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Opioids are powerful analgesics; however, their significant systemic adverse effects and the need for frequent administration restrict their use. Nalbuphine (NA) is a κ-agonist narcotic with limited adverse effects, but needs to be frequently administrated due to its short elimination half-life. Whereas sebacoyl dinalbuphine ester (SDE) is a NA prodrug, which can effectively prolong the analgesic effect, but lacks immediate pain relief. Therefore, in this study, a rapid and sustained local delivery formulation to introduce NA and SDE directly into surgical sites was developed. An amphiphilic nanostructured lipid carrier (NLC) poloxamer 407 (P407) gel (NLC-Gel) was developed to permit concurrent delivery of hydrophobic SDE from the NLC core and hydrophilic NA from P407, offering a dual rapid and prolonged analgesic effect. Benefiting from the thermal-sensitive characteristic of P407, the formulation can be injected in liquid phase and instantly transit into gel at wound site. NLC-Gel properties, including particle size, drug release, rheology, and stability, were assessed. In vivo evaluation using a rat spinal surgery model highlighted the effect of the formulation through pain behavior test and hematology analysis. NLC-Gels demonstrated an analgesic effect comparable with that of commercial intramuscular injected SDE formulation (IM SDE), with only 15 % of the drug dosage. The inclusion of supplemental NA in the exterior gel (PA12-Gel + NA) provided rapid drug onset owing to swift NA dispersion, addressing acute pain within hours along with prolonged analgesic effects. Our findings suggest that this amphiphilic formulation significantly enhanced postoperative pain management in terms of safety and efficacy.
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Analgésicos Opioides , Portadores de Fármacos , Liberación de Fármacos , Geles , Nalbufina , Dolor Postoperatorio , Poloxámero , Ratas Sprague-Dawley , Nalbufina/administración & dosificación , Dolor Postoperatorio/tratamiento farmacológico , Animales , Masculino , Poloxámero/química , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/química , Portadores de Fármacos/química , Ratas , Lípidos/química , Tamaño de la Partícula , Nanoestructuras/administración & dosificación , Nanoestructuras/química , Ésteres/químicaRESUMEN
STUDY DESIGN: The study included two fresh-frozen cadavers. OBJECTIVE: To elucidate the positional relationship between surgical instruments and nerve roots during full endoscopic facet-sparing (FE fs-TLIF) and facet-resecting (FE fr-TLIF) lumbar interbody fusion and propose safe instrumentation insertion procedures and recommend cage glider designs aimed at protecting nerve roots. SUMMARY OF BACKGROUND DATA: Endoscopic surgical techniques are increasingly used for minimally invasive lumbar fusion surgery with FE fr-TLIF and FE fs-TLIF being common approaches. However, the risk of nerve root injury remains a significant concern during these procedures. METHODS: Eight experienced endoscopic spine surgeons performed uniportal FE fr-TLIF and FE fs-TLIF on cadaveric lumbar spines, totaling 16 surgeries. Post-operation, soft tissues were removed to assess the positional relationship between the cage entry point and nerve roots. Distances between the cage entry point, traversing nerve root, and exiting nerve root were measured. Safe instrumentation design and insertion procedures were determined. RESULTS: In FE fr-TLIF, the mean distance between the cage entry point and traversing nerve root was significantly shorter compared to FE fs-TLIF (3.30±1.35 mm vs. 8.58±2.47 mm, respectively; P<0.0001). Conversely, the mean distance between the cage entry point and the exiting nerve root was significantly shorter in FE fs-TLIF compared to FE fr-TLIF (3.73±1.97 mm vs. 6.90±1.36 mm, respectively; P<0.0001). For FE fr-TLIF, prioritizing the protection of the traversing root using a two-bevel tip cage glider was crucial. In contrast, for FE fs-TLIF, a single-bevel tip cage glider placed in the caudal location was recommended. CONCLUSION: This study elucidates the anatomical relationship between cage entry points and nerve roots in uniportal endoscopic lumbar fusion surgery. Protection strategies should prioritize the traversing root in FE fr-TLIF and the exiting root in FE fs-TLIF, with corresponding variations in surgical techniques. LEVEL OF EVIDENCE: V.
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Background: The sagittal imbalance (SI) of spine triggers compensatory mechanisms (CMs) of lower extremity (LE) to restore trunk balance. These CMs can cause long-period stress on the femur and may possibly alter the femoral morphology. This cross-sectional observational study aimed to answer the following questions: (a) Do SI subjects exhibit greater femoral bowing compared to subjects with sagittal balance? (b) Are there associations between femoral bowing and CMs of LE in SI subjects? Methods: Subjects who underwent biplanar full body radiographs with the EOS imaging system between January 2016 and September 2021 were recruited. Sagittal parameters included T1-pelvic angle (TPA), pelvic incidence (PI), pelvic tilt (PT), sacral slope, lumbar lordosis (LL), PI-LL, and PT/PI ratio. LE parameters were femoral obliquity angle (FOA), knee flexion angle (KA), and ankle dorsiflexion angle. Femoral bowing was quantified as 3D radius of femoral curvature (RFC). Associations between 3D RFC and the radiographic parameters were analyzed. Results: A total of 105 subjects were included, classified into balance group (TPA < 14°, n = 40), SI group (TPA ≥ 14° and KA <5°, n = 30), and SI with knee flexion group (TPA ≥ 14° and KA ≥ 5°, n = 35). 3D RFC was significantly lower in SI with knee flexion group compared to the other two groups (both p < 0.001). Stepwise linear regression showed that age, SI and knee flexion, femoral length (FL), FOA, and KA were independent predictors for 3D RFC. Conclusion: Greater femoral bowing is observed in subjects with SI and knee flexion compared to the balanced population. CM parameters, including KA and FOA, are associated with 3D RFC. Further longitudinal study is needed to investigate the cause-and-effect relationship between SI, CMs of LE, and femoral bowing.
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BACKGROUND: Cervical spondylotic myelopathy (CSM) may seriously affect quality of life. In the literature, there is scarce evidence of the pros and cons of full endoscopic spine surgery in the treatment of CSM. The main purpose of this study was to conduct a systematic review to elucidate the efficacy of full endoscopic spine surgery in the management of patients with CSM. METHODS: This systematic review was conducted in accordance with the PRISMA guidelines. A systematic search of Web of Science, PubMed MEDLINE, Embase, and Cochrane Library was conducted from the database inception to February 1, 2023. RESULTS: The study included 183 patients and their age was 56.78 ± 7.87 years. The average surgical time calculated was 96.34 ± 33.58 minutes. Intraoperative blood loss ranged from a minimal amount to 51 mL. The average duration of hospital stay was 3.56 ± 1.6 days. The average span for follow-up was on an interval of 18.7 ± 6.76 months. Significant improvements were noted in all aspects of functional outcomes and image results after full endoscopic cervical spine surgery, with no major complications. CONCLUSIONS: The current study found that both anterior transcorporeal and posterior surgical approaches could be used for the treatment of CSM with a full endoscopic technique. Indications of full endoscopic cervical spine surgery for CSM included cervical disc herniation, central canal stenosis, calcified ligamentum flavum, and ossification of the posterior longitudinal ligament. Improved postoperative outcomes with acceptable surgical complications were noted in this systematic review.
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Enfermedades de la Médula Espinal , Espondilosis , Humanos , Persona de Mediana Edad , Calidad de Vida , Espondilosis/cirugía , Espondilosis/complicaciones , Resultado del Tratamiento , Enfermedades de la Médula Espinal/cirugía , Enfermedades de la Médula Espinal/complicaciones , Vértebras Cervicales/cirugía , Descompresión Quirúrgica/métodosRESUMEN
Ligamentum flavum hypertrophy (LFH) is a major cause of lumbar spinal stenosis (LSS). In hypertrophic ligamentum flavum (LF) cells, oxidative stress activates intracellular signaling and induces the expression of inflammatory and fibrotic markers. This study explored whether healthy and hypertrophic LF cells respond differently to oxidative stress, via examining the levels of phosphorylated p38 (p-p38), inducible nitric oxide synthase (iNOS), and α-smooth muscle actin (α-SMA). Furthermore, the efficacy of N-acetylcysteine (NAC), an antioxidant, in reversing the fibrogenic and proinflammatory effects of oxidative stress in hypertrophic LF cells was investigated by assessing the expression levels of p-p38, p-p65, iNOS, TGF-ß, α-SMA, vimentin, and collagen I under H2O2 treatment with or without NAC. Under oxidative stress, p-p38 increased significantly in both hypertrophic and healthy LF cells, and iNOS was elevated in only the hypertrophic LF cells. This revealed that oxidative stress negatively affected both hypertrophic and healthy LF cells, with the hypertrophic LF cells exhibiting more active inflammation than did the healthy cells. After H2O2 treatment, p-p38, p-p65, iNOS, TGF-ß, vimentin, and collagen I increased significantly, and NAC administration reversed the effects of oxidative stress. These results can form the basis of a novel therapeutic treatment for LFH using antioxidants.
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Ligamento Amarillo , Humanos , Ligamento Amarillo/metabolismo , Acetilcisteína/farmacología , Acetilcisteína/metabolismo , Vimentina/metabolismo , Peróxido de Hidrógeno/metabolismo , Hipertrofia/tratamiento farmacológico , Hipertrofia/metabolismo , Factor de Crecimiento Transformador beta/metabolismo , Colágeno Tipo I/metabolismo , Estrés OxidativoRESUMEN
OBJECTIVE: Anterior cervical discectomy and fusion (ACDF) has long been regarded as a gold standard in the treatment of cervical myelopathy. Subsequently, cervical artificial disc replacement (c-ADR) was developed and provides the advantage of motion preservation at the level of the intervertebral disc surgical site, which may also reduce stress at adjacent levels. The goal of this study was to compare clinical and functional outcomes in patients undergoing ACDF with those in patients undergoing c-ADR for cervical spondylotic myelopathy (CSM). METHODS: A systematic literature review and meta-analysis were performed using the Embase, PubMed, and Cochrane Central Register of Controlled Trials databases from database inception to November 21, 2021. The authors compared Neck Disability Index (NDI), SF-36, and Japanese Orthopaedic Association (JOA) scores; complication rates; and reoperation rates for these two surgical procedures in CSM patients. The Mantel-Haenszel method and variance-weighted means were used to analyze outcomes after identifying articles that met study inclusion criteria. RESULTS: More surgical time was consumed in the c-ADR surgery (p = 0.04). Shorter hospital stays were noted in patients who had undergone c-ADR (p = 0.04). Patients who had undergone c-ADR tended to have better NDI scores (p = 0.02) and SF-36 scores (p = 0.001). Comparable outcomes in terms of JOA scores (p = 0.24) and neurological success rate (p = 0.12) were noted after the surgery. There was no significant between-group difference in the overall complication rates (c-ADR: 18% vs ACDF: 25%, p = 0.17). However, patients in the ACDF group had a higher reoperation rate than patients in the c-ADR group (4.6% vs 1.5%, p = 0.02). CONCLUSIONS: At the midterm follow-up after treatment of CSM, better functional outcomes as reflected by NDI and SF-36 scores were noted in the c-ADR group than those in the ACDF group. c-ADR had the advantage of retaining range of motion at the level of the intervertebral disc surgical site without causing more complications. A large sample size with long-term follow-up studies may be required to confirm these findings in the future.
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BACKGROUND: Vertebral compression fractures, resulting in significant pain and disability, commonly occur in elderly osteoporotic patients. However, the current literature lacks long-term follow-up information related to image parameters and bone formation following vertebroplasty. PURPOSE: To evaluate new bone formation after vertebroplasty and the long-term effect of vertebroplasty. METHODS: A total of 157 patients with new osteoporotic compression fractures who underwent vertebroplasty were retrospectively analyzed. The image parameters, including wedge angles, compression ratios, global alignment, and new bone formation, were recorded before and after vertebroplasty up to three years postoperatively. RESULTS: The wedge angle improved and was maintained for 12 months. The compression ratios also improved but gradually deteriorated during the follow-up period. New bone formation was found in 40% of the patients at 36 months, and the multivariate analysis showed that this might have been related to the correction of the anterior compression ratio. CONCLUSIONS: Vertebroplasty significantly restored the wedge angles and compression ratios up to one year postoperatively, and new bone formation was noted on plain radiographs, which increased over time. Last, the restoration of vertebral parameters may contribute to new bone formation.
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The role of oxidative stress in ligamentum flavum (LF) hypertrophy has not been elucidated. We hypothesize that oxidative stress induces inflammatory responses and the subsequent fibrotic processes in LF, via activation of the Akt and MAPK pathways. Specimens of LFs were collected during surgeries for lumbar disc herniation (LDH) or lumbar spinal stenosis (LSS). Part of the LF specimens underwent analyses for ROS, fibrotic markers, and inflammatory mediators, with the remainder minced for cell cultures. The cell cultures were treated with H2O2, after which the cells were lysed and analyzed via western blotting. The specimens of the LSS patients showed increased infiltration of inflammatory cells and were stained positively for MMP-3, MMP-9, vimentin, and fibronectin. The LF of the LSS patients had increased oxidative stress and inflammation compared to that of the LDH patients. In vitro analyses demonstrated that oxidative stress rapidly activated the Akt and MAPK pathways. Inflammatory mediators, iNOS and NF-κB, and fibrotic markers, including TGF-ß, ß-catenin, α-SMA and vimentin, were significantly upregulated after induction of oxidative stress. Oxidative stress activated the intrinsic apoptotic pathway. These findings revealed that oxidative stress is one of the etiological factors of LF hypertrophy, which might provide new insights into treatment approaches.
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Apoptosis , Mediadores de Inflamación/metabolismo , Desplazamiento del Disco Intervertebral/enzimología , Ligamento Amarillo/enzimología , Proteínas Quinasas Activadas por Mitógenos/metabolismo , Estrés Oxidativo , Proteínas Proto-Oncogénicas c-akt/metabolismo , Estenosis Espinal/enzimología , Adulto , Factores de Edad , Anciano , Apoptosis/efectos de los fármacos , Proteínas Reguladoras de la Apoptosis/metabolismo , Células Cultivadas , Femenino , Fibrosis , Humanos , Peróxido de Hidrógeno/toxicidad , Hipertrofia , Desplazamiento del Disco Intervertebral/patología , Ligamento Amarillo/efectos de los fármacos , Ligamento Amarillo/patología , Masculino , Persona de Mediana Edad , Estrés Oxidativo/efectos de los fármacos , Transducción de Señal , Estenosis Espinal/patologíaRESUMEN
PURPOSE: To determine whether intravenous administration of tranexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. METHODS: This was a prospective, double-blind, randomized, and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group. receiving 1000 mg of TXA intravenously 10 minutes before surgery. or the placebo group. receiving the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anticoagulation medications were excluded. Visual clarity was rated using a Numeric Rating Scale from grade 1 (poor) to grade 3 (clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration, and associated comorbidities were recorded. Both parametric and nonparametric methods were used for the statistical analysis. RESULTS: In total, 72 patients were enrolled, 37 in the TXA group and 35 in the placebo group. The demographic data were similar between the 2 groups. Visual clarity was found to be significantly better in the TXA group, with a greater percentage of grade 3 vision clarity (53.7 ± 18.9 % vs 40.5 ± 22.1%, P = .036). The average visual score in the TXA group (2.5 ± 0.2) also was better than that of the control group (2.3 ± 0.3) (P = .048). The postoperative subjective pain score was significantly lower in the TXA group (3.0 ± 1.5) than in the control group (4.3 ± 2.0) (P = .009). In addition, postoperative analgesic usage was significant lower in the TXA groups (9.6 ± 9.7 morphine milligram equivalent) than in the control group (14.7 ± 13.4 morphine milligram equivalent) (P = .037). Other parameters, such as operative time, estimated perioperative blood loss, degree of shoulder swelling, and duration of inpatient stay were similar between the 2 groups. None of the patients developed complications after surgery. CONCLUSIONS: Intravenous administration of TXA is an alternative way to improve visual clarity in arthroscopic shoulder surgery. It also reduces subjective pain and analgesic consumption in the early postoperative period without significant side effects. LEVEL OF EVIDENCE: Therapeutic studies level II.
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Antifibrinolíticos/administración & dosificación , Artroscopía , Lesiones del Manguito de los Rotadores/cirugía , Ácido Tranexámico/administración & dosificación , Campos Visuales , Administración Intravenosa , Analgésicos/uso terapéutico , Método Doble Ciego , Utilización de Medicamentos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor Postoperatorio/prevención & control , Cuidados Preoperatorios , Estudios Prospectivos , Articulación del Hombro/cirugíaRESUMEN
INTRODUCTION: Controversy exists regarding the use of reamed interlocking nailing in femoral shafts with extremely narrow medullary canals (diameter ≤ 9â¯mm). The aims of this study were to (1) investigate the association of age and sex on femoral canal diameter in patients with a simple femoral shaft fracture and (2) compare the outcomes and complications of interlocking nailing between wide and extremely narrow intramedullary canals. PATIENTS AND METHODS: For the purposes of this retrospective cohort study, consecutive patients with simple femoral shaft fractures were recruited between January 2009 and December 2016. The patient demographic data were analyzed. Then, fractures treated with interlocking nailing were divided into the wide group (canal diameter > 9â¯mm) and narrow group. The primary outcome was union rate, and the secondary outcomes were complications such as thermal necrosis, fat embolism syndrome, iatrogenic fracture, and implant failure. RESULTS: This study included 340 femoral shaft fractures. The average canal diameter was 9.97⯱â¯1.79â¯mm, with significantly wider canals in men than in women. Overall, 289 of the patients had undergone interlocking nail fixation, and a similar union rate and complications were noted between the wide canal and narrow canal groups, with the exception of the incidence of iatrogenic fracture. CONCLUSIONS: Femoral shaft fractures associated with extremely narrow medullary canals are more common in women than in men. There was a similar union rate found when using interlocking nailing in a femoral shaft fracture in cases with extremely narrow and wider canals. Iatrogenic fracture is the only significant risk when using interlocking nailing in femoral shafts with extremely narrow canals.