Biomechanical Performance of BoneHelix® Compared with Elastic Stable Intramedullary Nailing (ESIN) in a Pediatric Tibia Fracture Model.
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SUBMITTER: Brandes LL
PROVIDER: S-EPMC8622329 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, high complication rates (10-50%) are reported in complex fractures. This biomechanical study compares the stiffness with a 3rd nail implanted to that in the classical 2C-shaped configuration and presents the application into clinical practice.For each of the 3 configurations of ESIN-osteosynthesis with titanium nails eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2C-shaped nails, 2 × 3.5 mm), 3CM configuration (3rd nail from medial) and 3CL configuration (3rd nail from lateral). Each group underwent biomechanical testing in 4-point bending, internal/external rotation and axial compression.2C and 3CM configurations showed no significant differences in this spiroid type fracture model. 3CL had a significantly higher stiffness during anterior-posterior bending, internal rotation and 9° compression than 2C, and was stiffer in the lateral-medial direction than 3CM. The 3CL was less stable during p-a bending and external rotation than both the others. As biomechanical testing showed a higher stability for the 3CL configuration in two (a-p corresponding to recurvation and 9° compression to shortening) of three directions associated with the most important clinical problems, we added a 3rd nail in ESIN-osteosynthesis for femoral fractures. 11 boys and 6 girls (2.5-15 years) were treated with modified ESIN of whom 12 were '3CL'; due to the individual character of the fractures 4 patients were treated with '3CM' (third nail from medial) and as an exception 1 adolescent with 4 nails and one boy with plate osteosynthesis. No additional stabilizations or re-operations were necessary. All patients achieved full points in the Harris-Score at follow-up; no limb length discrepancy occurred.The 3CL configuration provided a significantly higher stiffness than 2C and 3CM configurations in this biomechanical model. These results were successfully transmitted into clinical practice. All children, treated by 3CL or 3CM according to the individual character of each fracture, needed no additional stabilization and had no Re-Do operations. As a consequence, at our hospital all children with femoral diaphyseal fractures with open physis are treated with this modified ESIN-technique.
| S-EPMC4029588 | biostudies-literature
Project description:Elastic stable intramedullary nailing (ESIN) has been established as state of the art treatment for forearm fractures in children, if operative stabilization is required. Their use has been expanded to single bone shaft fractures, and also more complex injuries such as Monteggia fractures or Monteggia-like lesions. A wide range of complications has been reported in the literature, up to 70% in certain investigations. The purpose of this study was to assess the complication rate after ESIN treatment of forearm fractures in children and adolescents in a representative cohort of patients from a level 1 trauma center in Germany.Between 2000 and 2015, we retrospectively analyzed all patients, up to the age of 16 years, with forearm fractures, who were operatively treated using ESIN in our department of general and trauma surgery. The main outcome measurements were the rates of postoperative complications after ESIN such as re-fracture, malunion, nonunion, tendon lesion, wound infection, and limited range of motion.In all, 201 consecutive patients with 202 forearm fractures were included in this study. Age averaged 9.7 years (range 3-16 years). Fifteen (7.4%) fractures were open. Fractures were 82.2% diaphyseal both-bone forearm fractures. Follow-up averaged 10.2 months (range 0.7-176.3 months). Complications were 10 re-fractures, 2 malunions, 3 extensor pollicis longus tendon ruptures, 1 superficial wound infection, and 2 limited range of motions. Fourteen (6.9%) children required a secondary operative intervention for their complication. Time to implant removal averaged 3.8 months (range 0.4-16.3 months).Elastic stable intramedullary nailing is a minimally invasive and reliable technique with a low complication rate. Both-bone forearm fractures and single bone fractures, and also Monteggia and Monteggia-equivalent fractures can be successfully treated with this method. As a major complication, re-fractures are frequently seen, even with ESIN in situ.
| S-EPMC5406092 | biostudies-literature
Project description: Not available
| S-EPMC10549693 | biostudies-literature
Project description:OBJECTIVE:To study the activity and incidence of knee pain after sustaining an isolated tibia fracture treated with an infrapatellar intramedullary nail at 1 year. DESIGN:Retrospective review of prospective cohort. SETTING:Multicenter Academic and Community hospitals. PATIENTS:Four hundred thirty-seven patients with an isolated tibia fracture completed a 12-month assessment on pain and self-reported activity. INTERVENTION:Infrapatellar intramedullary nail. OUTCOMES:Demographic information, comorbid conditions, injury characteristics, and surgical technique were recorded. Knee pain was defined on a 1-7 scale with 1 being "no pain" and 7 being a "very great deal of pain." Knee pain >4 was considered clinically significant. Patients reported if they were "able," "able with difficulty," or "unable" to perform the following activities: kneel, run, climb stairs, and walk prolonged. Variables were tested in multilevel multivariable regression analyses. RESULTS:In knee pain, 11% of patients reported a "good deal" to a "very great deal" of pain (>4), and 52% of patients reported "no" or "very little" pain at 12 months. In activity at 12 months, 26% and 29% of patients were unable to kneel or run, respectively, and 31% and 35% of patients, respectively, stated they were able with difficulty or unable to use stairs or walk. CONCLUSIONS:Clinically significant knee pain (>4/7) was present in 11% of patients 1 year after a tibia fracture. Of note, 31%-71% of patients had difficulty performing or were unable to perform routine daily activities of kneeling, running, and stair climbing, or walking prolonged distances. LEVEL OF EVIDENCE:Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
| S-EPMC4761290 | biostudies-literature
Project description:BackgroundPrediction of negative postoperative outcomes after long-bone fracture treatment may help to optimize patient care. We recently completed the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT), a large, multicenter trial of reamed and unreamed intramedullary nailing of tibial shaft fractures in 1226 patients. Using the SPRINT data, we conducted an investigation of baseline and surgical factors to determine any associations with an increased risk of adverse events within one year of intramedullary nailing.MethodsUsing multivariable logistic regression analysis, we investigated fifteen baseline and surgical factors for any associations with an increased risk of negative outcomes.ResultsThere was an increased risk of negative events in patients with a high-energy mechanism of injury (odds ratio [OR] = 1.57; 95% confidence interval [CI], 1.05 to 2.35), a stainless steel compared with a titanium nail (OR = 1.52; 95% CI, 1.10 to 2.13), a fracture gap (OR = 2.40; 95% CI, 1.47 to 3.94), and full weight-bearing status after surgery (OR = 1.63; 95% CI, 1.00 to 2.64). There was no increased risk with the use of nonsteroidal anti-inflammatory agents, late or early time to surgery, or smoking status. Open fractures had a higher risk of events among patients treated with reamed nailing (OR = 3.26; 95% CI, 2.01 to 5.28) but not in patients treated with unreamed nailing (OR = 1.50; 95% CI, 0.92 to 2.47). Patients with open fractures who had wound management either without any additional procedures or with delayed primary closure had a decreased risk of events compared with patients who required subsequent, more complex reconstruction (OR = 0.18 [95% CI, 0.09 to 0.35] and 0.29 [95% CI, 0.14 to 0.62], respectively).ConclusionsWe identified several baseline fracture and surgical characteristics that may increase the risk of adverse events in patients with tibial shaft fractures. Surgeons should consider the predictors identified in our analysis to inform patients treated for tibial shaft fractures.Level of evidencePrognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
| S-EPMC3448300 | biostudies-literature
Project description:ObjectivesThis review evaluates the safety and efficacy of submuscular plating (SMP) vs. elastic stable intramedullary nailing (ESIN) in the treatment of pediatric femur shaft fracture.MethodStudies comparing the efficacy and safety of SMP and ESIN in pediatric shaft fracture were retrieved from five databases (PubMed, Embase, Cochrane, OVID, and Web of Science) from inception to March 2023 using a systematic literature search strategy. A total of 13 outcome measures, such as perioperative parameters, clinical outcomes, and radiographic results, were included in the meta-analysis.ResultsEight eligible studies involving 491 patients were included in the narrative synthesis. There were no significant differences in baseline characteristics between the two groups. Meta-analysis showed reduced radiation time (RT), soft tissue irritation and angular deformation in the SMP group than in the ESIN group. However, the SMP group had greater estimated blood loss (EBL) than the ESIN group. The duration of surgery, length of hospital stay (LOS), implant removal, complications requiring surgery, Flynn score, incidence of infection, fracture healing time, and limb length discrepancy (LLD) were similar between the two groups. Only one study reported higher incidences of fracture nonunion or delayed healing in the ESIN group.ConclusionSMP is an effective and safe intervention superior to ESIN in reducing soft tissue irritation, angular deformation and radiation time. Given the presence of potential bias and heterogeneity, surgeons should select the treatment that would provide the best outcomes for EBL, LOS, operation time, and bone nonunion or delayed healing based on their experience.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023404118, Identifier PROSPERO (CRD42021228512).
| S-EPMC10663353 | biostudies-literature
Project description:IntroductionExtra-articular proximal tibia fractures make up to one-tenth of all tibia shaft fractures. Treatment options include conservative, nailing, plating and external fixation. There is no consensus on which method is superior if the patient is to be managed surgically.Materials and methodsWe conducted a systematic review and meta-analysis to know which definitive surgical treatment option (nailing or plating) is better for extra-articular proximal tibia fracture. We used search engines like PubMed, Embase, Scopus, Ovid Medline and Google Scholar to find articles comparing the results of nailing versus plating. We could identify only 4 articles regarding this and data was extracted and meta-analysis was done.ResultsDelayed union was common in the nailing group with odds ratio of 8.29 favoring the plating group (95% CI 1.77, 38.80, p = 0.007) while malunion showed no difference in both groups. Rate of infection was higher in the plating group while anterior knee pain was common in the nailing group with odds ratio of 5.54 favoring the plating group (95% CI 1.49, 13.88, p = 0.008). Range of motion showed no difference between both groups, fractures in the nailing group united early and the difference was significant (p = 0.005, odds ratio - 4.48) (95% CI - 8.29, - 1.47).The surgical duration was less in the nailing group but was not significant.ConclusionConsidering lesser time for union, early weight bearing, lower chances of infection and lesser surgical duration, nailing seems to be more promising for extra articular proximal tibia fractures. Further research is required on this topic to provide a definitive evidence.
| S-EPMC8081780 | biostudies-literature
Project description:This study aims to describe the complications of elastic stable intramedullary nailing (ESIN) in the treatment of both-bone forearm diaphyseal fractures in the child. Between January 2009 and December 2013, 87 children with both-bone forearm diaphyseal fractures were treated by elastic stable intramedullary nailing with Métaizeau nails. 76 boys and 11 girls, with an average age of 12 years, were enrolled in the study. Nailing was promptly performed in 50 cases and after secondary displacement during plaster-cast treatment in the other cases. Both bones were nailed in all cases. All patients underwent systematic plaster immobilization for a period of about one month. On average, nails were removed after about 6 months. Functional outcomes were studied over a mean follow-up period of 10 months. Complications were marked by 14 superficial infections (14 cases), osteitis associated with material (2 cases), refracture (3 cases), pseudarthrosis (3 cases), delayed fracture consolidation (2 cases) and proximal radioulnar synostosis (1 case). Although intramedullary nailing ideally is an osteosynthesis technique suitable for the treatment of fractures in children, it is more invasive than orthopaedic treatment.Indications for treatment should remain within well-established limits.
| S-EPMC5554682 | biostudies-other
Project description:ObjectivesDetermine the impact of infections on direct costs and healthcare resource use in England for patients undergoing intramedullary nailing (IMN) for tibial shaft fractures.DesignNon-concurrent cohort based on retrospectively collected data with 2-year follow-up.SettingEngland.ParticipantsThe study population included adult patients (≥18 years) in England with a diagnosis of tibial shaft fracture (International Classification of Diseases-10, S822) in the inpatient setting between May 2003 and June 2017 followed by a procedure for IMN for tibial shaft fracture within 30 days. Patient data were derived from the Clinical Practice Research Datalink linked to National Health Service Hospital Episode Statistics datasets.Primary independent variableInfection.Primary and secondary outcome measuresThe primary outcome was total inpatient costs from index stay admission through 1 year of follow-up. Secondary outcome included cumulative total healthcare costs, and resource utilisation at 30 days, 90 days, 1 year and 2 years.ResultsOverall, 805 patients met the inclusion criteria. At index inpatient stay, 3.7% had a post-IMN infection, rising to 11.7% at 1 year. One-year inpatient costs were 80% higher for patients with infection (p<0.001). Total costs were estimated to be £14 756 (95% CI £13 123 to £16 593) for patients with infection versus £8279 (95% CI £7946 to £8626). Length of stay (LOS), readmission and reoperation were the key drivers of healthcare costs (all p<0.001). After adjustment, LOS was higher by 109% (95% CI 62% to 169%), from 10.5 days to 21.9 days, for patients with infection. The odds of being readmitted or requiring reoperation were higher by 5.18 times (95% CI 3.01 to 9.13) and 2.47 times (95% CI 1.48 to 4.09), respectively, for patients with infection versus those without infection.ConclusionsPost-IMN infection significantly increases inpatient costs, LOS, readmissions and reoperations associated with tibial fracture fixation. Healthcare burden could be reduced through novel surgical site infection prevention strategies.
| S-EPMC7451536 | biostudies-literature
Project description:ImportanceFractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence.ObjectiveTo compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS.Design, setting, and participantsThis randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022.InterventionsSurgical fixation with a Gamma3 IMN or an SHS.Main outcomes and measuresThe primary outcome was health-related quality of life (HRQOL), measured by the EuroQol-5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score).ResultsIn this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, -0.03 to 0.07 points; P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, -0.04 to 0.05; P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (β [SE] , 0.01 [0.05]; P = .82) or previous fracture (β [SE], 0.01 [0.10]; P = .88) and treatment group.Conclusions and relevanceThis randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip.Trial registrationClinicalTrials.gov Identifier: NCT01380444.
| S-EPMC10245197 | biostudies-literature