Clinical Research Directory

Frailty and Nottingham Hip Fracture Score for Predicting 90-Day Mortality After Hip Fracture Surgery

Hip fractures are serious injuries that occur mostly in older adults. Many people experience health problems or may die in the months after surgery. Doctors try to identify patients who have a higher risk of poor outcomes as early as possible. Doctors often use the Nottingham Hip Fracture Score (NHFS) to estimate the risk of death after hip fracture surgery. This score uses information such as age and other health conditions. However, it does not fully reflect how physically vulnerable a person may be. Another important concept is frailty. Frailty describes how strong or weak a person's overall health and physical reserve are. In this study, frailty will be measured using the Clinical Frailty Scale (CFS). This scale evaluates a person's level of independence and physical function before the fracture. The purpose of this study is to determine whether measuring frailty can improve the prediction of death after hip fracture surgery. Older adults with hip fractures who undergo surgery will be invited to participate in the study. Researchers plan to include about 200 participants or all eligible patients enrolled within one year, whichever occurs first. Health information that is already collected during routine hospital care will be recorded. Frailty will be assessed when participants are admitted to the hospital. Participants will be followed for 30 days and 90 days after surgery to determine survival status. Researchers will review hospital records and may contact participants or their relatives by phone if needed. The results of this study may help doctors better identify patients at higher risk and improve care planning after hip fracture surgery.

The Hip Fracture Surgical Approach Trial

The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.

Communication for Early Mobilisation of People Living With Dementia Following Surgery for Hip Fracture

This goal of this study is to identify ways that healthcare professionals communicate that are effective in helping a person living with dementia to stand or walk after surgery for a broken hip (hip fracture). We aim to identify 'what works' in successfully helping people with dementia to mobilise early, and share this in practice. The main question the research aims to answer is: What healthcare professional communication practices are effective in achieving early and continued mobilisation among people living with dementia following hip fracture surgery? We will use a research method called 'Conversation Analysis', to look at the fine detail of the language healthcare professionals use and responses to it. We will make video recordings of real-life ward care, when healthcare staff are trying to help a person with dementia get up early after hip fracture surgery. We will involve people with dementia in decisions to take part and get agreement from their families before we record anything. We have done this successfully in two previous studies. We will record up to 50 episodes of care on three trauma orthopaedic wards. We will identify specific, practical recommendations and 'teachable' approaches: ways of speaking, or sequences of requests or instructions. We will work with people with dementia, family carers, educators and clinicians to do this. We will use clips of videos in future communication training.

Hope Theory-Based Nursing Intervention After Hip Fracture Surgery

This is a randomized controlled trial to evaluate the effectiveness of a Snyder Hope Theory-based nursing intervention on elderly patients following hip fracture surgery. The study aims to improve the patient's psychological well-being, reduce pain, and enhance their functional recovery. Participants will be randomly assigned to either the intervention group or the control group. The intervention involves individualized counseling, goal setting, and rehabilitation training based on the Snyder Hope Theory. The trial will assess changes in hope levels, anxiety, pain, hip joint function, and quality of life before and after the intervention.

Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture

With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Due to their wearability and intelligence, exoskeleton robots provide an innovative solution for rehabilitation training. This study aims to explore the application effects of exoskeleton robots in postoperative rehabilitation for elderly patients with hip fractures by utilizing exoskeleton robot-assisted rehabilitation training for elderly hip surgery patients. The focus is on its improvements in motor ability, balance ability, and pain levels, while also assessing its impact on patients' overall quality of life and the prevention of complications.

Prediction of Mortality and Morbidity After Hip Fracture Using Monocyte Distribution Width (MDW)

Hip fracture is a common injury in older adults and is often associated with serious complications, longer hospital stays, and increased risk of death. One of the most important causes of poor outcomes after hip fracture surgery is infection, including severe infections such as sepsis. Early identification of patients at higher risk for complications could help improve treatment and survival. This study aims to examine whether a blood test parameter called Monocyte Distribution Width (MDW), along with other commonly used inflammatory markers, can help predict complications and survival in elderly patients with hip fracture. MDW is measured as part of a routine complete blood count and has shown promise in the early detection of infection and systemic inflammation. Approximately 100 patients aged 65 years or older who are admitted to the hospital with a low-energy hip fracture will be included in this study. Blood tests will be performed at hospital admission, after surgery, and at other time points as part of standard clinical care. These tests include routine blood counts and inflammatory markers such as C-reactive protein (CRP), procalcitonin (PCT), antithrombin III, and MDW. No additional invasive procedures are required beyond standard medical care. Researchers will collect information about each patient's medical history, overall health status, and daily activity level before the fracture. Patients will be followed after surgery to assess complications, length of hospital stay, and survival at 1 month, 3 months, and 1 year. The results of this study may help determine whether MDW can be used as a simple and reliable marker to identify patients at higher risk of complications or death after hip fracture. This could support earlier intervention, closer monitoring, and improved care for elderly patients with hip fractures in the future.

The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery

The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture The main questions it aims to answer are: It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration. The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score. Participants will: \- Receive either a single dose of intravenous FDI (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery. This trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.

External Validation of Ten Prediction Models for 30-day Mortality Following Hip Fracture

This study aims to externally validate ten existing prediction models with a low risk of bias for 30-day mortality following hip fracture. Data will be collected from the Dutch Hip Fracture Audit (DHFA) and supplemented with structured and unstructured data extracted through text mining using CTcue. Approximately 35 clinical variables will be used, including factors consistently associated with short-term mortality. The primary outcome is all-cause mortality within 30 days after hip fracture. Predictive performance will be assessed through discrimination (AUC), explained variance (R²), and calibration analysis. Clinical usefulness will be evaluated using Net Benefit and Decision Curve Analysis. This study seeks to identify models with strong predictive performance and practical applicability to support shared decision-making between clinicians and patients.

Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery

The main objective of this research will be to investigate whether the control of care provided by the family/caregiver can prevent the onset of delirium in individuals undergoing surgical intervention for hip fracture. The research will be a randomized, single-blind, parallel, two-arm clinical trial that compares two conditions: intervention group, hereafter IG (Delirium Zero protocol based on a space-temporal orientation poster for the patient, a clock hung on the wall next to the orientation poster, and a checklist for the preventive measures taken by the caregiver/family), and control group, hereafter CG (standard of care). The participants will be patients over 65 years old, admitted to the trauma hospitalization units of the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain), operated on for hip fracture and accompanied by a relative/caregiver. The research will be carried out at the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) because it is the reference hospital for the Valencian Community, and because the rooms in this center are private, which allows for no interference between the intervention under study (in GI) or the standard care (GC).

Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery

This study aims to compare two medications, Remimazolam and Midazolam, used for sedation during orthopedic surgeries performed under regional anesthesia. We want to find out which medication provides better sedation during the procedure and which one affects early recovery of brain function after surgery. Older adults (65 years and above) undergoing surgery for bone injuries or conditions will participate. We will monitor their sedation levels, blood pressure, heart rate, side effects, and how quickly they recover after surgery. We also want to see if either medication causes fewer problems with thinking and memory shortly after surgery. The study is designed so neither the patients nor the medical staff know which medication is being given, to ensure unbiased results. Participants will be randomly assigned to receive either Remimazolam or Midazolam. The information gathered will help doctors choose the safest and most effective sedative for older patients undergoing orthopedic surgeries, potentially improving patient comfort and recovery.

PENG vs. FIC Block for Hip Fracture ED Patients

Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression. The fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC. This aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.

Remote Ischaemic Conditioning for Post-surgical Complications in Hip Fracture (RIC-FRACTURE)

Background Hip fracture affects 70,000 people in the United Kingdom (UK) and costs an estimated £1.1 billion per year to the National Health Service (NHS). Key clinical indicators, such as early surgical repair, have been shown to improve patient outcomes, however morbidity and mortality remain extremely high, reflecting the urgent need for novel therapies to enhance outcomes. Common complications include infection, cardiovascular events, falls and venous thromboembolism. Remote Ischaemic Conditioning (RIC) is a treatment whereby a blood pressure cuff is inflated around an arm or leg to above systolic pressures to occlude blood flow to the limb for short periods of time, that do not result in harm, but trigger innate mechanisms that reduce inflammation, improve organ blood flow and improve bone healing. These may be beneficial effects after hip fracture. Methods This is a single centre, feasibility study; the participants will receive RIC daily for 40 minutes for 10 days during their inpatient stay. Outcome measures relating primarily to safety, tolerability and feasibility will be collected along with compliance with the intervention. Study feasibility will be determined by success criteria based on recruitment, outcome measure assessment compliance with intervention and follow up. Secondary outcomes including inpatient mortality, inpatient complications, length of inpatient stay, blood pressure, serum inflammatory and stress markers and functional recovery will also be collected at discharge and 3 month follow up. Results Data collected on safety, tolerability, and feasibility will be presented descriptively and simple analysis of variance will be undertaken on quantitative data such as blood pressure and serum inflammatory and stress markers between baseline and follow up time points. The study will hopefully establish whether this therapy is feasible to deliver after acute hip fracture.

Implementation of the MOX Activity Monitor in Hospitalized Geriatric Rehabilitation

Staying active is essential for healthy aging, but hospitalized older adults in rehabilitation often move very little. This study explores how much physical activity these patients actually get and how it relates to their recovery. Using the MOX activity monitor-a device that accurately tracks walking, standing, and sedentary time-the study aims to better understand daily activity patterns during rehabilitation. Researchers will test the best way to use the MOX monitor, develop a standard protocol for its use, and integrate its data into patients' electronic health records. By comparing MOX activity data with standard measures of physical performance, the study will determine how useful activity monitoring is for tracking recovery in older patients. This could lead to improved care and more personalized rehabilitation plans in the future.

PENG Block: Continuous Infusion vs. Programmed Intermittent Bolus in Neck of Femur Fracture

Pericapsular Nerve Group Block (PENG) is an effective regional anaesthesia modality in providing analgesia following neck of femur fracture. Continuous PENG techniques, using indwelling catheters and infusions of local anaesthetic, facilitate the continuation of analgesia for a number of days following hip fracture surgery. It is unclear from the published literature whether an optimal strategy of local anaesthetic delivery has been characterized. Similar doses of local anaesthetic agents can be administered by either continuous infusion or timed intermittent bolus. It is unclear whether one dosing strategy is superior to the other in the context of hip fracture analgesia. The study aims to evaluate the clinical efficacy of both dosing strategies in patients undergoing hip fracture surgery.

Ultrasound-Guided PENG Block vs Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Hip Fracture Surgery

This study will compare two types of ultrasound-guided nerve blocks-Pericapsular Nerve Group (PENG) block and Femoral Nerve Block (FNB)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. Proximal femur fractures will continue to be common, especially in older adults, and often will cause severe pain that will make it difficult to position patients for spinal anesthesia. Both nerve blocks will aim to reduce pain, improve comfort during spinal anesthesia, and decrease the need for postoperative pain medication. A total of 60 adult patients who will undergo proximal femur fracture fixation under spinal anesthesia will be enrolled and randomly assigned to receive either a Pericapsular Nerve Group (PENG) block or a femoral nerve block before the procedure. The study will monitor patients' pain scores using the Visual Analog Scale (VAS) at multiple time points, including during positioning and throughout the first 24 hours after surgery. It also will evaluate how long it will take before the patients require rescue pain medication, and how much total pain medication will be needed.

How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study

The goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. The main question the trial aims to answer is: • Do patients aged 75 and older with hip fractures benefit from quicker treatment of anaemia (low blood count) to reduce the risk of delirium? Researchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium. Participants will: * Undergo blood tests and have their vital signs checked, as well as be screened for delirium three times a day for the first 48 hours after surgery. * Receive blood transfusions promptly if their haemoglobin levels drop below a specified threshold. * Have a follow-up visit at 30 days to assess their memory and overall quality of life. * Have another follow-up at 90 days to check for hospital readmissions and survival

COmparison of PENG Block and SIFICB in Hip Fracture Surgeries

The aim of this study is to compare the effectiveness of the PENG block and SIFIB in facilitating the positioning for neuroaxial anesthesia and their impact on the quality of postoperative analgesia.

Is the CRP-Albumin-Lymphocyte (CALLY) Index Effective in Predicting Postoperative Delirium in Geriatric Patients Undergoing Hip Fracture Surgery

Introduction: Postoperative delirium (POD) is a common complication in elderly surgical patients and is significantly associated with prolonged hospital stays, cognitive impairment, functional decline, and increased mortality rates within 6 to 12 months. Its incidence has been reported to range between 10% and 70%, depending on the diagnostic criteria used, the population studied, and the type of surgical procedure performed. The incidence is particularly higher following vascular, cardiac, and hip fracture surgeries. According to the 2024 updated guidelines by the European Society of Anaesthesiology and Intensive Care (ESAIC), POD should be screened at least once daily for a minimum of three days, beginning in the post-anesthesia recovery unit, based on the DSM-5 criteria. POD is a complex syndrome associated with various phenotypes and is likely the result of a combination of neuroinflammatory and oxidative stress processes. Candidate biomarkers for POD include inflammatory parameters (such as interleukins, C-reactive protein \[CRP\], erythrocyte sedimentation rate, and CD68), dopamine receptors, norepinephrine levels, cortisol levels, genetic biomarkers (e.g., apolipoprotein E4), acetylcholinesterase levels, and albumin levels. However, systemic stress can lead to nonspecific activation of the immune system, resulting in a decrease in lymphocyte count. Although the relationships between CRP, albumin, and lymphocyte count with POD have been individually investigated in the literature, no study has examined the combined effect of these three parameters. Based on this, we aimed to investigate whether the CRP-Albumin-Lymphocyte (CALLY) Index, a novel index not previously reported in the literature, is effective in predicting POD in geriatric patients with hip fractures. The CALLY Index is calculated using the formula: (Albumin × Lymphocyte) / (CRP × 10⁴). Aim/Hypothesis: H₀: The CALLY Index cannot predict the risk of postoperative delirium in geriatric patients undergoing hip fracture surgery. H₁: The CALLY Index can predict the risk of postoperative delirium in geriatric patients undergoing hip fracture surgery. Material-Methods: The following data will be recorded for each patient: * Demographic variables: age, sex, height, weight, and body mass index (BMI) * American Society of Anesthesiologists (ASA) physical status classification * Comorbidities and medication use * Smoking and alcohol consumption history * Preoperative laboratory parameters: obtained from the hospital information system for CALLY Index calculation * Perioperative variables: type and duration of anesthesia, duration of surgery, type of surgical procedure, estimated blood loss, blood product transfusion status, and occurrence of intraoperative adverse events * Postoperative data: * Ward of admission after surgery (orthopedic ward/intensive care unit) * Presence of delirium, assessed twice daily (morning and evening) for three days using DSM-5 criteria, starting in the post-anesthesia recovery unit * Occurrence of postoperative complications * Length of stay in the intensive care unit * Total hospital length of stay * Mortality status Patients aged 65 years and older who undergo surgery for femoral neck or intertrochanteric fractures will be included in the study. Patients with preoperative delirium, preoperative dementia, pathological or open fractures, systemic or localized infections in the fracture region during the preoperative period, or multiple trauma will be excluded. Additionally, those with a BMI \<18.5 or ≥35 chronic organ failure, or advanced-stage cancer will be excluded from the study.

Relationship Between Fracture Type and Preoperative Nutritional Status with Postoperative Pain

The geriatric patient group is a population that should be considered differently than other age groups due to physiological characteristics that change with age. When literature data is examined, it is seen that patients over the age of 65 are evaluated differently in studies. The rapid aging of the general population causes more elderly patients to need surgery. However, malnutrition is a common comorbidity in surgical patients . In addition, chronic diseases, multiple drug addiction, low nutritional intake, decreased appetite and psychological conditions seen in geriatric patients are risk factors for the development of nutritional deficiencies . Therefore, it is important to specifically consider geriatric patients, who frequently have these risk factors, in terms of malnutrition and to evaluate the nutritional status of these patients before surgery. It is estimated that the prevalence of malnutrition in hospitalized geriatric patients varies between 30% and 60%, depending on the population studied and the assessment tools applied . Despite these high malnutrition rates, this issue has not received sufficient clinical attention. Furthermore, malnutrition is highly associated with the prognosis of elderly perioperative patients, which may lead to poor clinical outcomes, increased morbidity and mortality, complication rates, decreased quality of life, prolonged hospital stay, and increased hospital and healthcare costs. A number of different screening tools are currently available to assess nutritional status in the elderly. However, there is currently no gold standard. The Nutrition Risk Score 2002 (NRS2002) is a nutritional screening tool for adult inpatients, launched in 2002 by the European Society of Clinical Nutrition and Metabolism (ESPEN). The Mini Nutritional Assessment - Short Form (MNA-SF), recommended by the European Union, and the Geriatric Nutrition Risk Index (GNRI), which has recently been evaluated as a new screening tool, has been validated for the diagnosis of malnutrition and the prediction of clinical outcomes, and is based on objective measurements that do not require patient cooperation, and whose validity has been demonstrated in other studies for the prediction of short- and long-term outcomes. In addition, the Prognostic Nutrition Index (PNI) is an indicator used to assess the nutritional status of surgical patients, estimate the risk of surgery, and make prognostic judgments. Although it has been stated that all four nutritional screening tools mentioned above can be used as prognostic indicators in geriatric surgical patients, the relationship between these screening tools and postoperative pain, complications, and hospital stay in geriatric patients undergoing orthopedic hip surgery has not yet been evaluated. Hip fracture is a painful event that is frequently seen in older adults. Hip fractures are generally classified as femoral head fracture, femoral neck fracture, intertrochanteric fracture, and subtrochanteric fracture. Hip fracture is treated with proximal femoral nailing, partial hip replacement, and total hip replacement surgeries. Studies have reported that patients experience very high rates of moderate to severe pain following hip fracture surgery. This situation shows that the approach to pain management in hip surgery is still inadequate and that investigators need different perspectives on postoperative pain in these patients. It is known that hip fracture is associated with serious morbidity, mortality, and disability in the elderly. Inadequate pain management in these patients is associated with low motivation and has a high impact on functional recovery. Therefore, adequate pain management is important in patients with hip fractures to prevent mental and physical complications and to ensure appropriate compliance with rehabilitation. It is known that pain is affected by many factors such as biophysiological, biochemical, demographic, psychosocial, behavioral and moral variables and age. It is known that unmanaged postoperative pain will significantly affect cardiopulmonary and thromboembolic complications, morbidity and mortality, hospital discharge, quality of life and daily activities. In this context, determining the factors that predict acute pain will allow earlier intervention. Thus, short- and long-term morbidity, medication use, hospital stay and, accordingly, healthcare expenses will be reduced.This study aimed to evaluate the relationship between preoperative hip fracture type, surgery type, nutritional status and postoperative pain and prognosis (complications and hospital stay) in geriatric patients who will undergo hip surgery due to hip fracture. Secondly, it was aimed to determine which of the above-mentioned nutritional risk screening tools would be more appropriate in these patients and which nutritional risk screening tool could predict postoperative pain and prognosis in patients who will undergo hip surgery.

Population-based Registry Study on Primary Hip Fracture Surgery

This study aims to describe primary hip fracture surgeries and to identify patient-related and perioperative risk factors affecting outcomes. It will utilize data from the Swedish Perioperative Registry (SPOR) and the Swedish National Patient Register to track epidemiological changes, treatment outcomes, and perioperative factors.

Frailty, Hip Fractures and Inflammatory Biomarkers

We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.

Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy

PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance

The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery

The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.

Influence of Static Distal Locking of a Short Proximal Femoral Nail

Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.