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PURPOSE: To determine if an improvement in cord-level intraoperative neuromonitoring (IONM) data following data loss results in a reduced risk for new postoperative motor deficit in pediatric and adult spinal deformity surgery. METHODS: A consecutive series of 1106 patients underwent spine surgery from 2015 to 2023 by a single surgeon. Cord alerts were defined by Somatosensory-Evoked Potentials (SSEP; warning criteria: 10% increase in latency or > 50% loss in amplitude) and Motor-Evoked Potentials (MEP; warning criteria: 75% loss in amplitude without return to acceptable limits after stimulation up 100 V above baseline level). Timing of IONM loss and recovery, interventions, and baseline/postoperative day 1 (POD1) lower extremity motor scores were analyzed. RESULTS: IONM Cord loss was noted in 4.8% (53/11,06) of patients and 34% (18/53) with cord alerts had a POD1 deficit compared to preoperative motor exam. MEP and SSEP loss attributed to 98.1% (52/53) and 39.6% (21/53) of cord alerts, respectively. Abnormal descending neurogenic-evoked potential (DNEP) was seen in 85.7% (12/14) and detected 91.7% (11/12) with POD1 deficit. Abnormal wake-up test (WUT) was seen in 38.5% (5/13) and detected 100% (5/5) with POD1 deficit. Most cord alerts occurred during a three-column osteotomy (N = 23/53, 43%); decompression (N = 12), compression (N = 7), exposure (N = 4), and rod placement (N = 14). Interventions were performed in all 53 patients with cord loss and included removing rods/less correction (N = 11), increasing mean arterial pressure alone (N = 10), and further decompression with three-column osteotomy (N = 9). After intervention, IONM data improved in 45(84.9%) patients (Full improvement: N = 28; Partial improvement: 17). For those with full and partial IONM improvement, the POD1 deficit was 10.7% (3/28) and 41.2% (7/17), respectively. For those without any IONM improvement (15.1%, 8/53), 100% (8/8) had a POD1 deficit, P < 0.001. CONCLUSION: A full or partial improvement in IONM data loss after intraoperative intervention was significantly associated with a lower risk for POD1 deficit with an absolute risk reduction of 89.3% and 58.8%, respectively. All patients without IONM improvement had a POD1 neurologic deficit.
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BACKGROUND: There is currently no consensus regarding the optimal anesthetic technique for total hip and knee arthroplasty (THA, TKA). This study aimed to compare the utilization rates and safety of spinal vs. general anesthesia in contemporary THA/TKA practice. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), a retrospective review of 307,076 patients undergoing total hip or knee arthroplasty under either spinal or general anesthesia between January 2015 and December 2018 was performed. Propensity matching was used to compare differences in operative times, hospital length of stay, discharge destination, and 30-day adverse events. The annual utilization rates for both techniques between 2011 and 2018 were also assessed. RESULTS: Patients receiving spinal anesthesia had a shorter length of stay (P < 0.001) for TKA while no statistical differences in length of stay were observed for THA. Patients were also less likely to experience any 30-day complication (OR = 0.82, P <0.001 and OR = 0.92, P < 0.001 for THA and TKA, respectively) while being more likely to be discharged to home (OR = 1.46, P < 0.001 and OR = 1.44, P < 0.001 for THA and TKA, respectively). Between 2011 and 2018, spinal anesthesia utilization only increased by 1.4% for THA (P < 0.001) and decreased by 0.2% for TKA (P < 0.001), reaching 38.1% and 40.3%, respectively. CONCLUSION: Spinal anesthesia remains a grossly underutilized tool despite providing better perioperative outcomes compared to general anesthesia. As orthopedic surgeons navigate the challenges of value-based care, spinal anesthesia represents an invaluable tool that should be considered the gold standard in elective, primary total hip and knee arthroplasty.
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BACKGROUND: For hospitals participating in bundled payment programs, unplanned readmissions after surgery are often termed "bundle busters." The aim of this study was to develop the framework for a prospective model to predict 90-day unplanned readmissions after elective primary total hip arthroplasty (THA) at a macroscopic hospital-based level. METHODS: A national, all-payer, inpatient claims and cost accounting database was used. A mixed-effect logistic regression model measuring the association of unplanned 90-day readmissions with a number of patient-level and hospital-level characteristics was constructed. RESULTS: Using 427,809 unique inpatient THA encounters, 77 significant risk factors across 5 domains (ie, comorbidities, demographics, surgical history, active medications, and intraoperative factors) were identified. The highest frequency domain was comorbidities (64/100) with malignancies (odds ratio [OR] 2.26), disorders of the respiratory system (OR 1.75), epilepsy (OR 1.5), and psychotic disorders (OR 1.5), being the most predictive. Other notable risk factors identified by the model were the use of opioid analgesics (OR 7.3), Medicaid coverage (OR 1.8), antidepressants (OR 1.6), and blood-related medications (OR 1.6). The model produced an area under the curve of 0.715. CONCLUSION: We developed a novel model to predict unplanned 90-day readmissions after elective primary THA. Fifteen percent of the risk factors are potentially modifiable such as use of tranexamic acid, spinal anesthesia, and opioid medications. Given the complexity of the factors involved, hospital systems with vested interest should consider incorporating some of the findings from this study in the form of electronic medical records predictive analytics tools to offer clinicians with real-time actionable data.
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Artroplastia de Reemplazo de Cadera , Estados Unidos , Humanos , Artroplastia de Reemplazo de Cadera/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Factores de Tiempo , Readmisión del Paciente , Factores de Riesgo , Estudios RetrospectivosRESUMEN
BACKGROUND: The 24-question Early-Onset Scoliosis Questionnaire (EOSQ-24) is a proxy measure assessing health-related quality of life (HRQoL) among patients with early-onset scoliosis (EOS). There exists an increasing need to assess HRQoL through a child's own perspective, particularly for older children and adolescents with EOS. The purpose of this study was to develop and validate a self-reported questionnaire, the Early-Onset Scoliosis Self-Report Questionnaire (EOSQ-SELF), to assess HRQoL in older children and adolescents with EOS. METHODS: A literature review, an expert focus group, and patient interviews were used to generate a preliminary survey of appropriate domains and question items. This survey was provided to English-speaking patients with EOS who were 8 to 18 years of age and capable of answering survey questions. Content validity was assessed for clarity and relevance of questions. Confirmatory factors analysis was performed to reduce the number of items and determine domains that fit items. Reliability was evaluated by measuring the internal consistency of items and test-retest reliability. Construct validity was evaluated by convergent, discriminant, and known-group validity. RESULTS: The literature review, expert focus group, and patient interviews identified 59 questions in 14 domains. Psychometric analysis reduced these to 30 questions across 12 domains: General Health, Pain/Discomfort, Pulmonary Function, Transfer, Physical Function/Daily Living, Participation, Fatigue/Energy Level, Sleep, Appearance, Relationships, Emotion, and Satisfaction. The final questionnaire was found to have good content and construct validity and adequate reliability. CONCLUSIONS: The EOSQ-SELF is a valid and reliable instrument for measuring self-reported HRQoL among older children and adolescents with EOS (ages 8 to 18 years). This will serve as an important research outcome measure and enhance clinical care by providing a better understanding of HRQoL for these patients. LEVEL OF EVIDENCE: Diagnostic Level II . See Instructions for Authors for a complete description of levels of evidence.
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Calidad de Vida , Escoliosis , Adolescente , Niño , Fatiga , Humanos , Psicometría , Reproducibilidad de los Resultados , Escoliosis/diagnóstico , Escoliosis/psicología , Autoinforme , Encuestas y CuestionariosRESUMEN
BACKGROUND: Acute kidney injury (AKI) is one of the most common medical causes for readmission following total joint arthroplasty (TJA). This study aimed to (1) examine whether the incidence of AKI has changed over the past decade with the adoption of modern perioperative care pathways and (2) identify the risk factors and concomitant adverse events (AEs) associated with AKI. METHODS: 535,291 primary TJA procedures from the American College of Surgeons National Surgical Quality Improvement Program from 2011 to 2018 were retrospectively reviewed. The annual incidence of AKI was analyzed for significant changes over time. Matched cohort analyses were performed to identify the risk factors and AEs associated with AKI using multivariate logistic regression. RESULTS: The mean incidence of AKI was 0.051%, which remained unchanged during the study period (P = 0.121). Factors associated with AKI were diabetes (OR 1.96, P = 0.009), bilateral procedure (OR 6.93, P = 0.030), lower preoperative hematocrit level (OR 1.09, P = 0.015), body mass index (OR 1.04, P = 0.025), and higher preoperative BUN (OR 1.03, P = 0.043). AKI was associated with length of stay (LOS) > 2 days (OR 4.73, P < 0.001), non-home discharge (OR 0.25, P < 0.001), 30-day readmission (OR 12.29, P < 0.001), and mortality (OR 130.7, P < 0.001). CONCLUSIONS: The incidence of AKI has not changed over the past decade, and it remains a major bundle buster resulting in greater LOS, non-home discharge, readmissions, and mortality. Avoidance of bilateral TJA in patients with DM and high BMI as well as preoperative optimization of anemia and BUN levels are advised.
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INTRODUCTION: Serial body casting plays an important role in the treatment of early onset scoliosis (EOS), serving as a safer method compared to surgical intervention. There is no published evidence documenting the impact of casting on health-related quality of life (HRQoL) of patients and their caregivers. The purpose of this study was to utilize the 24-Item Early Onset Scoliosis Questionnaire (EOSQ-24) to compare the HRQoL of patients with EOS and the burden of care for their caregivers before, during, and after treatment with Mehta casting. METHODS: In this multicenter retrospective cohort study, two EOS databases were queried for patients with EOS who underwent serial casting from 2005 to 2016. Patients who had treatment prior to their initial cast application, including bracing or surgical intervention, were excluded from the study. Patients were stratified into two subgroups and analyzed separately: those with idiopathic etiology, and those with non-idiopathic etiology. HRQoL and burden of care were assessed using the EOSQ-24 completed before, during, and after cast treatment. RESULTS: 91 patients were identified in this study (mean age at the index casting: 2.1 ± 1.2 years, mean age at final cast removal: 4.1 ± 1.3 years). 59 (64.8%) had EOS of idiopathic etiology, while 32 (35.2%) had EOS of non-idiopathic etiology, including 10 congenital, 6 neuromuscular, and 16 syndromic. Idiopathic patients and non-idiopathic patients experienced an improvement in the coronal deformity from 45° pre-cast to 26° post-cast, and from 59° pre-cast to 34° post-cast, respectively. Patients with idiopathic scoliosis experienced a decrease from baseline in nearly all EOSQ-24 sub-domain scores except for general health. Furthermore, even after the removal of the cast, patients with idiopathic etiology suffered residual negative effects of casting on emotion and transfer sub-domains. Among patients with non-idiopathic etiology, decreased scores from baseline were observed only in transfer and emotion sub-domains during the casting intervention. After brace removal, patients with non-idiopathic etiology had increased scores compared to their baseline scores in most sub-domains. DISCUSSION: Serial body casting can prevent curve correction in patients with EOS. However, the psychosocial stresses secondary to this non-operative intervention can have significant negative impacts on HRQoL for both idiopathic and non-idiopathic patients during the course of treatment. Although non-idiopathic patients experience improved HRQoL following treatment, idiopathic patients do not seem to exhibit much improvement in HRQoL from baseline even years after the final cast removal.
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Carga del Cuidador , Cuidadores/psicología , Moldes Quirúrgicos , Calidad de Vida , Escoliosis/psicología , Escoliosis/terapia , Factores de Edad , Edad de Inicio , Moldes Quirúrgicos/efectos adversos , Preescolar , Femenino , Humanos , Lactante , Masculino , Estudios Retrospectivos , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
AIM: To describe the prevalence of symptomatic cervical spinal stenosis (CSS) in spastic cerebral palsy (CP) and associated characteristics. METHOD: This cross-sectional study of adults (>18y) with CP (2006-2016) at a single institution compared the patient characteristics (demographics, comorbidities, surgical history, medications, Gross Motor Function Classification System [GMFCS] level, and CP type) of patients with and without CSS. RESULTS: Of 424 patients (mean age 33y 4mo, SD 13y 6mo, range 18-78y; 225 females, 199 males), 32 patients (7.5%) had symptomatic CSS. GMFCS levels in the study cohort were distributed as follows: level I, 25%; level II, 25%; level III, 22%; level IV, 19%; level V, 9%. Twenty-five out of 32 (78.1%) patients had spastic CP, two (6.3%) had dystonic CP, and one (3.1%) had mixed characteristics. Individuals with CSS were older (mean age 54y 6mo, SD 10y 5mo vs mean age 31y 7mo, SD 12y 1mo, p<0.05) and had a higher body mass index (26.1, SD 4.8 vs 23.4, SD 6.2, p<0.05) than those without CSS. Presentations included upper-extremity symptoms (73%), ambulation decline (70%), neck pain (53%), and incontinence (30%). Common stenosis levels were C5-C6 (59%), C4-C5 (56%), and C6-C7 (53%). INTERPRETATION: Symptomatic CSS was identified in 7.5% of this adult cohort during the 2006 to 2016 period. Diagnosis in CP is difficult due to impaired communication and pre-existing gait abnormalities and spasticity. Given the high prevalence of symptomatic CSS in adults, we propose developing screening guidelines. Physicians must maintain a high level of suspicion for CSS if patients present with changes in gait or spasticity.
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Parálisis Cerebral/epidemiología , Estenosis Espinal/epidemiología , Adolescente , Adulto , Anciano , Parálisis Cerebral/fisiopatología , Vértebras Cervicales/fisiopatología , Comorbilidad , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Músculo Esquelético/fisiopatología , Prevalencia , Estenosis Espinal/fisiopatología , Adulto JovenRESUMEN
STUDY DESIGN: Multicenter retrospective review. OBJECTIVES: To compare the radiographic outcomes and complication rates in patients with primary and conversion magnetically controlled growing rod (MCGR) implants at one and two years after surgery. SUMMARY OF BACKGROUND DATA: Many initial early-onset scoliosis (MCGR) implantations in the United States were conversions from other types of growth-friendly systems, and the outcome similarities and differences between primary and conversion MCGR implantation procedures are still relatively unknown. METHODS: Multicenter retrospective review of EOS patients from two multicenter EOS registries identified consecutive EOS patients treated from 2014 to 2017 with a minimum of one-year follow-up. In addition, a subset of these patients who had two-year follow-up were further analyzed. RESULTS: In total, 383 MCGR patients were identified, of which 272 (71%) were primary (P) and 111 (29%) were conversion (C). Group P patients had significantly greater coronal curves at the time of MCGR implantation and greater initial coronal correction. There was no statistically significant difference in Cobb correction at one year or between follow-up at one and two years. The preimplantation thoracic spine height was identical in both groups, with statistically greater improvement at initial implantation in P than in C patients. Significantly greater height gains were seen in P than in C patients in the one-year follow-up cohort. There was a higher rate of complications in the C group than in the P group; however, the difference was not statistically significant. Overall, most complications were implant-related. No loss of curve correction occurred in either group. CONCLUSIONS: Patients with primary MCGR insertion can be expected to have greater radiographic correction and spine length gain than those with conversion from growth-friendly instrumentation to MCGR, most likely because of increased spine stiffness in conversion patients. The rate of complications, primarily implant-related, remains higher in conversion than in primary insertion patients. LEVEL OF EVIDENCE: Level III.
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Imanes , Procedimientos Ortopédicos , Escoliosis/cirugía , Niño , Femenino , Estudios de Seguimiento , Humanos , Masculino , Procedimientos Ortopédicos/efectos adversos , Procedimientos Ortopédicos/instrumentación , Procedimientos Ortopédicos/métodos , Procedimientos Ortopédicos/estadística & datos numéricos , Complicaciones Posoperatorias , Rango del Movimiento Articular , Estudios Retrospectivos , Columna Vertebral/cirugía , Resultado del TratamientoRESUMEN
Residual symptoms often persist even after successful operative reduction and internal fixation (ORIF) of ankle fractures. Concurrent ankle arthroscopic procedures (CAAPs) have been proposed to improve clinical outcomes; however, a dearth of evidence is available supporting this practice. The purpose of the present study was to investigate the reoperation and complication rates after ORIF of ankle fractures with and without CAAPs. Reoperations and complications after ORIF of ankle fractures were identified using the PearlDiver database from January 2007 to December 2011. The CAAPs included bone marrow stimulation, debridement, synovectomy, and unspecified cartilage procedures. Reoperation procedures consisted of ankle fracture repeat fixation, arthroscopic procedures, osteochondral autograft transfers, and ankle arthrodesis. Of the 32,307 patients who underwent ankle fracture fixation, 248 received CAAP and 32,059 did not. No significant difference was found in the reoperation rate between the 2 groups (7.7% versus 8.6%; odds ratio 0.89; 95% confidence interval 0.55 to 1.42; p = .61). Of the 248 patients in the CAAP group, 19 (7.7%) underwent reoperation, of which 13 (68.4%) were arthroscopic debridement and 6 were either ankle refixation or osteochondral autograft transfer. For the non-CAAP group, 3021 reoperation procedures were performed, consisting of ankle refixation in 83.2%, arthroscopic procedures in 14.3%, and ankle arthrodesis in 2.5%. The complication rate in the non-CAAP group included wound dehiscence in 2.4%, wound surgery in 0.4%, deep vein thrombosis in 0.8%, and pulmonary embolism in 0.4%. No complications were detected in the CAAP group. Ankle fracture fixation with CAAPs did not increase the postoperative reoperation rate compared with ankle fracture fixation without CAAPs.
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Fracturas de Tobillo/cirugía , Artroscopía/efectos adversos , Fijación Interna de Fracturas/efectos adversos , Fracturas Intraarticulares/cirugía , Complicaciones Posoperatorias/epidemiología , Reoperación , Bases de Datos Factuales , Humanos , Estudios Retrospectivos , Estados UnidosRESUMEN
STUDY DESIGN: Expert consensus building using combined Delphi method and Nominal group technique. OBJECTIVES: To identify the current state of equipoise surrounding the use of magnetically controlled growing rods (MCGRs) and to determine consensus for planning a randomized controlled trial (RCT) with MCGRs. BACKGROUND: The use of MCGRs for the treatment of early-onset scoliosis (EOS) is a new technology. Optimal use has not been thoroughly investigated and much uncertainty exists. Areas of uncertainty include construct architecture, timing of lengthenings, and amount of distraction per lengthening. Expert discussion and consensus is useful at this early juncture and necessary when designing an RCT. METHODS: Two rounds of surveys were administered to a group of experienced pediatric spine surgeons, followed by a 2-hour, face-to-face meeting in November 2015 and a 1-hour, face-to-face meeting in February 2016. The first survey used example cases to establish agreement around the proper use of MCGRs and identified areas of equipoise and disagreement. The second survey again used example cases-this time selected for their equipoise status-to solicit trial arms for a potential RCT of MCGRs and identified important open questions in the use of MCGRs. Lastly, the face-to-face meetings employed iterative voting to preliminarily plan an RCT of MCGRs. RESULTS: Following the Delphi survey rounds and the two Nominal face-to-face meetings, the group of experts decided on an MCGR RCT design that standardized all patients to bidirectional constructs, and randomized to a lengthening interval of 6 versus 16 weeks with a standardized equation for calculating the total yearly lengthening that approximates normal spine growth. CONCLUSION: This endeavor indicates expert support for the use of MCGR in children older than 6 years, with curves greater than 60°. The uncertainty surrounding frequency of lengthening justifies an RCT of MCGRs. LEVEL OF EVIDENCE: Level V.
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Imanes , Procedimientos Ortopédicos/instrumentación , Escoliosis/cirugía , Niño , Técnica Delphi , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Women with disabilities (WWD) have reported lower mammography rates than the general population, however rates for women with cerebral palsy (CP) have not been specifically studied. OBJECTIVE: To evaluate mammography rates in women with CP and to identify strengths and barriers with their screening experience. METHODS: Women with CP 40 years or older (nâ¯=â¯118) participating in a prospective cross-sectional survey were queried regarding screening status, imaging modality, and accommodation needs and availability. Categorical variables were summarized and Chi-square testing used to assess factors contributing to screening compliance. The effect of functional factors on screening was evaluated using logistic regression. RESULTS: 77 women (65.3%) had mammograms within the past two years; 56 (47.5%) were screening mammograms. Severity of fine motor deficits was associated with lack of screening (OR 0.559, pâ¯=â¯0.019). 85 (72.0%) experienced positive staff attitudes. Facilities most often met needs for ramps, elevators, and/or wide doorways (92.9%), exam explanations (84.4%), and accessible parking (82.5%). Needs least often met included accommodations for standing (59.3%) or for difficulties with arm/shoulder positioning (57.1%), and wheelchair-accessible mammogram machines (59.1%). CONCLUSIONS: The screening compliance rate for women with CP is low, although the 2-year mammography rate is comparable to that reported for WWD and the general female U.S. POPULATION: Women were usually offered respectful care. Adequate physical accommodations during the procedure were reported less often than overall facility environmental accommodations. These findings demonstrate the need for improved screening rates in women with CP, and highlight areas for improving their screening experience.
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Neoplasias de la Mama/diagnóstico , Parálisis Cerebral/complicaciones , Personas con Discapacidad , Detección Precoz del Cáncer , Accesibilidad a los Servicios de Salud , Mamografía , Aceptación de la Atención de Salud , Adulto , Accesibilidad Arquitectónica , Neoplasias de la Mama/complicaciones , Estudios Transversales , Femenino , Necesidades y Demandas de Servicios de Salud , Humanos , Mamografía/estadística & datos numéricos , Tamizaje Masivo , Persona de Mediana Edad , Postura , Relaciones Profesional-Paciente , Estudios Prospectivos , Silla de RuedasRESUMEN
PURPOSES: There is a lack of substantial clinical evidence endorsing the clinical outcomes of osteotomy for peroneal tendon dislocations. The aim of this study was to compare the post-operative reoperation rates following osteotomy techniques and soft tissues procedures using large database in order to investigate the efficacy of bony techniques. METHODS: Patients who underwent osteotomy and soft tissue procedures for peroneal tendon dislocations were identified and subsequently analysed using the United Healthcare Orthopedic and the Medicare datasets (PearlDiver Patient Record Database, PearlDiver Technologies Inc., Fort Wayne, IN). The investigated period was from 2005 to 2012. The annual incidence, gender distribution, and incidences of reoperation and wound dehiscence following primary operative procedures were determined in these cohorts. RESULTS: Of 6122 patients who received operative treatment for peroneal tendon dislocations, 1416 patients (23.1%) received the osteotomy technique, while 4706 (76.9%) were treated with the soft tissue techniques. The incidence of these operative procedures did not change significantly over the time periods of each database. In both databases, reoperation rates were 2.8% (40/1416) for osteotomy patients and 3.4% (158/4706) for soft tissue repair patients, with no statistical difference (2.8 vs. 3.4%. odds ratio 0.8, 95% confidence interval [CI] 0.6-1.2, [n.s.]) between them. Based on both databases, wound dehiscence occurred in 2.6% (37/1416) of the osteotomy patients and 2.3% (110/4706) of soft tissue repair patients with no statistical difference (2.6 vs. 2.3%, odds ratio 1.1, 95% CI 0.8-1.6, [n.s.]) between the groups. CONCLUSION: The results of this study show that osteotomy techniques were frequently performed for patients with peroneal tendon dislocations. Nevertheless, osteotomy techniques for peroneal tendon dislocations are not associated with a lower risk of reoperation. In conclusion, soft tissue procedures offer a satisfactory method of treating peroneal tendon dislocations without any additional risk of reoperation when compared to osteotomy techniques that have potentially greater complication rates. LEVEL OF EVIDENCE: III.
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Traumatismos del Tobillo/cirugía , Luxaciones Articulares/cirugía , Osteotomía/métodos , Segunda Cirugía/métodos , Dehiscencia de la Herida Operatoria/epidemiología , Traumatismos de los Tendones/cirugía , Tendones/cirugía , Adulto , Traumatismos del Tobillo/complicaciones , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Reoperación , RoturaRESUMEN
Patients undergoing primary insertion of magnetically controlled growing rod (MCGR) compared to Vertical Expandable Prosthetic Titanium Rib (VEPTR) have higher overall complication and implant-related complications per procedure despite similar complication risk per patient. While there was a reduction in total repetitive surgeries in patients with MCGR implants, there was no significant difference in mean unplanned OR visits per patient between the groups.