Femoral Neck Research Articles

Factors that influence surgical decision-making for geriatric displaced femoral neck fractures: Bullet Health Analysis (BHA) I

Factors that influence surgical decision-making for geriatric displaced femoral neck fractures: Bullet Health Analysis (BHA) I

Non-diabetic elderly populations: the MHR as a protective factor against bone abnormalities.

In China, osteoporosis has become a major health concern among elderly population, imposing significant burden on the country's social and economic systems. The monocyte to high-density lipoprotein ratio (MHR) has been currently recommended as a novel marker of inflammation and oxidative stress associated with osteoporosis in type 2 diabetes mellitus (T2DM). However, its reliability in non-diabetic elderly populations remains unclear. The present study was to evaluate the association between MHR and osteoporosis in a non-diabetic elderly population. The clinical data of 240 non-diabetic elderly subjects (115 in the osteoporosis group and 125 in the normal bone group) were retrospectively analyzed and all statistical analyses were performed by using SPSS 26.0. Differences in age, neutrophils, lymphocytes, monocytes, MHR, uric acid, creatinine, triglycerides,and high-density lipoprotein cholesterol were found to be statistically significant between the two groups. A binary logistic regression model was conducted by including age, MHR, UA and Cr as variables. The results showed that age was an independent risk factor and MHR was an independent protective factor for bone abnormality in the non-diabetic elderly population. The ROC analysis showed that the area under the curve for the predictive effect of MHR, age and their combined test on osteoporosis in non-diabetic elderly populations was 0.623, 0.728 and 0.761, respectively; the correlation analysis showed that MHR was positively correlated with lumbar and hip BMD, and negatively associated with femoral neck stress ratio, femoral intertrochanteric stress ratio, and femoral stem stress ratio, showing statistically significant differences (P<0.05). For the non-diabetic elderly population: the MHR is a protective factor against bone abnormalities and was significantly higher in the normal bone group than in the abnormal bone group.

A finite element analysis of a low-profile femoral neck system of screws in sleeves in a vertical femoral neck fracture model

BackgroundFemoral neck system (FNS) has exhibited some drawbacks, such as non-fit of the plate with the lateral femoral cortex, postoperative pain, and the potential risk of subtrochanteric fractures. We have developed a low-profile FNS system that addresses some compatibility issues in FNS. In this study, we conducted finite element analysis on the 1-hole FNS (1 H-FNS), 2-holes FNS (2 H-FNS), and low-profile FNS (LP-FNS) and compared their biomechanical performance.MethodsAfter the mesh convergence analysis, we established three groups of 1 H-FNS, 2 H-FNS, and LP-FNS. The interfragmentary gap, sliding distance, shear stress, and compressive stress and the bone-implant interface compression stress, stiffness, and displacement were determined under the neutral, flexion, or extension conditions of the hip joint, respectively. The stress and displacement of the femur after the implant removal were also investigated.Results(1) There were no obvious differences among the three FNS groups in terms of the IFM distance. However, the LP-FNS group showed less rotational angle compared with conventional FNS (neutral: 1 H-FNS, -61.64%; 2 H-FNS, -45.40%). Also, the maximum bone-implant interface compression stress was obviously decreased under the neutral, flexion, or extension conditions of the hip joint (1 H-FNS: -6.47%, -20.59%, or -4.49%; 2 H-FNS: -3.11%, 16.70%, or -7.03%; respectively). (2) After the implant removal, there was no notable difference in the maximum displacement between the three groups, but the maximum von Mises stress displayed a notable difference between LP-FNS and 1 H-FNS groups (-15.27%) except for the difference between LP-FNS and 2 H-FNS groups (-4.57%).ConclusionsThe LP-FNS may not only provide the same biomechanical stabilities as the 1 H-FNS and 2 H-FNS, but also have more advantages in rotational resistance especially under the neutral condition of the hip joint, in the bone-implant interface compression stress, and after the implant removal. In addition, the 1 H-FNS and 2 H-FNS have similar biomechanical stabilities except for the maximum von Mises stress after the implant removal. The femur after the LP-FNS removal not only is subjected to relatively little stress but also minimizes stress concentration areas.

Predictive value of sarcopenia components for all-cause mortality: findings from population-based cohorts

BackgroundLow grip strength and gait speed are associated with mortality. However, investigation of the additional mortality risk explained by these measures, over and above other factors, is limited.AimWe examined whether grip strength and gait speed improve discriminative capacity for mortality over and above more readily obtainable clinical risk factors.MethodsParticipants from the Health, Aging and Body Composition Study, Osteoporotic Fractures in Men Study, and the Hertfordshire Cohort Study were analysed. Appendicular lean mass (ALM) was ascertained using DXA; muscle strength by grip dynamometry; and usual gait speed over 2.4–6 m. Verified deaths were recorded. Associations between sarcopenia components and mortality were examined using Cox regression with cohort as a random effect; discriminative capacity was assessed using Harrell’s Concordance Index (C-index).ResultsMean (SD) age of participants (n = 8362) was 73.8(5.1) years; 5231(62.6%) died during a median follow-up time of 13.3 years. Grip strength (hazard ratio (95% CI) per SD decrease: 1.14 (1.10,1.19)) and gait speed (1.21 (1.17,1.26)), but not ALM index (1.01 (0.95,1.06)), were associated with mortality in mutually-adjusted models after accounting for age, sex, BMI, smoking status, alcohol consumption, physical activity, ethnicity, education, history of fractures and falls, femoral neck bone mineral density (BMD), self-rated health, cognitive function and number of comorbidities. However, a model containing only age and sex as exposures gave a C-index (95% CI) of 0.65(0.64,0.66), which only increased to 0.67(0.67,0.68) after inclusion of grip strength and gait speed.ConclusionsGrip strength and gait speed may generate only modest adjunctive risk information for mortality compared with other more readily obtainable risk factors.

Quality of cementing in hemiarthroplasty for elderly neck of femur fractures does not affect short term functional outcomes.

Cemented hip hemiarthroplasty is a routine surgical option for elderly neck of femur (NOF) fractures. It is uncertain if quality of cementing has any effect on functional outcomes. The aim of this study was to determine if the quality of cementing would affect short term functional outcomes in elderly neck of femur fractures. Retrospective analysis of 637 single-centre cemented hip hemiarthroplasties from 2014 to 2021 was performed. Each post-operative radiograph was double-read by 2 authors (1 resident and 1 fellowship trained surgeon) to determine quality of cementing via the Barrack grading. Disagreements were reviewed by a third reader. Cement grades were grouped as Optimal (Barrack grade A-B), or Suboptimal (Barrack grade C-D). Functional outcomes were compared using mobility (community- or home-ambulant), assistance required for mobility, and Modified Barthel Index (MBI). Surgical parameters were compared between the groups. There were 429 Optimal and 208 Suboptimal cases of cementing performed. There was no difference in age, American Society of Anesthesiologists score, mobility, assistance required, and MBI score pre-operatively (p > 0.05). Patients in the "Suboptimal" cementing group had a higher Charlson Comorbidity Index (CCI) score (p < 0.001). At 1year post-operation, there was no significant difference between "Optimal" and "Suboptimal" cementing with regards to the proportion of community ambulators (30.2% vs. 25.7%, p = 0.252), walking independence (independent walkers (19.8% vs.17.3%), independent walkers with aids (41.3%vs.42.1%), walker with caregiver assistance (29.2%vs.33.7%), wheelchair-bound (9.6%vs.6.9%), p = 0.478), and distribution of MBI score (81.1%vs.82.2% achieving MBI > 60, p = 0.767). There was no significant difference in the proportion of patients with postoperative delirium (7.9% vs. 5.8, p = 0.324) or 1-year mortality rates (3.5% vs. 2.9%, p = 0.685). Except for stem design (12.2% tapered vs 20.1% collared; p = 0.011), no other surgical parameters were significantly different. The kappa value for inter-reader agreement was "substantial" at 0.727 (95% CI 0.682-0.772) (p < 0.001). Quality of cementing in cemented hip hemiarthroplasty for elderly NOF fractures does not affect the short-term functional outcomes. In low demand patients and patients at risk of BCIS, optimal cementing may not be necessary to achieve similar short-term functional outcomes. Further studies should be conducted to determine the effect of sub-optimal cementing on long-term functional outcomes.

Prediction of subsequent fragility fractures: application of machine learning

BackgroundMachine learning (ML) has shown exceptional promise in various domains of medical research. However, its application in predicting subsequent fragility fractures is still largely unknown. In this study, we aim to evaluate the predictive power of different ML algorithms in this area and identify key features associated with the risk of subsequent fragility fractures in osteoporotic patients.MethodsWe retrospectively analyzed data from patients presented with fragility fractures at our Fracture Liaison Service, categorizing them into index fragility fracture (n = 905) and subsequent fragility fracture groups (n = 195). We independently trained ML models using 27 features for both male and female cohorts. The algorithms tested include Random Forest, XGBoost, CatBoost, Logistic Regression, LightGBM, AdaBoost, Multi-Layer Perceptron, and Support Vector Machine. Model performance was evaluated through 10-fold cross-validation.ResultsThe CatBoost model outperformed other models, achieving 87% accuracy and an AUC of 0.951 for females, and 93.4% accuracy with an AUC of 0.990 for males. The most significant predictors for females included age, serum C-reactive protein (CRP), 25(OH)D, creatinine, blood urea nitrogen (BUN), parathyroid hormone (PTH), femoral neck Z-score, menopause age, number of pregnancies, phosphorus, calcium, and body mass index (BMI); for males, the predictors were serum CRP, femoral neck T-score, PTH, hip T-score, BMI, BUN, creatinine, alkaline phosphatase, and spinal Z-score.ConclusionML models, especially CatBoost, offer a valuable approach for predicting subsequent fragility fractures in osteoporotic patients. These models hold the potential to enhance clinical decision-making by supporting the development of personalized preventative strategies.

Treatment algorithm for metastatic malignancies in the lower extremities.

A high prevalence of proximal femoral metastases persists in patients with cancer, particularly regarding lower extremity fractures. This study offers a detailed analysis of clinical characteristics of patients undergoing surgical treatment for pathological or impending fractures, enhancing treatment strategies for metastatic malignancies. A total of thirty patients who underwent treatment of impending and pathological fractures at Kindai University Hospital (Osakasayama, Japan) were included. The retrospective study comprised parameters including age, sex, fracture site, type of primary malignancy, number of metastases, pre-fracture Eastern Cooperative Oncology Group performance status (ECOG-PS) score, adjuvant therapy, treatment modality, operative time, blood loss, postoperative complications, Musculoskeletal Tumor Society (MSTS) score, outcome and follow-up period. Post-treatment MSTS scores were compared in cases of impending and pathological fractures, and between intramedullary nailing and other surgical procedures. In addition, one-year postoperative survival rates were calculated. Furthermore, operative time, blood loss and survival rates were compared between impending and pathological fractures. The participants' median age was 70.5 years, with disease sites primarily in the subtrochanteric femur, trochanteric femur, femoral diaphysis, femoral neck and other locations. Pathologies included multiple myeloma and unknown primary, lung, breast, kidney, liver, gastric, esophageal and uterine cancers. The median ECOG-PS score pre-fracture was 2. Treatment approaches involved radiotherapy, chemotherapy and a combination of both. Surgical interventions included intramedullary nailing (16 cases), endoprosthesis (1 case), bipolar head replacement (3 cases) and compression hip screw (3 cases), among others. A negative correlation (R=-0.63) existed between MSTS and pre-fracture ECOG-PS scores. The operative time was significantly shorter in impending than in pathological fractures, with impending fractures showing significantly lower blood loss. The treatment algorithm for malignant bone tumors of the lower extremity provided in the present study was efficient, potentially optimizing treatment strategies for such cases, and contributing to improved patient care and outcomes in oncology and orthopedic surgery.

The Association Between CYP2R1 rs10741657 Polymorphisms and Bone Variables, Vitamin D, and Calcium in Iranian Children and Adolescents: A Cross-Sectional Study.

Osteoporosis is a common disorder with a strong genetic component. Bone mineral density (BMD), vitamin D, and calcium levels declining are a main contributor of osteoporosis and fragility fractures. This cross-sectional study designed to explore the possible link between CYP2R1 rs10741657 polymorphism and BMD of the total hip, lumbar spine and femoral neck, vitamin D, and calcium in Iranian children and adolescents. 247 children and adolescents (127 girls and 120 boys) between 9 and 18 years old from Kawar (an urban area located 50 km east of Shiraz, the capital city of the Fars province in the south of Iran) were randomly selected based on age-stratified systematic sampling and recruited for genetic analysis. The polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method was used for genotyping CYP2R1 rs10741657. Anthropometric, biochemical, and bone mineral density (BMD) parameters were also measured. The results specified that in the dominant [P < 0.0001, -2.943 (-4.357-1.529)] and over-dominant [P < 0.0001, 2.789 (1.369-4.209)] models, vitamin D concentration significantly differed between genotypes. The highest vitamin D levels were displayed for participants carrying the rs10741657 AG genotype (16.47 ng/ml). In regard to calcium, in a dominant model [P = 0.012, 0.194 (0.043-0.345)] and over-dominant model [P = 0.008, 0.206 (-0.357-0.055), there was a significant association. AG genotype displayed the highest (9.96 mg/dl) and GG genotype the lowest (9.75 mg/dl) calcium values. This study reported the association of CYP2R1 rs10741657 polymorphisms with calcium and vitamin D levels in Iranian children and adolescents.

An in-depth analysis of young adults with osteonecrosis secondary to developmental dysplasia of the hip who underwent total hip arthroplasty

BackgroundPatients with osteonecrosis of the femoral head secondary to DDH frequently require total hip arthroplasty (THA), but it is not well understood which factors necessitate this requirement. We determined the incidence of THA in patients who have osteonecrosis secondary to DDH and factors associated with need for THA.MethodsWe included patients who received closed or open reductions between 1995 and 2005 with subsequent development of osteonecrosis. We determined osteonecrosis according to Bucholz and Ogden; osteoarthritis severity (Kellgren-Lawrence), subluxation (Shenton’s line); neck-shaft angle; and acetabular dysplasia (centre-edge and Sharp angles). We also recorded the number of operations of the hip in childhood and reviewed case notes of patients who received THA to describe clinical findings prior to THA. We assessed the association between radiographic variables and the need for THA using univariate logistic regression.ResultsOf 140 patients (169 hips), 22 patients received 24 THA (14%) at a mean age of 21.3 ± 3.7 years. Associated with the need for THA were grade III osteonecrosis (OR 4.25; 95% CI 1.70-10.77; p = 0.0019), grade IV osteoarthritis (21.8; 7.55–68.11; p < 0.0001) and subluxation (8.22; 2.91–29.53; p = 0.0003). All patients who required THA reported at least 2 of: severe pain including at night, stiffness, and reduced mobility. Acetabular dysplasia and number of previous operations were not associated with the need for THA.ConclusionsWe identified a 14% incidence of THA by age 34 years in patients with osteonecrosis secondary to DDH. Grade III osteonecrosis (global involvement femoral head and neck) was strongly associated with THA, emphasising the importance to avoid osteonecrosis when treating DDH.

Bone mineral density in women with rheumatoid arthritis: A link between immune and biochemical markers

To study the association of bone mineral density (BMD) with serum biochemical and immunological markers in postmenopausal women with rheumatoid arthritis (RA). The study included 173 women with RA (age 61.0 [56.0; 66.0] years). A survey, dual-energy X-ray absorptiometry to measure the BMD of the lumbar spine (LI-LIV), femoral neck (FN) and total hip (TH), routine blood chemistry, measurement of C-reactive protein (CRP), rheumatoid factor, cyclic citrullinated peptide antibodies (CCPA), parathyroid hormone (PTH), vitamin D3, myostatin, follistatin, interleukin-6 (IL-6), IL-6 receptors, insulin-like growth factor 1, adiponectin, leptin, fibroblast growth factor 23, and tumor necrosis factor SF12 were performed. PTH (β=-0.22, -0.35 and -0.30 for LI-LIV, FN and TH, respectively), CRP (β=-0.18, 0.23 and -0.22 for LI-LIV, FN and TH, respectively) and leptin (β=0.35, 0.32 and 0.42 for LI-LIV, FN and TH, respectively) were shown a significant association with BMD in all sites of measurement. It was independent of age, body mass index and postmenopause duration. Associations were also found between adiponectin and BMD of LI-LIV and TH (β=-0.36 and -0.28, respectively), CCPA and BMD of FN and TH (β=-0.21, -0.24, respectively) and IL-6 and BMD of FN (β=0.37). The study of biochemical and immunological markers in women with RA demonstrated that CRP, CCPA, PTH, IL-6, adiponectin, and leptin influenced BMD.

Hip Fracture Risk Assessment Tools for Adults Aged 80 Years and Older

While adults aged 80 years and older account for 70% of hip fractures in the US, performance of fracture risk assessment tools in this population is uncertain. To compare performance of the Fracture Risk Assessment Tool (FRAX), Garvan Fracture Risk Calculator, and femoral neck bone mineral density (FNBMD) alone in 5-year hip fracture prediction. Prognostic analysis of 3 prospective cohort studies including participants attending an index examination (1997 to 2016) at age 80 years or older. Data were analyzed from March 2023 to April 2024. Participants contacted every 4 or 6 months after index examination to ascertain incident hip fractures and vital status. Predicted 5-year hip fracture probabilities calculated using FRAX and Garvan models incorporating FNBMD and FNBMD alone. Model discrimination assessed by area under receiver operating characteristic curve (AUC). Model calibration assessed by comparing observed vs predicted hip fracture probabilities within predicted risk quintiles. A total of 8890 participants were included, with a mean (SD) age at index examination of 82.6 (2.7) years; 4906 participants (55.2%) were women, 866 (9.7%) were Black, 7836 (88.1%) were White, and 188 (2.1%) were other races and ethnicities. During 5-year follow-up, 321 women (6.5%) and 123 men (3.1%) experienced a hip fracture; 818 women (16.7%) and 921 men (23.1%) died before hip fracture. Among women, AUC was 0.69 (95% CI, 0.67-0.72) for FRAX, 0.69 (95% CI, 0.66-0.72) for Garvan, and 0.72 (95% CI, 0.69-0.75) for FNBMD alone (FNBMD superior to FRAX, P = .01; and Garvan, P = .01). Among men, AUC was 0.71 (95% CI, 0.66-0.75) for FRAX, 0.76 (95% CI, 0.72-0.81) for Garvan, and 0.77 (95% CI, 0.72-0.81) for FNBMD alone (P < .001 Garvan and FNBMD alone superior to FRAX). Among both sexes, Garvan greatly overestimated hip fracture risk among individuals in upper quintiles of predicted risk, while FRAX modestly underestimated risk among those in intermediate quintiles of predicted risk. In this prognostic study of adults aged 80 years and older, FRAX and Garvan tools incorporating FNBMD compared with FNBMD alone did not improve 5-year hip fracture discrimination. FRAX modestly underpredicted observed hip fracture probability in intermediate-risk individuals. Garvan markedly overpredicted observed hip fracture probability in high-risk individuals. Until better prediction tools are available, clinicians should prioritize consideration of hip BMD, life expectancy, and patient preferences in decision-making regarding drug treatment initiation for hip fracture prevention in late-life adults.

Diagnostic Challenges of Osteoid Osteoma of the Femoral Neck in an Adolescent: A Case Report

Non-traumatic hip pain in adolescents presents a significant diagnostic challenge. We report the case of a 19-year-old female patient treated for idiopathic juvenile osteoporosis with zoledronic acid, presenting with chronic inflammatory right hip pain that responded well to NSAIDs, associated with back and buttock pain. The inflammatory markers, including CRP and ESR, were negative. The pelvic radiography was normal, though thoracolumbar spine radiography revealed scoliosis. Consequently, MRI of the sacroiliac joints was performed to search for sacroiliitis but revealed a 5 mm nidus with reactive sclerosis, suggestive of an osteoid osteoma. The natural progression of the patient's pain showed spontaneous regression within one year.

Stem anteversion is not affected by proximal femur geometry in robotic-assisted total hip arthroplasty

BackgroundIn the present study, the surgeon aimed to align the stem at 5° to 25° in anteversion. The robotic technology was used to measure stem anteversion with respect to proximal femur anteversion at different levels down the femur.MethodsA total of 102 consecutive patients underwent robotic-arm-assisted total hip arthroplasty (RTHA). 3D CT-based preoperative planning was performed to determine femoral neck version (FNV), posterior cortex anteversion (PCA), anterior cortex anteversion (ACA), and femoral metaphyseal axis anteversion (MAA) at 3 different levels: D (10 mm above lesser trochanter), E (the midpoint of the planned neck resection line) and F (head-neck junction). The robotic system was used to define and measure stem anteversion during surgery.ResultsMean FNV was 6.6° (SD: 8.8°) and the mean MAA was consistently significantly higher than FNV, growing progressively from proximal to distal. Mean SV was 16.4° (SD: 4.7°). There was no statistically significant difference (P = 0.16) between SV and MAA at the most distal measured level. In 96.1% cases, the stem was positioned inside the 5°–25° anteversion range.ConclusionsFemoral anteversion progressively increased from neck to proximal metaphysis. Aligning the stem close to femoral anteversion 10 mm above the lesser trochanter often led to the desired component anteversion.

Risk of low bone mineral density in young pediatric cancer survivors with sarcopenia.

10070 Background: Required treatments to cure pediatric cancer at such a young age increase the risk of later health-related complications. Early exposure to DNA damaging agents, during a vital period of active skeletal growth, interferes with accrual of bone mass. Treatments not only impair bone health, but also affect skeletal muscle function and mass. Long-term pediatric cancer survivors present these limitations due to myofibrillary atrophy caused by degradation of myosin heavy chain and decrease in myosin synthesis death. Muscle weakness (both muscle strength deficits and low lean mass hereafter referred to as sarcopenia) and low areal bone mineral density (aBMD) have been observed to coexist in adult survivors of paediatric cancer. However, in young pediatric cancers survivors, associations between sarcopenia and low aBMD are not well described. Therefore, this study aimed to examine the risk of low aBMD in young pediatric cancer survivors with sarcopenia confirmed/probable, compared to not having sarcopenia. Methods: This cross-sectional study included 116 pediatric cancer survivors (12.1±3.3 years old; 42% female) enrolled on a randomized controlled trial designed to improve bone health (iBoneFIT project). Handgrip strength was used to assessed muscle strength. Dual-energy X-ray absorptiometry estimated aBMD (g/cm2) at the total body (less head), lumbar spine, total hip and femoral neck, and appendicular lean mass index (ALMI, kg/m2). Sarcopenia status was determined using age and sex specific international reference data from a healthy population. “No sarcopenia” was defined when muscle strength was &gt;decile 2. “Sarcopenia probable” was defined when muscle strength was ≤decile 2 and ALMI Z-score was &gt; -1.5 standard deviation (SD). “Sarcopenia confirmed” was defined when muscle strength was ≤decile 2 and ALMI Z-score ≤-1.5 SD. Logistic regression, adjusted for time from treatment completion and radiation exposure, was used to evaluate the risk of low aBMD (age-, sex- and race-specific aBMD Z-score &lt; -1.0) by sarcopenia status. Results: More than one-third of survivors met criteria for sarcopenia confirmed (37.9%); 19.0% met criteria for sarcopenia probable. Survivors with sarcopenia confirmed had higher risk of low aBMD at the total body (odd ratio [OR]: 6.91, 95% confidence interval [CI]: 2.31-24.15), total hip (OR: 2.98, 95% CI: 1.02-9.54) and femoral neck (OR: 4.72, 95% CI: 1.72-14.19) than those without sarcopenia. Survivors with sarcopenia probable had higher risk of having low aBMD only at the total body (OR: 4.13, 95% CI: 1.04-17.60) than those without sarcopenia. Conclusions: Over one-third of young paediatric cancer survivors presented sarcopenia confirmed with higher risk of low aBMD. These findings suggest that interventions to mitigate osteosarcopenia in this population should be implemented at early stages after treatment completion.

A randomized, double-blind, study to evaluate the efficacy, pharmacodynamics, safety and immunogenicity of FKS518 proposed biosimilar to denosumab with the originator in postmenopausal women with osteoporosis (LUMIADE-3 study).

3155 Background: Biosimilars can increase patient access to treatment. FKS518 is a candidate biosimilar of denosumab, a RANKL inhibitor used in patients with bone metastases from certain solid tumors and in multiple myeloma. To establish biosimilarity, comparative studies are conducted in the most sensitive patient population to detect if there are clinically meaningful differences. LUMIADE-3 was designed to assess the safety and efficacy of FKS518 compared to the originator in postmenopausal women with osteoporosis (PMO). Methods: A randomized, double-blind, multicenter, 2-arm study recruited female patients aged 55 to 85 years with confirmed postmenopausal status and lumbar spine bone mineral density (LS-BMD) T-score ≤ -2.5 and ≥ -4.0, as measured by central dual-energy X-ray absorptiometry (DXA) assessment. Subjects with prior osteoporosis treatment that could add risk for cumulative effect or affect the interpretation of results were excluded. Patients were randomized and received three 60 mg administrations. At week 52, patients receiving denosumab originator were re-randomized to continue their treatment or switch to FKS518 for the third dose. Those receiving FKS518 continued receiving FKS518. The primary efficacy endpoint was the percent change from baseline in LS-BMD DXA at week 52. An analysis of the covariance model was used to compare the two treatments and two separate one-sided tests at alpha=0.05 were performed to assess equivalence. Secondary efficacy endpoints included the percent change from baseline in BMD at the femoral neck and total hip. Results: A total of 553 patients were randomized to FKS518 (n= 276) or the originator (n=277). Clinically relevant increases in LS-BMD were evident at week 52 in both the FKS518 and originator product groups. The results demonstrated therapeutic equivalence: the lower bound of the 90% CI for non-inferiority (-0.05) was above -1.45, and the upper bound of the 90% CI for non-superiority (1.20) was below 1.45. All secondary objectives were met. At week 52, a similar percent change from baseline in BMD at the femoral neck and total hip was observed between the two groups. 374 patients (67.6%) experienced treatment-emergent adverse events: 185 (66.8%) in the FKS518 group and 189 (68.5%) in the originator product group. Safety evaluation did not point to notable differences between FKS518 and the originator product groups. Conclusions: We demonstrated the therapeutic equivalence of FKS518 and originator product. The safety data showed similar safety profiles for the FKS518 and the originator product groups. Results from this study add to the totality of evidence supporting the similarity of FKS518 as a proposed biosimilar to denosumab originator product, a RANKL inhibitor used in patients with bone metastases from solid tumors. Clinical trial information: NCT04934072 .

Risk Factors for Osteoporosis in Chronic Hemodialysis Patients

Introduction: in hemodialysis patients. Osteoporosis associated with kidney disease chronic is a complex entity with significant morbidity and mortality relative to risk of fracture. Its prevalence is high, but the incrimination of clinical and biological factors remains poorly identified. The purpose of our study is to determine the prevalence and factors associated with osteoporosis. Methods: A cross-sectional study included 40 chronic hemodialysis patients for at least 6 months. All subjects underwent a bone mineral density (BMD) assay with dual-energy x-rays absorptiometry (DXA) at the lumbar spine (LS) and femoral neck (FN). Data were statistically analyzed by means of descriptive analysis. Patients were divided into 2 groups based on the T-score to define the osteoporotic (t score≤-2.5) and the no-osteoporotic (t score&gt;-2.5). The search for the risk factors studied [age, duration of hemodialysis, parathyroid hormone (PTH), alkaline phosphatases (ALP), and calcification of the abdominal aorta (AAC)] has been carried out by logistic regression. Results: The average age was 59 ± 16 years, 47% were women, and the median of hemodialysis duration was 54 months. The prevalence of osteoporosis at the lumbar spine was 27.5% and at the femoral neck was 32.5%. Regarding risk factors, at the LS, the factors associated with osteoporosis retained in the univariate analysis were age (p=0.034), PTH (p=0.024), AAC (p=0.024), ALP (p=0.027) and in the multivariate analysis, only PTH was significantly associated (p=0.019). At the FN; The factors associated with osteoporosis retained in analysis univariate were age (p = 0.03), AAC (p = 0.01), ALP (p=0.04) and in analysis multivariate was the APL (p= 0.035). Conclusion: Osteoporosis is associated with turnover abnormalities. We suggest that regular screening for fracture risk using DXA and early correction of the disorders.

Efficacy, tolerability, and bone density outcomes of elagolix with add-back therapy for endometriosis-associated pain: twelve months of an ongoing randomized phase 3 trial

Elagolix, an approved oral treatment for endometriosis-associated pain, has been associated with hypoestrogenic effects when used as monotherapy. Hormonal add-back therapy has the potential to mitigate these effects. To evaluate efficacy, tolerability, and bone density outcomes of elagolix 200mg twice daily with 1mg estradiol/0.5mg norethindrone acetate (add-back) therapy once daily compared with placebo in premenopausal women with moderate-to-severe endometriosis-associated pain. This ongoing, 48-month, phase 3 study consists of a 12-month double-blind period, with randomization 4:1:2 to elagolix 200mg twice daily with add-back therapy, elagolix 200mg twice daily monotherapy for 6months followed by elagolix with add-back therapy, or placebo. The coprimary endpoints were proportion of patients with clinical improvement (termed "responders") in dysmenorrhea and nonmenstrual pelvic pain at month 6. We report 12-month results on efficacy of elagolix with add-back therapy vs placebo in reducing dysmenorrhea, nonmenstrual pelvic pain, dyspareunia, and fatigue. Tolerability assessments include adverse events and change from baseline in bone mineral density. A total of 679 patients were randomized to elagolix with add-back therapy (n=389), elagolix monotherapy (n=97), or placebo (n=193). Compared with patients randomized to placebo, a significantly greater proportion of patients randomized to elagolix with add-back therapy responded with clinical improvement in dysmenorrhea (62.8% vs 23.7%; P≤.001) and nonmenstrual pelvic pain (51.3% vs 36.8%; P≤.001) at 6months. Compared with placebo, elagolix with add-back therapy produced significantly greater improvement from baseline in 7 hierarchically ranked secondary endpoints including dysmenorrhea (months 12, 6, 3), nonmenstrual pelvic pain (months 12, 6, 3), and fatigue (months 6) (all P<.01). Overall, the incidence of adverse events was 73.8% with elagolix plus add-back therapy and 66.8% with placebo. The rate of severe and serious adverse events did not meaningfully differ between treatment groups. Study drug discontinuations associated with adverse events were low in patients receiving elagolix with add-back therapy (12.6%) and those receiving placebo (9.8%). Patients randomized to elagolix monotherapy exhibited decreases from baseline in bone mineral density of-2.43% (lumbar spine),-1.54% (total hip), and-1.78% (femoral neck) at month 6. When add-back therapy was added to elagolix at month 6, the change from baseline in bone mineral density remained in a similar range of-1.58% to-1.83% at month 12. However, patients who received elagolix plus add-back therapy from baseline exhibited little change from baseline in bone mineral density (<1% change) at months 6 and12. Compared with placebo, elagolix with add-back therapy resulted in significant, clinically meaningful improvement in dysmenorrhea, nonmenstrual pelvic pain, and fatigue at 6months that continued until month 12 for both dysmenorrhea and nonmenstrual pelvic pain. Elagolix with add-back therapy was generally well tolerated. Loss of bone mineral density at 12months was greater in patients who received elagolix with add-back therapy than those who received placebo. However, the change in bone mineral density with elagolix plus add-back therapy was <1% and was attenuated compared with bone loss observed with elagolix monotherapy.

Arthroscopic Fixation With Absorbable Suture Anchors for Pipkin Type I Femoral Head Fractures—Letter V Technique

Femoral head fractures are relatively uncommon high-energy injuries and usually associated with traumatic hip dislocation. Pipkin classified these fractures into 4 types according to the location of the head fragment related to the fovea and associated lesions on the femoral neck or acetabulum. Traditional open reduction and internal fixation for femoral head fracture has been proven to be effective, but it could be associated with significant complications. Arthroscopic fixation with screws is a less-invasive alternative to open reduction and internal fixation that offers several advantages. However, technical challenges could be encountered during the procedure and catastrophic consequences could occur in cases of fixation failure. Therefore, we propose an effective arthroscopic technique for Pipkin type I (small fracture caudal to the fovea capitis) femoral head fractures that uses an absorbable suture anchors. The anchors provide initial stability to the fracture fragments, and then the sutures are tied in a double-pulley fashion to further secure the fracture. Finally, a triangular suture bridge (“letter V”) is created, which supplies a convenient and stable fixation for proper femoral head fracture.

Osteoporosis and Fracture Risk Associated with Novel Antidepressants: A Systematic Review and Meta-Analysis.

The use of antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), has been linked to adverse effects on bone health, but findings are conflicting. This study aimed to quantify the associations between newer antidepressants and bone mineral density (BMD) and fracture risk through a comprehensive meta-analysis. Observational studies on the association between the use of novel antidepressants and BMD and hip fracture were systematically searched in PubMed, Embase, CINAHL, Cochrane Library, and Scopus. Random effects meta-analyses were conducted to pool results across the eligible studies. The heterogeneity, publication bias, and influence were assessed extensively. 14 eligible studies with 1,417,134 participants were identified. Antidepressant use was associated with significantly lower BMD compared to non-use at all skeletal sites examined, with pooled standardized mean differences (SMD) ranging from -0.02 (total hip) to -0.04 (femoral neck). Importantly, antidepressant use was associated with a 2.5-fold increased risk of hip fracture (pooled odds ratio (OR) 2.50, 95% CI 2.26-2.76). While heterogeneity was detected, the overall findings were robust in sensitivity analyses. This meta-analysis provided strong evidence that novel antidepressants, especially widely used SSRIs, have detrimental impacts on bone health. The observed associations with decreased BMD and doubled hip fracture risk have important clinical implications.

Birmingham Hip Resurfacing at 25 years.

The Birmingham Hip Resurfacing (BHR) was introduced in 1997 to address the needs of young active patients using a historically proven large-diameter metal-on-metal (MoM) bearing. A single designer surgeon's consecutive series of 130 patients (144 hips) was previously reported at five and ten years, reporting three and ten failures, respectively. The aim of this study was to extend the follow-up of this original cohort at 25 years. The study extends the reporting on the first consecutive 144 resurfacing procedures in 130 patients for all indications. All operations were undertaken between August 1997 and May 1998. The mean age at operation was 52.1 years (SD 9.93; 17 to 76), and included 37 female patients (28.5%). Failure was defined as revision of either component for any reason. Kaplan-Meier survival analysis was performed. Routine follow-up with serum metal ion levels, radiographs, and Oxford Hip Scores (OHSs) was undertaken. Overall implant survival was 83.50% (95% confidence interval (CI) 0.79 to 0.90) at 25 years, and the number at risk was 79. Survival in male patients at 25 years was 89.5% (95% CI 0.83 to 0.96) compared to 66.9% for female patients (95% CI 0.51 to 0.83). Ten additional failures occurred in the period of ten to 25 years. These involved an adverse reaction to metal debris in four patients, a periprosthetic femoral neck fracture affecting five patients, and aseptic loosening in one patient. The median chromium levels were 49.50 nmol/l (interquartile range (IQR) 34 to 70), and the median cobalt serum levels were 42 nmol/l (IQR 24.50 to 71.25). The median OHS at last follow-up was 35 (IQR 10 to 48). During the 25-year study period, 29 patients died. Patient survival at 25 years was 75.10% (95% CI 0.67 to 0.83). This study demonstrates that MoM hip resurfacing using the BHR provides a durable alternative to total hip arthroplasty (THA), particularly in younger male patients with osteoarthritis wishing to maintain a high level of function. These results compare favourably to the best results for THAs.