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Background There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo ® / Forsteo ® , recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing. Questions/purposes We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety. Methods We initiated two separate, but identically designed, clinical trials to meet FDA requirements to provide substantial evidence to support approval of a new indication. The two prospective, randomized double-blind, placebo-controlled Phase III studies were designed to evaluate the effect of subcutaneous teriparatide (20 μg/day) for 6 months versus placebo on fracture healing at 24 months. The trials were conducted concurrently with a planned enrollment of 1220 patients per trial. However, enrollment was stopped owing to very slow patient accrual, and an a priori decision was made to pool the results of those studies for statistical analyses before study completion; pooling was specified in both protocols. Randomization was stratified by fixation (sliding hip screw or multiple cancellous screws) and fracture type (displaced or nondisplaced). An independent Central Adjudication Committee reviewed revision surgical procedures and radiographs. A total of 159 patients were randomized in the two trials (81 placebo, 78 teriparatide). The combined program had very low power to detect the originally expected treatment effect but had approximately 80% power to detect a larger difference of 12% between treatment groups for risk of revision surgery. Results The proportion of patients undergoing revision surgery at 12 months was 14% (11 of 81) in the placebo group versus 17% (13 of 78) in the teriparatide group. Central Adjudication Committee review excluded two of these patients treated with placebo from the primary analysis. After exclusions, the proportion of patients who did not undergo revision surgery at 12 months (primary endpoint) was not different between the study and placebo groups, at 88% in the placebo group (90% CI, 0.79–0.93) versus 84% in the teriparatide group (90% CI, 0.75–0.90; p = 0.743). There also were no differences between groups in the proportion of patients achieving radiographic fracture healing at 12 months (75% [61 of 81] placebo versus 73% [57 of 78] teriparatide; odds ratio, 0.89; 90% CI, 0.46–1.72; p = 0.692) or in measures of pain control (such as pain during ambulation, 92% [55 of 62] placebo versus 91% [52 of 57] teriparatide; odds ratio, 0.91; 90% CI, 0.25–3.37; p = 0.681). The frequency of patients reporting adverse events was 49% [40 of 81] in the placebo group versus 45% [35 of 78] in the teriparatide group (p = 0.634) during the 6-month treatment period. Conclusions The small sample size limited this study’s power to detect potential differences, and the results are exploratory. With the patients available, teriparatide did not decrease the risk of revision surgery, improve radiographic signs of fracture healing, or decrease pain compared with the placebo. The adverse event data observed were consistent with the teriparatide safety profile. Functional and health outcome data from the studies may help improve our understanding of patients recovering from femoral neck fractures. Further large controlled studies are required to determine the effect of teriparatide on fracture healing. Level of Evidence Level II, prospective study.

Associated ipsilateral femoral neck fractures have been reported to occur in 1% to 9% of femoral shaft fractures. The associated femoral neck fracture is often nondisplaced, and the diagnosis is delayed or missed in up to one-third of cases. It is essential to carefully evaluate the femoral neck in all patients sustaining high-energy femoral shaft fractures. Although there are a number of different implant options available for management of this challenging injury, most authors recommend that priority be given to anatomic reduction and optimal stabilization of the femoral neck fracture because nonunion, malunion, or avascular necrosis of this injury is more difficult to successfully treat. [Associated ipsilateral femoral neck fractures have been reported to occur in 1% to 9% of femoral shaft fractures. The associated femoral neck fracture is often nondisplaced, and the diagnosis is delayed or missed in up to one-third of cases. It is essential to carefully evaluate the femoral neck in all patients sustaining high-energy femoral shaft fractures. Although there are a number of different implant options available for management of this challenging injury, most authors recommend that priority be given to anatomic reduction and optimal stabilization of the femoral neck fracture because nonunion, malunion, or avascular necrosis of this injury is more difficult to successfully treat. [ Orthopedics. 2015; 38(4):247–251.]

Purpose. To compare the outcome in patients who underwent surgery for unstable intertrochanteric femoral fractures using the proximal femoral locking plate versus the dynamic hip screw (DHS). Methods. 15 men and 5 women aged 32 to 78 (mean, 55) years were randomised to the proximal femoral locking plate group, whereas 14 men and 6 women aged 38 to 75 (mean, 59) years were randomised to the conventional 135° DHS group. The time to union, medialisation of the shaft, neck-shaft angle, limb shortening, varus collapse, and functional outcome (using the Hospital for Special Surgery Hip Rating System) were assessed. Results. Respectively in the locking plate and DHS groups, the mean times to union were 14.6 and 16.5 weeks (p=0.067) and the mean limb shortenings were 0.3 and 1.4 cm (p<0.001). Medialisation of the shaft occurred in 0 and 15 patients (p<0.0001); varus collapse occurred in 2 and 5 patients (p=0.408); the functional hip score was good-to-excellent in 18 and 11 patients (p=0.031); deep wound infection occurred in 3 and 2 patients; and implant cut-out occurred in one patient each group. Conclusion. A non-collapsing locking plate achieved bone union in unstable intertrochanteric fractures with lower risks of limb shortening and medialisation of the shaft.

Background The poor outcome after a hip fracture is not fully understood. The aim of the study was to describe the prevalence of co-morbidities, complications and causes of death and to investigate factors that are able to predict mortality in old people with femoral neck fracture. Methods Data was obtained from a randomized, controlled trial with a 3-year follow-up at Umeå University Hospital, Sweden, which included 199 consecutive patients with femoral neck fracture, aged ≥70 years. The participants were assessed during hospitalization and in their homes 4, 12 and 36 months after surgery. Medical records and death certificates were analysed. Results Multivariate analysis revealed that cancer, dependence in P-ADL (Personal Activities of Daily Living), cardiovascular disease, dementia at baseline or pulmonary emboli or cardiac failure during hospitalization were all independent predictors of 3-year mortality. Seventy-nine out of 199 participants (40 %) died within 3 years. Cardiovascular events (24 %), dementia (23 %), hip-fracture (19 %) and cancer (13 %) were the most common primary causes of death. In total, 136 participants suffered at least one urinary tract infection; 114 suffered 542 falls and 37 sustained 56 new fractures, including 13 hip fractures, during follow-up. Conclusion Old people with femoral neck fracture have multiple co-morbidities and suffer numerous complications. Thus randomized intervention studies should focus on prevention of complications that might be avoidable such as infections, heart diseases, falls and fractures.

Introduction Piriformis fossa entry antegrade femoral nailing is a common method for stabilizing diaphyseal femur fractures. However, clinically significant complications such as chronic hip pain, hip abductor weakness, heterotopic ossification and femoral head osteonecrosis have been reported. A recent cadaveric study found that piriformis entry nailing damaged either the deep branch of the medial femoral circumflex artery (MFCA) or its distal superior retinacular artery branches in 100 % of specimens and therefore recommended against its use. However, no study has quantitatively assessed the effect of different femoral entry points on femoral head perfusion. Materials and methods Twelve fresh-frozen cadaveric lower extremity specimens were randomly allocated to either piriformis fossa or trochanteric entry nailing using a 13-mm reamer. The contralateral hip served as an internal matched control. All specimens subsequently underwent gadolinium-enhanced fat-suppressed gradient-echo sequence MRI to assess femoral head perfusion. Gross dissection was also performed to assess MFCA integrity and distance to the opening reamer path. Results MRI quantification analysis revealed near full femoral head perfusion with no significant difference between the piriformis and trochanteric starting points (95 vs. 97 %, p  = 0.94). There was no observed damage to the deep MFCA in either group. The mean distance from the reamer path to the deep MFCA was 3.2 mm in the piriformis group compared to 18.5 mm in the trochanteric group ( p  = 0.001). Additionally, there was a significantly greater number of mean terminal superior retinacular vessels damaged by the opening reamer in the piriformis cohort (1 vs. 0; p  = 0.007). Conclusions No statistically significant difference in femoral head perfusion was found between the two groups. Therefore, we cannot recommend against the use of piriformis entry femoral nails. However, we caution against multiple errant starting point attempts and recommend meticulous soft tissue protection during the procedure.

Background Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. Methods/Design FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. Discussion This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. Trial registration The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813 ).

The objective of this study was to compare the clinical results and complications of proximal femoral nail antirotation (PFNA) on treatment of intertrochanteric fractures in 120 elderly Chinese patients using Randomized Controlled Trials (RCTs). Totaly 120 cases enrolled were randomly assigned to a lateral decubitus position group and supine position group. The hospital stay, operating time, intraoperative blood loss, length of incision, X-ray fluoroscopy time, and out-of-bed activity time in the lateral decubitus position group were significantly lower than those in the supine position group. There was not statistical significance on union time and Harris values in the two position groups. Moreover, only complications of superficial wound infection were observed in the lateral decubitus position group, but two complications of deep venous thrombosis and wound deep infection were found in the supine position group. The present findings suggested that PFNA applied in elderly patients with intertrochanteric fracture can get satisfactory effects, and the treatment of intertrochanteric fractures using lateral decubitus position showed a satisfactory clinical outcome and a lower radiological complication rate.

Background Intramedullary nailing is the standard surgical treatment for mid-diaphyseal fractures of long bones; however, it is also a high radiation dose procedure. Distal locking is regularly cited as a demanding element of the procedure, and there remains a reliance on X-ray fluoroscopy to locate the distal holes. A recently developed electromagnetic navigation (EMN) system allows radiation-free distal locking, with a virtual on-screen image. Objective To compare operative duration, fluoroscopy time and radiation dose when using EMN over fluoroscopy, for the distal locking of intramedullary nails. Method Consecutive patients with mid-diaphyseal fractures of the tibia and femur, treatable with intramedullary nails, were prospectively enrolled during a 9-month period. The sample consisted of 29 individuals, 19 under fluoroscopic guidance and 10 utilising EMN. Participants were allocated depending on the type of intramedullary nail used and surgeon’s preference. These were further divided into tibial and femoral subcategories, relative to the fracture site. Results EMN reduced fluoroscopy time by 49 ( p  = 0.038) and 28 s during tibial and femoral nailings, respectively. Radiation dose was reduced by 18 cGy/cm 2 ( p  = 0.046) during tibial and 181 cGy/cm 2 during femoral nailings when utilising EMN. Operative duration was 11 min slower during tibial nailings using EMN, but 38 min faster in respect of femoral nailings. Conclusions This study has evidenced statistically significant reductions in both fluoroscopy time and radiation dose when using EMN for the distal locking of intramedullary nails. It is expected that overall operative duration would also decrease in line with similar studies, with increased usage and a larger sample.

Background The relevance of femoral neck fractures (FNFs) increases with the ageing of numerous societies, injury-related decline is observed in many patients. Treatment strategies have evolved towards primary joint replacement, but the impact of different approaches remains a matter of debate. The aim of this trial was to evaluate the benefit of an anterior minimally-invasive (AMIS) compared to a lateral Hardinge (LAT) approach for hemiarthroplasty in these oftentimes frail patients. Methods Four hundred thirty-nine patients were screened during the 44-months trial, aiming at the evaluation of 150 patients > 60 yrs. of age. Eligible patients were randomised using an online-tool with completely random assignment. As primary endpoint, early mobility, a predictor for long-term outcomes, was evaluated at 3 weeks via the “Timed up and go” test (TUG). Secondary endpoints included the Functional Independence Measure (FIM), pain, complications, one-year mobility and mortality. Results A total of 190 patients were randomised; both groups were comparable at baseline, with a predominance for frailty-associated factors in the AMIS-group. At 3 weeks, 146 patients were assessed for the primary outcome. There was a reduction in the median duration of TUG performance of 21.5% (CI [− 41.2,4.7], p  = 0.104) in the AMIS-arm (i.e., improved mobility). This reduction was more pronounced in patients with signs of frailty or cognitive impairment. FIM scores increased on average by 6.7 points (CI [0.5–12.8], p  = 0.037), pain measured on a 10-point visual analogue scale decreased on average by 0.7 points (CI: [− 1.4,0.0], p  = 0.064). The requirement for blood transfusion was lower in the AMIS- group, the rate of complications comparable, with a higher rate of soft tissue complications in the LAT-group. The mortality was higher in the AMIS-group. Conclusion These results, similar to previous reports, support the concept that in elderly patients at risk of frailty, the AMIS approach for hemiarthroplasty can be beneficial, since early mobilisation and pain reduction potentially reduce deconditioning, morbidity and loss of independence. The results are, however, influenced by a plethora of factors. Only improvements in every aspect of the therapeutic chain can lead to optimisation of treatment and improve outcomes in this growing patient population. Trial registration www.clinicaltrials.gov : NCT01408693 (registered August 3rd 2011).

Background The Dynamic Locking Blade Plate (DLBP) was recently introduced for fixation of displaced femoral neck fractures (FNF) and has been well received. Although the results of this implant in young patients are promising, the DLBP has not yet been compared to a standard device such as the Dynamic Hip Screw (DHS). The aim of this study is to compare the clinical outcome and costs of displaced FNF treated with internal fixation by means of either the DLBP or the DHS in patients up to 65 years of age. We hypothesize that the DLBP is superior compared to the DHS in terms of revision surgery rate, union rate, incidence of avascular necrosis and implant related failure. Methods The DEFENDD (DisplacEd Femoral Neck fractures Dlbp versus Dhs) trial is a multicentre randomized controlled trial that will include 266 patients of 18–65 years with a displaced FNF. Patients will be randomized to receive either a DLBP or a DHS with a 1:1 allocation using a random block size, stratified for centre. Clinical follow up will last 1 year and questionnaires will be obtained up to 2 years. The main outcome parameter is the incidence of revision surgery within 1 year, due to either non-union, avascular necrosis (AVN) or cut out of the implant. Secondary study parameters are the incidence of avascular necrosis, non-union, (implant related) complications, functional outcome, elective removal of the implant and health-related quality of life and costs. Discussion The outcome of the DEFENDD trial will provide high-level evidence of which implant is favourable for the treatment of femoral neck fractures in young patients (≤65 years). Trial registration Netherlands Trial Register, NL7300 Registration date 25-09-2018.