Injury

FDA regulatory considerations for innovative orthopedic devices: A review

Injury. 2025 Mar 22;56(4):112291. doi: 10.1016/j.injury.2025.112291. Online ahead of print.

ABSTRACT

Novel and innovative orthopedic devices are needed to address clinical challenges in orthopedic practice. Obtaining regulatory authorization for such devices, however, can prove challenging. An inherent dilemma exists between innovation to address unmet needs and imitation to demonstrate substantial equivalence to a predicate device, which is required for the less burdensome 510(k) pathway. This article provides both an overview of highly innovative orthopedic devices over the last 10 years as well as considerations for FDA regulatory pathways and programs available to manufacturers of such devices. A review of 20 innovative orthopedic devices receiving Breakthrough Device Designation and/or a De Novo classification found that devices had diverse features and applications, but did possess shared technological trends including bioresorption, flexible components, and new substance/material use. A review of all new orthopedic devices authorized through the three major regulatory pathways in the last 10 years was also conducted. Spinal devices represented the largest share of recent orthopedic devices (38 % of 510(k) clearances and 25 % of De Novo classifications). Across all three pathways, decision time was on average around 30 % shorter for orthopedic devices with a Breakthrough Device Designation versus those without, though differences were not significant. New orthopedic devices authorized in the last 10 years were found to be highly reliant on the 510(k) pathway, with a 99 % utilization rate. However, the FDA Breakthrough Devices Program and De Novo pathway offer opportunities specific to innovative technologies, such as expedited review and potential market competition protection, as demonstrated through specific case studies in this review. As these FDA initiatives continue to evolve and manufacturers continue to take advantage of these opportunities, orthopedic device development, which has primarily prioritized incremental innovation, may too evolve to produce more breakthrough innovations.

PMID:40157338 | DOI:10.1016/j.injury.2025.112291

Prediction of psychological continuing health problems based on types of injury and manner of accident in Mozambique: A population-based analysis of burns, fractures, internal injuries, and wound injuries

Injury. 2025 Mar 20;56(6):112274. doi: 10.1016/j.injury.2025.112274. Online ahead of print.

ABSTRACT

The long-term effects of injuries have significant implications for forensic practice. There is a dearth of research highlighting long-term psychological problems resulting from various injuries in under-researched populations like Mozambique. This study employed multiple logistic regression analyses on the 2022-2023 Mozambique Demographic and Health Survey (DHS) data to determine injury types predictive of emotional trauma, limb function loss, and chronic pain as continuing health problems. The data from the Accidents and Injury module was used for all participants. The injuries analyzed included broken bones, wounds, internal injuries, and burns. Additionally, we investigated the predictive capacity of unintentional and violent injuries on emotional trauma as a continuing health problem. The total number of injured people (whether due to traffic or non-traffic accidents) was 419. The proportion of unintentional injuries was much higher than violent injuries (86.4% vs 7.7%). Our results indicated that burn injuries were strongly associated with emotional trauma (Odds Ratio (OR) = 4.15, 95% CI: [1.24-13.84], P = 0.021), broken-bone injuries predicted both limb function loss (OR = 2.67, 95% CI: [1.17- 6.09], P = 0.02) and emotional trauma (OR = 3.73, 95% CI: [1.51-9.22], P = 0.005), internal injuries predicted chronic pain (OR = 2.52, 95% CI: [1.18-5.38], P = 0.018), and violent injuries predicted emotional trauma (OR = 4.41, 95% CI: [1.16-16.67], P = 0.03). These findings enhance comprehension of how injury types predict long-term psychological complications in Mozambique and provide valuable insights regarding the enduring consequences of various injuries in similar populations.

PMID:40157228 | DOI:10.1016/j.injury.2025.112274

Comparative evaluation and ranking of anterior surgical approaches for acetabular fractures: A systematic review and network meta-analysis

Injury. 2025 Mar 3;56(4):112241. doi: 10.1016/j.injury.2025.112241. Online ahead of print.

ABSTRACT

BACKGROUND: To compare the outcome of pararectus, ilioinguinal, and intrapelvic approaches in patients with acetabular fracture and to rank the best, second best, and third best surgical approach.

METHODS: A literature search was conducted in PubMed, Epistemonikos, and Embase up to 30 November 2024. A network meta-analyses was conducted to assess the outcomes of pararectus, ilioinguinal, and intrapelvic surgical approaches. Random-effects models with mean differences (MDs) and odds ratios (ORs) were calculated for continuous and binary variables, respectively, all with 95 % confidence intervals (CIs).

RESULTS: A total of 30 primary studies (2,348 patients) were included. There was no statistically significant difference between the pararectus and intrapelvic approach in overall complications (OR 0.86, 95 % CI 0.47 to 1.58). The pararectus approach had 0.51 lower odds for overall complications compared with the ilioinguinal approach (OR 0.51, 95 % CI 0.28 to 0.94). The intrapelvic approach had 0.59 lower odds for overall complications compared with the ilioinguinal approach (OR 0.59, 95 % CI 0.37 to 0.94). There was no statistically significant difference between the pararectus and intrapelvic approach in reduction quality (OR 1.32, 95 % CI 0.89 to 1.95). The pararectus approach had 2.02 higher odds for reduction quality compared with the ilioinguinal approach (OR 2.02, 95 % CI 1.30 to 3.15). The intrapelvic approach had 1.53 higher odds for reduction quality compared with the ilioinguinal approach (OR 1.53, 95 % CI 1.12 to 2.10). There was no statistically significant difference between the pararectus and intrapelvic approach in intraoperative blood loss (MD -31.38, 95 % CI -105.62 to 42.85). The pararectus approach had a 207.35 mL lower intraoperative blood loss compared with the ilioinguinal approach (MD -207.35, 95 % CI -288.52 to -126.18). The intrapelvic approach had a 175.97 mL lower intraoperative blood loss compared with the ilioinguinal approach (MD -175.97, 95 % CI -233.51 to -118.42).

CONCLUSION: This is the first study to rank the three anterior surgical approaches for acetabular fractures. The findings establish that while the pararectus and intrapelvic approaches are comparable, the ilioinguinal approach ranks third. The superior outcomes of the pararectus and intrapelvic approaches in complications, operative efficiency, and reduction quality highlight their importance in surgical practice.

PMID:40154238 | DOI:10.1016/j.injury.2025.112241

Time to union in ballistic trauma lower extremity diaphyseal fractures treated with intramedullary nailing

Injury. 2025 Mar 14;56(4):112268. doi: 10.1016/j.injury.2025.112268. Online ahead of print.

ABSTRACT

BACKGROUND: Time to union in civilian firearm injuries is variable and not well described in the literature. This study measures the time to union for femoral and tibial shaft fractures treated with an intramedullary nail (IMN). Time to union is compared across open, closed, or ballistic trauma (BT) fractures. The goal of the study is to answer the questions: (1) Do tibial shaft fractures heal in specific temporal patterns based on mechanism of injury and (2) Do these temporal healing patterns apply to both the tibia and femur?

PATIENTS AND METHODS: Included patients had tibial or femoral shaft fractures (OTA/AO 32 and 42) treated at an urban level 1 trauma center between 2015 and 2020 with IMN. Patients were eligible if radiographic imaging was available for any four of five follow-up timepoints, absence of preexisting hardware, and BT was from low velocity handgun injuries. Radiographic union scale (RUS) was compared amongst six groups (Open, Closed or BT for Femur and Tibia fractures), at 60-90 days, 91-180 days, 181- 270 days, and 271-365 days and greater than 365 days. Statistical comparison was performed using a two-way ANOVA and Tukey's multiple comparisons.

RESULTS: Included in the study were 114 patients, with 20 patients in each group except the OPEN femur fracture group with 14.

TIBIA: At the 91-180 day time point, CLOSED tibia RUS was significantly higher than for BT and OPEN tibia RUS. At 181-270 days, CLOSED tibia RUS was significantly higher than OPEN tibia. At 271-365 days and >365, CLOSED and BT RUS were significantly higher than OPEN RUS.Femur: At the 91-180 day time point, OPEN femur RUS was significantly lower than CLOSED and BT femur RUS. At later timepoints, all three groups achieved union with mean RUS>10.

DISCUSSION: This study demonstrates that healing of tibial shaft fractures from BT is not significantly different from closed fractures after 180 days post-operatively. Additionally, femoral shaft fractures from a BT healed similarly to closed and open fractures after 180 days post-operatively.

LEVEL OF EVIDENCE: Prognostic Level III.

PMID:40154237 | DOI:10.1016/j.injury.2025.112268

Artificial intelligence versus orthopedic surgeons as an orthopedic consultant in the emergency department

Injury. 2025 Mar 22;56(4):112297. doi: 10.1016/j.injury.2025.112297. Online ahead of print.

ABSTRACT

INTRODUCTION: ChatGPT, a widely accessible AI program, has demonstrated potential in various healthcare applications, including emergency department (ED) triage, differential diagnosis, and patient education. However, its potential in providing recommendations to emergency department providers with orthopedic consultations has not been evaluated yet.

METHODS: This study compared the performance of four board certified orthopedic surgeons, two attendings and two trauma fellows who take independent call at the same institution and ChatGPT-4 in responding to clinical scenarios commonly encountered in emergency departments. Five common orthopedic ED scenarios were developed (lateral malleolar ankle fractures, distal radius fractures, septic arthritis of the knee, shoulder dislocations, and Achilles tendon ruptures), each with four questions related to diagnosis, management, surgical indication, and patient counseling, totaling 20 questions. Responses were anonymized, coded, and evaluated by independent reviewers including emergency medicine physicians using a five-point Likert scale across five criteria: accuracy, completeness, helpfulness, specificity, and overall quality.

RESULTS: When comparing the ratings of AI answers to non-AI responders, the AI answers were shown to be superior in completeness, helpfulness, specificity, and overall quality with no difference in regards to accuracy (p < 0.05). When considering question subtypes including diagnosis, management, treatment, and patient counseling, AI was shown to have superior scores in helpfulness, and specificity in diagnostic questions(p < 0.05). In addition, AI responses were superior in all the assessed categories when looking at the patient counseling questions (p < 0.05). When considering different clinical scenarios, AI outperformed non-AI groups in completeness in the distal radius fracture scenario. Furthermore, AI outperformed non-AI groups in helpfulness in the lateral malleolus fracture scenario. In the shoulder dislocation scenario, AI responses were more complete, helpful, and had a better overall quality. AI responses were non-inferior in the remaining categories of the different scenarios.

CONCLUSION: Artificial intelligence exhibited non-inferior and often superior performance in common orthopedic-ED consultations compared to board certified orthopedic surgeons While current AI models are limited in their ability to integrate specific images and patient scenarios, our findings suggest AI can provide high quality recommendations for generic orthopedic consultations and with further development, will likely have an increasing role in the future.

PMID:40147063 | DOI:10.1016/j.injury.2025.112297

Trends and determinants of falls: A generalized estimating equations modelling approach using serial data from the geelong osteoporosis study

Injury. 2025 Mar 24;56(4):112298. doi: 10.1016/j.injury.2025.112298. Online ahead of print.

ABSTRACT

BACKGROUND: With Australia's aging population, the incidence of falls is expected to rise. The proportion of adults aged ≥65 years is projected to increase from 15 % in 2017 to 22 % by 2057, highlighting the growing need for effective fall prevention measures. Therefore, this study aimed to assess fall trends and determinants using repeated follow-up data from a population-based study.

METHODS: This study utilized data from the Geelong Osteoporosis Study (GOS) to analyse fall trends in men and women. Men's data were collected at baseline (2001-2006; n = 1533), 5 years (2006-2011; n = 968), and 15 years (2016-2021; n = 627), while women's data were from 6 years (2001-2003; n = 1014), 10 years (2004-2008; n = 1098), and 15 years (2011-2014; n = 844). Falls data, self-reported for the past 12 months, were age-standardised to the Australian population. Data included self-reported prior fractures, medications, comorbidities, alcohol use, and smoking, along with measured anthropometrics, muscle strength, biochemical tests, and imaging. A multivariable Generalised Estimating Equation model identified fall determinants, reporting adjusted odds ratios (AORs) and 95 % confidence intervals.

RESULTS: In men, the age-adjusted prevalence of falls declined over time, while in women, it initially dropped by 4.2 % before a slight 0.6 % increase. After adjusting for confounders, each additional year of age raised the fall risk by 1 % (AOR = 1.01, 95 % CI: 1.00-1.02). Women had a 52 % higher likelihood of falling than men (AOR = 1.52, 95 % CI: 1.22-1.88). Diabetes increased the risk by 69 % (AOR = 1.69, 95 % CI: 1.23-2.31), while a 1 N/kg increase in hip flexion strength lowered the risk by 3 % (AOR = 0.97, 95 % CI: 0.95-0.99).

CONCLUSION: Men experienced a steady decrease in fall prevalence over time, whereas women displayed a more intricate trend, with falls initially declining before subsequently rising, following a polynomial pattern. The key predictors of falls included age, sex, diabetes and hip flexion strength. Policies should prioritize tailored fall prevention, strength training, and diabetes care integration.

PMID:40139100 | DOI:10.1016/j.injury.2025.112298

Decrease in pediatric farm-related injuries presenting to United States emergency departments: A national study from 2014-2023

Injury. 2025 Mar 22;56(4):112299. doi: 10.1016/j.injury.2025.112299. Online ahead of print.

ABSTRACT

INTRODUCTION: Pediatric farm-related injuries, while less common than other pediatric injuries, are often more severe. Agricultural youth injuries can require costly treatment and have higher hospitalization rates, often resulting from industrial hazards, unsafe worksites, or agricultural recreational activities. Injuries in rural areas often necessitate travel to larger hospitals for specialized treatment, delaying care.

OBJECTIVE: This study aims to evaluate trends in farm-related injuries among youth presenting to emergency departments (EDs) in the United States (US).

METHODS: The National Electronic Injury Surveillance System (NEISS), a publicly available database representing approximately 100 US EDs, was queried for all injuries among individuals aged 0-18 occurring in farms (land, pasture, farm, barn, outbuildings). Queries were restricted to injuries from 2014 to 2023.

RESULTS: From 2014 to 2023, a total of 750 ED visits from farm-related injuries were identified, resulting in a national estimate (NE) of 33,664 cases. Injury rates decreased significantly across the study period (P=0.012). The most common diagnosis was fracture (NE 7337, 21.8 % of all injuries), with males accounting for 52.1 % and females for 47.9 %. In an age-specific analysis, 12-year-olds experienced more farm-related injuries than any other age group (NE 3185, 9.5 %), followed by 11-year-olds (NE 2769, 8.2 %), who also sustained the highest number of head injuries (NE 711, 13.2 % of all head injuries). The most commonly affected body part across ages was the head (NE 5384, 16 % of all injuries). The most common mechanism of injury was horseback riding (NE 10,691, 31.8 % of all injuries). The overall rate of hospitalization was 13.5 %.

CONCLUSION: The incidence of farm-related injuries in young people has decreased over time. Most injuries are caused by horseback riding, with a majority involving the head and relatively high hospitalization rates. 11-12-year-olds are the most affected, highlighting the importance of continued targeted prevention efforts. Although occupational hazards are a concern, this study demonstrates that younger patients are also frequently affected by farm injuries, emphasizing the need for increased focus on child access and safety in agricultural recreational activities.

PMID:40139099 | DOI:10.1016/j.injury.2025.112299

Post-traumatic pericarditis: A single center review: Post-Traumatic Pericarditis

Injury. 2025 Mar 18:112276. doi: 10.1016/j.injury.2025.112276. Online ahead of print.

ABSTRACT

BACKGROUND: Post-traumatic pericarditis is a rare and poorly studied entity that can have significant consequences on recovery and treatment after traumatic injury. Our objective was to identify the incidence, presentation, treatment, and complications of post-traumatic pericarditis at a level 1 trauma center.

METHODS: We performed a single institution retrospective review of patients with post-traumatic pericarditis admitted to our trauma center from January 2010 to December 2022. We reviewed all patients with a discharge diagnosis of pericarditis after an associated trauma, as well as trauma patients that were at high risk based on procedures performed including those having cardiothoracic procedures.

RESULTS: A total of 32 patients were identified with pericarditis out of 8,436 admitted patients with a chest AIS ≥1, giving an incidence of 0.38 % among those with thoracic injury. Penetrating and blunt mechanisms were evenly distributed. The majority had significant chest trauma on admission with a median chest-specific AIS of 3. Post-pericardiotomy pericarditis occurred in 8patients out of a total of 214 procedures that violated the pericardium for an incidence of 3.7 %. The majority (59.4 %) were treated with colchicine and 7 (20.5 %) patients required procedural intervention for significant effusions. Three (9.4 %) patients were found to have recurrent pericarditis.

CONCLUSION: Pericarditis is an uncommon sequela of traumatic injury but can have significant consequences and management varied widely among those diagnosed. Post-traumatic pericarditis is likely underrecognized, but a large prospective study would be necessary to further identify the true incidence and risk factors.

PMID:40128133 | DOI:10.1016/j.injury.2025.112276

Biomechanical study and preliminary application of percutaneous retrograde sacral alar-iliac screw for fixation of sacroiliac joint with low bone density

Injury. 2025 Mar 14;56(4):112267. doi: 10.1016/j.injury.2025.112267. Online ahead of print.

ABSTRACT

BACKGROUND: The Sacral alar-iliac screw (SAIS) has stronger stability for sacroiliac joint fixation compared to the classical sacroiliac screw, making it particularly suitable for osteoporotic patients. However, the spinous process can hinder its percutaneous implantation. To address this, we developed a percutaneous retrograde SAIS (RSAIS) technique. This study aimed to explore the stability and preliminary application effects of percutaneous RSAIS for fixation of sacroiliac joint with low bone density.

METHODS: A Tile type C fracture was simulated in fifteen artificial pelvises with low bone density and assigned to three groups. Each group received posterior fixation using one of the following: one sacroiliac screw (SIS) on each side, one transsacral-transiliac screw (TSTIS) on both sides, or one RSAIS on each side. Axial stiffness and maximum load to failure were analyzed. Additionally, two patients with sacroiliac joint pain (SIJP) and three patients with Tile type C pelvic fractures were treated with percutaneous RSAIS fixation. Four males and one female, aged 56 to 68 years with a T-value of -1.6 to -2.5 SD. The study observed screw insertion time, X-ray fluoroscopy time, screw position (Smith criterion), pain (VAS), and functional recovery (ODI and Majeed scores).

RESULTS: RSAIS stiffness and maximum load were significantly greater than those of TSTIS and SIS (p < 0.05). The average insertion time was 30 min, intraoperative bleeding averaged 16 ml, and fluoroscopy time was 55 s per RSAIS placement. There were no surgery-related complications, and all screw positions were excellent. At 7-20 months postoperative follow-up, the VAS score recovered from preoperative 5.6-1.6, the ODI improved from 50.4 to 17, and the Majeed score for patients with pelvic fractures recovered from 59.7 to 81. No screw loosening was observed.

CONCLUSION: RSAIS fixation stability for sacroiliac joints with low bone density is superior to SIS and TSTIS. The screw placement is simple, safe, and provides satisfactory therapeutic effects, making it suitable for patients with low bone density.

PMID:40127561 | DOI:10.1016/j.injury.2025.112267

Bone healing response to systemic bisphosphonate-prostaglandin E2 receptor 4 agonist treatment in female rats with a critical-size femoral segmental defect

Injury. 2025 Mar 14;56(4):112269. doi: 10.1016/j.injury.2025.112269. Online ahead of print.

ABSTRACT

Despite the wide body of research into prevention and treatment of nonunion, current bone fracture therapies remain suboptimal in their efficacy. Previous animal studies show that MES-1022, a bone-targeted prodrug that activates the prostaglandin E2 receptor EP4, stimulates bone healing when applied locally in uneventful defects. Here we investigated the healing capacity of systemically administered MES-1022 in a rat femoral critical size segmental defect. Ten-week-old female Sprague-Dawley rats (n = 8/group) underwent a 5 mm osteotomy of the left femoral midshaft, stabilized by a unilateral external fixator. Rats received weekly subcutaneous injections of MES-1022 at 5 mg/kg (MES1022-Hi), 1.7 mg/kg (MES1022-Lo), or Vehicle without a defect site scaffold. Serum bone markers and open field activity were measured pre-osteotomy and throughout the study. Rats were sacrificed after 12 weeks and osteotomized femora were imaged via microcomputed tomography (microCT) followed by histology and immunohistochemistry to assess healing. Complete bridging of the defect occurred in one rat from the MES1022-Hi group and zero from MES1022-Lo and Vehicle groups. However, healing outcomes in both MES-1022 groups for bone volume fraction, bone volume, bridging score, callus tissue composition, callus blood vessel density, P1NP levels, TRAcP-5b levels, and physical activity did not differ from Vehicle. Fracture callus osteoclast density and spleen weight were increased in MES1022-Hi rats relative to Vehicle. Overall, systemic administration of MES-1022 alone may not suffice for treatment of large segmental bone defects. Additional studies are needed to determine whether systemic MES-1022 is a useful therapeutic in conjunction with local scaffolds like bone graft substitutes.

PMID:40127560 | DOI:10.1016/j.injury.2025.112269

Removal of bent or broken tibial intramedullary nails: A systematic review of case studies

Injury. 2025 Mar 14;56(4):112261. doi: 10.1016/j.injury.2025.112261. Online ahead of print.

ABSTRACT

BACKGROUND: The bending or fracture of a tibial intramedullary nail is a rare complication with a paucity of literature regarding available methods of extraction. This systematic review discusses the currently described surgical techniques for extracting deformed tibial intramedullary nails as well any potential associated challenges.

METHODS: A review of the PubMed, EMBASE, and Scopus databases was conducted for articles describing the extraction of deformed tibial intramedullary nails according to the Preferred Reporting Items for Systematic Reviews guidelines. Study quality was assessed using the Joanna Briggs Institute Quality Appraisal tool.

RESULTS: 24 case reports were identified as describing the extraction of 27 deformed tibial intramedullary nails. The most common methods of removal were the use of hook extractors (29.6 %), standard extraction (14.8 %) and grasping of broken distal segments via forceps (11.1 %). Challenges included nails with small internal diameters, nail segment tilting during extraction, poor capture of the nail, and subsidence of the proximal segment of the nail. Factors to consider during preoperative planning include the type and material of IMN, degree and direction of IMN angulation, and access to instrumentation.

CONCLUSION: There are a few core methods of removing deformed intramedullary nails depending on the nature of the deformity, nail type, material, and diameter, and tools available to the surgeon. Regardless of technique, extraction of deformed tibial intramedullary nails is associated with satisfactory patient outcomes.

LEVEL OF EVIDENCE: Level IV, a systematic review of Level IV studies.

PMID:40127559 | DOI:10.1016/j.injury.2025.112261

Ocular injuries after the pagers explosion in Lebanon: A novel form of modern warfare

Injury. 2025 Mar 16:112273. doi: 10.1016/j.injury.2025.112273. Online ahead of print.

ABSTRACT

BACKGROUND: The incidence of ocular injuries in modern conflicts has significantly increased, particularly in explosive device-related incidents. This study aims to investigate and characterize the nature and outcomes of ocular injuries resulting from the September 2024 pagers explosions in Lebanon, which caused over 37 deaths and 3,000 injuries.

METHODS: This retrospective descriptive study analyzed 38 patients (76 eyes) with ocular injuries who presented to the Hôtel-Dieu de France hospital following the Pager explosion in Lebanon on September 17-18, 2024. Patients were identified from emergency department, OR, and ophthalmology clinic records. Data was collected from ED, OR, ophthalmology and imaging records.

RESULTS: Thirty-six patients (95 %) were male, and the mean age was 32.8 ± 9 years (SD), ranging from 5 to 52 years. Bilateral eye injuries were observed in 28 patients (74 %). One-third of the eyes had no light perception (NLP) at presentation. Five patients (13 %) had bilateral NLP vision on presentation. Open globe injuries were present in 42 (57 %) eyes and required immediate surgical reparation. Twenty-one percent of eyes presented expulsive injury and were eviscerated. Twenty-seven patients (36 %) had intraocular foreign bodies. Ocular surface injuries were present in 42 % of eyes. Thirty-six eyes (47 %) had superior and/or inferior lid lacerations requiring surgical repair. Twenty-four percent of eyes had an orbital wall fracture. Vitreous hemorrhage was reported in 20 eyes (26 %), while two eyes (3 %) had total hyphema. Cataract was identified in two eyes (3 %), and lens subluxation in four eyes (5 %). One eye had retrobulbar hematoma and required a lateral canthotomy. On the follow-up, four eyes developed endophthalmitis, while two eyes progressed to phtisis bulbi and were eviscerated. Five eyes developed cataract. Visual acuity remained unchanged in 60 % of eyes and deteriorated in 40 %.

CONCLUSION: This study highlights the severity of ophthalmic injuries in modern warfare, emphasizing the need for immediate surgical intervention to optimize patient outcomes.

PMID:40122732 | DOI:10.1016/j.injury.2025.112273

Biomechanical evaluation of novel 3D-printed magnesium alloy scaffolds for treating proximal humerus fractures with medial column instability

Injury. 2025 Mar 18;56(4):112266. doi: 10.1016/j.injury.2025.112266. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with complex proximal humerus fractures (PHFs) have a higher complication rate when treated with locking compression plate (LCP) alone. This increased complication rate may be due to humeral head collapse and insufficient medial column support in the proximal humerus. In response, we proposed the use of bionic porous 3D-printed magnesium alloy scaffolds (MAS) in combination with LCP for the treatment of PHFs. The aim of this study is to compare the biomechanical characteristics of the LCP alone versus LCP-MAS fixation constructs in treating PHFs with medial column instability.

METHODS: A three-dimensional model of a PHF with medial column instability was developed using computed tomography, and fixation was applied using LCP and LCP-MAS. Finite element analysis was employed to evaluate the biomechanical characteristics of these two fixation models, focusing on construct stiffness, von Mises stress distribution, and fracture displacements.

RESULTS: The construct stiffness of the LCP-MAS fixation construct was approximately 3.50 to 7.30 times greater than that of the LCP fixation construct under normal bone conditions, and 2.60 to 4.90 times greater under osteoporotic bone conditions. The LCP-MAS fixation reduced the maximum von Mises stress on the implants by at least 70 %-80 %. Furthermore, the LCP-MAS fixation significantly minimized fracture displacement compared to LCP alone.

CONCLUSIONS: The findings of this study suggest that the additional use of MAS can significantly enhance both the overall and local stability of PHFs. Thus, the LCP-MAS fixation approach presents a viable alternative for the treatment of PHFs.

PMID:40121861 | DOI:10.1016/j.injury.2025.112266

Fibula graft under compression for the optimization of the transtibial amputation stump

Injury. 2025 Mar 14;56(4):112264. doi: 10.1016/j.injury.2025.112264. Online ahead of print.

ABSTRACT

This study evaluates the effects of a modified bone bridge technique using a fibular graft with interfragmentary compression in transtibial amputation stumps, with the goal of reducing tibia-fibula mobility and enhancing terminal weight-bearing capacity and rehabilitation. Eleven patients, eight males and three females, underwent transtibial amputation using this technique. All grafts weresuccessfully integrated, with fragment union achieved within three months. No major stump complications were observed, although three patients required screw removal due to washer-related pain. Functionally, all patients underwent axial loading assessed by an examiner, with stump load tolerance being evaluated using a conventional scale. All patients tolerated axial loading without pain or discomfort, with an average maximum load-bearing capacity of approximately 50 % of body weight. This technique effectively creates a rigid bone bridge suitable for shorter residual limbs, facilitating prosthetic fitting and rehabilitation.

PMID:40121860 | DOI:10.1016/j.injury.2025.112264

Distal locking screw migration in the depuy-synthes retrograde femoral nail-advanced-an unexpected consequence of an implant upgrade

Injury. 2025 Mar 13;56(4):112265. doi: 10.1016/j.injury.2025.112265. Online ahead of print.

ABSTRACT

AIMS: The Retrograde Femoral Nailing Advanced (RFNA) system is a new generation of retrograde femoral nail (RFN) introduced to extend the range of distal fractures treated by intramedullary (IM) nailing. There is concern that the rate of distal interlock screw back-out may be higher for the RFNA. This study aims to highlight a higher-than-expected incidence of distal locking screw migration.

METHOD: Patient and implant data were prospectively collected from theatre and electronic patient records. The study focused on monitoring the migration of distal locking screws, treating each screw as an "at-risk" unit for analysis.

RESULTS: We report a high rate of distal locking screw migration in the Depuy-Synthes RFNA, with 16 (8.1 %) of screws migrating out of the 197 distal locking screws implanted. Per patient screw migration was seen in 11 (16.9 %) of the 65 patients studied. Oblique screws had a higher backing out rate of 13.7 % (10 out of 73) compared to the 4.8 % (6 out of 124) rate for transverse screws.

CONCLUSION: We found a higher-than-expected rate of screw migration in this new generation nail. The oblique screws were more often affected. We hypothesize that the screw orientation alongside the new polymer inlay contributes to this effect. The use of an end cap and the locking attachment washer (LAW) seems to reduce the rate of migration. The study highlights the importance of a local metalwork governance process in identifying unexpected adverse implant events. We recommend that early user centers prospectively monitor new trauma implants.

PMID:40121859 | DOI:10.1016/j.injury.2025.112265

Influence of pulseless electrical activity and asystole on the prognosis of patients with traumatic cardiac arrest: A retrospective cohort study

Injury. 2025 Mar 13:112262. doi: 10.1016/j.injury.2025.112262. Online ahead of print.

ABSTRACT

BACKGROUND: Traumatic cardiac arrest (TCA) is associated with poor prognosis. Recent advancements in resuscitation techniques have improved outcomes; however, the prognostic value of the initial cardiac rhythm in TCA remains unclear. Pulseless electrical activity (PEA) is often a sign of life, leading to ongoing resuscitation efforts; however, its effect on survival remains controversial. This study aimed to clarify the prognostic impact of PEA and asystole in patients with TCA to inform decision-making.

METHODS: This retrospective cohort study was conducted in a tertiary trauma center in Tainan, Taiwan, between 2016 and 2022 and enrolled patients with TCA transported by emergency medical services. Exclusion criteria included patients aged < 18 years with prehospital return of spontaneous circulation (ROSC) or specific trauma etiologies. Only non-shockable rhythms (PEA and asystole) were analyzed. Data on patient characteristics, trauma mechanisms, and resuscitation interventions were collected from electronic medical records. The primary outcome was ROSC at any time after reaching hospital, with secondary outcomes including sustained ROSC (ROSC for over 20 min), survival to admission, survival to discharge, and the cerebral performance category scale. Statistical analyzes were performed using the chi-square test and multivariate logistic regression. Statistical significance was defined as p < 0.05.

RESULTS: Of the 2,029 out-of-hospital cardiac arrest cases, 182 were TCA, and 46 were excluded based on various criteria. The final analysis included 136 patients divided into the PEA (n = 78, 57 %) and asystole (n = 58, 43 %) groups. No significant differences were observed in patient demographics, clinical characteristics, or resuscitative interventions between the groups. The PEA group had a significantly higher rate of ROSC (49 % vs. 26 %, p = 0.007), although survival to discharge remained low. Multivariable analysis revealed that PEA was the only factor significantly associated with ROSC (odds ratio: 2.87, p = 0.007).

CONCLUSION: In patients with TCA presenting with non-shockable rhythms, PEA was significantly associated with achieving ROSC, but not sustained ROSC or survival to admission. As a subset of patients in the PEA group survived until discharge, the existing guidelines for termination of resuscitation in TCA cases may require further evaluation.

PMID:40121170 | DOI:10.1016/j.injury.2025.112262

Understanding disparities in firearm mortality: The role of person- and place-based factors

Injury. 2025 Mar 18:112275. doi: 10.1016/j.injury.2025.112275. Online ahead of print.

ABSTRACT

BACKGROUND: Racial and socioeconomic disparities in firearm homicide rates are well-established in the United States. However, findings have been mixed regarding disparities for in-hospital mortality among firearm injury patients. The aim of this study was to evaluate the extent of in-hospital mortality disparities and whether differences persist after adjusting for person- and place-based factors.

METHODS: This retrospective analysis evaluated all pediatric and adult patients admitted to a single level I trauma center with a statewide catchment area from 2010 to 2020. Patients with assault-related firearm injuries were included; those with accidental or self-inflicted firearm injuries were excluded. The primary outcome was in-hospital mortality. Predictors included demographic (i.e., race, sex, age), socioeconomic (i.e., health insurance), injury (i.e., severity), and area-level (i.e., community distress, social vulnerability, rurality/urbanicity) characteristics.

RESULTS: The sample consisted of 2,081 patients with assault-related firearm injuries, including 1,836 Black patients (88 %) and 1,838 males (88 %). The mean age was 32.3 (SD=11.9) years. A smaller proportion of Black (19 %) compared to White (27 %) patients had health insurance coverage. Among injury patients, there were 210 firearm deaths (10 %). In logistic regression analyses adjusting for demographic, injury, and socioeconomic characteristics, both insured patients and those with unspecified insurance status had lower risk of mortality than uninsured patients; these differences in mortality risk remained after accounting for potential survivor bias. Contrary to expectation, there were no racial differences in mortality risk. In multilevel models accounting for nesting of patients within geographic areas (i.e., zip codes, counties), differences in mortality risk by insurance status remained after accounting for community distress, social vulnerability, and rurality/urbanicity. However, racial and area-level differences in mortality risk emerged after accounting for survivor bias.

CONCLUSIONS: The present findings are consistent with research showing lower in-hospital mortality among insured compared to uninsured trauma patients. Notably, this reduced mortality risk remained after controlling for important social determinants of trauma outcomes, and extended to patients with unspecified insurance status. Future research is needed to identify person- and place-based factors that could help to explain and mitigate differences in mortality risk based on insurance status.

PMID:40121169 | DOI:10.1016/j.injury.2025.112275

Surgical outcomes for Gartland type III supracondylar distal humerus fracture in children: Comparison between flexion and extension types

Injury. 2025 Mar 14;56(4):112263. doi: 10.1016/j.injury.2025.112263. Online ahead of print.

ABSTRACT

BACKGROUND: Supracondylar distal humeral (SCH) fractures account for 50-70 % of pediatric elbow fractures, which are divided into extension and flexion type based on the injury mechanism. However, there has been no study comparing the surgical outcome between two types of SCH fractures in terms of radiographic and clinical outcomes. This study aimed to compare the surgical outcomes between the flexion and extension types of Gartland type III SCH fractures in children.

MATERIALS AND METHODS: This retrospective study included the children who underwent surgery for Gartland type III SCH fractures. Radiographic and clinical outcomes were compared between patients who had extension- and flexion-type fractures. Radiographic outcomes were evaluated by measuring the Baumann angle (BA), carrying angle (CA), and lateral capitellohumeral angle (LCHA). Clinical outcomes were assessed using the Flynn criteria. Univariable and multivariable logistic regression analysis was used to assess the risk factors for angular deformities after surgery.

RESULTS: This study included 257 patients (mean age, 6.1 years, 37 flexion-type and 220 extension-type). Pin configuration was significantly different between the two groups (p = 0.001). There were significant differences in radiographic outcomes in terms of BA (p = 0.040) and LCHA (p = 0.001) between the two groups. Flexion-type fractures were a significant risk factor for sagittal deformity, with an odds ratio of 3.225 (p = 0.002). According to the Flynn criteria, a satisfactory outcome (excellent or good) was observed in 158 patients (84.1 %) with the extension type and 25 (67.6 %) with the flexion type, but not statistically significant (p = 0.058).

CONCLUSIONS: In this study, we found that flexion-type supracondylar fractures had poor radiographic outcomes after surgery compared to extension-type fractures although, there was no significant difference between groups in clinical outcomes. Flexion-type fractures were significantly associated with poor sagittal alignment. Clinicians should focus on alignment during surgery, particularly in flexion-type SCH fractures.

PMID:40120489 | DOI:10.1016/j.injury.2025.112263

Reexamining the need for antibiotic prophylaxis in pediatric upper extremity surgery

Injury. 2025 Mar 17;56(4):112271. doi: 10.1016/j.injury.2025.112271. Online ahead of print.

ABSTRACT

AIMS: The literature has recently questioned the routine use of prophylactic antibiotics in adults undergoing clean, upper extremities surgeries. Moreover, consensus remains elusive if antibiotic prophylaxis in upper extremity (UE) and hand pediatric procedures are necessary. Therefore, we aim to investigate whether antibiotic prophylaxis has no effect on reducing postoperative surgical site infection (SSI) rates in pediatric upper extremity (UE) procedures.

METHODS: A retrospective review of all pediatric patients undergoing clean UE surgery between November 2021 and November 2023 at a single institution was performed. Primary outcome measures were diagnosis of SSI by 14-days and 30-days. Secondary outcomes included the type of management employed to treat infection, including the use of antibiotics only, operative washout and hardware removal. Chi-square and Fisher's exact tests were performed for categorical variables, and Wilcoxon rank-sum tests were performed for continuous variables. A p-value of < 0.05 for all analyses was considered statistically significant.

RESULTS: 396 patients (150 female and 246 male) were included for analysis- 217 received preoperative antibiotics and 179 did not. Among those who received preoperative antibiotics, only two patients were diagnosed with an SSI, with an infection rate of 0.9 %. Similarly, in those who did not receive preoperative antibiotics, two patients were diagnosed with an SSI, with an infection rate of 1.1 %. Infection rates were not statistically different (p = 0.846). The odds ratio (OR) of having an SSI when not receiving preoperative antibiotics is 1.21 (95 % CI: 0.16 - 8.71).

CONCLUSION: The study challenges the historical dogma of the necessity of preoperative antibiotics in pediatric upper extremity surgeries. The findings suggest that there is no statistical difference in postoperative SSI rates whether antibiotic prophylaxis is administered. To reassess the necessity of preoperative antibiotics in upper extremity cases, further randomized controlled studies with larger patient populations should be advocated for.

PMID:40120488 | DOI:10.1016/j.injury.2025.112271

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