon Clinical Study.

BACKGROUND: This report documents 1-year results of 250 patients enrolled in a prospective, multicenter study of a minimally invasive (MI) sacroiliac joint fusion (SIJF) system that uses decortication, graft placement, and joint fixation. METHODS: The cohort includes all patients enrolled in the EVoluSIon (EVSI) clinical study who had MI SIJF surgery and completed 1-year follow-up. Average age at baseline was 60.5 years, and 70.8% were female. Sacroiliac (SI) joint-related pain duration was ≥2 years in 56% of patients. Visual analog scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life, and opioid use were assessed preoperatively and at 1 year. RESULTS: At 1 year, the mean VAS pain demonstrated a significant reduction of more than 43 points, from 76.4 at baseline to 33.0 (P < 0.0001), with 72.2% of patients attaining the minimal clinically important difference (MCID, ≥20-point improvement). Mean ODI scores also significantly improved from 54.4 at baseline to 30.5 at 1 year (P < 0.0001), with 62.5% of patients achieving the MCID (≥15-point improvement). Prior to surgery, 62.7% (126/201) of patients were taking opioids or other narcotics, but by 1 year postsurgery, only 26.9% (54/201) of patients reported using these medications, representing a significant 57.1% decrease in narcotic/opioid use (P < 0.0001). Fusion of the SI joint was seen in 68.7% of patients. Few procedural complications were reported. In all, there were 8 (8/250) serious procedure-related events, including 1 device malposition observed on the day of surgery that required replacing the superior screw with a shorter screw. CONCLUSIONS: Analysis of patients treated with MI SIJF in the EVSI study demonstrated that the procedure can be performed safely and results in significant improvements in pain, quality of life, and opioid use at 1 year as well as causing fusion in the majority of patients. CLINICAL RELEVANCE: MI SIJF differs from most procedures currently being performed in that it applies true orthopedic principles with decorticating, bone grafting, fusion, and placement of implants perpendicular to the joint for greatest stability. The 12-month data show improvement in functionality, reduction in pain, and, most notably, a reduction in narcotic usage, which is important considering the ongoing opioid epidemic.

The Clinical Impact of Image Guidance and Robotics in Spinal Surgery: A Review of Safety, Accuracy, Efficiency, and Complication Reduction.

Image guidance (IG) and robotic-assisted (RA) surgery are modern technological advancements that have provided novel ways to perform precise and accurate spinal surgery. These innovations supply real-time, three-dimensional imaging information to aid in instrumentation, decompression, and implant placement. Although nothing can replace the knowledge and expertise of an experienced spine surgeon, these platforms do have the potential to supplement the individual surgeon's capabilities. Specific advantages include more precise pedicle screw placement, minimally invasive surgery with less reliance on intraoperative fluoroscopy, and lower radiation exposure to the surgeon and staff. As these technologies have become more widely adopted over the years, novel uses such as tumor resection have been explored. Disadvantages include the cost of implementing IG and robotics platforms, the initial learning curve for both the surgeon and the staff, and increased patient radiation exposure in scoliosis surgery. Also, given the relatively recent transition of many procedures from inpatient settings to ambulatory surgery centers, access to current devices may be cost prohibitive and not as readily available at some centers. Regarding patient-related outcomes, much further research is warranted. The short-term benefits of minimally invasive surgery often bolster the perioperative and early postoperative outcomes in many retrospective studies on IG and RA surgery. Randomized controlled trials limiting such confounding factors are warranted to definitively show potential independent improvements in patient-related outcomes specifically attributable to IG and RA alone. Nonetheless, irrespective of these current unknowns, it is clear that these technologies have changed the field and the practice of spine surgery. Surgeons should be familiar with the potential benefits and tradeoffs of these platforms when considering adopting IG and robotics in their practices.

Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial.

BACKGROUND: Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE: To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS: This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS: At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION: Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study.

Background Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited.  Methods This was a post-market study to determine the real-world outcomes of the Barricaid device when used in addition to primary lumbar discectomy in patients with large annular defects. Main outcomes included leg pain severity, Oswestry Disability Index (ODI), adverse events, symptomatic reherniation, and reoperation. Imaging studies were read by an independent imaging core laboratory. This paper reports the initial three-month primary endpoint results from the trial; one-year patient follow-up is ongoing. Results Among 55 patients (mean age 41±13 years, 60% male), the mean percent reduction in leg pain severity was 92%, and the mean percent reduction in ODI score was 79%. The three-month rate of symptomatic reherniation was 3.6% and the rate of reoperation was 1.8%. The serious adverse event rate was 5.5%; no device migrations or fractures were observed.  Conclusion Among patients with large annular defects following lumbar discectomy treated with the Barricaid device in real-world conditions, early results demonstrated clinically meaningful improvements in patient symptoms and low rates of symptomatic reherniation, reoperation, and complications, which were comparable to those observed with the device in an FDA-regulated trial.

Helicobacter pylori eradication in the management of glaucoma.

BACKGROUND: To investigate the possibility that the eradication of H pylori infection is associated with a reduction in the risk of glaucoma. METHODS: Sixty-five successive patients with elevated intraocular pressure (IOP) or glaucoma were included in the study. Serum samples from all subjects were analyzed for the presence of H pylori- antibodies using ELISA. Forty patients with positive serologic test were included. Half of the patients enrolled into intervention group and the other half registered as control. Intervention arm was referred to the Gastroenterology Clinic for eradication of H pylori and evaluated for the effect of H pylori regimen eradication on IOP and glaucoma over 2 months of follow-up. The age-matched controls did not receive treatment. Urea breath test was applied to confirm eradication. RESULTS: There was a significant (p=0.005) reduction in IOP after complete eradication in the intervention group. This value was not significant in control patients (p=0.08). The mean IOP before treatment of glaucoma in the control group was 23.60±2.37 mmHg and after treatment with anti-glaucoma drugs was 14.25±1.48 mmHg on the onset of study, and 13.55±2.01 mmHg after follow up. The mean IOP before treatment of glaucoma in the intervention group was 24.55±3.6 mmHg and after treatment with anti-glaucoma drugs was 15.15±1.8 mmHg, and 14.3±1.6 mmHg after the eradication of H pylori with a drug regimen. However, after the treatment of glaucoma in all patients, the overall comparison of mean IOP differences showed no statistical difference (P=0.65). CONCLUSION: H pylori eradication therapy may have a positive effect on the management of glaucoma.

Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.

STUDY DESIGN: Systematic review. OBJECTIVES: Superiority claims for medical devices are commonly derived from noninferiority trials, but interpretation of such claims can be challenging. This study aimed to (a) establish the prevalence of noninferiority and superiority designs among spinal device trials, (b) assess the frequency of post hoc superiority claims from noninferiority studies, and (c) critically evaluate the risk of bias in claims that could translate to misleading conclusions. METHODS: Study bias was assessed using the Cochrane Risk of Bias Tool. The risk of bias for the superiority claim was established based on post hoc hypothesis specification, analysis of the intention-to-treat population, post hoc modification of a priori primary outcomes, and sensitivity analyses. RESULTS: Forty-one studies were identified from 1895 records. Nineteen (46%) were noninferiority trials. Fifteen more (37%) were noninferiority trials with a secondary superiority hypothesis specified a priori. Seven (17%) were superiority trials. Of the 34 noninferiority trials, 14 (41%) made superiority claims. A medium or high risk of bias was related to the superiority claim in 9 of those trials (64%), which was due to the analyzed population, lacking sensitivity analyses, claims not being robust during sensitivity analyses, post hoc hypotheses, or modified endpoints. Only 4 of the 14 (29%) noninferiority studies provided low bias in the superiority claim, compared with 3 of the 5 (60%) superiority trials. CONCLUSIONS: Health care decision makers should carefully evaluate the risk of bias in each superiority claim and weigh their conclusions appropriately.

International Society for the Advancement of Spine Surgery Policy 2019-Surgical Treatment of Lumbar Disc Herniation with Radiculopathy.

Lumbar disc herniation (LDH) is a frequent cause of low back pain and radiculopathy, disability, and diminution in quality of life. While nonsurgical care remains the mainstay of initial treatment, symptoms that persist for prolonged periods of time are well treated with discectomy surgery. A large body of evidence shows that, in patients with unremitting symptoms despite a reasonable period of nonsurgical treatment, discectomy surgery is safe and efficacious. In patients with symptoms lasting greater than 6 weeks, various forms of discectomy (open, microtubular, and endoscopic) are superior to continued nonsurgical treatment. The small but significant proportion of patients with recurrent disc herniation experience less improvement overall than patients who do not experience reherniation after primary discectomy. Lumbar discectomy patients with large annular defects (≥6 mm wide) are at a higher risk for recurrent herniation and revision surgery. Annular closure via a bone-anchored device has been shown to decrease the rate of recurrent disc herniation and associated reoperation in these high-risk patients. After a detailed review of the literature, current clinical evidence supports discectomy (open, microtubular, or endoscopic discectomy) as a medically necessary procedure for the treatment of LDH with radiculopathy in indicated patients. Furthermore, there is new scientific evidence that supports the use of bone-anchored annular closure in patients with large annular defects, who are at greater risk for recurrent disc herniation.

International Society for the Advancement of Spine Surgery Policy 2020 Update-Minimally Invasive Surgical Sacroiliac Joint Fusion (for Chronic Sacroiliac Joint Pain): Coverage Indications, Limitations, and Medical Necessity.

The index 2014 International Society for the Advancement of Spine Surgery Policy Statement-Minimally Invasive Surgical Sacroiliac Joint Fusion-was generated out of necessity to provide an International Classification of Diseases, Ninth Revision (ICD-9)-based background and emphasize tools to ensure correct diagnosis. A timely ICD-10-based 2016 update provided a granular threshold selection with improved level of evidence and a more robust and relevant database (Appendix Table A1). As procedures and treatment options have evolved, this 2020 update reviews and analyzes the expanding evidence base and provides guidance relating to differences between the lateral and dorsal surgical procedures for minimally invasive surgical sacroiliac joint fusion.

Time Savings and Related Economic Benefits of Suction-Curette Device for Transforaminal Lumbar Interbody Fusion Discectomy.

BACKGROUND: Performing an adequate transforaminal lumbar interbody fusion (TLIF) discectomy requires numerous instrument passes, increasing surgical time and the risk of complications. The purpose of this study was to evaluate the efficacy and efficiency of discectomy and endplate preparation during TLIF using traditional manual instrumentation versus a novel suction discectomy curette. The direct economic benefit with use of the suction discectomy curette is calculated. METHODS: Three experienced, spine-fellowship-trained surgeons performed TLIF discectomies on 3 cadaveric specimens from T12 to S1 using either traditional manual discectomy instruments or CONCORD Clear (Xtool) devices supplemented with manual discectomy instruments. For each level in which a discectomy was performed, the following were measured: elapsed time, number of instrument passes and the number of instrument exchanges, and estimated tissue volume. RESULTS: Transforaminal lumbar interbody fusion discectomy times improved on average 11:32 minutes per level, which equates to an estimated procedural time savings of 15:85 minutes, using 1.4 levels per TLIF, the average number of levels in a large series. Usage of the CONCORD Clear significantly reduced instrument passes compared to traditional, with a mean of 62.0 for traditional versus 7.1 for CONCORD Clear, an 8.7-fold improvement. Instrument exchanges showed a 5.9-fold improvement, with means of 26.8 and 4.6, respectively. Wet discectomy tissue volume was measured for each discectomy, with a mean of 5.4 cc for traditional versus 12.9 cc for CONCORD Clear, a 2.4-fold improvement. CONCLUSIONS: This study estimates that, in a typical TLIF procedure, over 15 minutes should be saved by using the CONCORD Clear l device (a quarter of the time of a traditional discectomy), and by considering the direct cost-benefit associated with this time savings as well as reduced sterilization costs, it is estimated that a hospital could save approximately $1300 in operating room time and sterilization cost with the use of the CONCORD Clear device in a typical 1-level TLIF procedure.

Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial.

PURPOSE: This report documents six-month results of the first 50 patients treated in a prospective, multi-center study of a minimally invasive (MI) sacroiliac (SI) joint fusion system. PATIENTS AND METHODS: This cohort includes 50 patients who had MI SI joint fusion surgery and completed 6 month follow-up. Average age at baseline was 61.5, 58% were female, and SI joint-related pain duration was ≥2yrs in 54.0% of patients. Visual Analog Scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life and opioid use were assessed preoperatively and at 6 months. RESULTS: At 6 months, mean VAS pain demonstrated a significant reduction from 76.2 at baseline to 35.1 (54% reduction, p<0.0001), with 72% of patients attaining the minimal clinically important difference (MCID, ≥20 point improvement). Mean ODI improved from 55.5 to 35.3 at 6 months (p < 0.001), with 56% of patients achieving the MCID (≥15 point improvement). Prior to surgery 33/50 (66%) of patients were taking opioids, but by 6 months the number of patients taking opioids had decreased by 55% to 15/50 (30%). Few procedural complications were reported. Two procedure-related events required hospitalization: a revision procedure (2%) for nerve impingement and one case of ongoing low back pain. CONCLUSION: Analysis of patients treated with MI SI joint fusion using the SImmetry System demonstrated that the procedure can be performed safely and results in significant improvements in pain, disability, and opioid use at 6 months. Longer term follow-up in this study will determine whether these improvements are durable, as well as the associated radiographic fusion rates.

Idiopathic septic arthritis of a lumbar facet joint associated with paraspinal abscess.

A 48-year-old woman presented with a 1-month history of severe lower back pain on a background of 24 h of mild fever and general tiredness with an associated right-sided foot drop. Five weeks after the onset and with no improvement in symptoms in spite of analgesia and physiotherapy, the patient had a lumbar spine MRI which demonstrated a collection extending from the facet joints of L5 and L6 to the iliacus muscle on the right. A CT-guided aspiration was performed with a lengthy hospital stay for intravenous antibiotic treatment. The culture and sensitivity study of the aspirate isolated Streptococcus pneumoniae.

Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial.

STUDY DESIGN: A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. OBJECTIVE: To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. SUMMARY OF BACKGROUND DATA: Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. METHODS: Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases.Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. RESULTS: Preoperative characteristics were statistically similar for the 1- and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1- and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. CONCLUSION: A 4-year post hoc comparison of 1- and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates. LEVEL OF EVIDENCE: 1.

Enhanced chemical synthesis at soft interfaces: a universal reaction-adsorption mechanism in microcompartments.

A bimolecular synthetic reaction (imine synthesis) was performed compartmentalized in micrometer-diameter emulsion droplets. The apparent equilibrium constant (Keq) and apparent forward rate constant (k1) were both inversely proportional to the droplet radius. The results are explained by a noncatalytic reaction-adsorption model in which reactants adsorb to the droplet interface with relatively low binding energies of a few kBT, react and diffuse back to the bulk. Reaction thermodynamics is therefore modified by compartmentalization at the mesoscale--without confinement on the molecular scale--leading to a universal mechanism for improving unfavorable reactions.

Enhanced imine synthesis in water: from surfactant-mediated catalysis to host-guest mechanisms.

An environment-responsive and fluorogenic reaction is reported and used as a model system to demonstrate experimentally three mechanisms of enhanced imine synthesis in water using either surfactants (below and above their CMC) or double-stranded DNA (acting as a reaction host).

Prospective, multicenter, randomized, controlled study of anular repair in lumbar discectomy: two-year follow-up.

STUDY DESIGN: Prospective, multicenter, single-blind, randomized, controlled clinical study. OBJECTIVE: To investigate outcomes associated with repairing the anulus fibrosus after lumbar discectomy for the surgical management of herniated nucleus pulposus. SUMMARY OF BACKGROUND DATA: In patients undergoing discectomy, the incidence of reherniation ranges from 10% to 15%. Repair of the anulus fibrosus defect after lumbar discectomy may decrease the incidence of recurrent herniation for these patients. METHODS: A total of 750 patients were treated for herniated lumbar discs and randomly assigned in a 2:1 ratio to discectomy with the Xclose Tissue Repair System (Anulex Technologies, Minnetonka, MN) for anular repair (n = 500) or discectomy without anular repair (n = 250). Patient self-reported measures included visual analogue scales for leg and back pain, Oswestry Disability Index, and Short Form-12 Health Survey. Adverse events and subsequent reherniation surgical procedures were documented. Preoperative outcome measures were compared with follow-up visits at 2 weeks, 6 months, 1 year, and 2 years. RESULTS: Patient symptoms were improved after surgery in an equivalent manner in both study groups. In the overall study analysis, the rate of reherniation surgery was lower for Xclose patients at all follow-up time points, but these differences were not statistically significant. In patients with predominant leg pain, there was a significant reduction in reherniation risk at 3 and 6 months postoperation for patients receiving Xclose. A positive reduction was maintained through 2 years, with a clinically relevant risk reduction of 45%, although not statistically significant. Safety was demonstrated with similar improvements in patient outcomes and no difference in reported adverse events. CONCLUSION: Without a safe and effective method for closing the anulus fibrosus after discectomy, current practice has been to leave the anulus in a compromised state. This multicenter randomized study demonstrated that, while not statistically significant, anular repair reduced the need for subsequent reherniation surgery while retaining the benefits of discectomy with no increased risk for patients. LEVEL OF EVIDENCE: 1.

A completely in vitro ultrahigh-throughput droplet-based microfluidic screening system for protein engineering and directed evolution.

In vitro screening systems based on the coupled transcription and translation of genes using cell-free systems have a number of attractive features for protein engineering and directed evolution. We present a completely in vitro ultrahigh-throughput screening platform using droplet-based microfluidics. Single genes are compartmentalized in aqueous droplets, dispersed in inert carrier oil, and amplified using the polymerase chain reaction (PCR). After amplification, the droplets, now containing 30,000 copies of each gene, are fused one-to-one with droplets containing a cell-free coupled transcription-translation (IVTT) system and the reagents for a fluorogenic assay. Fluorescence-activated electrocoalescence with an aqueous stream is then used to selectively recover genes from droplets containing the desired activity. We demonstrate, by selecting mixtures of lacZ genes encoding the enzyme ß-galactosidase and lacZmut genes encoding an inactive variant, that this system can sort at 2000 droplets s(-1): lacZ genes were enriched 502-fold from a 1 : 100 molar ratio of lacZ : lacZmut genes. Indeed, the false positive and false negative error rates were both <0.004 and the results indicate that enrichment is not limited by the sorting efficiency, but by the co-encapsulation of multiple genes in droplets, which is described by the Poisson distribution. Compared to screening using microtiter plate-based systems, the volume and cost of PCR and IVTT reagents are reduced by almost 10(5)-fold, allowing the screening of 10(6) genes using only 150 µL of reagents.

Minimally invasive percutaneous transpedicular screw fixation: increased accuracy and reduced radiation exposure by means of a novel electromagnetic navigation system.

BACKGROUND: Minimally invasive percutaneous pedicle screw instrumentation methods may increase the need for intraoperative fluoroscopy, resulting in excessive radiation exposure for the patient, surgeon, and support staff. Electromagnetic field (EMF)-based navigation may aid more accurate placement of percutaneous pedicle screws while reducing fluoroscopic exposure. We compared the accuracy, time of insertion, and radiation exposure of EMF with traditional fluoroscopic percutaneous pedicle screw placement. METHODS: Minimally invasive pedicle screw placement in T8 to S1 pedicles of eight fresh-frozen human cadaveric torsos was guided with EMF or standard fluoroscopy. Set-up, insertion, and fluoroscopic times and radiation exposure and accuracy (measured with post-procedural computed tomography) were analyzed in each group. RESULTS: Sixty-two pedicle screws were placed under fluoroscopic guidance and 60 under EMF guidance. Ideal trajectories were achieved more frequently with EMF over all segments (62.7% vs. 40%; p = 0.01). Greatest EMF accuracy was achieved in the lumbar spine, with significant improvements in both ideal trajectory and reduction of pedicle breaches over fluoroscopically guided placement (64.9% vs. 40%, p = 0.03, and 16.2% vs. 42.5%, p = 0.01, respectively). Fluoroscopy time was reduced 77% with the use of EMF (22 s vs. 5 s per level; p < 0.0001) over all spinal segments. Radiation exposure at the hand and body was reduced 60% (p = 0.058) and 32% (p = 0.073), respectively. Time for insertion did not vary between the two techniques. CONCLUSIONS: Minimally invasive pedicle screw placement with the aid of EMF image guidance reduces fluoroscopy time and increases placement accuracy when compared with traditional fluoroscopic guidance while adding no additional time to the procedure.