Clinical Research Directory

Cervical Myelopathy in Hip Fracture Patients

Recent evidence has demonstrated a high rate of undiagnosed cervical myelopathy in patients presenting with hip fractures from a ground level fall. Identification and treatment of cervical myelopathy can help prevent falls and future fragility fractures. The purpose of this study is to screen ground level fall hip fracture patients for cervical myelopathy using a history, physical exam, and then offer an MRI if indicated.

Caregivers' eCourse for Recovery After Hip Fracture

In this two part study, we will seek 1. general feedback on the feasibility of an online education and skill development program for family/caregivers of older adults recovering from a surgically repaired low-trauma hip fracture. We will also 2. test its feasibility and acceptability with family caregivers.

PENG vs Femoral Block for Hip Fracture Analgesia

This study aims to compare the Pericapsular Nerve Group (PENG) block with femoral block for hip fracture pain. Participants presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block will receive either a PENG or femoral block. The choice of block will be dictated by a randomized monthly schedule, and all participants presenting during each four-week period will receive the designated block. A sub-group analysis will be performed to determine any difference in efficacy in participants with intracapsular versus extracapsular fractures.

Women's Health Initiative Strong and Healthy Study

The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to \~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise \& Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.

How TENS Affects Pain, Medication Use, and Muscle Function in Older Adults With Hip Fractures

The goal of this clinical trial is to learn if transcutaneous electrical nerve stimulation (TENS) can reduce perioperative pain in older adults with hip fractures. It will also evaluate its effects on physiological and psychological outcomes. The main questions it aims to answer are: Does adding TENS to usual care during the preoperative phase reduce pain intensity and analgesic consumption? Does TENS affect pressure pain threshold and vital signs (blood pressure, heart rate, and respiratory rate)? Researchers will compare active TENS to sham TENS (no perceptible stimulation) to see if TENS is effective in reducing pain and improving related outcomes. Participants will: * Undergo a standardized baseline assessment, including evaluation of pain, vital signs, anxiety, discomfort, and pressure pain threshold * Complete questionnaires assessing quality of life, physical activity, depressive symptoms, anxiety, fear of falling, and pain catastrophizing * Be randomly assigned to receive either active TENS or sham TENS * Receive a single 45-minute TENS session * Have their analgesic use recorded for the 24 hours before and after the intervention.

SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries

The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study.

Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture

The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip. The main questions aim to answer: * how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered * what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation.

Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blocks for Hip Surgery Analgesia

This study aims to investigate the efficacy of adding a Posterior Pericapsular Deep gluteal block to two other standard nerve blocks-the Pericapsular Nerve Group block and the Lateral Femoral Cutaneous Nerve block-for patients undergoing orthopedic hip surgery. While standard blocks target the front of the hip, many patients still feel pain in the back (posterior) of the joint. Researchers will compare two groups of patients to see if this triple-block combination provides better pain relief and reduces the need for rescue opioid medications in the 24 hours following surgery.

Endoprosthetic Replacement for Pathological Fractures of the Hip: A 35-year Update

This study will be based on a retrospective review of patients who received endoprosthetic reconstruction for pathologic fracture of the proximal femur. The objectives would be two-fold: (1) to compare rates ofambulation, pain, and survival to the historic cohort and (2) to identify predictors of ambulation in the current population.

Effect of Remimazolam and Propofol on Postoperative Delirium

Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.

Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP)

Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.

MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).

Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)

The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are: 1. Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction? 2. What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery? Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery. Participants will: 1. Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance. 2. Undergo hip replacement surgery under spinal anesthesia. 3. Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.

Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.

Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®

Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.

One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures

The goal of this clinical trial is to learn whether giving one dose or two doses of tranexamic acid can safely lower blood loss in older adults having surgery for certain hip fractures. The study includes adults aged 65 years or older who need surgery for pertrochanteric or subtrochanteric hip fractures. The main questions the study aims to answer are: * Does giving two doses of tranexamic acid lower the need for blood transfusions compared to one dose? * Does tranexamic acid help keep hemoglobin levels higher after surgery? * Is tranexamic acid safe in this group of participants? Researchers will compare participants who receive one dose of tranexamic acid with those who receive two doses to see which approach works better and is safe. Participants will: * Receive either one dose of tranexamic acid before surgery or two doses, one before and one after surgery * Have standard surgery to fix their hip fracture within 48 hours of hospital admission * Be monitored during their hospital stay for blood loss, transfusions, and medical problems * Be followed for up to 90 days after surgery to check for safety A total of 120 participants will take part in this study, which is being conducted at the University Clinic "St. Naum Ohridski" in Skopje, North Macedonia.

Precision Care for Older Persons

This study aims to 1) develop an Advanced Person-Centered (APC) Smart Home Care Model that is able to predict patient outcomes; and 2) evaluate the effectiveness of this model by assessing improvements in care and recovery for older individuals post hip fracture.

Conjoint Analysis of Patient Preferences in Joint Interventions

This study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment for any one of 11 musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus. This study aims to understand how multiple treatment variables, including pain, rehabilitation time, cost, and choice of surgical versus non-surgical intervention, impact patients' decision-making processes and ultimate choice of treatment.

Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA

The goal of the clinical trial is to compare different surgical methods for internal fixation of femoral neck fractures in younger adults. The main question it aims to answer is: Is internal fixation with the novel implant consisting of three angle stable screws locked together by a plate equal to internal fixation with cancellous screws or a sliding hip screw in younger adults under 65 years of age in terms of fracture migration? The study will examine how stable the fracture remains during healing. This will be measured by assessing how much the fracture moves after surgery using a highly precise imaging method called radiostereometric analysis (RSA). The study will also record complications and evaluate pain, health related quality of life, and hip function over time. The participants will be treated with either a novel angle stable implant (Dynaloc), cannulated cancellous screws or sliding hip screw and followed up at 6 weeks, 12 weeks, 6 months and 12 months. Recruitment will continue until 75 participants, 25 in each group, have completed the 12-week follow-up for the primary outcome.

The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture

The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age \>= 65) after recovering from surgical treatment of hip fractures.

Haemodynamic Effects and Complications of Continuous Versus Single-shot Spinal Anaesthesia for HIP Fracture Surgery

This research project aims to identify a safer method of spinal anaesthesia for elderly patients undergoing surgical stabilisation of proximal femoral fractures. The study's primary objective is to compare two spinal anaesthesia techniques: the continuous method (investigational), which allows titration of local anaesthetic doses through a catheter placed in the subarachnoid space, and the conventional single-shot bolus injection. The main hypothesis is that the continuous catheter technique reduces the incidence of intraoperative hypotension and related complications, such as delirium, acute kidney injury, and cardiovascular events. Beyond haemodynamic stability-assessed through advanced continuous monitoring of cardiac output and vascular resistance-the study will evaluate early and late complications, as well as quality of life up to 24 months post-surgery. The project is a prospective, randomised, multicentre clinical trial including at least 216 patients over 50 years of age, randomly assigned to one of the two groups. Proximal femoral fractures are a major and growing global health issue, particularly among geriatric patients with multiple comorbidities. The conventional single-shot spinal anaesthesia, though widely used, carries a high risk of hypotension, potentially leading to delirium, acute kidney injury, stroke, and cardiac events. These complications worsen prognosis, decrease quality of life, and increase mortality. Most existing studies are over two decades old, based on small cohorts and outdated anaesthetic protocols, and lack long-term follow-up data (\>30 days) on neurological outcomes, functional recovery, quality of life, and mortality. Moreover, no modern trials have provided direct, comprehensive comparisons between single-shot and continuous spinal anaesthesia. This project therefore seeks to fill this critical evidence gap through a robust randomised clinical trial. Using precise, continuous measurements of arterial pressure, vascular resistance, and cardiac output, alongside long-term assessments of neurological outcomes, quality of life, and survival, it aims to determine whether continuous spinal anaesthesia offers superior safety and should become the new standard of care for this vulnerable population.

Delivery and Implementation of a Randomised Crossover Trial on Thrombosis

What is the Study About? The DIRECT study (Delivery and Implementation of a Randomised Crossover Trial on Thrombosis) is a large research project investigating the best way to prevent blood clots (thrombosis) in people who break their hip. The study will compare two common treatments: aspirin (a tablet) and low molecular weight heparin (LMWH, an injection). Every year, thousands of people in the UK suffer a hip fracture, which often requires surgery and hospital care. After a hip fracture, patients are at risk of developing serious blood clots in their legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE), which can be life-threatening. Currently, doctors prescribe different medications to prevent these clots, but there is uncertainty about which treatment is best for people with hip fractures. Why is This Study Needed? Blood clot prevention is vital for hip fracture patients, but the current recommended treatment (LMWH) involves daily injections for 28 days, which some patients find uncomfortable and difficult to manage at home. Aspirin, a tablet taken by mouth, is a much simpler alternative, but there is not enough evidence to confirm whether it is as effective and safe as LMWH in this group of patients. The DIRECT study will help doctors and the NHS understand whether aspirin could be a safe and cost-effective alternative to LMWH. If aspirin is found to be just as effective, it could make treatment easier for patients and save millions of pounds for the NHS. How Will the Study Work? The study will involve 96 hospitals across the UK and will include over 21,000 patients aged 60 and older who have broken their hip. Hospitals will be randomly assigned to use either aspirin or LMWH as their standard treatment for a set period. After this, they will switch to the other treatment. This approach allows researchers to compare the two treatments fairly. All data will be collected from national NHS databases, which routinely record patient care and outcomes. This means patients will not need to do anything extra or attend additional follow-ups. What Are the Expected Benefits? This study will provide clear evidence on which treatment is better for preventing blood clots while minimising risks like bleeding. If aspirin is shown to be as effective as LMWH, it could: * Reduce the need for daily injections, making treatment more comfortable for patients. * Lower NHS costs, as aspirin is much cheaper than LMWH. * Provide a simple, widely available treatment option for older adults with hip fractures. How Will Patient Data Be Protected? The study will use anonymised patient data from NHS records. This means that all personal details will be kept confidential and protected according to strict NHS and research regulations. Patients who do not want their data to be used can opt out via NHS data-sharing policies. Summary The DIRECT study is an important project that will help improve care for hip fracture patients by determining whether aspirin can be a safe and effective alternative to injections for preventing blood clots. The results will help shape future NHS guidelines, ensuring patients receive the best possible treatment while reducing unnecessary costs and discomfort.