Eficacia y seguridad del clavo intramedular trocantérico con sistema antirrotatorio para pacientes adultos mayores con fracturas trocantéricas inestables / Efficacy and safety of trochanteric intramedullary nail with antirotation system for older adult patients with unstable trochanteric fractures

ANTECEDENTES En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, y ampliada con Resolución N°97-IETSIESSALUD-2022, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad del clavo intramedular trocantérico con mecanismo antirrotatorio (Proximal Femoral Nail Antirotation, PFNA, por sus siglas en inglés) para pacientes adultos mayores con fracturas trocantéricas inestables. De este modo, el Dr. Daniel Cauti De la Cruz, médico traumatólogo del servicio de fracturas y osteosíntesis del Hospital Nacional Edgardo Rebagliati Martins (HNERM), siguiendo la Directiva N° 001- IETSI-ESSALUD-2018, envió al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la solicitud de inclusión del dispositivo médico "clavo intramedular trocantérico canulado con hoja espinal angulaciones con cementación". ASPECTOS GENERALES: Las fracturas trocantéricas, también conocidas como fracturas proximales del fémur, representan una creciente preocupación de salud pública en la población adulta mayor, principalmente debido a la vulnerabilidad del hueso envejecido a lesiones menores o de baja energía (Court-Brown & McQueen, 2016). Se estima que, en el 2050, más de 6.3 millones de estas fracturas ocurrirán anualmente a nivel mundial (Gullberg et al., 1997). Además, estas fracturas están asociadas con altos índices de morbilidad y mortalidad. Según la OMS, la mortalidad al año después de una fractura de cadera en adultos mayores es de hasta el 30 % (World Health Organization, s/f). Las tendencias demográficas actuales, que indican un rápido envejecimiento de la población global, anticipan una creciente carga de morbilidad y mortalidad asociada a estas fracturas en las próximas décadas (United Nations, 2019). En la actualidad, el manejo de las fracturas trocantéricas inestables en adultos mayores se realiza mediante estrategias que intentan favorecer la movilización temprana y disminuir las complicaciones postoperatorias (Fischer et al., 2021). El sistema de placa con tornillo dinámico de cadera (DHS por sus siglas en inglés) es una opción comúnmente utilizada en este contexto. Con este dispositivo la placa se fija extramedularmente, mediante la colocación de tornillos a nivel del cuello femoral y del fémur (Parker, 1992). Aunque algunos estudios han reportado que el DHS puede ser efectivo en el manejo de las fracturas trocantéricas (Anglen & Weinstein, 2008; Bhandari et al., 2009), otros informes han identificado varias limitaciones con este dispositivo. Las complicaciones reportadas incluyen la falla de la fijación, pérdida de reducción y complicaciones relacionadas con la herida debido a la incisión significativa que se requiere para su colocación (Lindskog & Baumgaertner, 2004). Asimismo, el tornillo deslizante de compresión dinámica (Dynamic Compression Screw, DCS por sus siglas en inglés) es un dispositivo de fijación extramedular, similar al DHS, empleado en el tratamiento de las fracturas trocantéricas en adultos mayores. A diferencia del DHS, el DCS permite fijación rígida a la fractura y evita el deslizamiento del tornillo, lo que podría fomentar la compresión y cicatrización de la fractura porque mantiene los fragmentos de hueso firmemente unidos sin permitir su desplazamiento, lo cual podría favorecer la estabilidad en determinados tipos de fracturas (Müller et al., 1990). METODOLOGÍA: Se realizó una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia sobre la eficacia y seguridad del clavo intramedular trocantérico con mecanismo antirrotatorio para pacientes adultos mayores con fracturas trocantéricas inestables. La búsqueda bibliográfica se realizó en las bases de datos Medline, Cochrane library, Web of Science3y LiLACS. Así mismo se realizó una búsqueda manual dentro de las páginas web pertenecientes a la Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), la Agency for Healthcare Research and Quality's (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), la Comissáo Nacional de Incorporagáo de Tecnologias no Sistema Único de Saúde (CONITEC), el Instituto de Evaluación Tecnológica en Salud (IETS), el Instituto de Efectividad Clínica y Sanitaria (IECS), la Hauté Autorité de Santé (HAS), la Unidad de Análisis y Generación de Evidencias en Salud Pública (UNAGESP), el National Institute for Health and Care Excellence (NICE), la Canadian Agency for Drugs and Technologies in Health (CADTH), el Scottish Medicines Consortium (SMC), el Scottish Intercollegiate Guidelines Network (SIGN), el Institute for Clinical and Economic Review (ICER), el Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), la Organización Mundial de la Salud (OMS), el Ministerio de Salud del Perú (MINSA) y el IETSI, a fin de poder identificar guías de práctica clínica (GPC) y evaluaciones de tecnología sanitarias (ETS) de relevancia que pudiesen haber sido omitidas por la estrategia de búsqueda o que no hayan sido publicadas en las bases de datos consideradas. RESULTADOS: Luego de la búsqueda bibliográfica hasta el 27 de junio del 2023 se incluyeron dos GPC (NICE, 2023; O'Connor & Switzer, 2022), una RS (Y. R. Zhang et al., 2019) y tres ECA (Huang et al., 2017; Xu et al., 2010a; Zehir et al., 2015) provenientes de las referencias de la RS. CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación no aprueba el uso del clavo intramedular trocantérico con mecanismo antirrotatorio para pacientes adultos mayores con fracturas trocantéricas inestables en comparación con las tecnologías disponibles en la institución.

Eficacia y seguridad del sistema de clavo intramedular retrógrado para artrodesis en pacientes adultos con fracturas complejas y/o deformidades de la articulación tibia-astrágalo-calcáneo / Efficacy and safety of the retrograde intramedullary nail system for arthrodesis in adult patients with complex fractures and/or deformities of the tibia-talar-calcaneus joint

ANTECEDENTES En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución del Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen preliminar sobre la evaluación de la eficacia y seguridad del sistema de clavo intramedular retrógrado (CIR) para artrodesis en pacientes adultos con fracturas complejas y/o deformidades de la articulación tibia-astrágalo-calcáneo. Mediante la Nota N° 2761-GRPA-ESSALUD-2020, los médicos especialistas del Servicio II de Ortopedia del Hospital Guillermo Almenara Irigoyen (HNGAI), a través de la gerencia de su red prestacional, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación para incorporación del dispositivo "sistema de clavo intramedular retrógrado para artrodesis tibia-astrágalo-calcáneo". ASPECTOS GENERALES: Las patologías del tobillo' y retropié2, por lo general, pueden ser ocasionadas debido a traumatismo agudo o como secuela de alguna condición crónica (ógüt and Yontar 2017). Las fracturas y deformidades son dos de las condiciones patológicas que pueden ser identificadas con mayor frecuencia a este nivel. Se estima que aproximadamente un 70 % de las fracturas son unimaleolares3, 20 % bimaleolares4y un 10 % trimaleolares5 (Court-Brown, McBirnie, and Wilson 1998). Además, se reporta una tasa similar de fracturas según sexo; sin embargo, esto puede variar según diferentes grupos de edad (Daly et al. 1987). Por su parte, se reporta que algunas deformidades de tobillo, como la osteoartritis, están presentes en aproximadamente 13 millones de adultos mayores de 60 años en los Estados Unidos (Thomas et al. 2017). A nivel local, según información proporcionada por los especialistas del Servicio II de Ortopedia del HNGAI en los anexos de la solicitud, se presentan anualmente alrededor de 36 casos nuevos de pacientes que presentan fracturas complejas que involucran la tibia distal, el astrágalo y el calcáneo. METODOLOGÍA: Se realizó una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia disponible sobre la eficacia y seguridad de la artrodesis con el sistema de CIR, en comparación con la artrodesis utilizando tornillos o fijación externa, en pacientes con fracturas complejas y/o deformidades de la articulación tibia-astrágalo-calcáneo. La búsqueda bibliográfica8se realizó en las bases de datos de PubMed, The Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan guías de práctica clínica (GPC) y evaluaciones de tecnologías sanitarias (ETS), incluyendo, el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), Agency for Healthcare Research and Quality (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), Comissáo Nacional de IncorporaQáo de Tecnologias no Sistema Único de Saúde (CONITEC), Instituto de Evaluación Tecnológica en Salud (IETS), Instituto de Efectividad Clínica y Sanitaria (IECS), Scottish Medicines Consortium (SMC), Canadian Agency for Drugs and Technologies in Health (CADTH), Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), y Haute Autorité de Santé (HAS). RESULTADOS: Luego de la búsqueda bibliográfica con fecha 15 de febrero de 2022, se incluyeron para evaluación dos GPC orientadas al manejo de pacientes con fracturas del pie y tobillo: CENETEC e IMSS (Centro Nacional de Excelencia Tecnológica en Salud 2011, Instituto Mexicano del Seguro Social 2010); no se identificaron GPC orientadas al manejo de deformidades de la articulación tibia-astrágalo-calcáneo, o deformidades que involucran al pie, retropié y/o tobillo. Además, se incluyó un ECA (Georgiannos, Lampridis, and Bisbinas 2017) que evaluó la eficacia y seguridad del procedimiento de artrodesis con CIR, en comparación con las artrodesis con tornillos en pacientes con fracturas de tobillo. Asimismo, se incluyó el protocolo de un ECA (ACTRN12617001588381), el cual aún no cuenta con publicación de resultados, y tiene fecha aproximada de finalización en diciembre de 2022 (Tuckett et al. 2019). No se identificaron estudios que evalúen comparativamente al dispositivo CIR, y a la fijación externa en este tipo de 4,1;"147 procedimientos. CONCLUSIÓN: Por lo expuesto, el IETSI no aprueba el uso de clavo intramedular retrógrado para artrodesis en pacientes adultos con fracturas complejas y/o deformidades de la articulación tibia-astrágalo-calcáneo. El equipo evaluador del IETSI, está a la espera de nueva evidencia proveniente de ECA sobre la eficacia y seguridad de la tecnología solicitada. Por otro lado, se recomienda a los especialistas que, de tener conocimiento sobre otras tecnologías sanitarias que puedan representar un beneficio adicional a las tecnologías de uso actual en EsSalud para procedimientos de artrodesis en la población de interés, hagan envío de sus solicitudes para ser valoradas en nuevos documentos de ETS.

[Nailing of long bone fractures in precarious situations: focus on the Surgical Implant Generation Network (SIGN) nail]. / Enclouage des os longs en situation précaire: intérêt du clou SIGN (Surgical Implant Generation Network).

Economic development in low-income countries has led to a considerable increase in motor vehicles, in particular motorcycles. Traffic accident-related fractures are therefore increasing. The treatment of long bone fractures is, in the majority of cases, based on locked intramedullary nailing, a procedure which is rarely available in countries with poor sanitary conditions. To provide optimal treatment to these countries, the SIGN (Surgical Implant Generation Network) nail was developed in 1999 by Lewis Zirkle. It is currently used free of charge in 53 countries. In return, an international database must be completed in order to assess and develop it. In the light of our experiences in Haiti and Burundi and on the basis of a literature review, we here highlight the conceptual and technical features of SIGN nail whose implant in French-speaking countries is still limited.

The risk assessment model of fracture nonunion after intramedullary nailing for subtrochanteric femur fracture.

ABSTRACT: To investigate the influencing factors of fracture nonunion after intramedullary nailing for subtrochanteric fractures and to construct a risk assessment model.Based on the multicenter retrospective analysis of 251 patients, all patients were divided into modeling group and verification group. In the modeling group, postoperative fracture nonunion rate, general data, fracture-related factors, surgical reduction-related factors, mechanical and biological factors were calculated, and the influencing factors of fracture nonunion were screened by univariate analysis. Logistic regression model was used for multifactor analysis to construct the risk assessment model. Based on the logistic regression model, the risk prediction model was constructed by drawing the Nomogram diagram. Through the verification group, the influencing factors were evaluated again, and the differentiation and calibration of the model were evaluated. The calibration degree was evaluated by Hosmer-Lemeshow test, goodness of fit test, and calibration curve. The discriminant degree was evaluated by the receiver operating characteristic curve.Fracture nonunion occurred in 34 of 149 patients in the modeling group. Among the 14 potential influencing factors, univariate analysis and logistic regression analysis showed that postoperative hip varus, intramedullary nail fixation failure, and reduction of fracture with large incision were the risk factors of fracture nonunion. The medial cortex fracture was seen reduced on X-Ray was a protective factor for fracture nonunion, and a regression equation was established. Based on the logistic regression model, the Nomogram diagram is drawn. Twenty-four cases of fracture nonunion occurred in the verification group. The area under the receiver operating characteristic curve was area under curve =0.883 > 0.7, indicating that there was a moderate differentiation to evaluate the occurrence of fracture nonunion after operation. The goodness of fit test: the Hosmers-Lemeshow test (X2 = 2.921, P = .712 > .05) showed that the model had a good calibration.After intramedullary nailing of subtrochanteric fracture, hip varus, failure of intramedullary nail fixation and wide surgical dissection are the risk factors of fracture nonunion, and the postoperative reduction of medial cortex fracture is protective factor.National key research and development projects: 2016YFC0105806.

A Novel Low-Cost Surgical Simulation Tool for Pinning Supracondylar Humerus Fractures.

BACKGROUND: Simulation-based training is one way to improve basic competence for surgical trainees and thus improve patient safety. Closed reduction and percutaneous pinning of a supracondylar humerus fracture is a common procedure that encompasses many basic orthopaedic skills and has been identified as a residency milestone. Despite this, no quantitative tools exist to help learners attain this basic skill. This study seeks to validate a quantitative, low-cost simulation-based training tool for teaching orthopaedic surgery trainees the fundamentals of fracture stabilization with pins. METHODS: Two low-cost models were developed with simulated cancellous bone blocks and cortical bone sheets: a pinning agility tool to teach pin placement and redirection, and a low-cost construct stability tool to replicate pinning. A high-cost construct stability tool was cut using a pediatric supracondylar humerus model to simulate pinning a real fracture. Construct stability was assessed by adding weight until ∼1.6 mm of displacement was observed. Participants were tested naively on all 3 models and then completed a training session using only the low-cost models. Performance following training was then assessed and compared with fellowship-trained pediatric orthopaedic surgeons. Participants also rated their preintervention and postintervention confidence, skill, and knowledgeability. RESULTS: A total of 18 novice trainees participated (10 PGY1 and PGY2 orthopaedic surgery residents and 8 medical student members of the orthopaedic surgery interest club), whereas the reference group consisted of 7 orthopaedic surgery attendings. The subjects significantly improved their scores on both the low-cost (P=0.002) and high-cost (P<0.001) construct stability tools after the training with only the low-cost tools. Compared with the attending benchmark, trainee scores improved on the high-fidelity model from 31% preintervention to 86% postintervention and their pinning times decreased by 38%. Trainees reported increased knowledge, skill, and confidence after the intervention (P<0.001). CONCLUSIONS: A novel, low-cost simulation model and training session for supracondylar humerus fracture pinning resulted in improved performance in stabilizing a supracondylar humerus model and increased trainee knowledgeability, confidence, and skill. LEVEL OF EVIDENCE: Level II-economic.

Does an Implant Usage Report Card Impact Orthopaedic Trauma Implant Stewardship?

OBJECTIVES: As hospitals seek to control variable expenses, orthopaedic surgeons have come under scrutiny because of relatively high implant costs. We aimed to determine whether feedback to surgeons regarding implant costs results in changes in implant selection. METHODS: This study was undertaken at a statewide trauma referral center and included 6 fellowship-trained orthopaedic trauma surgeons. A previously implemented implant stewardship program at our institution using a "red-yellow-green" (RYG) implant selection tool classifies 7 commonly used trauma implant constructs based on cost and categorizes each implant as red (used for patient-specific requirements, most expensive), yellow (midrange), and green (preferred vendor, least expensive). The constructs included were femoral intramedullary nail, tibial intramedullary nail, long and short cephalomedullary nails, distal femoral plate, proximal tibial plate, and lower-limb external fixator. Baseline implant usage from the previous year was obtained and provided to each surgeon. Each surgeon received a monthly feedback report containing individual implant utilization and overall ranking. RESULTS: The overall RYG score increased from 68.7 to 79.1 of 100 (P < 0.001). Three of the 7 implants (tibial and femoral nails and lower-limb external fixation) had significant increases in their RYG scores; implant selections for the other 4 implants were not significantly altered. A decrease of 1.8% (95% confidence interval, 0.4-3.2, P = 0.01) was noted in overall implant costs over the study period. CONCLUSION: Our intervention resulted in changes in surgeons' implant selections and cost savings. However, surgeons were unwilling to change certain implants despite their being more expensive.

Retrograde intramedullary nail fixation compared with fixed-angle plate fixation for fracture of the distal femur: the TrAFFix feasibility RCT.

BACKGROUND: Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate. OBJECTIVES: This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial. DESIGN: A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation. SETTING: Seven NHS hospitals. PARTICIPANTS: Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment. INTERVENTIONS: Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon's discretion. OUTCOMES: The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants' and staff views were obtained, at interview, for the process evaluation. RESULTS: The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail, n = 11; plate, n = 12). The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month. Data completeness of the EQ-5D-5L was estimated at 65% (95% CI 43% to 83%). CONCLUSIONS: This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Health Technol Assess 2018;22(25)], which delivered to target and budget. FUTURE WORK: A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions. REGISTRATION: Current Controlled Trials ISRCTN92089567. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 51. See the NIHR Journals Library website for further project information. Funding was also supported by the NIHR Oxford Biomedical Research Centre.

Breaks of the lower end of the thigh bone are increasingly common injuries. Two operations are used to treat these injuries: a rod placed along the centre of the bone or a plate attached to the edge of the bone. It is not clear which is better. We report the results from a study that will help develop the design of a definitive study to test which operation produces the best outcomes for patients. Adult patients with a break at the end of the thigh bone treated in one of seven hospitals were eligible to take part in the study. Participants were treated with one of two operations; the choice was made by chance using a computer program. Participants' basic information and pre-injury health status were recorded and participants were followed up at 6 and 16 weeks. We assessed the rate at which participants agreed to take part in the study and the number who completed follow-up. A value-for-money analysis was performed to determine how to plan this element of a future study. Staff and patients were interviewed about the study processes and the context of the treatments and hospitals to understand how the treatments work and the practicalities of delivering the study. Lower than expected numbers of participants took part in the study; 173 patients were considered for the study, but only 23 agreed to participate. The main reason was that several of the participating surgeons felt strongly that one or the other operation was superior. The rate of follow-up was similar to that of other studies using these treatments. Therefore, the proposed definitive trial is unlikely to be successful if designed in the same way as this feasibility study. Several important considerations that informed the planning of this study were found not to hold true. We believe a modified study could be delivered and could answer this important research question.

Does Implant Choice Affect the Episode Cost of Pertrochanteric Hip Fracture for US Veterans?

OBJECTIVE: To investigate an association between a surgeon's choice of a cephalomedullary nail (CMN) or sliding hip screw (SHS) with the cost of treating a pertrochanteric hip fracture. DESIGN: Multicenter retrospective cohort study. SETTING: US Veterans Health Administration Sierra Pacific Network. PATIENTS/PARTICIPANTS: Two hundred ninety-four consecutive US veterans admitted for a principal diagnosis of an OTA/AO 31A-type pertrochanteric hip fracture of a native hip from 2000 to 2015. INTERVENTION: Internal fixation using a CMN or an SHS. MAIN OUTCOME MEASUREMENTS: Veterans Administration Health Economic Resource Center average national cost estimate of combined acute and postacute care episode cost, excluding implant cost, normalized to 2015 US dollars by the Consumer Price Index. RESULTS: Median episode cost was $8223 lower with a CMN than an SHS (95% confidence interval, $5700-$10,746, P < 0.001) after matching on a propensity score for treatment with a CMN based on age, sex, body mass index, Charlson Comorbidity Index, fracture characteristics, study site, and admission year. A subgroup propensity-matched analysis excluding reverse obliquity pertrochanteric fractures was not sufficiently powered to detect a difference in episode cost (ß = 0.76, P = 0.311). CONCLUSIONS: Implant choice significantly affected the episode cost of care of hip fracture at Veterans Health Administration facilities. LEVEL OF EVIDENCE: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Digital Assessment of the Implantation Angle of Proximal Femoral Nail Antirotation Helical Blade Using CT Three-dimensional Reconstruction.

OBJECTIVES: To facilitate simple and safe manipulation during proximal femoral nail antirotation (PFNA) operation, we studied the range of safe implantation angle of the helical blade of the PFNA system by using a digital-based three-dimensional reconstruction model of CT images. METHODS: Thirty-five healthy volunteers were recruited. Original multilayer helical CT scan data of the left femur were collected and imported into Mimics software. Anatomic features of the femur, including the safe implantation angle, anterior and posterior angle, were measured. Differences in each angle between male and female subjects were compared using Student's t test, and the determinants of each angle were analyzed by linear regression. RESULTS: The mean safe implantation angle was 30.09° ± 4.73°, the mean anterior angle was 15.82° ± 2.07°, and the mean posterior angle was 14.27° ± 3.19°. All the three angles were greater in males than females (P < 0.05). Neck shaft angle and the diameter of the femoral neck and head were linearly correlated with the safe implantation angle, the anterior and posterior angle, respectively. Femoral neck diameter was a significant determinant of the safe implantation angle and posterior angle, respectively. Moreover, femoral neck diameter and femoral head diameter were significant determinants of the anterior angle. CONCLUSIONS: The study has introduced and delineated a novel parameter, the safe implantation angle, for FPNA surgery, which may help orthopedic surgeons in deciding a safe range of PFNA operation and improve the accuracy of PFNA helical blade implantation.

Association of the Anterolateral Thigh Osteomyocutaneous Flap With Femur Structural Integrity and Assessment of Prophylactic Fixation.

Importance: The chimeric anterolateral thigh osteomyocutaneous (ALTO) free flap is a recently described microvascular option for head and neck osseous defects associated with complex soft-tissue requirements. To date, the association of ALTO flap harvest with femur structural integrity and the need for routine prophylactic fixation following harvest has been incompletely described. Objective: To investigate the association of ALTO flap harvest, with and without prophylactic fixation, on femur structural integrity as measured by 4-point bend and torsional biomechanical testing. Design and Setting: At a research laboratory, 24 synthetic fourth-generation composite femurs with validated biomechanical properties underwent 10-cm-long, 30% circumferential osteotomies at the proximal middle third of the femur; 6 femurs served as controls. Osteotomized femurs with and without fixation underwent torsional and 4-point bend biomechanical testing. Femur fixation consisted of intramedullary nail and distal interlock screw placement. Main Outcomes and Measures: Force and torque to fracture (expressed in kilonewtons [kN] and Newton meters [N∙m], respectively) were compared between controls, osteotomized femurs without fixation, and osteotomized femurs with fixation. Additional outcome measures included femur stiffness and fracture patterns. Results: On posterior to anterior (PA) 4-point bend testing, force to fracture of osteotomized femurs was 22% of controls (mean difference, 8.3 kN; 95% CI, 6.6-10.0 kN). On torsional testing the torque to fracture of osteotomized femurs was 12% of controls (mean difference, 351.1 N∙m; 95% CI, 307.1-395.1 N∙m). Following fixation there was a 67% improvement in PA force to fracture and a 37% improvement in torque to fracture. However, osteotomized femurs with fixation continued to have a reduced PA force to fracture at 37% of controls (mean difference, 6.8 kN; 95% CI, 4.5-9.2 kN) and torque to fracture at 16% of controls (mean difference, 333.7 N∙m; 95% CI, 306.8-360.6 N∙m). On torsional testing, all osteotomized femurs developed similar spiral fractures through a corner of the distal osteotomy site. This fracture pattern changed after prophylactic fixation with femurs developing nondisplaced fractures through the proximal osteotomy site. There were no underlying hardware failures during testing of osteotomized femurs with fixation. Conclusions and Relevance: Anterolateral thigh osteomyocutaneous flap harvest results in significant changes in the structural integrity of the femur. Postoperative stabilization should be strongly considered, with future research directed at investigating the clinical significance of residual biomechanical changes following femur fixation.

Intramedullary nails in the treatment of the distal radius fractures.

The distal radius fracture is a common injury in old persons. Its treatment remains a critical challenge because of number of cases, the final cost of the procedure, the level of X-ray irradiation, and the demand of technique of fixation in osteoporotic bone. The entire closed procedure requires a strict percutaneous nailing. This offers advantages in terms of postoperative pain, per-operative irradiation, and cost. The main problem was so far the ability to insure a stable reduction in time. This point is discussed with the introduction of the "Nail-o-Flex®" nail. A continuous series of 83 patients is introduced.

Intramedullary Implant Choice and Cost in the Treatment of Pediatric Diaphyseal Forearm Fractures.

OBJECTIVES: To compare outcomes and costs between titanium elastic nails (TENs), stainless steel elastic nails (SENs), and Kirschner wires (K-wires) in the treatment of pediatric diaphyseal forearm fractures with intramedullary fixation. DESIGN: Retrospective cohort study. SETTING: Level 1 Pediatric Trauma Center. PATIENTS/PARTICIPANTS: A total of 100 patients (65 male and 35 female) younger than 18 years with diaphyseal forearm fractures treated with intramedullary fixation were included in the study. INTERVENTION: Patients received single or both bone intramedullary fixation with either TENs, SENs, or K-wires. MAIN OUTCOME MEASUREMENTS: Time to radiographic union, complication rate, surgical time, and average cost per implant. RESULTS: One hundred patients were included in the study. Thirty-one patients were treated with TENs, 30 with SENs, and 39 with K-wires. No significant difference in time to radiographic union, complication rate, or surgical time was found between the 3 types of fixation. Average time to union was 9.4 ± 5.4 weeks, and complication rate was 12.9% for TENs, 10.0% for SENs, and 12.8% for K-wires. There was a significant difference in cost per implant, with an average cost of $639, $172, and $24 for TENs, SENs, and K-wires, respectively (P < 0.001). CONCLUSIONS: This study demonstrates no difference between TENs, SENs, and K-wires in the treatment of pediatric diaphyseal forearm fractures with regards to outcome, time to union, surgical time, or complication rates. Given the significant cost difference between these implants, we recommend that surgeons consider modifying their implant selection to help mitigate cost. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Extended applications of the reamer-irrigator-aspirator (RIA) system.

While the RIA system was initially designed for reaming and clearing the femoral canal contents in preparation for femoral nailing, it has since been used in various other applications in the field of orthopaedic surgery. The RIA is an ideal device for accessing large quantities of autogenous bone graft, to be used in the treatment of nonunions, segmental bone loss, or arthrodesis. The RIA has also been used for treatment of intramedullary infections and osteomyelitis, as well as intramedullary nailing of long bones with metastatic lesions, as it allows for clearing the canal of infectious/tumour burden, and lowers the risk of dissemination into the soft tissues and systemic circulation. There is also some limited evidence that the RIA may be used for clearing the femoral/tibial canal of cement debris. Despite multiple applications, the use of RIA has a risk of eccentric reaming and iatrogenic fractures. RIA is also a costly procedure, and its routine use may not be advantageous in the setting of limited health care resources.

Implant options for the treatment of intertrochanteric fractures of the hip: rationale, evidence, and recommendations.

AIMS: The aim of this paper is to review the evidence relating to the anatomy of the proximal femur, the geometry of the fracture and the characteristics of implants and methods of fixation of intertrochanteric fractures of the hip. MATERIALS AND METHODS: Relevant papers were identified from appropriate clinical databases and a narrative review was undertaken. RESULTS: Stable, unstable, and subtrochanteric intertrochanteric fractures vary widely in their anatomical and biomechanical characteristics, as do the implants used for their fixation. The optimal choice of implant addresses the stability of the fracture and affects the outcome. CONCLUSION: The treatment of intertrochanteric fractures of the hip has evolved along with changes in the design of the implants used to fix them, but there remains conflicting evidence to guide the choice of implant. We advocate fixation of 31A1 fractures with a sliding hip screw and all others with an intramedullary device. Cite this article: Bone Joint J 2017;99-B:128-33.

Outcomes of Surgical Management of Supracondylar Periprosthetic Femur Fractures.

BACKGROUND: Fracture location is an important consideration in managing supracondylar periprosthetic femur fractures. The outcomes of locked plating and intramedullary (IM) nail fixation were therefore compared based on fracture location, being above or at/below the total knee arthroplasty (TKA) flange. METHODS: Fifty-seven patients were identified from surgical records as being treated for supracondylar periprosthetic femur fracture with either a locking plate (n = 38) or IM nail (n = 19). Based on fracture location, either above or at/below the TKA flange, both groups were assessed for time to full weight bearing, time to radiographic union, number of postoperative complications, subsequent surgery, transfusion requirements, as well as range of motion, pain, and instability at most recent follow-up. Radiographs were reviewed to assess fracture alignment with comparisons made immediately postoperative to most recent. RESULTS: Mean follow-up for IM nail and locking plate fixation was 13.9 and 15.6 months, respectively. There was no statistical difference between groups in the mean time to fully weight bear, the incidence of postoperative pain, range of motion, use of gait aids, time to full radiographic union, or the overall radiographic alignment of a healed fracture (P > .05). Comparison based on fracture location yielded similar outcomes. Nonunion was only demonstrated in the IM nail cohort, particularly for fractures below the TKA flange (n = 2). CONCLUSION: The use of either IM nail or locking plate fixation for supracondylar periprosthetic fractures provides comparable clinical outcomes. Caution is recommended in using IM nails for fractures below the flange where limited fixation may increase the risk of nonunion.

An assessment of outcomes with intramedullary fixation of fractured ribs.

BACKGROUND: Surgical management of fractured ribs with internal fixation is an increasingly accepted therapy. Concurrently, specific rib fixation prostheses are being developed which should improve results and minimise hardware and rib/splint construct failures. The Synthes titanium intramedullary splint lends itself to difficult to access areas such as posterior rib fractures and fractures under the scapula. We analyse a case series of patients in whom this rib fixation prosthesis has been used. METHODS: Fifteen patients received 35 intramedullary splints. Follow up at 3 and 6 months was performed with three dimensional computed tomography scanning to assess for bone alignment, callus formation and healing, residual deformity, hardware failure or cut through. Computerized finite element analysis (FEA) was used to model forces acting on a posterior fracture with and without an intramedullary fixation splint in situ. RESULTS: Complete healing (bony union) was noted in only 3 (9 %) of the fractures fixed with splints by 3 months. Partial healing (cartilaginous union) was noted in 28 of the 33 fractures (85 %), and non healing was noted in only 2 (6 %). In both those two patients, failure at the rib / splint interface was noted after both patients reported sneezing. No hardware failures were noted. By 6 months the fractures which had shown partial healing, had all completely healed. There were no late failures (between 3 and 6 months) of either hardware or rib/splint interfaces. FEA modelling identified sites of increased stress in the rib at the rib / splint interface and in a modelled intramedullary splint where it spans the fracture. CONCLUSIONS: Further analysis of outcomes with intramedullary splints is warranted as well as further development of intramedullary rib fixation solutions.

Controversies in Intramedullary Fixation for Intertrochanteric Hip Fractures.

Intertrochanteric hip fractures are common and costly. Intramedullary fixation has gained popularity as a means of stabilizing intertrochanteric hip fractures. This review article presents some of the controversies surrounding the treatment of intertrochanteric fractures using a cephalomedullary nail. These topics include nail length, the need for distal interlocking, proximal screw design, the number of proximal lag screws, and integrated proximal sliding lag screws. LEVEL OF EVIDENCE: Therapeutic Level V. See Instructions for Authors for a complete description of levels of evidence.

Costs and Complications of Short Versus Long Cephalomedullary Nailing of OTA 31-A2 Proximal Femur Fractures in U.S. Veterans.

OBJECTIVES: In fractures without subtrochanteric extension, the indications for the use of short versus long cephalomedullary nails (CMNs) for intertrochanteric femur fractures are unclear. We hypothesized that long nails would be associated with higher costs and similar complication rates. DESIGN: Retrospective comparative study. SETTING: United States Department of Veterans Affairs Medical Centers. PARTICIPANTS: Patients receiving CMNs for OTA 31-A2 pertrochanteric fractures from 2001 to 2010. INTERVENTIONS: Short versus long cephalomedullary nailing. MAIN OUTCOME MEASUREMENTS: Costs, perioperative complications, readmissions, surgical failures, and mortality. RESULTS: We identified 262 patients with OTA 31-A2 pertrochanteric fractures (125 treated with short CMNs and 137 treated with long CMNs). The 2 cohorts had similar demographic and medical characteristics. There were no significant differences in perioperative complications, readmissions within 30 days, surgical failures within one year, or death within 30 days or one year. The average cost of hospitalization was significantly higher for the cohort treated with long nails (greater than $7000 in actual costs, and greater than $3000 when statistically adjusted for differences in postoperative lengths of stay). Multivariable analyses showed no significant differences in the rates of development of at least one complication, readmission, or death. CONCLUSIONS: In a cohort of patients with similar characteristics and fracture patterns, the use of long CMNs was associated with similar rates of complications, readmission, and reoperations, but significantly higher costs than with the use of short nails. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Short Versus Long Intramedullary Nails in the Treatment of Pertrochanteric Hip Fractures: Incidence of Ipsilateral Fractures and Costs Associated With Each Implant.

OBJECTIVES: Both short intramedullary nails (SIMNs) and long intramedullary nails (LIMNs) are routinely used in the surgical treatment of pertrochanteric hip fractures. The purpose of this study was to assess the incidence of ipsilateral femur fractures after the surgical treatment of hip fractures and the overall costs associated with each implant. DESIGN: Retrospective cohort study. SETTING: Level I trauma center and 2 community hospitals. PATIENTS/PARTICIPANTS: A total of 609 patients with pertrochanteric hip fractures treated with an SIMN or LIMN from 2005 to 2011. INTERVENTION: Review of patient demographics and clinical outcomes over a 5-year follow-up period. MAIN OUTCOME MEASUREMENTS: Ipsilateral femur refracture rates were recorded for both groups, and a cost analysis was then performed to compare SIMNs and LIMNs while accounting for their observed refracture rates and surgical/hospital costs to determine the overall cost of each implant. RESULTS: Union rates were equivalent between groups and averaged over 97%. The incidence of ipsilateral femur fractures in both groups steadily increased with greater follow-up time to reach nearly 10% at 5 years. Although only 47% of all nails were locked distally, 15 of the 16 refractures occurred in nails that were not distally locked. Cost analysis revealed no significant difference in the use of short versus LIMNs over a 5-year period (P = 0.76). CONCLUSIONS: The incidence of ipsilateral femur refractures steadily rose with greater follow-up in both SIMN and LIMNs. Distally locking the initial fixation seems to protect against future femur fractures and may also affect the refracture location when using LIMNs. No differences in overall costs were seen at 1, 2, or 5 years between SIMNs and LIMNs. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.