Clinical Research Directory

Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients

The purpose of this study is to determine whether an indocyanine green (ICG) fluorescence imaging system (cBPI) can be used to provide surgeons with information about bone health or bone blood flow. This will help surgeons better understand the healing potential of bone and relative risk of complication. This is important to help surgeons select the most appropriate treatment for severe traumatic injuries and infections.

Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.

Assessing AI-Supported Fracture Detection in Emergency Care Units

Brief Summary The purpose of this study is to determine if artificial intelligence (AI) can assist doctors in detecting broken bones, effusions, dislocations and bone lesions more quickly and accurately in an emergency room setting. The study will also evaluate whether AI can save time and reduce costs in healthcare. The main questions to be addressed are: * Does AI improve the accuracy of detecting broken bones/dislocations/effusions/bone lesions? * Can AI expedite the process of diagnosing broken bones/dislocations/effusions/bone lesions? * Does AI reduce healthcare costs by enhancing efficiency? To investigate these questions, two groups of patients will be compared. One group will follow the traditional diagnostic approach, while the other group will utilize AI to assist in diagnosing X-rays. Participants in the study will: Undergo standard X-ray imaging of injured arms or legs, as part of routine care. Have X-rays reviewed by doctors with or without AI support, depending on the assigned group. The study will include patients of all ages presenting to the emergency room with an isolated injury or joint complaints. No additional tests or treatments beyond standard care will be involved.

855303-RNA Biomarker Validation

The purpose of this study is to test the accuracy of using RNA in blood as a way to forecast new fracture healing outcome.

Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures

An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.

MDR - Biomet Cannulated Screws

The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).

Cast Art for Kids With Extremity Fractures

The goal of this clinical trial is to compare casts with cast art versus those without art in children who sustain a fracture of the extremity. The main goals are: * Determine the difference in satisfaction as measured by the visual analog scale for satisfaction between patients treated in a cast with cast customization versus those in a cast with no cast art * Determine the difference in perceived pain scores between patients treated in a cast with cast customization versus those in a case with no cast art Participants will be randomized to one of three groups: one with plain white cast, one with cast of color wrap of choice, and one with custom cast art. Researchers will compare to see the differences in satisfaction and perception of pain based on what cast the study participant receives.

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development.

VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma

The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.

Anticholinergic Burden and Osteoporosis in Rheumatoid Arthritis

Background: Rheumatoid arthritis (RA) is a chronic, progressive, inflammatory rheumatological disease. Use of corticosteroids for more than 3 months in RA treatment is considered an important risk factor in terms of developing secondary osteoporosis and increasing the risk of fracture. The cumulative effect of taking one or more drugs with anticholinergic properties is called anticholinergic load. It is stated that anticholinergic load also increases the risk of fracture in individuals. The aim of this study is to investigate the effects of drugs used by patients with Rheumatoid Arthritis (RA) on anticholinergic load and fracture risk. The Fracture Risk Assessment Tool (FRAX) will be used to assess fracture risk in patients. Materials and methods: The study was planned as a prospective cohort study. The study will included 100 patients who were followed up as outpatients with rheumatoid arthritis diagnosis in the physical medicine and rehabilitation clinic between 2024-2025. Patients of both genders and over 18 years of age diagnosed with rheumatoid arthritis will be included in the study. Patients with systemic diseases or medications affecting bone metabolism and those with metallic materials in the hip or lumbar vertebrae affecting bone mineral density measurement will be excluded from the study. Demographic characteristics, systemic diseases, medications used, bone density measurement and blood test values of the patients will be recorded. Patients taking multiple medications with anticholinergic effects create an anticholinergic burden. The Anticholinergic Drug Scale, Anticholinergic Cognitive Burden Scale and Anticholinergic Risk Scale will be used to measure anticholinergic burden in the study.

PAINED: Project Addressing INequities in the Emergency Department

Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.

Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care

Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

The investigators will directly compare the visual analog scale scores and narcotic pain medication requirements in the patients who have continuous passive motion (CPM) versus those who do not during the course of the hospital admission following an open reduction internal fixation surgery for acetabular fracture, supracondylar femur fracture, or a tibial plateau fracture.

Point-of-care Gastric Ultrasound for Fracture Surgery

Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Since ultrasound has been a part of perioperative anesthesiology practice, it is simple to assess gastric content preoperatively with bedside ultrasonography (USG). More research is necessary to define elective surgeries with a possible risk of aspiration. Therefore, we aimed to evaluate the adequacy of standard fasting protocols in post-traumatic fracture surgery by measuring and evaluating gastric volume and content with USG in the preoperative operating room.

Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma

This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

Patients with Type 1 Diabetes Mellitus (T1DM) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. The bone density of people with Type 1 Diabetes is higher at the time of fracture than in non-diabetics. This suggests the presence of underlying bone tissue mechanical defects. The potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. On a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health

Powdered Intrawound Vancomycin in Open Fractures Trial

The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture.

The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes.

A digital education for osteoporosis patients (DEOP) has been developed and tested on patients in Region Vastra Gotaland, Sweden. Currently, the evidence regarding the efficacy of patient education on fracture risk, medication adherence, injurious falls, levels of physical activity, and diet is insufficient. Most patients with osteoporosis in Sweden are diagnosed and treated in primary care, where the knowledge about osteoporosis is often very limited. Thus, in general, osteoporosis patients are not sufficiently informed before receiving a treatment recommendation. This randomized controlled trial aims to investigate if DEOP vs. standard care can reduce the incidence of fracture in older women and men, and if the intervention leads to better adherence to osteoporosis medication, higher quality of life, increased physical activity, and enhanced diet. The primary objective is to investigate if DEOP compared to standard care (without DEOP), can reduce the incidence of clinical fractures in men and women, over the age of 65 years, without previous osteoporosis medication the last year, who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic. The secondary objectives are to investigate if DEOP compared to standard care (without DEOP), can reduce the incidence of injurious falls, have positive effects on adherence to osteoporosis medication, positively affect diet (calcium and vitamin D intake), physical activity, and improve quality of life in men and women, over the age of 65 years, without previous osteoporosis medication the last year, who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic. Study design: randomized multicentre clinical trial. Patients over the age of 65 visiting an osteoporosis unit for a bone density scan (DXA) will be asked to participate in the study. The participants will be randomized to one of two arms where one arm will be invited to DEOP and the other arm will receive standard care, without DEOP.

Boneview-ED - Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study

Traumatic emergencies are the primary reason for consultation in emergency departments and standard radiography is the primary imaging exam for osteoarticular trauma. However, with the increase in the number of patients admitted to emergency departments and thus the increased workload for emergency room attendants, Interpretation of radiographs in trauma emergencies is made more difficult, resulting in a high risk of misinterpretation. The growing presence of artificial intelligence in the medical field, notably through the involvement of diagnostic software on imageries, makes its use more relevant in the aid of the replay of osteoarticular imageries. A recent meta-analysis of 32 studies evaluating the performance of artificial intelligence in fracture detection found comparable performance between experienced radiologists and AI-based diagnosis. However, these were mainly retrospective studies, and thus more distant from the reality of its use in a care stream such as emergencies. The objective of this study is therefore to prospectively validate the use of artificial intelligence software during its implementation in an emergency department for patients admitted for a suspicion of osteoarticular trauma.

Assessment of Depression Levels in Elderly Patients With an Orthopedic Fracture Compared to Patients After a Stroke.

Depression is common among elderly patients hospitalized due to acute conditions like strokes or osteoporotic fractures. It has significant impacts on quality of life, hospitalization rates, and mortality. Although studies have explored depression and its assessment, most focus on non-geriatric or ambulatory populations. This study examined depressive symptoms in elderly patients after a stroke or fracture. We assessed all patients for depression symptoms using the validated Geriatric Depression Scale - 15 item (GDS-15) and searched for contributing factors in each condition.

Treatment of Displaced Medial Epicondyle Fractures In Children

Compare the outcome of the operative and non-operative treatment; for fractures of the medial epicondyle of humerus in children as regards union, alignment and complications.

Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing

The study will be conducted to investigate the effects of electrical charges (flexoelectric effect) \& mechanical brachioradialis muscle bending force on the displacement and strain of fracture gap on children with Distal radius greenstick fracture via finite element method.

Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures

The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The main question it aims to answer is: \- What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures? Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge.

EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV

The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest pan-European cohort study and few studies of a comparable design are available on a global scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into the study through 11 cohorts since 1994. The main objective of the study remains the same as in 1994: to prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine their long-term virological, immunological and clinical outcomes. Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected patients, it is important for EuroSIDA to remain in the forefront of investigating the treatment benefits and adverse effects. All study documents, study status, newsletters, scientific publications and presentations are available online and are updated continuously at project website. In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort of consecutive HIV infected patients from across Europe in order to (1) assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.