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1.
N Engl J Med ; 390(5): 409-420, 2024 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-38294973

RESUMEN

BACKGROUND: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).


Asunto(s)
Antiinfecciosos Locales , Clorhexidina , Fijación de Fractura , Fracturas Óseas , Yodo , Infección de la Herida Quirúrgica , Humanos , 2-Propanol/administración & dosificación , 2-Propanol/efectos adversos , 2-Propanol/uso terapéutico , Antiinfecciosos Locales/administración & dosificación , Antiinfecciosos Locales/efectos adversos , Antiinfecciosos Locales/uso terapéutico , Antisepsia/métodos , Canadá , Clorhexidina/administración & dosificación , Clorhexidina/efectos adversos , Clorhexidina/uso terapéutico , Etanol , Extremidades/lesiones , Extremidades/microbiología , Extremidades/cirugía , Yodo/administración & dosificación , Yodo/efectos adversos , Yodo/uso terapéutico , Cuidados Preoperatorios/efectos adversos , Cuidados Preoperatorios/métodos , Piel/microbiología , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/prevención & control , Fracturas Óseas/cirugía , Estudios Cruzados , Estados Unidos
2.
OTA Int ; 6(4): e287, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37860179

RESUMEN

Objectives: Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. Methods: At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Results: Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Conclusions: Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.

3.
Artículo en Inglés | MEDLINE | ID: mdl-37056956

RESUMEN

Following orthopaedic trauma, bone devitalization is a critical determinant of complications such as infection or nonunion. Intraoperative assessment of bone perfusion has thus far been limited. Furthermore, treatment failure for infected fractures is unreasonably high, owing to the propensity of biofilm to form and become entrenched in poorly vascularized bone. Fluorescence-guided surgery and molecularly-guided surgery could be used to evaluate the viability of bone and soft tissue and detect the presence of planktonic and biofilm-forming bacteria. This proceedings paper discusses the motivation behind developing this technology and our most recent preclinical and clinical results.

4.
Artículo en Inglés | MEDLINE | ID: mdl-37034555

RESUMEN

Necrotizing soft-tissue infections (NSTIs) are aggressive and deadly. Immediate surgical debridement is standard-of-care, but patients often present with non-specific symptoms, thereby delaying treatment. Because NSTIs cause microvascular thrombosis, we hypothesized that perfusion imaging using indocyanine green (ICG) would show diminished fluorescence signal in NSTI-affected tissues, particularly compared to non-necrotizing, superficial infections. Through a first-in-kind clinical study, we performed first-pass ICG fluorescence perfusion imaging of patients with suspected NSTIs. Early results support our hypothesis that ICG signal voids occur in NSTI-affected tissues and that dynamic contrast-enhanced fluorescence parameters reveal tissue kinetics that may be related to disease progression and extent.

5.
Artículo en Inglés | MEDLINE | ID: mdl-37034554

RESUMEN

Accelerating innovation in the space of fluorescence imaging for surgical applications has increased interest in safely and expediently advancing these technologies to clinic through Food and Drug Administration-(FDA-) compliant trials. Conventional metrics for early phase trials include drug safety, tolerability, dosing, and pharmacokinetics. Most procedural imaging technologies rely on administration of an exogenous fluorophore and concurrent use of an imaging system; both of which must receive FDA approval to proceed to clinic. Because fluorophores are classified as medical imaging agents, criteria for establishing dose are different, and arguably more complicated, than therapeutic drugs. Since no therapeutic effect is desired, medical imaging agents are ideally administered at the lowest dose that achieves adequate target differentiation. Because procedural imaging modalities are intended to enhance and/or ease proceduralists' identification or assessment of tissues, beneficial effects of these technologies may manifest in the form of qualitative endpoints such as: 1) confidence; 2) decision-making; and 3) satisfaction with the specified procedure. Due to the rapid expansion of medical imaging technologies, we believe that our field requires standardized criteria to evaluate existing and emerging technologies objectively so that both quantitative and qualitative aspects of their use may be measured and useful comparisons to assess their relative value may occur. Here, we present a 15-item consensus-based survey instrument to assess the utility of novel imaging technologies from the proceduralist's standpoint.

6.
Artículo en Inglés | MEDLINE | ID: mdl-37034556

RESUMEN

Indocyanine green (ICG)-based dynamic contrast-enhanced fluorescence imaging (DCE-FI) can objectively assess bone perfusion intraoperatively. However, it is susceptible to motion artifacts due to patient's involuntary respiration during the 4.5-minute DCE-FI data acquisition. An automated motion correction approach based on mutual information (MI) frameby-frame was developed to overcome this problem. In this approach, MIs were calculated between the reference and the adjacent frame translated and the maximal MI corresponded to the optimal translation. The images obtained from eighteen amputation cases were utilized to validate the approach and the results show that this correction can significantly reduce the motion artifacts and can improve the accuracy of bone perfusion assessment.

7.
Mol Imaging Biol ; 25(1): 46-57, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36447084

RESUMEN

Fluorescence-guided surgery (FGS) is an evolving field that seeks to identify important anatomic structures or physiologic phenomena with helpful relevance to the execution of surgical procedures. Fluorescence labeling occurs generally via the administration of fluorescent reporters that may be molecularly targeted, enzyme-activated, or untargeted, vascular probes. Fluorescence guidance has substantially changed care strategies in numerous surgical fields; however, investigation and adoption in orthopaedic surgery have lagged. FGS shows the potential for improving patient care in orthopaedics via several applications including disease diagnosis, perfusion-based tissue healing capacity assessment, infection/tumor eradication, and anatomic structure identification. This review highlights current and future applications of fluorescence guidance in orthopaedics and identifies key challenges to translation and potential solutions.


Asunto(s)
Neoplasias , Procedimientos Ortopédicos , Ortopedia , Cirugía Asistida por Computador , Humanos , Fluorescencia , Imagen Óptica/métodos , Cirugía Asistida por Computador/métodos , Colorantes Fluorescentes
8.
Artículo en Inglés | MEDLINE | ID: mdl-36061412

RESUMEN

ICG-based dynamic contrast-enhanced fluorescence imaging (DCE-FI) and intraoperative DCE- magnetic resonance imaging (MRI) have been carried out nearly simultaneously in three lower extremity bone infection cases to investigate the relationship between these two imaging modalities for assessing bone blood perfusion during open orthopedic surgeries. Time-intensity curves in the corresponding regions of interest of two modalities were derived for comparison. The results demonstrated that ICG-based DCE-FI has higher sensitivity to perfusion changes while DCE-MRI provides superior and supplemental depth-related perfusion information. Research applying the depth-related perfusion information derived from MRI to improve the overall analytic modeling of intraoperative DCE-FI is ongoing.

9.
Injury ; 53(11): 3814-3819, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-36064758

RESUMEN

BACKGROUND: Tibial plateau fractures with an ipsilateral compartment syndrome are a clinical challenge with limited guidance regarding the best time to perform open reduction and internal fixation (ORIF) relative to fasciotomy wound closure. This study aimed to determine if the risk of fracture-related infection (FRI) differs based on the timing of tibial plateau ORIF relative to closure of ipsilateral fasciotomy wounds. METHODS: A retrospective cohort study identified patients with tibial plateau fractures and an ipsilateral compartment syndrome treated with 4-compartment fasciotomy at 22 US trauma centers from 2009 to 2019. The primary outcome measure was FRI requiring operative debridement after ORIF. The ORIF timing relative to fasciotomy closure was categorized as ORIF before, at the same time as, or after fasciotomy closure. Bayesian hierarchical regression models with a neutral prior were used to determine the association between timing of ORIF and infection. The posterior probability of treatment benefit for ORIF was also determined for the three timings of ORIF relative to fasciotomy closure. RESULTS: Of the 729 patients who underwent ORIF of their tibial plateau fracture, 143 (19.6%) subsequently developed a FRI requiring operative treatment. Patients sustaining infections were: 21.0% of those with ORIF before (43 of 205), 15.9% at the same time as (37 of 232), and 21.6% after fasciotomy wound closure (63 of 292). ORIF at the same time as fasciotomy closure demonstrated a 91% probability of being superior to before closure (RR, 0.75; 95% CrI, 0.38 to 1.10). ORIF after fasciotomy closure had a lower likelihood (45%) of a superior outcome than before closure (RR, 1.02; 95% CrI; 0.64 to 1.39). CONCLUSION: Data from this multicenter cohort confirms previous reports of a high FRI risk in patients with a tibial plateau fracture and ipsilateral compartment syndrome. Our results suggest that ORIF at the time of fasciotomy closure has the highest probability of treatment benefit, but that infection was common with all three timings of ORIF in this difficult clinical situation.


Asunto(s)
Síndromes Compartimentales , Fracturas de la Tibia , Humanos , Estudios Retrospectivos , Fijación Interna de Fracturas/métodos , Teorema de Bayes , Infección de la Herida Quirúrgica/etiología , Factores de Riesgo , Fracturas de la Tibia/complicaciones , Fracturas de la Tibia/cirugía , Síndromes Compartimentales/cirugía , Síndromes Compartimentales/complicaciones , Estudios de Cohortes , Resultado del Tratamiento
10.
Expert Rev Med Devices ; 19(6): 469-475, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35912406

RESUMEN

INTRODUCTION: Reconstructing long bone defects following intercalary tumor resection presents an exciting challenge with a greater range of surgical solutions than more typical situations requiring arthroplasty. Segmental bone transport (distraction osteogenesis) is the least utilized option for intercalary reconstruction; however, it arguably provides patients with the most desirable result. Distraction osteogenesis can be used in the management of multiple skeletal conditions including deformity (congenital or acquired), or in the presence of bone defects (by trauma or planned surgical excision). Lack of broader adoption of transport is likely due to the highly technical demands and common complications of utilizing fine-wire fixators via the Ilizarov method. More recently, internal lengthening nails such as the PRECICE nail have been employed to facilitate distraction osteogenesis without the added complexity of external fixation. AREAS COVERED: This review will examine the literature on the indications, design, and safety of the PRECICE nail (NuVasive) for intercalary reconstruction after tumor resection. EXPERT OPINION: Bone transport using the PRECICE nail represents a viable alternative to Ilizarov distraction and has the benefit of avoiding the complications of an external fixator. For large defects, the PRECICE nail can be supplemented with a locking plate for additional stability and maintenance of limb length.


Asunto(s)
Osteogénesis por Distracción , Clavos Ortopédicos/efectos adversos , Fijadores Externos/efectos adversos , Fémur/cirugía , Humanos , Diferencia de Longitud de las Piernas/cirugía , Uñas , Resultado del Tratamiento
11.
Foot Ankle Int ; 43(10): 1269-1276, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35837716

RESUMEN

BACKGROUND: Ankle fracture displacement is an important outcome in clinical research examining the effectiveness of surgical and rehabilitation interventions. However, the assessment of displacement remains subjective without well-described or validated measurement methods. The aim of this study was to assess inter- and intrarater reliability of ankle fracture displacement radiographic measures and select measurement thresholds that differentiate displaced and acceptably reduced fractures. METHODS: Eight fellowship-trained orthopaedic surgeons evaluated a set of 26 postoperative ankle fracture radiographs on 2 occasions. Surgeons followed standardized instructions for making 5 measurements: coronal displacement (3) talar tilt (1), and sagittal displacement (1). Inter- and intraobserver interclass correlations were determined by random effects regression models. Logistic regression was used to determine the optimal sensitivity and specificity for the measurements with the highest correlation. RESULTS: Three of the 5 measures had excellent interobserver reliability (correlation coefficient > 0.75): (1) coronal plane distance between the lateral border of tibia and lateral border of talus, (2) coronal plane talar tilt, and (3) sagittal plane displacement. The threshold that best discriminated displaced from well-aligned fractures was 2 mm for coronal plane distance (sensitivity 82.1%, specificity 85.4%), 3 degrees for talar tilt (sensitivity 80.4%, specificity 82.2%), and 5 mm for sagittal plane distance (sensitivity 83.9%, specificity 84.9%). CONCLUSION: This study identified 3 reliable measures of ankle fracture displacement and determined optimal thresholds for discriminating between displaced and acceptably reduced fractures. These measurement criteria can be used for the design and conduct of clinical research studying the impact of surgical treatment and rehabilitation interventions.


Asunto(s)
Fracturas de Tobillo , Astrágalo , Tobillo , Fracturas de Tobillo/diagnóstico por imagen , Fracturas de Tobillo/cirugía , Articulación del Tobillo/cirugía , Humanos , Reproducibilidad de los Resultados , Astrágalo/diagnóstico por imagen , Astrágalo/cirugía
12.
J Bone Joint Surg Am ; 104(6): 497-503, 2022 03 16.
Artículo en Inglés | MEDLINE | ID: mdl-35041629

RESUMEN

BACKGROUND: Next-generation DNA sequencing (NGS) detects bacteria-specific DNA corresponding to the 16S ribosomal RNA gene and can identify bacterial presence with greater accuracy than traditional culture methods. The clinical relevance of these findings is unknown. The purpose of the present study was to compare the results from bacterial culture and NGS in order to characterize the potential use of NGS in orthopaedic trauma patients. METHODS: A prospective cohort study was performed at a single academic, level-I trauma center. Three patient groups were enrolled: (1) patients undergoing surgical treatment of acute closed fractures (presumed to have no bacteria), (2) patients undergoing implant removal at the site of a healed fracture without infection, and (3) patients undergoing a first procedure for the treatment of a fracture nonunion who might or might not have subclinical infection. Surgical site tissue was sent for culture and NGS. The proportions of culture and NGS positivity were compared among the groups. The agreement between culture and NGS results was assessed with use of the Cohen kappa statistic. RESULTS: Bacterial cultures were positive in 9 of 111 surgical sites (110 patients), whereas NGS was positive in 27 of 111 surgical sites (110 patients). Significantly more cases were positive on NGS as compared with culture (24% vs. 8.1%; p = 0.001), primarily in the acute closed fracture group. No difference was found in terms of the percent positivity of NGS when comparing the acute closed fracture, implant removal, and nonunion groups. With respect to bacterial identification, culture and NGS agreed in 73% of cases (κ = 0.051; 95% confidence interval, -0.12 to 0.22) indicating only slight agreement compared with expected chance agreement of 50%. CONCLUSIONS: NGS identified bacterial presence more frequently than culture, but with only slight agreement between culture and NGS. It is possible that the increased frequency of bacterial detection with molecular methods is reflective of biofilm presence on metal or colonization with nonpathogenic bacteria, as culture methods have selection pressure posed by restrictive, artificial growth conditions and there are low metabolic activity and replication rates of bacteria in biofilms. Our data suggest that NGS should not currently substitute for or complement conventional culture in orthopaedic trauma cases with low suspicion of infection. LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.


Asunto(s)
Fracturas Cerradas , Ortopedia , Bacterias/genética , ADN Bacteriano/genética , Humanos , Estudios Prospectivos , Análisis de Secuencia de ADN
13.
J Bone Joint Surg Am ; 103(7): 609-617, 2021 04 07.
Artículo en Inglés | MEDLINE | ID: mdl-33411466

RESUMEN

BACKGROUND: Prompt administration of antibiotics is a critical component of open fracture treatment. Traditional antibiotic recommendations have been a first-generation cephalosporin for Gustilo Type-I and Type-II open fractures, with the addition of an aminoglycoside for Type-III fractures and penicillin for soil contamination. However, concerns over changing bacterial patterns and the side effects of aminoglycosides have led to interest in other regimens. The purpose of the present study was to describe the adherence to current prophylactic antibiotic guidelines. METHODS: We evaluated the antibiotic-prescribing practices of 24 centers in the U.S. and Canada that were participating in 2 randomized controlled trials of skin-preparation solutions for open fractures. A total of 1,234 patients were evaluated. RESULTS: All patients received antibiotics on the day of admission. The most commonly prescribed antibiotic regimen was cefazolin monotherapy (53.6%). Among patients with Type-I and Type-II fractures, there was 61.1% compliance with cefazolin monotherapy. In contrast, only 17.2% of patients with Type-III fractures received the recommended cefazolin and aminoglycoside therapy, with an additional 6.7% receiving piperacillin/tazobactam. CONCLUSIONS: There is moderate adherence to the traditional antibiotic treatment guidelines for Gustilo Type-I and Type-II fractures and low adherence for Type-III fractures. Given the divergence between current practice patterns and prior recommendations, high-quality studies are needed to determine the most appropriate prophylactic protocol.


Asunto(s)
Antibacterianos/uso terapéutico , Profilaxis Antibiótica/estadística & datos numéricos , Fijación de Fractura/efectos adversos , Fracturas Abiertas/cirugía , Adhesión a Directriz/estadística & datos numéricos , Infección de la Herida Quirúrgica/epidemiología , Adulto , Profilaxis Antibiótica/normas , Cefazolina/uso terapéutico , Esquema de Medicación , Femenino , Fracturas Abiertas/complicaciones , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Guías de Práctica Clínica como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/prevención & control , Factores de Tiempo
14.
Artículo en Inglés | MEDLINE | ID: mdl-36082047

RESUMEN

Forty two patients with high energy open fractures were involved into the study to investigate whether an indocyanine green (ICG)-based dynamic contrast-enhanced fluorescence imaging (DCE-FI) can be used to objectively assess bone perfusion and guide surgical debridement. For each patient, fluorescence images were recorded after 0.1 mg/kg of ICG was administered intravenously. By utilizing a bone-specific kinetic model to the video sequences, the perfusion-related metrics were calculated. The results of this study shown that the quantitative ICG-based DEC-FI can accurately assess the human bone perfusion during the orthopedic surgery.

15.
Biomed Opt Express ; 11(11): 6458-6469, 2020 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-33282501

RESUMEN

In this study, an indocyanine green (ICG)-based dynamic contrast- enhanced fluorescence imaging (DCE-FI) technique was evaluated as a method to provide objective real-time data on bone perfusion using a porcine osteotomy model. DCE-FI with sequentially increasing injury to osseous blood supply was performed in 12 porcine tibias. There were measurable, reproducible and predictable changes to DCE-FI data across each condition have been observed on simple kinetic curve-derived variables as well variables derived from a novel bone-specific kinetic model. The best accuracy, sensitivity and specificity of 89%, 88% and 90%, have been achieved to effectively differentiate injured from normal/healthy bone.

16.
J Arthroplasty ; 35(12): 3445-3451.e1, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-32723505

RESUMEN

BACKGROUND: Surgeon compensation models could potentially influence the utilization of elective procedures. We assessed whether transitioning from salaried to a relative value unit (RVU) productivity-based physician compensation model changed the surgical rate and patient selection in elective total hip and knee arthroplasty (THA and TKA) procedures. METHODS: Our institution transitioned from salaried to RVU productivity-based reimbursement in July 2016. We performed a retrospective analysis on patients undergoing primary THA and TKA from July 2014 to July 2018 before and after the transition (salary period n = 820; RVU period n = 1188). Beta regression was used to determine the reimbursement structure as a predictor of surgery. The surgical rate was defined as the number of primary THA and TKA procedures per reimbursement period divided by all arthroplasty and osteoarthritis outpatient clinic encounters. RESULTS: There was a surgical rate of 15.8% (95% confidence interval [CI] 13.8%-17.8%) THA and 16.7% (95% CI 15.1%-18.1%) TKA procedures during RVU reimbursement compared to 11.1% (95% CI 9.8%-12.8%) THA and 11.7% (95% CI 10.5%-12.8%) TKA procedures during the salaried period (P < .001). The adjusted odds of undergoing a THA or TKA procedure increased in the RVU compared to the salaried model (THA odds ratio 1.48, 95% CI 1.43-1.53; TKA odds ratio 1.50, 95% CI 1.46-1.55; P < .001). There were no significant differences in patient age, gender, race, body mass index, or Charlson Comorbidity Index in salaried vs RVU productivity periods (P > .05 for all covariates). CONCLUSIONS: Productivity-based physician compensation may encourage higher rates of elective arthroplasty procedures without broadening patient selection.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Procedimientos Quirúrgicos Electivos , Humanos , Articulación de la Rodilla , Estudios Retrospectivos
17.
Artículo en Inglés | MEDLINE | ID: mdl-32483397

RESUMEN

Due to the lack of objectively measurable or quantifiable methods to assess the bone perfusion, the success of removing devitalized bone is based almost entirely on surgeon's experience and varies widely across surgeons and centers. In this study, an indocyanine green (ICG)-based dynamic contrast-enhanced fluorescence imaging (DCE-FI) has been developed to objectively assess bone perfusion and guide surgical debridement. A porcine trauma model (n = 6 pigs × 2 legs) with up to 5 conditions of severity in loss of flow in each, was imaged by a commercial fluorescence imaging system. By applying the bone-specific hybrid plug-compartment (HyPC) kinetic model to four-minute video sequences, the perfusion-related metrics, such as peak intensity, total bone blood flow (TBBF) and endosteal bone blood flow to TBBF fraction (EFF) were calculated. The results shown that the combination of TBBF and EFF can effectively differentiate injured from normal bone with the accuracy, sensitivity and specificity of 89%, 88% and 90%, respectively. Our subsequent first in human bone blood flow imaging study confirmed DCE-FI can be successfully translated into human orthopaedic trauma patients.

18.
JAMA Netw Open ; 3(4): e202215, 2020 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-32259266

RESUMEN

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.


Asunto(s)
Antiinfecciosos Locales/uso terapéutico , Clorhexidina/uso terapéutico , Fracturas Óseas/cirugía , Yodóforos/uso terapéutico , Infección de la Herida Quirúrgica/tratamiento farmacológico , Humanos , Procedimientos Ortopédicos/efectos adversos , Reoperación/estadística & datos numéricos
19.
Iowa Orthop J ; 40(2): 20-29, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33633504

RESUMEN

Background: Open reduction and internal fixation (ORIF) of proximal humerus fractures in elderly individuals (age >70) carries a relatively high short-term complication and reoperation rate but is generally durable once healed. Reverse total shoulder arthroplasty (RTSA) for fractures may be associated with superior short-term quality of life but carries the lifelong liabilities of joint replacement. The tradeoff between short and long-term risks, coupled with disparities in quality of life and cost, makes this clinical decision amenable to cost-effectiveness analysis. Methods: A Markov state-transition model was constructed with a base case of a 75 year-old patient. Reoperation rates, quality of life values, mortality rates, and costs were based upon published literature. The model was run until all patients had died to simulate the accumulated costs and benefits. Results: RTSA was associated with greater quality of life (7.11 QALYs) than ORIF (6.22 QALYs). RTSA was cost-effective with an incremental cost-effectiveness ratio of $3,945/QALY and $27,299/ QALY from payor and hospital perspectives, respectively. RTSA was favored and cost-effective at any age above 65 and any Charlson Score. The model was sensitive to the utility of both procedures. Conclusion: RTSA resulted in a higher quality of life and was cost-effective in comparison to ORIF for elderly patients.Level of Evidence: III.


Asunto(s)
Artroplastía de Reemplazo de Hombro/economía , Fijación Interna de Fracturas/economía , Fracturas del Húmero/cirugía , Reducción Abierta/economía , Anciano , Anciano de 80 o más Años , Artroplastía de Reemplazo de Hombro/mortalidad , Análisis Costo-Beneficio , Fijación Interna de Fracturas/mortalidad , Humanos , Fracturas del Húmero/mortalidad , Reducción Abierta/mortalidad , Complicaciones Posoperatorias , Calidad de Vida
20.
J Orthop Trauma ; 33(5): 234-238, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30640296

RESUMEN

OBJECTIVES: To evaluate physical function and return to independence of geriatric trauma patients, to compare physical function outcomes of geriatric patients who sustained high-energy trauma with that of those who sustained low-energy trauma, and to identify predictors of physical function outcomes. DESIGN: Retrospective. SETTING: Urban Level I trauma center. PATIENTS: Study group of 216 patients with high-energy trauma and comparison group of 117 patients with low-energy trauma. INTERVENTION: Injury mechanism (high- vs. low-energy mechanism). MAIN OUTCOME MEASUREMENT: Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) patient-reported outcome measure, and change in living situation and mobility. RESULTS: Physical function outcomes and return to independence differed between patients with high-energy and low-energy injuries. High-energy geriatric trauma patients had significantly higher PROMIS PF scores compared with low-energy geriatric trauma patients (PROMIS PF score 42.2 ± 10.4 vs. 24.6 ± 10.4, P < 0.001). High-energy geriatric trauma patients were able to ambulate outdoors without an assistive device in 67% of cases and were living independently 74% of the time in comparison with 28% and 45% of low-energy geriatric trauma patients, respectively (P < 0.001, P < 0.001). Multivariate linear regression analysis demonstrated that low-energy mechanism injury was independently associated with a 13.2 point reduction in PROMIS PF score (P < 0.001). CONCLUSIONS: Geriatric patients greater than 1 year out from sustaining a high-energy traumatic injury seem to be functioning within the expected range for their age, whereas low-energy trauma patients seem to be functioning substantially worse than both age-adjusted norms and their high-energy cohorts. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.


Asunto(s)
Evaluación Geriátrica/métodos , Actividad Motora/fisiología , Medición de Resultados Informados por el Paciente , Recuperación de la Función , Heridas y Lesiones/rehabilitación , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Pronóstico , Estudios Retrospectivos , Índices de Gravedad del Trauma , Heridas y Lesiones/diagnóstico , Heridas y Lesiones/fisiopatología
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