Infusion Rate Research Articles

A Phase 4 Study to Evaluate the Safety and Tolerability of Higher Infusion Rates of Agalsidase Beta to Shorten Infusion Duration in Fabry Disease: Interim Analysis

A Phase 4 Study to Evaluate the Safety and Tolerability of Higher Infusion Rates of Agalsidase Beta to Shorten Infusion Duration in Fabry Disease: Interim Analysis

Efficacy, safety, and quality of life 4 years after valoctocogene roxaparvovec gene transfer for severe hemophilia A in the phase 3 GENEr8-1 trial

BackgroundValoctocogene roxaparvovec, an adeno-associated virus-mediated gene therapy for severe hemophilia A, enables endogenous factor VIII (FVIII) expression and provides bleed protection. ObjectivesDetermine valoctocogene roxaparvovec durability, efficacy, and safety 4 years post-treatment. MethodsIn the phase 3 GENEr8-1 trial, 134 adult males with severe hemophilia A without inhibitors and previously using FVIII prophylaxis received a 6x1013 vg/kg infusion of valoctocogene roxaparvovec. Efficacy endpoints included annualized bleed rate (ABR), annualized FVIII infusion rate, FVIII activity, and the Haemophilia-Specific Quality of Life Questionnaire for Adults (Haemo-QOL-A). Adverse events (AEs) and immunosuppressant use were assessed. Change from baseline was assessed after participants discontinued prophylaxis (scheduled for week 4). ResultsMedian follow-up was 214.3 weeks; 2 participants discontinued since the previous data cutoff. Declines from baseline in mean treated ABR (−82.6%; P<0.0001) and annualized FVIII infusion rate (−95.5%; P<0.0001) were maintained from previous years in the primary analysis population of 112 participants who enrolled from a noninterventional study. During year 4, 81/110 rollover participants experienced 0 treated bleeds. Week 208 mean and median chromogenic FVIII activity were 16.1 IU/dL and 6.7 IU/dL, respectively, in 130 modified intention-to-treat (mITT) participants. Seven participants resumed prophylaxis since the previous data cutoff. Mean change from baseline to week 208 in Haemo-QOL-A Total Score (P<0.0001) remained clinically meaningful for mITT participants. Alanine aminotransferase elevation was the most common AE during year 4 (56/131 participants); none required immunosuppressants. ConclusionsValoctocogene roxaparvovec provides persistent FVIII expression, hemostatic control, and health-related quality of life improvements with no new safety signals.

Off-Label Bone Morphogenetic Protein 2 Use Results in Successful Posterolateral Lumbar Fusion in a Veteran Population.

Patients within the US Veterans Health Administration (VA) system have higher rates of comorbidities and chronic pain, increasing risks of complications/poor outcomes following spine surgery. Although the use of bone morphogenetic protein 2 (BMP-2) is established for anterior lumbar interbody fusion, its indications for off-label use in posterolateral fusion are unclear. The objective of this study was to evaluate safety and utility of BMP-2 in posterolateral fusion through a 15-year experience at the VA. Patients underwent posterolateral lumbosacral fusions with BMP-2 by a single VA surgeon from January 1, 2005, to January 1, 2020. The primary outcome was fusion assessed through postoperative radiographs. Secondary outcomes included adjacent segment disease (ASD) and postoperative pain clinic utilization. Sixty-eight patients underwent lumbosacral posterolateral fusion with BMP-2; 77.9% were discharged home and had no postoperative complications. All patients achieved bony fusion at a mean of 113.3 ± 59.9 days postoperatively. Five patients were diagnosed with cancer postoperatively, and eight patients required revision for ASD. No notable predictors of ASD exist. Preoperative opioid use predicted postoperative pain clinic utilization. Posterolateral lumbar fusion with BMP-2 in veterans yields high fusion rates and favorable complication profiles and should be considered in multimorbid hosts. Retrospective review of prospectively collected data.

Effect of Cage Material and Size on Fusion Rate and Subsidence Following Biportal Endoscopic Transforaminal Lumbar Interbody Fusion.

Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is an emerging, minimally invasive technique performed under biportal endoscopic guidance. However, concerns regarding cage subsidence and sufficient fusion during BE-TLIF necessitate careful selection of an appropriate interbody cage to improve surgical outcomes. This study compared the fusion rate, subsidence, and other radiographic parameters according to the material and size of the cages used in BE-TLIF. In this retrospective cohort study, patients who underwent single-segment BE-TLIF between April 2019 and February 2023 were divided into 3 groups: group A, regular-sized three-dimensionally (3D)-printed titanium cages; group B, regular-sized polyetheretherketone cages; and group C, large-sized 3D-printed titanium cages. Radiographic parameters, including lumbar lordosis, segmental lordosis, anterior and posterior disc heights, disc angle, and foraminal height, were measured before and after surgery. The fusion rate and severity of cage subsidence were compared between the groups. No significant differences were noted in the demographic data or radiographic parameters between the groups. The fusion rate on 1-year postoperative computed tomography was comparable between the groups. The cage subsidence rate was significantly lower in group C than in group A (41.9% vs. 16.7%, p=0.044). The severity of cage subsidence was significantly lower in group C (0.93±0.83) than in groups A (2.20±1.84, p=0.004) and B (1.79±1.47, p=0.048). Cage materials did not affect the 1-year postoperative outcomes of BE-TLIF; however, subsidence was markedly reduced in large cages. Larger cages may provide more stable postoperative segments.

Biportal Endoscopic Transforaminal Lumbar Interbody Fusion: How to Improve Fusion Rate?

Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is a minimally invasive surgical technique for treating degenerative lumbar spine conditions. It offers advantages such as reduced soft tissue trauma and lower infection rates, but certain technical aspects may be challenging. The current study aims to identify strategies to enhance the fusion rate in BE-TLIF by addressing these specific challenges. A literature review was conducted on techniques to improve fusion rates in BE-TLIF. The review suggests that lateral-based portals supplemented with medial portals allowed for safe insertion of interbody cages with large footprint. Direct visualization of the disc space with a 30° endoscope assisted with better disc space preparation. Facetectomies performed with osteotomes, rather than burrs, ensured maximum retrieval of autologous bone graft. Utilizing bone morphogenetic proteins with sustained release carriers such as hydroxyapatite can be useful to increase fusion rates of BE-TLIF. To our knowledge, the current literature is the first comprehensive review of strategies to enhance fusion rates in BE-TLIF. The proposed techniques and biological adjuncts are effective means to address key challenges associated with the procedure, and such strategies would potentially shorten the learning curve and improve clinical outcomes. Further clinical studies are required to validate these findings and establish standardized protocols. These findings provide practical solutions to overcome common challenges in BE-TLIF. The suggested techniques would reduce the incidence of pseudarthrosis, improve patient outcomes, and ultimately offer a safer and more reliable option for lumbar interbody fusion patients.

Midterm Follow-Up Of Tlif In Single-Level Lumbar Disc Degeneration

OBJECTIVES This study aims to evaluate the midterm clinical and radiological outcomes of TLIF in patients with single-level lumbar disc degeneration. The focus is on assessing the procedure's effectiveness in terms of pain relief, functional improvement, and any potential complications. METHODOLOGY A retrospective cohort study was conducted at Hayatabad Medical Complex, Peshawar involving 120 patients who underwent single-level TLIF for lumbar disc degeneration between 2018-2023. The patients with a diagnosis of single-level lumbar disc degeneration confirmed by MRI, failure of conservative treatment for at least 6 months, and who underwent TLIF during the study period were included in the study. Data were collected on preoperative and postoperative pain scores, Oswestry Disability Index (ODI), and radiological parameters. SPSS version 24 was used. RESULTSThe mean follow-up period was 36 months (range 24-48 months). There was a statistically significant improvement in both pain scores (p &lt; 0.001) and ODI scores (p &lt; 0.001). Fusion rates were high, with 92% of patients achieving solid fusion by the final follow-up. Complications were observed in 15% of the cases, with adjacent segment disease being the most common. CONCLUSION TLIF provides significant pain relief and functional improvement in patients with single-level lumbar disc degeneration at midterm follow-up. The procedure demonstrates a high fusion rate with an acceptable complication profile, making it a reliable option for this patient population

Controlling the Apex in Early Onset Scoliosis Through Active Apex Correction (APC) Non Fusion Growth Modulating Technique, Is It a Myth?

A multicenter retrospective study. To determine the rate of Apex facet fusion in children with Early Onset Scoliosis treated surgically with the Active Apex Correction (APC) technique. Seventeen patients were treated with the APC technique as index surgery for Early Onset Scoliosis with more than 1year of follow-up. A 3D CT scan was done to determine the facet fusion rate in the deformity's apex controlled with posterior tethering. The average follow-up time was 26.4months (12-56), Average age at index surgery was 81.2months (30-132), and average number of surgeries done 1.3. Apical vertebrae studied for facet fusion were the 3 vertebrae in the apex in each patient that were subjected to posterior tethering according to the APC technique. In total they were 86 apical vertebrae (172 Facets studied with 86 convex side, 86 concave side). Our observations showed that 29 facet joints were fused (16% of the total facets studied),15 were on the convex, 14 on the concave side (no statistically significant difference). Regarding the facet joint distance in the non-fused facets was 0.99mm on the convex side and 1.08mm on the concave side with no statistical significance difference. APC for Early Onset Scoliosis achieves apical growth modulation and control utilizing posterior tethering without inducing fusion. This study demonstrated that APC is an effective non-fusion technique through the low incidence of facet fusion levels at the Apex, limiting the crankshaft phenomena seen in cases with apex control through arthrodesis.

Comparison of midline lumbar interbody fusion and minimally invasive transforaminal lumbar interbody fusion for treatment of lumbar degeneration disease

Midline lumbar interbody fusion (MIDLIF) and minimally invasive transforaminal interbody fusion (MIS-TLIF) are two minimally invasive lumbar fusion methods that have gained popularity in the past two decades. MIDLIF involves the use of cortical bone trajectory screws, whereas MIS-TLIF uses traditional pedicle screws. However, there is a significant lack of research directly examining the clinical efficacy of these two methods in treating single-segment lumbar degenerative diseases. Hence, the objective of our retrospective study is to assess and contrast the surgical and clinical results of MIDLIF and MIS-TLIF. The study population comprised 133 patients diagnosed with single-segment lumbar degenerative disease that received treatment using either MIDLIF (n = 65) or MIS-TLIF (n = 68) in our department from January 2017 to January 2019. The fusion rates for MIDLIF were consistently lower than MID-TLIF at all post-operative time periods of follow-up, however, the differences between the two groups were not statistically significant. The 1-year fusion rates were 81.5% (MIDLIF) and 83.8% (MIS-TLIF) (P = 0.728), and the 2-year fusion rates were 87.7% (MIDLIF) and 91.2% (MIS-TLIF) (P = 0.513). The final follow-up fusion rates were 93.8% (MIDLIF) and 95.6% (MIS-TLIF) (P = 0.653). MIDLIF had several advantages over MIS-TLIF, including a shorter operative time (135.2 ± 15.70 vs. 160.1 ± 17.2 min, P < 0.001), decreased intraoperative blood loss (147.9 ± 36.4 vs. 169.5 ± 24.7 mL, P < 0.001), and a shorter length of hospital stay (10.8 ± 3.1 vs. 12.4 ± 4.1d; P = 0.014). No significant differences were seen between the groups in terms of the postoperative day of ambulation, Oswestry dysfunction index (ODI) scores, and visual analog scale (VAS) scores for leg and lower back pain (P > 0.05). Although not significant (P = 0.707), MIDLIF (13.8%) had fewer overall complications than MIS-TLIF (16.2%). Therefore, compared to MIS-TLIF, MIDLIF provides perioperative benefits while achieving the same outcomes as MIS-TLIF in terms of fusion rate, pain relief, functional improvement, and complication rate.

A retrospective comparative study of robot-assisted unilateral biportal endoscopic lumbar decompression and fusion surgery versus percutaneous endoscopic lumbar decompression and fusion surgery.

The objective of this study is to illustrate the advantages of robot-assisted unilateral biportal endoscopy in lumbar decompression fusion and internal fixation surgery. According to the different surgical methods, we divided the 26 patients into 2 groups, robot-assisted unilateral biportal endoscopy for lumbar interbody fusion (R-ULIF) group and percutaneous endoscopic lumbar decompression and interbody fusion (Endo-LIF) group, with a 1:1 ratio. Gender, disease course, lesion site, fluoroscopy times, operative time, blood loss, postoperative hospital stay, screw placement success rate, fusion rate, complications rate, postoperative pain visual analog scale (VAS) (The VAS score is used only to evaluate pain in the lower back and legs.) Oswestry Disability Index (ODI) (The ODI score can serve as a reference indicator for evaluating the effectiveness of treatment for patients with low back pain, and has good responsiveness in assessing patients with chronic low back pain), and MacNab (The MacNab standard is divided into 4 levels: excellent, good, fair, and poor, which can be used to evaluate the therapeutic efficacy of certain spinal surgeries) standard efficacy evaluation were analyzed and compared between the 2 groups. All patients successfully completed the surgery. Compared with the Endo-LIF group, the R-ULIF group had fewer fluoroscopy procedures, less intraoperative blood loss, and shorter postoperative hospital stay (P < .05). The VAS scores and ODI scores of both groups significantly decreased at all-time points (P < .05). The ODI scores of the R-ULIF group were better than the Endo-LIF group at 1 month and 3 months after surgery (P = .017/P = .047), but there was no statistically significant difference between the groups before surgery and 1 week after surgery (P > .05). The efficacy was evaluated using the MacNab criteria at 6 months after surgery. The R-ULIF group has an excellent and good rate of 84.6%, while the Endo-LIF group has an excellent and good rate of 76.9% (P = 1.000). Robot-assisted unilateral biportal endoscopy for lumbar interbody and fusion surgery has shown short-term clinical efficacy in the treatment of lumbar disc herniation combined with lumbar instability, surpassing endoscopic lumbar interbody fusion surgery. Robot-assisted unilateral biportal endoscopy for lumbar interbody and fusion surgery has demonstrated high success rate in screw placement, minimal radiation exposure, less intraoperative blood loss, shorter hospital stay, and thus deserves further clinical promotion.

Impact of increasing post-filter ionised calcium target on regional citrate anticoagulation efficacy in ICU continuous renal replacement therapy: the non-inferiority randomised controlled Ca-CIBLE protocol

IntroductionContinuous renal replacement therapy (CRRT) is a critical therapeutic intervention for patients with severe acute kidney injury in intensive care. However, premature filter clotting remains a significant challenge during CRRT,...

Bone graft substitutes used in anterior lumbar interbody fusion: a contemporary systematic review of fusion rates and complications.

Anterior lumbar interbody fusion (ALIF) uses a broad-footprint interbody cage designed to maximize fusion rates for treating degenerative disc disease. Bone graft substitutes are being increasingly utilized during ALIF to replace or supplement autologous iliac crest bone grafts. This approach aims to optimize fusion efficacy while minimizing associated postoperative complications. The objective of this systematic review was to examine recent studies on fusion rates and postoperative complications associated with bone graft substitutes used in ALIF. We conducted a systematic review of the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, MEDLINE, and PubMed databases, to critically examine a decade of research (January 1, 2012, to July 6, 2023) on the effectiveness and safety of various bone graft substitutes in ALIF. This timeframe was chosen to build on a previous systematic review published in 2013. The PRISMA guidelines were used. In total, 27 articles met our stringent inclusion and exclusion criteria. A substantial portion of these studies (67%) focused on recombinant human bone morphogenetic protein-2 (rhBMP-2) and highlighted its efficacy for achieving high fusion rates. However, the literature presents a dichotomy regarding the association of rhBMP-2 with increased postoperative complications. Notably, the methodologies for evaluating spinal fusion varied across studies. Only one-third of studies employed computed tomography to assess interbody fusion at 12 months postoperatively, highlighting the urgent need to establish uniform fusion criteria to facilitate more accurate comparative analyses. Moreover, there was considerable variability in the criteria used for diagnosing and detecting postoperative complications, significantly influencing the reported incidence rates. This review underscores the need for continued research into bone graft substitutes, particularly focusing on assessment of long-term complications. Future research endeavors should concentrate on developing comprehensive clinical guidelines to aid in the selection of the most suitable bone graft substitutes for use in ALIF, thereby enhancing patient outcomes and surgical efficacy.

Maintenance infusion rate of oxytocin after initial 1-IU bolus for elective Cesarean delivery: a dose-finding study.

The purpose of our study was to determine the minimum effective dose of oxytocin maintenance infusion required to maintain adequate uterine tone in 90% of patients (ED90) after administration of the initial bolus at elective Cesarean delivery (CD) under spinal anesthesia. We conducted a prospective, double-blind dose-finding study with biased coin up-down design. Immediately after delivery, a 1-IU oxytocin bolus was administered, followed by a maintenance infusion. The obstetrician assessed the uterine tone by palpation as satisfactory or unsatisfactory. In case of unsatisfactory response, the dose for the next patient was increased by 2 IU·hr-1. For satisfactory response, the dose for the next patient was either decreased by 2 IU·hr-1 with a probability of 1/9, or remained unchanged. The primary outcome was a satisfactory uterine tone from five minutes after delivery until discharge from postanesthesia care unit. The secondary outcomes were blood loss, need for additional uterotonics, and side effects. We analyzed data for 40 patients. The ED90 of oxytocin maintenance infusion was 4.5 IU·hr-1 (95% confidence interval, 3.3 to 5.5) based on the isotonic regression estimator. The median [interquartile range] blood loss was 861 [553-1,181] mL; 18% received additional uterotonics, and 38% developed hypotension post delivery. Based on the results of this dose-finding study, we recommend a maintenance infusion rate of 4.5 IU·hr-1 following an oxytocin bolus of 1 IU for adequate uterine tone in pregnant patientsundergoing elective CDs. This infusion rate is four-fold lower than that required without an initial bolus. ClinicalTrials.gov ( NCT04946006 ); first submitted 25 June 2021.

Minimally Invasive Surgery for Posterior Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF): A Muscle-Sparing Procedure for Atlantoaxial Instability or Dislocation.

Conventional surgical procedures for atlantoaxial instability or dislocation (AAI/D) have been associated with a high prevalence of postoperative occipitocervical pain and dysfunction, as well as substantial perioperative blood loss. We hypothesized that minimally invasive surgery for posterior atlantoaxial lateral mass joint fusion (MIS-PALF), a procedure that can largely avoid disruption of suboccipital musculature, would be superior to the standard Goel-Harms technique in terms of postoperative pain and perioperative blood loss. This was a prospective cohort study of patients undergoing MIS-PALF for AAI/D at Peking University Third Hospital's Department of Orthopaedics from January 2021 to December 2021 and a historical control group of patients with the same diagnoses who were treated with the Goel-Harms technique. The duration of surgery, perioperative blood loss, postoperative length of hospital stay, postoperative body temperature, pain, supplementary use of narcotics, spinal cord function/improvement (assessed using the Japanese Orthopaedic Association [JOA] scores), reduction of AAI/D (determined based on radiographic parameters), rate of successful fusion, and complication rate were all compared between the 2 groups. No significant differences were noted between the groups (43 MIS-PALF cases, 86 control cases) regarding baseline data, operative time, spinal cord function or improvement, reduction of AAI/D, rate of successful fusion, and complication rate. MIS-PALF was associated with significantly less perioperative blood loss, a shorter postoperative hospital stay (decreased by 30.8%), lower intensity and frequency of postoperative pain (decreased by 10.6% and 61.9%, respectively), less need for supplementary narcotics, and less frequent postoperative fever (decreased by 48.7%). This was the first prospective cohort study of which we are aware on minimally invasive procedures for atlantoaxial fusion. Clinical efficacy (AAI/D reduction, rate of successful atlantoaxial fusion, JOA score improvement), efficiency (operative time), and safety (complications) of MIS-PALF appeared to be noninferior to those of the Goel-Harms technique. MIS-PALF was superior in terms of postoperative occipitocervical pain and length of hospital stay, both of which directly affect overall patient satisfaction and postoperative recovery of quality of life. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Accurate Machine Learning-based Monitoring of Anesthesia Depth with EEG Recording.

General anesthesia, pivotal for surgical procedures, requires precise depth monitoring to mitigate risks ranging from intraoperative awareness to postoperative cognitive impairments. Traditional assessment methods, relying on physiological indicators or behavioral responses, fall short of accurately capturing the nuanced states of unconsciousness. This study introduces a machine learning-based approach to decode anesthesia depth, leveraging EEG data across different anesthesia states induced by propofol and esketamine in rats. Our findings demonstrate the model's robust predictive accuracy, underscored by a novel intra-subject dataset partitioning and a 5-fold cross-validation method. The research diverges from conventional monitoring by utilizing anesthetic infusion rates as objective indicators of anesthesia states, highlighting distinct EEG patterns and enhancing prediction accuracy. Moreover, the model's ability to generalize across individuals suggests its potential for broad clinical application, distinguishing between anesthetic agents and their depths. Despite relying on rat EEG data, which poses questions about real-world applicability, our approach marks a significant advance in anesthesia monitoring.

Fractional-Order Modeling of the Depth of Analgesia as Reference Model for Control Purposes

Little research has been carried out in terms of modeling and control of analgesia. However, emerging new technology and recent prototypes paved the way for several ideas on pain modeling for control. Recently, such an idea has been proposed for measuring the Depth of Analgesia (DoA). In this paper, that solution is further exploited towards obtaining a novel fractional-order model and dedicated controller for DoA. First, clinical data from patients undergoing general anesthesia are used to determine a commensurate fractional-order model of the skin impedance at each sampling period. Second, we provide a proof of concept indicating that fractional order changes due to variations in the infused opioid drug (Remifentanil). Third, a fractional-order model for DoA is developed correlating the changes in the pain index (as the output signal) and the Remifentanil infusion rate (as the input signal). Standard optimization routines are used to estimate the parameters. A database of 19 real patients is used. Lastly, a preliminary fractional-order controller is designed and tested in simulation for the 19 patients. The closed-loop simulation results correspond to the expected clinical outcomes.

Effect of zoledronic acid and pamidronate on renal function.

There is limited data on the effect bisphosphonates have on renal function and the use of bisphosphonates in patients with baseline renal dysfunction. The purpose of this study was to determine the incidence of acute kidney injury (AKI) in patients after receiving zoledronic acid or pamidronate. A retrospective cohort analysis was conducted of patients who received one dose of a bisphosphonate, either zoledronic acid or pamidronate. The primary objective of this study was to determine the incidence of AKI after bisphosphonate administration. Baseline characteristics were compared, and unadjusted analyses of primary and secondary outcomes were completed using Pearson's chi-square or Fisher's exact test for categorical data and Mann-Whitney U test for continuous data. There was no difference found in AKI incidence between zoledronic acid and pamidronate (17.1% vs. 15.0%; p = 1.00). Additionally, there was no difference found in AKI incidence between patients with baseline renal dysfunction and those without, (25.0% vs. 15.0%; p = 0.322). There were no differences observed in either corrected calcium within seven days or serum creatinine (SCr) within 30 days returning to baseline after administration, nor were there differences in fever or hypophosphatemia incidences. Bisphosphonates may be used to treat hypercalcemia of malignancy in patients with and without renal dysfunction. AKI may occur post infusion; however, long-term effects on renal function are infrequent when hydrating patients prior to administration and adhering to the manufacturer's recommended infusion rate.

A Comparison of the Use of Propofol versus Midazolam for Pediatric Magnetic Resonance Imaging Sedation: Retrospective Cohort Study.

The aim of the present study was to do a comparison of the recovery profiles and airway-related adverse events of pediatric magnetic resonance imaging (MRI) sedation patients who received propofol alone to those who received midazolam alone. This retrospective cohort study was approved by the Mutah University Ethical Approval Committee (No. 2378). A search of the patients' medical records was performed between September 2021 and April 2022 to identify children aged 4 months-11 years who received propofol or midazolam for MRI sedation. The patients were subdivided into two groups: Those who had propofol alone (propofol group) and those who received midazolam (midazolam group) for pediatric MRI sedation. In propofol group, a 1-2 mg/kg of propofol bolus was given to have a deep sedation (Ramsay Sedation Scale score of 5). Patients in midazolam group received 0.05 mg/kg of midazolam. During the maintenance state of sedation, the patient received 150 µg/kg/min of propofol, and the infusion rate was adjusted in 25 μg/kg/min increments up or down at the discretion of the anesthesiologists to maintain a state of deep sedation. The major targets of this study were recovery profiles (time to awake and time to discharge) and airway-related intervention ratios in pediatric MRI sedation patients. Patient demographics, MRI sedation, and recovery data, including propofol induction dose, airway intervention, and sedation-related adverse events from the pediatric sedation recovery unit were also collected. The mean (standard deviation [SD]) propofol induction dose was higher compared to midazolam group (2.4 [0.7] mg vs. 1.3 [0.5] mg; mean difference, 1.1 mg; P < 0.001). The mean (SD) infusion rate was higher in propofol group compared to midazolam group (161.3 [37.6] μg/min/kg vs. 116.2 [25.6] μg/min/kg; mean difference 45.1 μg/min/kg; P < 0.001). The mean (SD) propofol total dose was higher in propofol group compared to midazolam group (236.3 [102.4] mg vs. 180.7 [80.9] mg; mean difference, 155.4 mg; P < 0.001). The mean (SD) time to awake was longer in midazolam group compared to propofol group (21.2 [5.6] min vs. 23.0 [7.1] min; mean difference, 1.8 min; P < 0.001). The mean (SD) time to discharge was longer in midazolam group compared to propofol group (34.5 [6.9] min vs. 38.6 [9.4] min; mean difference, 4.1 min; 95% confidence interval, 3.0-5.1; P < 0.001). The administration of midazolam during pediatric MRI sedation can decrease the frequency of airway complications without prolonging the clinically significant recovery profile.

High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.

Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches). Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis. A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05). CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches. The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes. NCT02969616.

Comparative Biomechanical Analysis of Anterior Lumbar Interbody Fusion and Bilateral Expandable Transforaminal Lumbar Interbody Fusion Cages: A Finite Element Analysis Study.

Expandable transforaminal lumbar interbody fusion (TLIF) cages could offer an alternative to anterior lumbar interbody fusion (ALIF). Bilateral cage insertion enhances endplate coverage, potentially improving stability and fusion rates and maximizing segmental lordosis. This study aims to compare the biomechanical properties of bilateral expandable TLIF cages to ALIF cages using finite element modeling. We used a validated 3-dimensional finite element model of the lumbar spine. ALIF and TLIF cages were created based on available product data. Our focus was on analyzing spinal motion in the sagittal plane, evaluating forces transmitted through the vertebrae, and comparing an ALIF model with various TLIF cage models. The largest TLIF cage model exhibited a 407.9% increase in flexion motion and a 42.1% decrease in extension motion compared with the ALIF cage. The second largest TLIF cages resulted in more flexion motion and less extension motion compared with ALIF, while smaller cages were inferior to ALIF. ALIF cages were associated with increased adjacent segment motion compared with TLIF cages, primarily in extension. Endplate stress analysis revealed higher stress in the ALIF cage model with a more uniform stress distribution. ALIF cages excel in stabilizing L5 to S1 during flexion, while largest TLIF cages offer superior stability in extension. Large bilateral TLIF cages may provide biomechanical stability comparable to ALIF, especially in extension and could potentially reduce the risk of adjacent segment disease with lower adjacent segment motion.

Minimally invasive versus mini-open transforaminal lumbar interbody fusion in managing low-grade degenerative spondylolisthesis

Data backgroundBecause the traditional open-TLIF approach has several drawbacks, minimally invasive surgery (MIS) approaches for TLIF (MISTLIF) have been developed to speed up recovery after surgery and minimize pressure on the para-spinal muscles, necessitating a cost-utility analysis for comparison in healthcare reforms.Objectives and aim of the workThis study aimed to compare the radiological and clinical parameters between mini-open TLIF and minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) surgery in patients with single-level lumbar degenerative spondylolisthesis.HypothesisThis study hypothesizes that both minimally invasive and mini-open methods using sublaminar trimming laminoplasty (SLTL) (while preserving midline structures) and interbody cages have comparable mid- and long-term clinical and radiological outcomes.MethodsRetrospective analyses were performed on 120 patients who underwent single-level TLIF procedures with a minimum of two years of follow-up utilizing either the mini-open (n = 60) or MIS (n = 60) technique. Records of the operation's time frame, intraoperative fluoroscopy, blood loss, postoperative drainage volume, duration of bed rest, and complications were recorded. The Oswestry Disability Index (ODI) and visual analog scale (VAS) scores for both groups were utilized to assess improvements in clinical scores, and t tests were employed to statistically compare the outcomes. For comparison, radiological parameters, including lumbar lordosis, pelvic incidence (PI), and localized lordosis at the index level, were measured preoperatively, postoperatively, and at the final follow-up. To assess postoperative interbody fusion, the Bridwell grading system was used.ResultsIn the Mini-open TLIF group, the average follow-up time was 24.91 ± 5.7 months, while in the MIS-TLIF group, the average follow-up time was 25.15 ± 4.2 months. In the MIS-TLIF group, the mean operation and radiological time were longer. However, compared to the Mini-open TLIF group, the MISTLIF group experienced less blood loss and a shorter hospital stay. The MIS-TLIF group outperformed the Open-TLIF group in terms of the VAS score for back pain and the ODI at less than 6 months following surgery, and the differences were statistically significant. However, at the final follow-up, there were no statistically significant differences in the VAS score for the back between the two groups, but the ODI score was significantly greater in the MIS-TLIF group. Both groups' lumbar lordosis and focal lordosis significantly improved at the index level, with the Mini-open-TLIF group showing more focal lordosis. The interbody fusion rate did not significantly differ between the two groups.ConclusionMIS-TLIF and mini-open-TLIF can be surgically effective in treating single-level degenerative lumbar spine spondylolisthesis.