Implant manufacturers develop new products to improve existing fracture fixation methods or to approach new fracture challenges. New implants are commonly tested and approved with respect to their corresponding predecessor products, because the knowledge about the internal forces and moments acting on implants in the human body is unclear. The aim of this study was to evaluate and validate implant internal forces and moments of a complex physiological loading case and translate this to a standard medical device approval test. A finite elements model for a transverse femur shaft fracture (AO/OTA type 32-B2) treated with a locked plate system (AxSOS 3 Ti Waisted Compression Plate Broad, Stryker, Kalamazoo, USA) was developed and experimentally validated. The fractured construct was physiologically loaded by resulting forces on the hip joint from previously measured in-vivo loading experiments (Bergmann et. al). The forces were reduced to a level where the material response in the construct remained linear elastic. Resulting forces, moments and stresses in the implant of the fractured model were analysed and compared to the manufacturers’ approval data. The FE-model accurately predicted the behaviour of the whole construct and the micro motion of the working length of the osteosynthesis. The resulting moment reaction in the working length was 24 Nm at a load of 400 N on the hip. The maximum principle strains on the locking plate were predicted well and did not exceed 1 %. In this study we presented a protocol by the example of locked plated femur shaft fracture to calculate and validate implant internal loading using finite element analysis of a complex loading. This might be a first step to move the basis of development of new implants from experience from previous products to calculation of mechanical behaviour of the implants and therefore, promote further optimization of the implants’ design

Femoral shaft fractures are fairly common injuries in paediatric age group. The treatment protocols are clear in patients of age less than 4 years and greater than 6 years. The real dilemma lies in the age group of 4–6 years. The aim of this study is to find whether a conservative line should be followed, or a more aggressive surgical intervention can provide significantly better results in these injuries. This study was conducted in a tertiary care hospital in Bhubaneswar, India from January 2020 to March 2021. A total of 40 patients with femur shaft fractures were included and randomly divided in two treatment groups. Group A were treated with a TENS nail while group B were treated with skin traction followed by spica cast. They were regularly followed up with clinical and radiological examination to look out for signs of healing and any complications. TENS was removed at 4–9 months’ time in all Group A patients. Group A patients had a statistically significant less hospital stay, immobilisation period, time to full weight bearing and radiological union. Rotational malunions were significantly lower in Group A (p-value 0.0379) while there was no statistically significant difference in angular malunion in coronal and sagittal plane at final follow up. Complications unique to group A were skin necrosis and infection. We conclude that TENS is better modality for treatment of shaft of femur fractures in patients of 4–6 years age as they significantly reduce the hospital stay, immobilization period and rotational malalignment

Background: Polytrauma patients with bilateral femur shaft fractures are known to have a higher rate of complications when compared with those who have sustained unilateral fractures. The current study tests the hypothesis that the high incidence of posttraumatic complications in patients who have no severe head or chest injury is caused by accompanying injuries rather than by the additional femur fracture. Methods: Prospective cohort study. Inclusion criteria: Injury severity score > 16 points; No AIS score value of the head or chest > 3 points. Two study groups: a unilateral (group USF) (n=146) and a bilateral femur shaft fracture (group BSF) (n=29). A further differentiation was made according to the patient’s status. All patients underwent early (< 24 hours after injury) fixation of their extremity fractures. Endpoints monitored were: Pneumonia, Acute lung injury (ALI), Systemic inflammatory response syndrome (SIRS), Sepsis. Statistics: Pearson chi-square test for binary indicators of injury severity, regression analyses regarding clinical complications. Results: Patients with bilateral femur fractures exhibited a longer ICU stay (p< 0.01), a higher incidence of pneumonia (p< 0.02) and SIRS (p=0.04) than those with unilateral fractures. Following corrective analyses for injury severity, no differences in blood transfusion rates, length of ICU stay, or complications was observed. Patients in borderline condition spend significantly more time in the ICU in comparison to those in stable condition. For analyses predicting presence of systemic inflammatory response syndrome, only the variable indicating receipt of a blood transfusion upon admission to the hospital emerged as a significant predictor. Bilateral fracture patients who were in uncertain condition preoperatively, developed significantly more complications postoperatively(p=0.02). Conclusions: Polytrauma patients with bilateral femur shaft fractures have a similar clinical course as those with unilateral fractures when no significant head or chest injury is present. An increased incidence of systemic inflammatory response syndrome was associated with three variables: presence of borderline condition, hemothorax and requirement of blood transfusion. This may have important treatment implications, including the management of major fractures

Patients with bilateral femur shaft fractures are known to have a higher rate of complications when compared with those who have unilateral fractures. Many contributing factors have been considered responsible, however due to the heterogeneity of the studied populations solid conclusions cannot be substantiated. Patients included in our study were separated according to the presence of a unilateral (group USF) (n=146) versus bilateral femur shaft fracture (group BSF) (n=19)Endpoints of the study included the incidence of systemic (SIRS, Sepsis, Acute Lung Injuries) complications. The perioperative assessment included documentation of clinical and laboratory data assessing blood loss, coagulopathy, wound infection, and pneumonia. Local (wound infection, compartment syndrome etc.) and systemic complications (ALI, MOF, Sepsis) were documented. Statistical analyses were conducted to examine the relation between the occurrence of unilateral versus bilateral femoral fractures and variables indexing patient demographic characteristics and other indicators of initial injury severity. Independent sample t-tests were used to examine treatment group differences for variables that approximated a Gaussian distribution. For non-normal indicators of injury severity Mann-Whitney tests were performed. Pearson chi-square tests were performed for binary indicators of injury severity, except when expected cell counts did not exceed 5 participants. When this occurred, the Fisher exact test was used Evidence indicated that patients who suffered a bilateral femoral fracture were significantly more likely to have hemothorax and receive a blood transfusion upon admission to the hospital in comparison to patients who suffered a unilateral femoral fracture. Bivariate analyses also indicated that patients with bilateral femoral fractures exhibited a longer clinical recovery time and were more likely to experience clinical complications in comparison to those with unilateral fractures. However, there were no significant differences between the fracture groups in terms of the number of hours spent on a ventilator or the occurrence of pneumonia, acute lung injury, acute respiratory distress, sepsis, and multiple organ failure following surgery. Patients in borderline condition spent significantly more time in the ICU in comparison to those in stable condition. The high incidence of posttraumatic complications in poly-trauma patients with bilateral femur shaft fractures is caused by the accompanying injuries rather than by the additional femur fracture itself. It also documents that a thorough preoperative assessment can help differentiate those who have a high like hood of developing systemic complications from those who do not

Objectives:. To measure compliance with the Trauma Unit guideline relating to the early application of the Thomas splint in patients with a femur shaft fracture on clinical examination. Design:. Retrospective review of clinical and radiological records of patients presenting from 01 January 2012 to 31 December 2012 at a Level 1 Trauma Unit. Patients:. We included all patients with femur shaft fractures independently of their mechanism of injury. Exclusion criteria were: ipsilateral fracture of the lower limb, neck and supracondylar fractures, pathological, periprosthetic and incomplete fractures. The database available for review included demographic information, mechanism of injury, side injured, surgical procedure and time when a radiological study (Lodox and/or x-ray) was performed. Outcome measures:. Primary outcome measure was the application of a Thomas splint before the first radiological examination was performed. Secondary outcome measure was the increase in patients immobilized with a Thomas splint before their second radiological examination was performed. Results:. We identified 160 fractures, 107 (66.9%) had a femur or pelvis x-ray as the first radiological exam. In 44 (41.1%) of these fractures, a Thomas splint had already been applied. Of the 160 fractures, 53 (33.1%) had a Lodox as first radiological examination. In 16 (30.2%) of these fractures, a Thomas splint had already been applied. The remaining 37 fractures where no Thomas splint was applied prior to the Lodox had been immobilized with either a different type of splint (backslab or Kramer wires) or not immobilized at all. Of these “incorrectly” immobilized or not immobilized fractures, 17 (45.9%) were then correctly immobilized with a Thomas splint prior to the x-ray (x-ray as second radiological exam). Conclusion:. Out of 160 fractures, 60 were immobilized with a Thomas splint prior to the first radiological examination, corresponding to a 37.5% compliance rate with internal guidelines

Background. Intramedullary nailing is a widely accepted treatment method for femoral fractures. Failure of locking screws is often a threatening complication, particularly on comminuted fractures. For comminuted fractures, the locking nails are load-bearing devices. The load transfer between fractured fragments is made through especially the locking screws for these load bearing situations. Nonunion, malunion, delayed union, shortening, and nail migration are the expected results if early failure of locking screws is present with comminuted fractures. In this study our aim was to compare the bending resistance of titanium and stainless steel locking screws. Methods. We tested 60 locking screws in six groups (titanium, stainless steel, unthreaded, low threaded and high threaded) in a steel tube that has 30 mm inner diameter, which imitates the lesser trochanter level. We determined the yield points at three-point bending tests that permanent deformation started in the locking screws using an axial compression testing machine. Results. The three-point bending resistance of 5 mm low threaded titanium locking screws (bending at 1413 N loading) was 46.5 % less than the three-point bending resistance of 5 mm low threaded stainless steel locking screws (bending at 2171 N loading) (p < 0.001). Five mm stainless steel locking screws are 29–57 % more resistant to three-point bending deformation than titanium ones. Conclusions. Therefore, stainless steel locking screws instead of titanium ones must be preferred in comminuted femur shaft fractures. In intramedullary nailing of comminuted or long oblique femur fractures, a locking screw should be 5 mm low threaded or unthreaded stainless steel or 5 mm unthreadedtitanium. Five mm high threaded titanium or stainless steel screws must not ever be used as a locking screw. Level of Evidence. 5. Disclosure. Authors declare that there is no conflict of interest related to the present study

Purpose of study. The addition of interlocking screws to intramedullary nails adds greatly to the stability of these constructs, yet the placement of distal screws accounts for a significant proportion of the total fluoroscopy and operative times. The Sureshot® (Smith and Nephew™) is a computerised system that allows placement of distal screws without fluoroscopy by using electromagnetic guided imagery. The purpose of this study is to compare traditional free-hand technique to the Sureshot® technique in terms of operating time, radiation dose and accuracy. Methods. Between September 2011 and March 2012 we prospectively randomised 66 consecutive patients presenting to us with femur shaft fractures requiring intramedullary nails to either free-hand (n=33) or Sureshot® assisted (n=28) distal locking. Fractures warranting only one distal locking screw, or those requiring retrograde or cephalo-medullary nailing, were excluded. Five patients' data was not suitable for analysis. The two groups were assessed for distal locking time, distal locking radiation and accuracy of distal locking. Results. The average total operative time was 51 minutes (range 25–88) for the free-hand group and 59 minutes (range 40–103) for the Sureshot® group. The average time for distal locking time was 10 minutes (range 4–16) with free-hand and 11 minutes (range 6–28) with Sureshot®. The average radiation dose for distal locking was 746.27 μGy (range 200–2310) for the free-hand group and 262.54 μGy (range 51–660) for the Sureshot® group. There were 2 misplaced drill bits in the free-hand group and 3 in the SureShot® group. Conclusion. SureShot® assisted distal locking reduces radiation exposure, but in a high-volume institution like ours it didn't reduce operative time or improve our accuracy. The benefits of this reduction in radiation still need to be quantified. The slightly higher number of misplaced drill bits and screws may represent our learning curve with SureShot®. NO DISCLOSURES

Femur shaft fractures (FSF) are markers of high energy transfer after injury. The comprehensive, population based epidemiology of FSF is unknown. The purpose of this prospective study was to describe the epidemiology of FSF with special focus on patient physiology and timing of surgery. A 12-month prospective population-based study was performed on consecutive FSF in a 600,000 population area including all ages and pre-hospital deaths. Patient demographics, mechanism, injury severity score (ISS), shock parameters (SBP, BD and Lactate), transfusion requirement, fracture type (AO), co-morbidities, performed procedure and outcomes were recorded. Patients were categorized: Stable, borderline, unstable and in extremis. A total of 125 patients (20.8/100,000/year) with 134 femur fractures. (62% male, age 37±28 years, ISS 20±19, 51% multiple injuries) were identified in two hospitals. 69 patients (55%) sustained a high energy injury (MVA, MBA, train related, high fall) with 16 (23%) of these being polytrauma patients (ISS 28±12, SBP 98±39, BD 6.5±5.8, Lactate 4±2), 15 (94%) required massive transfusion (12±12 URBC, 8±5 FFP, 1±0.4 PLT, 13±8 Cryo). Of the 125 patients 69% were stable (14.5/100,000/year), 9% borderline (1.8/100,000/year), 4% unstable (0.8/100,000/year) patients and 2% (0.3/100,000/year) were in extremis. 2 borderline, 1 unstable and 2 extremis patients died of severe CHI. One patient in extremis died due to uncontrollable hemorrhage from a pelvic fracture. 20 patients (16%) (3.3/100,000/year) with FSF were prehospital deaths and died due to the severity of their multiorgan injuries or CHI. The overall LOS was 18±15 days and the ICU LOS was 5±6 days. All high energy patients went to theatre within 6±13 hours. 56 patients (45%) sustained a low energy injury. Of these patients 85% had multiple co-morbidities. 8 patients needed 3±1 transfusions and none of the patients died. Time to surgery was 25±37 hrs and LOS was 15±11 days. There were 29 paediatric FSF, 20 of these were low and 9 high energy injuries. Only 3 patients required surgery. LE-FSF are as frequent as HE-FSF. 73% of the femur fractures are complicated (open, compromised physiology, multiple injured, bilateral, elderly with co-morbidities etc.) requiring major resources and highly specialized care

Purpose: Filling bone loss during revision total hip arthroplasty raises many problems related both to the surgical technique and to the type of bone substitute used. The purpose of this study was to report the clinical and radiographic results obtained in a series of femur reconstructions using impacted calcium phosphate ceramics. Material and methods: The technique used here was derived from the method developed for impacted fragmentary grafts by Ling and Gie. Grains of macroporous biphasic calcium phosphate ceramic (MBCP) were impacted into the femoral shaft to obtain a stable sheath into which the stem could be cemented (Ceraver Osteal). This technique was used from March 1996 to october 2000 in 18 patients (20 hips) undergoing revision for femoral loosening in 11 (including septic loosening in eight), femoral osteolysis (one hip), pain (one hip), and instability (one hip). Mean age ate revision was 66 years (range 30–79). Most of the femoral bone defects were classed grade IV. The grains of MBCP were used alone in 13 cases, in a mixture with allografts in five cases, and in a mixture with autologous bone in two cases. Results: Mean follow-up was 31 months (range 8–70). None of the patients were lost to follow-up. There were two intraoperative femur shaft fractures which healed without sequela. Two patients required a second revision for loosening (including one septic) 20 and 16 months after the first revision. At last follow-up, the mean PMA score had improved to 16 (12–18) (p< 0.05) and 67% of the patients achieved a good or excellent clinical result. Radiologically, there were 14 cases of good osteointegration of the MBCP grains without implant migration. Mean shortening was 3 mm (3–5) was observed in three cases and a stable incomplete lucent line was observed in one patient with no clinical impact. Discussion: Calcium phosphate ceramic material can be useful to overcome the problem of major bone loss in RTHA. It provides an attractive alternative to the disadvantages of bone grafting and helps, in theory, improve primary implant stability. The original technique presented here has allowed us to achieve promising short-term results in young patients with an adequate femur

Although there is strong evidence that bisphosphonates prevent certain types of osteoporotic fractures, there are concerns that they may be associated with rare atypical femoral fractures. 1480 patients of proximal femur and shaft fractures over a period of 2 years from Jan 2014 to Jan 2016 were retrospectively reviewed in Gloucestershire Hospitals NHS trust. Hospital trauma database was used.195 patients had fractures in subtrochancteric and femoral shaft area. 11 patients had atypical femur fractures as defined by American society for bone and mineral research (ASBMR) task force 2013, revised criteria. Ten were female, one was male. Patients were aged from 68 to 97. In 6 patients, fractures were in the shaft, 5 in subtrochancteric area and 4 patients out of these had bilateral fractures. 10 out of 11 patients were on bisphosphonates. 4 patients had delayed diagnosis. 5 out of 11 patients did not have contralateral femoral x-rays. Treatment, 9 patients had intramedullary nail, one blade plate, and one treated conservatively. One patient in the IM group, had bilateral nailing. Average follow up was 7.6 months (range 1 to 16 months). At the end of the study, only 4 had united, 6 had not united and one not followed up. 4 out of 7 had low Vitamin D levels, 3 out of 7 had their bisphosphonate treatment stopped and 2 had histology which showed necrotic bone with trabeculae surrounded by fibrosis. Increasing number of patients are on bisphosphonates for osteoporosis. Atypical femur fractures from bisphosphonates are often occult, often bilateral, with delayed healing. Patients on bisphosphonatetreatment should be advised to report any thigh or groin pain. Painful incomplete fractures need treatment with cephalomedullary nailing. Bone biology needs correcting by stopping bisphosphonatesand administering calcium & vitamin D supplements. Implications: We need to raise awareness amongst treating clinicians and have national guidelines