Clinical Research Directory

Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries

The goal of this study is to determine if the computer software, RBfracture, developed by Radiobotics, helps primary care, emergency, and radiology clinicians more easily identify bone injuries caused by a traumatic impact (such as a fall or car collision). RBfracture uses artificial intelligence (AI) to analyze X-ray images of patients to identify fractures and joint dislocations visible on the X-ray images. RBfracture also identifies fluid buildup in the elbow and knee joints resulting from a fracture or dislocation. Sixteen clinicians will review X-ray images from 415 adult patients, who may have sustained a bone injury, to diagnose any injuries visible on their X-ray images. First, the clinicians will review half of the images with and half of the images without the help of the RBfracture software. After a 4-week break, the clinicians will once again review the same images. This time, the software's help will be switched, so it is unavailable for the images the clinicians previously reviewed with it, and available for the images they reviewed without it. The number of correct and incorrect diagnoses made by the clinicians when they were helped by the software will be compared to the number of correct and incorrect diagnoses made by the clinicians when they did not receive any help from the software. This comparison will reveal if using the software helps clinicians to diagnose more injuries and miss less injuries.

Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study

The goal of this clinical trial is to learn if buprenorphine can treat pain in older adults who have broken bones. The main questions it aims to answer are: Is buprenorphine as effective as opioids to treat pain? Are there less side effects with buprenorphine? Researchers will compare buprenorphine and hydromorphone to see if there are differences in pain control and side effects. Participants will be given one of the two study drugs after breaking a bone and asked about their pain scores and side effects for the next 48 hours.

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance

The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement improve musculoskeletal health and prevent falls and declining physical performance in the increasing number of older adults in the U.S. with potential for clinical and public health benefits.

Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study

Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch. Method: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital Jinshan Branch health care system. The Jinshan Branch program enrolled patient with 1) new hip fracture 2) newly identified vertebral fractures (radiological or clinical) from both inpatients and outpatients. At the same time, a osteoporosis medication management service is also establish as a complement of FLS to enroll patients on antiosteoporosis medications (AOMs) but not necessary with fracture. Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases. During the whole study period, the investigators planed to enroll 200 patients (with or without fracture). Each patient would be assessed at baseline, and every 4 months last for two years.

Exactech Shoulder Post Market Clinical Follow-up Study

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

Metagenomic Next-Generation Sequencing for the Diagnosis of Fracture-related Infection

The value of next-generation sequencing (NGS) using Nanopore technology has been demonstrated in the case of diabetic patients' wounds or in prosthetic joint infections. The aim of this study is to demonstrate its relevance as a new diagnostic approach for fracture-related infections (FRI). Bone samples from patient with FRI will be submitted to shotgun metagenomic Next-generation sequencing using Oxford Nanopore Technology (ONT) in order to establish its diagnostic value in this context in comparison with the reference method.

Pediatric Orthopaedic Implant Safety & Efficacy

Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity. Given the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy. Prospective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).

Single Shot Exparel vs Catheters in Lower Extremity Trauma

This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.

Clinical and Radiological Outcomes of Medacta Shoulder System

This is a post-marketing surveillance on Medacta Shoulder System

Clinical and Radiological Outcomes of Medacta Shoulder System FR

This is a post-marketing surveillance on Medacta Shoulder System

Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

This is a post-market surveillance study on Medacta Shoulder System

Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems

The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System. A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation. Outcomes will be collected until up to 2 years after surgery.

Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Acute blood loss in orthopaedic trauma and operative fracture care contributes substantially to perioperative anemia, which places participants at increased risk for complications including surgical site infection, cardiovascular complications, and even death. Anemia has further clinical implications in quality of life measures and is associated with fatigue, impaired physical performance, decreased exercise capacity, and mood disturbances. Thus, evaluation and treatment of perioperative anemia is critical in risk mitigation within orthopaedic surgery. The current standard of care for anemia is transfusion of packed red blood cells in only cases of severe anemia due to the substantial associated risks. A safer alternative is desirable because a critical number of participants do not meet the restrictive transfusion threshold and may suffer negative effects from anemia during recovery from the acute insult. The focus of this project is to pilot an investigation of the benefits of intravenous iron therapy (IVIT) in traumatically injured patients. Specifically, Aim I will determine feasibility of study design, recruitment, randomization, intervention implementation, blinded procedures, and retention. In Aim II, time to return to normal hemoglobin following traumatic orthopaedic injury will be assessed. With Aim III, the investigators will measure IVIT effect on participant-reported fatigue, physical function, and depression, and further determine if resolution of anemia is correlated to improvements in these measures in traumatically injured orthopaedic patients. Aim IV will focus on evaluating the role of IVIT on immune cells through a variety of novel laboratory assessments. The investigators expect this study to provide a better understanding of IVIT, which has the potential to alter providers' treatment approach of anemia in participants who sustain traumatic orthopaedic injury, thereby leading to decreased risks and improved recovery.

Cannabidiol After Multi-Trauma for Pain and Opioid Therapy

The aim of this project is to investigate the therapeutic potential and safety of acute Cannabidiol (CBD) treatment on longitudinal pain symptoms, and to assess potential interactions with pain mediators including opioids and sex on CBD treatment response. To this end, this research protocol proposes a comprehensive translational approach including a placebo-controlled randomized clinical trial comparing two daily doses of CBD treatment administered for one month on pain relief. This study will also compare intervention conditions on inflammation markers, participant quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function.

The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)

To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.

Immediate Fracture Risk After Antihypertensive Drug Initiation

This retrospective observational study aims to evaluate the short-term fracture risk associated with anti-hypertensive medication initiation using a self-controlled case series (SCCS) design and investigate temporal trends of initial anti-hypertensive regimen (monotherapy vs combination therapy) and subsequent fracture incidence. The investigators use the Korean Health Insurance Review and Assessment (HIRA) database to identify adults aged ≥65 with a new prescription for anti-hypertensive therapy and at least one incident non-traumatic fracture. In the SCCS analysis, the investigators estimate the within-person incidence rate of overall fractures during the 30-day period following anti-hypertensive initiation compared to control periods. Temporal trends will be recorded through 2013 - 2022. The primary outcome is overall non-traumatic fracture occurrence; the secondary outcome is incident proximal hip fracture. These outcomes are defined using diagnostic and procedural codes validated for use in claims data. This study aims to quantify both the immediate temporal association between treatment initiation and fracture risk, and the comparative safety of different initial anti-hypertensive regimens.

Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial

Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures. These fractures have historically been treated mainly conservatively with good results. Recent development in fracture treatment and findings that certain fracture types are more prone to non-union and bracing-related functional problems of adjacent joints are somewhat common have caused increasing interest in treating these fractures surgically. Return to activities is also considered to be quicker among surgically treated patients. The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who are willing to participate in the study after informed consent are randomly assigned to two different treatment methods: 1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking plate. 2. Conservative treatment with functional bracing The randomization is done using blocked randomization (block sizes are not known by the enrolling or assigning physician) and stratification is done according to fracture type (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no palsy). Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and clinical and radiological assessments are made. The physiotherapist doing objective functional measurements is blinded to treatment method. Both study groups receive physiotherapy after the initial treatment.

Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation

Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).

Anti-osteoporosis Medication Monitoring and Management Service

BACKGROUND: One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares. OBJECTIVES: To establish a anti-osteoporosis medication management service at National Taiwan University Hospital and its BeiHu Branch. METHODS: Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases. the investigators plan to enroll 500 patients with 18-month follow up for each.

Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.

Fragility Fracture Liaison Service Project

Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB). Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital (NTUH) health care system. The main hospital (MH) program enrolled patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3) clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB) program enrolled only the later two types of patients from outpatients. During the whole study period, two programs planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 month for at least one year.

Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute

This prospective research project aims to evaluate the effectiveness and clinical outcomes of utilizing antibiotic-impregnated bioactive bone substitute (PerOssal®) in the surgical management of osteoarticular infections. Osteoarticular infections pose significant challenges in orthopaedic surgery due to the risk of persistent infection, bone loss, and functional impairment. Traditional treatment approaches involve extensive debridement followed by systemic antibiotic therapy and bone grafting. However, antibiotic-impregnated bioactive bone substitutes offer a promising alternative by providing local antibiotic delivery and promoting bone regeneration simultaneously. This study will prospectively enrol patients undergoing surgical intervention for osteoarticular infections and assess their clinical outcomes, including infection resolution, bone healing, functional recovery, and complication rates. Comprehensive data collection will include preoperative patient characteristics, intraoperative details, postoperative outcomes, and long-term follow-up assessments. Statistical analyses will be performed to compare outcomes between patients treated with antibiotic-impregnated bioactive bone substitute and those past managed with traditional methods. The findings of this study are expected to contribute valuable insights into the effectivennes and safety of this novel approach, potentially informing future clinical practices and optimizing patient care in the management of osteoarticular infections.