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1.
J Craniovertebr Junction Spine ; 15(1): 114-117, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38644920

RESUMO

We report the use of computerized tomography (CT)-guided navigation for complex spinal deformity correction (anterior and posterior) in an 8-year-old patient with neurofibromatosis complicated by dystrophic pedicles, dural ectasia, and extensive vertebral scalloping. A retrospective review was conducted of the patient's medical records for the past 3 years, including the patient's office visit notes, operative reports, pre- and 2-year postoperative imaging studies. The patient successfully underwent anterior lumbar interbody fusion from L3-S1 using CT-guided navigation to negotiate the challenges posed by dural ectasia and vertebral body scalloping. One week after the anterior procedure, she underwent navigation-guided T10-to-pelvis posterior instrumented fusion. There were no perioperative or postoperative complications at 2 years. In patients with complex deformities of the spine, including dural ectasia, scalloped vertebral bodies, and decreased pedicle integrity, the use of intraoperative CT-guided navigation can benefit surgeons by facilitating the safe placement of interbody spacers and pedicle screws.

2.
J Org Chem ; 89(7): 5159-5163, 2024 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-38532683

RESUMO

Dissymmetrical chiral peropyrenes with electron-rich and electron-deficient aryl substituents in the bay regions were synthesized via iridium-catalyzed C-H activation and alkyne benzannulation. The electronic properties were studied using cyclic and differential pulse voltammetry. The enantiomers were separated and exhibited high glum and gabs values in circularly polarized luminescence (CPL) and circular dichroism (CD), respectively. Variable-temperature NMR experiments were conducted on symmetrical and dissymmetrical chiral peropyrenes to compare the barrier to rotation of the aryl groups in the bay region.

3.
Global Spine J ; : 21925682241234016, 2024 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-38358094

RESUMO

STUDY DESIGN: Retrospective case control study. OBJECTIVES: To determine the role of TXA when used as topical soaked sponges (tTXA) on peri-operative blood loss and changes in hemoglobin following posterior spinal fusion (PSF) for neuromuscular and syndromic scoliosis (NMS). METHODS: A single center review of NMS patients who underwent PSF was conducted. The initial set of patients where no tTXA (control) was used were compared to consecutive NMS patients in whom tTXA was used. In the tTXA group, sponges soaked in 1g TXA in 500 mL normal saline were packed in the wound instead of dry sponges. Estimated blood loss (EBL) was calculated intraoperatively using a standard way. Pre-operative, intra-operative and immediate post-operative variables were collected and compared between the 2 groups. RESULTS: 33 patients were included (mean age- 13.5 yrs., BMI- 21, 17 patients in tTXA and 16 patients in control group). Pre-op demographic and radiographic variables were similar between the 2 groups. EBL, EBL per level, EBVL, operative time and number of levels fused were similar in both groups. tTXA group received less intra-operative pRBC transfusion as compared to the control group (150 ± 214 vs 363 ± 186 cc, P = .004). No difference was noted in post-op blood transfusion and drain output for 3 days in both the groups. tTXA group had lesser hospital (5.1 vs 8.9 days) and ICU length of stay (2 vs 4.2 days) and fewer immediate post-operative complications (23.5 vs 52.9%) compared to the control group but not statistically significant (P > .05). CONCLUSION: Administration of tTXA-soaked sponges is an effective and safe method to reduce intraoperative blood transfusion requirements in the correction of spinal deformity in patients with NMS.

4.
Spine Deform ; 12(3): 717-725, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38332392

RESUMO

PURPOSE: To identify 3D measures of scoliosis from preoperative imaging that are associated with optimal radiographic outcomes after selective thoracic fusion (STF) for adolescent idiopathic scoliosis (AIS). METHODS: Subjects with primary thoracic curves (Lenke 1-4, B or C modifiers) fused selectively (L1 or above) who had preoperative 3D reconstructions and minimum 2 years of follow-up were included. An optimal outcome at 2 years was defined as having 4 of 5 parameters previously defined in the literature: (1) lumbar curve < 26º, (2) deformity flexibility quotient < 4, (3) C7-CSVL < 2 cm, (4) lumbar prominence < 5º and (5) trunk shift < 1.5 cm. Univariate and CART analyses were performed to identify preoperative variables associated with achieving an optimal outcome 2 years postoperatively. RESULTS: Ninety-nine (88F, 11 M) patients met inclusion. Mean age was 15 ± 2 years. Fifty-one subjects (52%) had an optimal outcome. Seven preoperative deformity measures representing smaller thoracolumbar/lumbar deformity in the optimal group were found to be significant on univariate analysis. CART analysis identified the following variables associated with optimal outcomes: difference in apical rotation > 30° = 27% optimal outcomes, difference in apical rotation ≤ 30° and coronal vertebral wedging of lumbar apex > 3° = 46% optimal outcomes, and difference in apical rotation ≤ 30° and coronal vertebral wedging of lumbar apex ≤ 3° = 80% optimal outcomes (p < 0.05). CONCLUSION: Optimal outcomes after STF were associated with a preoperative difference in apical vertebral rotation in the axial plane less than 30° between thoracic and lumbar curves as well as coronal plane vertebral wedging of the lumbar apical vertebra less than 3°.


Assuntos
Imageamento Tridimensional , Escoliose , Fusão Vertebral , Vértebras Torácicas , Humanos , Escoliose/cirurgia , Escoliose/diagnóstico por imagem , Fusão Vertebral/métodos , Adolescente , Vértebras Torácicas/cirurgia , Vértebras Torácicas/diagnóstico por imagem , Feminino , Masculino , Imageamento Tridimensional/métodos , Resultado do Tratamento , Vértebras Lombares/cirurgia , Vértebras Lombares/diagnóstico por imagem , Período Pré-Operatório , Tomada de Decisão Clínica/métodos , Estudos Retrospectivos , Cuidados Pré-Operatórios/métodos
5.
Spine Deform ; 12(1): 159-164, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37606796

RESUMO

INTRODUCTION: AIS type 1 Curves are sub-classified based on the tilt of L4 as 1AR and 1AL. These curves are different w.r.t their curve behavior, progression and level selection. Presently there is no known anatomic etiology for the different behavior. Facet tropism (FT) is defined as the asymmetry between the facet angle of the left and right facet joints. The purpose of this study was to evaluate the correlation between facet tropism in the lumbar segments and occurrence of type 1AR and 1AL curves in AIS patients. METHODS: AIS patients with diagnosis of type 1 AR and 1AL right thoracic AIS curves who underwent posterior instrumented fusion were queried from a single institutions' database. Patients needed to have an MRI of their entire spine to be included. L2-3, L3-4 and L4-5 Facet angles (FA, angle made by the facet line with the mid-sagittal line at respected vertebral level) were calculated. FT was classified as follows: ≤ 5° (minimal), 6- 10° (mild) and ≥ 11° (severe). 1AR and 1AL curves were compared for FA, FT and FT grade at each lumbar segmental levels. RESULTS: One hundred nineteen patients were included (77 females, mean age-13.85 years, mean BMI- 21.63, 73 1AL and 46 1AR). The mean thoracic Cobb was 52.5 ± 9.8°, thoracic kyphosis was 28.12 ± 12° and lumbar lordosis was 53.48 ± 12.6°. L3-4 FA on the right side was more coronally oriented in 1AR curves compared to 1AL curves (37° vs. 31°, p = 0.04). On comparing FT at each level, 1AR curves had a higher FT at L3-4 (1.5° vs. - 2.3°, p = 0.01) and L4-5 levels (5.8° vs. - 0.28°, p < 0.001) compared to 1AL patients. Similarly, 1AR patients had significantly more patients with severe FT at L3-4 (34.8% vs. 13.7%, p = 0.02) and at L4-5 (17.3% vs. 6.8%, p = 0.01) compared to 1ALcurves. CONCLUSION: L3-4 joints are more coronally oriented in 1AR curves compared to 1AL curves. 1AR patients displayed higher FT at L3-4 and L4-5 compared to 1AL patients. 1AR curves also reveal a higher percentage of severe FT at L3-4 and L4-5 levels. This may influence the curve behavior and progression in these two curve types.


Assuntos
Escoliose , Fusão Vertebral , Articulação Zigapofisária , Feminino , Humanos , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Articulação Zigapofisária/diagnóstico por imagem , Vértebras Lombares/diagnóstico por imagem , Radiografia , Tropismo
6.
Arch Dis Child Fetal Neonatal Ed ; 109(2): 182-188, 2024 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-37923385

RESUMO

OBJECTIVE: To determine the impact of transanastomotic tube (TAT) feeding in congenital duodenal obstruction (CDO). DESIGN: Systematic review with meta-analysis. PATIENTS: Infants with CDO requiring surgical repair. INTERVENTIONS: TAT feeding following CDO repair versus no TAT feeding. MAIN OUTCOME MEASURES: The main outcome was time to full enteral feeds. Additional outcomes included use of parenteral nutrition (PN), cost and complications from either TAT or central venous catheter. Meta-analyses were undertaken using random-effects models (mean difference (MD) and risk difference (RD)), and risk of bias was assessed using the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool. RESULTS: Twelve out of 373 articles screened met the inclusion criteria. All studies were observational and two were prospective. Nine studies, containing 469 infants, were available for meta-analysis; however, four were excluded due to serious or critical risk of bias. TAT feeding was associated with reduced time to full enteral feeds (-3.34; 95% CI -4.48 to -2.20 days), reduced duration of PN (-6.32; 95% CI -7.93 to -4.71 days) and reduction in nutrition cost of £867.36 (95% CI £304.72 to £1430.00). Other outcomes were similar between those with and without a TAT including inpatient length of stay (MD -0.97 (-5.03 to 3.09) days), mortality (RD -0.01 (-0.04 to 0.01)) and requirement for repeat surgery (RD 0.01 (-0.03 to 0.05)). CONCLUSION: TAT feeding following CDO repair appears beneficial, without increased risk of adverse events; however, certainty of available evidence is low. Earlier enteral feeding and reduced PN use are known to decrease central venous catheter-associated risks while significantly reducing cost of care. PROSPERO REGISTRATION NUMBER: CRD42022328381.


Assuntos
Obstrução Duodenal , Nutrição Enteral , Humanos , Nutrição Enteral/efeitos adversos , Estudos Prospectivos , Nutrição Parenteral , Estado Nutricional
7.
Spine Deform ; 11(6): 1419-1426, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37402122

RESUMO

PURPOSE: Utility of pre-operative MRI for patients undergoing scoliosis correction has expanded to include an MRI classification for identifying patients at increased risk of experiencing intra-operative neuromonitoring (IONM) alerts based on the shape of the spinal cord and circumferential presence of CSF at the apex of the thoracic curve. In the present study, the authors explore the utility of this new MRI classification and multiple X-ray radiographic parameters in identifying the AIS sub-population at high risk of IONM alerts. METHODS: AIS patients < 18 years old who underwent posterior spinal fusion between 2018 and 2022 at a single institution. Imaging reviewed to determine main thoracic (MT) and thoraco-lumbar (TL) Cobb angles, major thoracic Apical Vertebral Translation (AVT) and lumbar/thoraco-lumbar AVT (TL AVT), thoracic kyphosis (TK), coronal main thoracic Deformity Angular Ratio (cDAR), sagittal DAR (sDAR), and MRI to determine the spinal cord type (1, 2, or 3). RESULTS: A total of 155 AIS patients who met the inclusion criteria between 2018 and 2022 were included. There was a trend to have an increased incidence of Type 3 spinal cord shape both with increase in the MT Cobb angle and MT AVT. There was also a shift toward more IONM alerts in patients with Type 3 (19.5%) spinal cords, AVT ≥ 5 cm (18.9%), and Cobb angle ≥ 650 (28.2%). CONCLUSION: Higher magnitude of thoracic Cobb angle and AVT are associated with higher likelihood of type 3 spinal cord at the apex in MRI. Patients with Type 3 spinal cord, Cobb angle ≥ 650, AVT > 5 cm, and cDAR > 10 have higher likelihood to have IONM alerts. Patient with a Type 3 spinal cord and a Cobb angle ≥ 650 (50.0%), cDAR > 10 (43.7%), and AVT > 5 cm (35.2%) have the highest risk of having IONM alerts.

8.
Clin Trials ; 20(6): 603-612, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37366172

RESUMO

BACKGROUND: Standard futility analyses designed for a proportional hazards setting may have serious drawbacks when non-proportional hazards are present. One important type of non-proportional hazards occurs when the treatment effect is delayed. That is, there is little or no early treatment effect but a substantial later effect. METHODS: We define optimality criteria for futility analyses in this setting and propose simple search procedures for deriving such rules in practice. RESULTS: We demonstrate the advantages of the optimal rules over commonly used rules in reducing the average number of events, the average sample size, or the average study duration under the null hypothesis with minimal power loss under the alternative hypothesis. CONCLUSION: Optimal futility rules can be derived for a non-proportional hazards setting that control the loss of power under the alternative hypothesis while maximizing the gain in early stopping under the null hypothesis.


Assuntos
Futilidade Médica , Projetos de Pesquisa , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamanho da Amostra
9.
Curr Opin Oncol ; 35(3): 151-157, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-36966499

RESUMO

PURPOSE OF REVIEW: The bodily fluids of patients with solid cancers representing a minimally-invasive source of clinically exploitable biomarkers have attracted an increasing amount of attention in recent years. In patients with head and neck squamous cell carcinoma (HNSCC), cell-free tumour DNA (ctDNA) belongs to the most promising liquid biomarkers for monitoring disease burden and identifying patients at high risk of recurrence. In this review, we highlight recent studies, evaluating the analytical validity and clinical utility of ctDNA as a dynamic biomarker in HNSCC, especially as it relates to risk stratification and contrasting human papilloma virus (HPV+ and HPV-) and carcinomas. RECENT FINDINGS: The clinical potential of minimal residual disease monitoring through viral ctDNA in identifying HPV+ oropharyngeal carcinoma patients at higher risk of recurrence has recently been demonstrated. Furthermore, accumulating evidence supports a potential diagnostic value of ctDNA dynamics in HPV-negative HNSCC. Altogether, recent data suggest that ctDNA analysis may be a valuable tool in guiding (de)escalation of surgical interventions as well as adaptation in radiotherapy dosage, both in the definitive and adjuvant settings. SUMMARY: Rigorous clinical trials with patient-relevant endpoints are critical in order to demonstrate that treatment decisions based on ctDNA dynamics result in better outcomes in HNSCC.


Assuntos
Neoplasias de Cabeça e Pescoço , Neoplasias Orofaríngeas , Infecções por Papillomavirus , Humanos , Carcinoma de Células Escamosas de Cabeça e Pescoço , Infecções por Papillomavirus/complicações , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/patologia , Neoplasias de Cabeça e Pescoço/diagnóstico , Neoplasias de Cabeça e Pescoço/genética , Neoplasias Orofaríngeas/terapia , Papillomavirus Humano , Biópsia Líquida
10.
Spine (Phila Pa 1976) ; 48(10): 683-687, 2023 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-36917707

RESUMO

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To examine SRS-Self Image scores at up to 10 years after surgery for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Self-image is complex with implications for surgical and patient-reported outcomes after AIS surgery. Surgically modifiable factors that impact self-image are inconsistently reported in the literature with few longer-term reports. We examined the rate and durability of self-image improvement. MATERIALS AND METHODS: An AIS registry was queried for patients with up to 10 years of follow-up after AIS surgery. A mixed effects model estimated change in SRS-22 Self Image from baseline to 6 weeks, 1 year, 2 years, 5 years, and 10 years. All enrolled patients contributed data to the mixed effects models. A sub-analysis of patients with 1-year and 10-year follow-up evaluated worsening/static/improved SRS-22 Self Image scores examined stability of scores over that timeline. Baseline demographic data and 1-year deformity magnitude data were compared between groups using parametric and nonparametric tests as appropriate. RESULTS: Data from 4608 patients contributed data to the longitudinal model; 162 had 1-year and 10-year data. Mean SRS-Self Image improvement at 10-year follow-up was 1.0 (95% CI: 0.9-1.1) point. No significant changes in Self-Image domain scores were estimated from 1-year to 10-year (all P >0.05) postoperative. Forty (25%) patients had SRS-Self Image worsening from 1 year to 10 years, 36 (22%) improved, and 86 (53%) were unchanged. Patients who worsened over 10 years had lower SRS-Self Image at baseline than those unchanged at enrollment (3.3 vs. 3.7, P =0.007). Neither radiographic parameters nor SRS-Mental Health were different at baseline for the enrolled patients. CONCLUSION: Ten years after surgery, 75% of patients reported similar or better SRS-Self Image scores than one year after surgery. Nearly 25% of patients reported worsening self-image at 10 years. Patients who worsened had lower baseline SRS-Self Image scores, without radiographic or mental health differences at baseline or follow-up.


Assuntos
Cifose , Escoliose , Humanos , Adolescente , Seguimentos , Estudos Retrospectivos , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Escoliose/psicologia , Qualidade de Vida
12.
Cardiovasc Revasc Med ; 45: 3-8, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35995656

RESUMO

BACKGROUND: Mixed reality head-mounted displays (MR-HMD) are a novel and emerging tool in healthcare. There is a paucity of data on the safety and efficacy of the use of MR-HMD in the cardiac catheterization laboratory (CCL). We sought to analyze and compare fluoroscopy time, procedure time, and complication rates with right heart catheterizations (RHCs) and coronary angiographies (CAs) performed with MR-HMD versus standard LCD medical displays. METHODS: This is a non-randomized trial that included patients who underwent RHC and CA with MR-HMD between August 2019 and January 2020. Their outcomes were compared to a control group during the same time period. The primary endpoints were procedure time, fluoroscopy time, and dose area product (DAP). The secondary endpoints were contrast volume and intra and postprocedural complications rate. RESULTS: 50 patients were enrolled in the trial, 33 had a RHC done, and 29 had a diagnostic CA performed. They were compared to 232 patients in the control group. The use of MR-HMD was associated with a significantly lower procedure time (20 min (IQR 14-30) vs. 25 min (IQR 18-36), p = 0.038). There were no significant differences in median fluoroscopy time (1.5 min (IQR 0.7-4.9) in the study group vs. 1.3 min (IQR 0.8-3.1), p = 0.84) or median DAP (165.4 mGy·cm2 (IQR 13-15,583) in the study group vs. 913 mGy·cm2 (IQR 24-6291), p = 0.17). There was no significant increase in intra- or post-procedure complications. CONCLUSION: MR-HMD use is safe and feasible and may decrease procedure time in the CCL.


Assuntos
Realidade Aumentada , Cateterismo Cardíaco , Humanos , Fluoroscopia
13.
Spine (Phila Pa 1976) ; 47(12): 873-878, 2022 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-35752896

RESUMO

STUDY DESIGN: Multicenter retrospective review. OBJECTIVE: To calculate overall incidence of pedicle screw "plowing" in adolescent idiopathic scoliosis (AIS) patients who underwent posterior spinal fusion (PSF). To identify risk factors for pedicle screw plowing and associated postoperative outcomes, including loss of correction and revision rate. SUMMARY OF BACKGROUND DATA: Curve correction of AIS generates perpendicular stresses that can cause pedicle screws to lose alignment and "plow" through pedicles craniocaudally. METHODS: We reviewed records of 1057 patients who underwent PSF for AIS from 2002 to 2015. Preoperative and first postoperative erect radiographs were evaluated by two observers to determine (1) presence of plowing and (2) subsequent loss of correction (LOC). Plowing was defined as more than 25° sagittal angulation compared with pedicle axis or entry of the most dorsal part of the screw outside the pedicle projection. LOC was defined as postoperative change in focal angulation of an instrumented spinal level, when in consensus of both reviewers. Bivariate analyses were performed (alpha = 0.05). RESULTS: Nineteen thousand five hundred sixty nine screws were assessed across our cohort of 1057 patients. Both observers agreed that 48 patients (4.5%) demonstrated plowing of more than or equal to one pedicle screw. For 72 screws (0.4%), both observers noted plowing, most commonly through the cranial cortex of the pedicle (65/72 screws) and at the lowest instrument vertebra (LIV) (17/72 screws). Factors associated with plowing included larger curves (P = 0.02); lower mean pedicle screw density (P = 0.0003); skeletal immaturity as measured by open triradiate cartilage (P = 0.04); and younger chronological age at time of surgery (P = 0.04). LOC occurred in 13 patients, most commonly at LIV (P < 0.0001). Revision rate for loss of screw fixation was higher in the plowing group (P = 0.003). CONCLUSION: Pedicle screw plowing occurred in 4.5% of AIS patients, especially in those skeletally immature and with decreased implant density. Plowing commonly occurred in the cranial direction and was associated with LOC, particularly at the LIV.Level of Evidence: 3.


Assuntos
Cifose , Parafusos Pediculares , Escoliose , Fusão Vertebral , Adolescente , Humanos , Cifose/etiologia , Estudos Multicêntricos como Assunto , Parafusos Pediculares/efeitos adversos , Estudos Retrospectivos , Escoliose/diagnóstico por imagem , Escoliose/etiologia , Escoliose/cirurgia , Fusão Vertebral/efeitos adversos , Vértebras Torácicas/diagnóstico por imagem , Vértebras Torácicas/cirurgia , Resultado do Tratamento
14.
Global Spine J ; 12(8): 1731-1735, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33504205

RESUMO

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: The purpose of the study is to evaluate the role of supine radiographs in determining flexibility of thoracic and thoracolumbar curves. METHODS: Ninety operative AIS patients with 2-year follow-up from a single institution were queried and classified into MT structural and TL structural groups. Equations were derived using linear regression to compute cut-off values for MT and TL curves. Thresholds were externally validated in a separate database of 60 AIS patients, and positive and negative predictive values were determined for each curve. RESULTS: MT supine values were highly predictive of MT side-bending values (TL group: 0.63, P < 0.001; MT group: 0.66, P = 0.006). Similarly, TL supine values were highly predictive of TL side-bending values (TL group: 0.56, P = 0.001 MT group: 0.68, P = 0.001). From our derived equations, MT and TL curves were considered structural on supine films if they were ≥ 30° and 35°, respectively. Contingency table analysis of external validity sample showed that supine films were highly predictive of structurality of MT curve (Sensitivity = 0.91, PPV = 0.95, NPV = 0.81) and TL curve (Sensitivity = 0.77, PPV = 0.81, NPV = 0.94). ROC analysis revealed that the area under curve for MT structurality from supine films was 0.931 (SEM: 0.03, CI: 0.86-0.99, P < 0.001) and TL structurality from supine films was 0.922 (SEM: 0.03, CI- 0.84-0.98, P < 0.001). CONCLUSIONS: A single preoperative supine radiograph is highly predictive of side-bending radiographs to assess curve flexibility in AIS. A cut-off of ≥ 30° for MT and ≥ 35° for TL curves in supine radiographs can determine curve structurality.

15.
J Appl Stat ; 48(6): 1091-1110, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34024982

RESUMO

Clinical trials in the era of precision cancer medicine aim to identify and validate biomarker signatures which can guide the assignment of individually optimal treatments to patients. In this article, we propose a group sequential randomized phase II design, which updates the biomarker signature as the trial goes on, utilizes enrichment strategies for patient selection, and uses Bayesian response-adaptive randomization for treatment assignment. To evaluate the performance of the new design, in addition to the commonly considered criteria of type I error and power, we propose four new criteria measuring the benefits and losses for individuals both inside and outside of the clinical trial. Compared with designs with equal randomization, the proposed design gives trial participants a better chance to receive their personalized optimal treatments and thus results in a higher response rate on the trial. This design increases the chance to discover a successful new drug by an adaptive enrichment strategy, i.e., identification and selective enrollment of a subset of patients who are sensitive to the experimental therapies. Simulation studies demonstrate these advantages of the proposed design. It is illustrated by an example based on an actual clinical trial in non-small-cell lung cancer.

16.
Spine Deform ; 9(5): 1387-1393, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33844193

RESUMO

PURPOSE: To evaluate the effectiveness of the use of topical tranexamic acid (tTXA) in spinal deformity correction in AIS patients METHODS: Sixty consecutive operative AIS patients were reviewed from a single institution and divided into two groups with similar demographics. Standardized peri-operative blood salvage techniques were utilized in all 60 patients. In the latter 30 patients, tTXA soaked sponges (1 g mixed in 500 ml Normal Saline) was utilised for wound packing during the entire surgical procedure compared to dry sponges as used in the former 30 patients. Both the groups were compared for the magnitude of deformity corrected, EBL per level fused, total EBL, blood transfused, drain output and peri-operative events. RESULTS: Sixty AIS patients (mean age 14.4 yrs, 43 females, mean BMI 21.5, mean levels 10.7) were included. Both groups achieved similar change in Coronal Cobb correction. The EBVL (Estimated blood volume loss) % lost in the topical TXA group was 38% less than the control group (11.2 vs. 18.3%, p = 0.006). Similarly, the EBL/level was significantly lower in the topical TXA group (41 ± 30 ml vs. 57 ± 26 ml, p = 0.03). Three of 30 patients in the control group required at least 1 unit of blood transfusion, whereas only 1 patient in the topical TXA group required transfusion (10 vs. 3.3%, p = 0.001). No differences were noted in post-operative drain output, change in hemoglobin levels, and peri-operative complication rates. CONCLUSION: When used as an adjunct to the conventional blood salvage techniques in spinal deformity correction procedures, the use of tTXA resulted in reduced operative blood loss, and blood transfusion requirements.


Assuntos
Antifibrinolíticos , Escoliose , Ácido Tranexâmico , Adolescente , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue , Feminino , Humanos , Escoliose/cirurgia
18.
BMC Musculoskelet Disord ; 22(1): 204, 2021 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-33607982

RESUMO

BACKGROUND: Pediatric deformity surgery traditionally involves major blood loss. Patients refusing blood transfusion add extra clinical and medicolegal challenges; specifically the Jehovah's witnesses population. The objective of this study is to review the safety and effectiveness of blood conservation techniques in patients undergoing pediatric spine deformity surgery who refuse blood transfusion. METHODS: After obtaining institutional review board approval, we retrospectively reviewed 20 consecutive patients who underwent spinal deformity surgery and refused blood transfusion at a single institution between 2014 and 2018. We collected pertinent preoperative, intraoperative and most recent clinical and radiological data with latest follow-up (minimum two-year follow-up). RESULTS: Twenty patients (13 females) with a mean age of 14.1 years were identified. The type of scoliotic deformities were adolescent idiopathic (14), juvenile idiopathic (1), neuromuscular (3) and congenital (2). The major coronal Cobb angle was corrected from 55.4° to 11.2° (80% correction, p <  0.001) at the latest follow-up. A mean of 11.4 levels were fused and 5.6 levels of Pontes osteotomies were performed. One patient underwent L1 hemivertebra resection and three patients had fusion to pelvis. Estimated blood loss, percent estimated blood volume loss, and cell saver returned averaged 307.9 mL, 8.5%, and 80 mL, respectively. Average operative time was 214 min. The average drop in hemoglobin after surgery was 2.9 g/dL. The length of hospital stay averaged 5.1 days. There were no intraoperative complications. Three postoperative complications were identified, none related to their refusal of transfusion. One patient had in-hospital respiratory complication, one patient developed a late infection, and one patient developed asymptomatic radiographic distal junctional kyphosis. CONCLUSIONS: Blood conservation techniques allow for safe and effective spine deformity surgery in pediatric patients refusing blood transfusion without major anesthetic or medical complications, when performed by an experienced multidisciplinary team. LEVEL OF EVIDENCE: Level IV.


Assuntos
Escoliose , Fusão Vertebral , Adolescente , Transfusão de Sangue , Criança , Feminino , Humanos , Estudos Retrospectivos , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Fusão Vertebral/efeitos adversos , Resultado do Tratamento
19.
Spine Deform ; 9(3): 751-755, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33403657

RESUMO

PURPOSE: Late infection following posterior spinal fusion (PSF) for deformity is a leading cause of revision. The purpose of this study is to evaluate clinical and radiographic outcomes following a single-stage debridement and exchange of spinal implants with titanium in adolescent patients with late-onset infections following PSF METHODS: A retrospective review of prospectively collected data of adolescent patients with spinal deformity, who were surgically treated with PSF was collected. Patients were included for the study if they developed late arising infection (> 1 year after index posterior fusion for the deformity) from 2006-2019. Treatment consisted of irrigation, debridement, implant exchange with titanium screws and rods, and antibiotics. Parameters evaluated include radiographic Cobb angles, operative data, and clinical data, all at minimum 2-year follow-up. RESULTS: 31 patients (29 with AIS and 2 with Scheuermann's kyphosis) developed late spinal infections. Mean age was 11.4 ± 2.3 years, 84% female, mean time from index surgery was 52.5 months. 25 had all stainless steel implants and 6 had cobalt chrome during the index procedure. Positive cultures were obtained in 5 patients (2 Staphylococcus Aureus, 1 Staphylococcus epidermidis, 1 Peptostreptococcus, 1 Pseudomonas aeruginosa) with cultures followed till 7 days post-operatively. At 2-years following the exchange, there was no change in coronal and sagittal alignment. Three (9%) patients developed subsequent infection necessitating implant removal. CONCLUSION: A single-stage procedure consisting of implant removal, irrigation, and debridement, and replacement with all titanium implants is an effective treatment strategy in patients developing late wound infection following PSF with regards to maintenance of curve correction and minimizing recurrent infections.


Assuntos
Escoliose , Fusão Vertebral , Adolescente , Criança , Feminino , Humanos , Masculino , Estudos Retrospectivos , Fusão Vertebral/efeitos adversos , Coluna Vertebral , Titânio
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