Dataset Information

Biomechanical Performance of BoneHelix® Compared with Elastic Stable Intramedullary Nailing (ESIN) in a Pediatric Tibia Fracture Model.

ABSTRACT: Tibial shaft fractures are common injuries in the pediatric and adolescent populations. Elastic stable intramedullary nailing (ESIN) is the treatment of choice for cases that require surgical stabilization. A new intramedullary device, BoneHelix® (BH), may be an alternative for use with fractures that cannot be satisfactorily stabilized with ESIN. This study aimed to assess the biomechanical performance of BH compared with ESIN in a porcine tibia fracture model, observing cyclic fatigue and load to failure. Computed tomography was used to monitor the implant position and to rule out unintended damage. No implant or bone failure occurred during the fatigue testing. An increase in the cumulative plastic displacement was observed in both test groups over the loading cycles applied. Both implant-bone constructs displayed a trend toward closure of the osteotomy gap. During the load-to-failure test, the average loads at failure in specimens instrumented with ESIN and BH were 5364 N (±723) and 4350 N (±893), respectively, which were not statistically significant (p = 0.11). The values of both groups were two to three times higher than the estimated maximal load (2000 N) during physiological weight bearing. The biomechanical results thus indicate equivalent performance and stability by the implants tested.

SUBMITTER: Brandes LL

PROVIDER: S-EPMC8622329 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Biomechanical Performance of BoneHelix<sup>®</sup> Compared with Elastic Stable Intramedullary Nailing (ESIN) in a Pediatric Tibia Fracture Model.

Brandes Laura Leonie LL Nicolini Luis Fernando LF Greven Johannes J Lichte Philipp P Stopinski Thomas Thaddäus TT Sattler Martin M Hildebrand Frank F Pishnamaz Miguel M

Life (Basel, Switzerland) 20211105 11

Tibial shaft fractures are common injuries in the pediatric and adolescent populations. Elastic stable intramedullary nailing (ESIN) is the treatment of choice for cases that require surgical stabilization. A new intramedullary device, BoneHelix<sup>®</sup> (BH), may be an alternative for use with fractures that cannot be satisfactorily stabilized with ESIN. This study aimed to assess the biomechanical performance of BH compared with ESIN in a porcine tibia fracture model, observing cyclic fatig ...[more]

PMID: 34833065

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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.

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.

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.

Project description:BackgroundExternal fixators (EFs) and intramedullary nailing (IMN) are two effective methods for open tibial fractures. However, both methods have advantages and disadvantages, and the optimal surgical approach remains controversial. Thus, we performed a meta-analysis of randomized controlled trials (RCTs) to compare EF with IMN to evaluate their efficacy and safety.MethodsA systematic study of the literature was conducted in relevant studies published in PubMed, Embase, the Cochrane Library, Web of Science, CNKI, CBM, Wanfang and Weipu from database inception to April 2022. All eligible literature was critically appraised for methodological quality via the Cochrane's collaboration tool. The primary outcome measurements included postoperative superficial infection, postoperative deep infection, union time, delayed union, malunion, nonunion, and hardware failure.ResultsNine RCTs involving 733 cases were included in the current meta-analysis. The pooled results suggested that cases in the IMN group had a significantly lower postoperative superficial infection rate [risk ratio (RR) = 2.84; 95% confidence interval (CI) = 1.83 to 4.39; P < 0.00001)] and malunion rate (RR = 3.05; 95% CI = 2.06 to 4.52; P < 0.00001) versus EF, but IMN had a significantly higher hardware failure occurrence versus EF (RR = 0.38; 95% CI = 0.17 to 0.83; P = 0.02). There were no significant differences in the postoperative deep infection rate, union time, delayed union rate or nonunion rate between the two groups (p > 0.05).ConclusionsCompared to EF, IMN had a significantly lower risk of postoperative superficial infection and malunion in patients with open tibial fractures. Meanwhile, IMN did not prolong the union time and increased the risk of the deep infection rate, delayed union rate and nonunion rate but had a higher hardware failure rate. The reanalysis of union time showed that it was significantly shorter in the IMN group than in the EF group after excluding the study with significant heterogeneity during sensitivity analysis. Therefore, IMN is recommended as a preferred method of fracture fixation for patients with open tibial fractures, but more attention should be given to the problem of hardware failure.

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.

Dataset Information

Biomechanical Performance of BoneHelix® Compared with Elastic Stable Intramedullary Nailing (ESIN) in a Pediatric Tibia Fracture Model.

Publications

Biomechanical Performance of BoneHelix<sup>®</sup> Compared with Elastic Stable Intramedullary Nailing (ESIN) in a Pediatric Tibia Fracture Model.

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