Clinical Research Directory

Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics

compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life

Hip fractures often lead to functional limitations, loss of independence, weight loss and decreased well-being. Only half of the patients regain their functional level and 24% die within the following year. Financial consequences are significant due to costly surgery and long-term care. Hip fracture incidence is expected to increase sharply due to the ageing population, reducing accessibility to and quality of rehabilitation care. Therefore, optimizing treatment is essential. Previous protein and exercise studies showed improved muscle and bone health in healthy or frail community-dwelling older adults, but effects in older hip fracture patients are not known. Better rehabilitation may improve bone and muscle health, nutritional status, quality of life, lower costs and lower burden for healthcare. The overall objective is to investigate the effectiveness, costs and cost-effectiveness of a protein-enriched diet and resistance exercise for 3 months compared to usual care on bone and muscle health, and quality of life in older adults recovering from an acute hip fracture.

Stronger at Home: Improving Outcomes for Older Adults After Hip Fracture

The goal of this clinical trial is to compare the effectiveness of a new 14-week individually-tailored home-based rehabilitation program called "Stronger at Home" with usual care in improving functional recovery in community-dwelling older adults after hip fractures. The main question this trial aims to answer are: • Is the Stronger at Home program more effective than usual care in improving functional recovery at the end of the 14-week intervention? secondary questions include: * What is the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge? * Does the program have a sustained impact on functional recovery at 6 months and 12 months post-discharge? Participants in the trial will be asked to engage in the following tasks: * Participate in the Stronger at Home program, which includes using a self-directed toolkit consisting of educational resources and an illustrated exercise program. * Follow the guidelines provided in the toolkit for gradually increasing exercise intensity and incorporating different types of exercises into their daily life. The effects of the Stronger at Home program will be compared to those of usual care.

Zoledronate Early to Hip Fracture Patients - Safe and Effective?

To prevent hip fracture patients for having another fracture, secondary fracture preventing medication should be given as soon as possible. Zoledronate is the most efficient bisphosphonate and is given as an intravenous infusion once yearly. However, the appropriate time to initiate zoledronate treatment after a hip fracture has not yet been established. To clarify the optimal timing of zoledronate to hip fracture patients we have designed a double-blinded, placebo-controlled randomized non-inferiority trial to compare if zoledronate administered early (within 5 days) after hip fracture surgery is as good as zoledronate given late (3 months) after hip fracture surgery.

Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation

This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.

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.

Pericapsular Nerve Group Block Versus Femoral Nerve Block Study

Hip fractures are common in older adults and are often associated with severe pain, making it difficult for patients to sit for spinal anesthesia before surgery. Peripheral nerve blocks may improve pain control and facilitate patient positioning, but it remains uncertain whether the Pericapsular Nerve Group (PENG) block provides advantages over the traditional femoral nerve block during the spinal anesthesia procedure.

Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion

Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.

PENG Block + LIA For Endoprosthesis Surgery

The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. The main questions it aims to answer are: * Is the new local anesthesia technique as effective as standard spinal anesthesia in managing pain during the first two days after surgery? * Does the new technique allow participants to move their leg sooner after the operation? Researchers will compare the new local anesthesia technique (numbing medicine injected directly around the hip joint) to standard spinal anesthesia (a numbing injection in the back) to see if the new technique works just as well for pain control while possibly causing fewer side effects like nausea. Participants who join this study will be randomly placed into one of two groups. One group will receive the standard spinal anesthesia before their surgery. The other group will receive the new local anesthesia technique before their surgery. After the operation, researchers will track the amount of extra pain medicine each participant uses and will check their ability to move their hip, knee, and foot.

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.

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.