Clinical Research Directory

Evaluation of the Diagnostic Potential of Nanox.ARC Tomosynthesis System for Different Diseases

This is a prospective, single-arm, clinical study evaluating the diagnostic performance of the Nanox.ARC Digital Tomosynthesis (DTS) system in adult patients with suspected or confirmed musculoskeletal (MSK) pathologies presenting to the Emergency Department (ED) or orthopedic outpatient clinic at Meir Medical Center, Israel. The study aims to assess whether DTS provides additional diagnostic information beyond conventional radiography and whether it can reduce the need for advanced imaging (CT/MRI) in MSK patients.

Nerve Block Resolution Time Display and Pain Complaints

This randomized prospective study will evaluate whether displaying the expected nerve block resolution time on a patient's splint reduces postoperative pain-related complaints after orthopedic surgery. Adults with a fracture who undergo surgery at the Medical University of South Carolina and receive a preoperative nerve block may be eligible. Participants will be randomly assigned to receive standard verbal communication alone or standard verbal communication plus a written display of the expected nerve block resolution time on the splint. The study will compare the number of postoperative pain-related phone calls between the two groups.

REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction

This prospective, observational, comparative diagnostic study will evaluate the performance of Radiofrequency Echographic Multi Spectrometry (REMS) for the diagnosis of osteoporosis and prediction of fragility fracture risk in a U.S. population, using dual-energy X-ray absorptiometry (DXA) as the reference standard. Approximately 250 male and female participants aged 30-90 years who are undergoing evaluation for bone health will be enrolled at Rheumatology Associates of Delmarva. Participants will have clinically obtained DXA results and undergo REMS assessment of the lumbar spine and proximal femur. Diagnostic performance, including sensitivity, specificity, predictive values, and concordance between REMS and DXA, will be evaluated. Participants will also be followed by telephone at 6 and 12 months to identify incident non-traumatic fragility fractures and assess the ability of REMS and DXA to predict fracture risk.

Opioid Analgesia Impacts on Neurological Development

Background: Pain in childhood - whether from injuries like fractures or long-term conditions like scoliosis - is often treated with opioid medicines. These drugs are effective for pain relief. Recent research suggests that they may affect brain development if given during key stages of growth. This study will explore how different types of pain and opioid use impact brain activity in children using a child-friendly brain scan called OPM-MEG. Objectives: 1. To compare brain activity patterns in different regions of the brain in children with different pain and opioid exposure profiles. 2. To investigate the relationships between brain activity and clinical features, including subjective pain ratings, pain sensitivity, and psychological outcomes (e.g. trauma symptoms, distress). Participants will be asked to attend a single visit, which may coincide with their follow-up clinical appointment to orthopaedics or at an alternative convenient time. The visit will take approximately 1-1.5 hours and consist of recording brain activity using the child-friendly OPM-MEG (like a bicycle helmet) during rest and in response to a variety of sensory stimuli. Participants will also be asked to complete a small number of questionnaires.

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.

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.

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.

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.

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.

Soft Part Management for Surgical Fractures of the Lower Limb

The assessment consists in comparing corticoids injection versus placebo in surgery of lower limb fractures The aim of study is to assess (state cutaneous, efficacy, safety) corticoids injection on a prospective, randomized analysis

Multimodal Decision Support for Perioperative Risk Stratification in Older Adults Undergoing Surgery for Fracture

The goal of this observational study is to establish a standardized multicenter cohort and develop and validate clinically interpretable models for perioperative risk stratification, brain-state risk prediction, objective pain assessment, sleep-pain-delirium association analysis, and longer-term prognosis.The main questions it aims to answer are: Can clinically interpretable predictive models be developed for perioperative risk stratification and brain-state changes? What are the associations among objective pain measures, sleep quality, and postoperative delirium? Are these perioperative factors associated with longer-term patient outcomes? This is a multicenter cohort study without a separate comparator group. Participants will undergo routine perioperative clinical assessments and standardized follow-up evaluations according to the study protocol.

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.

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.

Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department

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.

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.

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.

Relationships Between Vitamin D and Orthopedic Trauma

Vitamin D is an essential hormone involved in bone metabolism, bone mineral density maintenance, and bone health. Vitamin D deficiency is putatively linked to poor pediatric orthopedic outcomes \[1\]. Further, the risk of low vitamin D associated fractures may be greater in minority pediatric populations \[2\]. In adults, utility of vitamin D alleles as a biomarker for bone density and fracture risk has been debated for over 10 years \[3-5\]. Peak bone density is achieved at 25 years old; however, most orthopedic trauma patients less than 25 years of age present with substantial vitamin D deficiencies.

Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study

Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures. In this preliminary study, RAGT will be conducted using an end-effector-type gait-training robot. Participants will receive 60 min of gait training daily (30 min of conventional gait training and 30 min of RAGT) for 8 weeks. We plan to conduct clinical evaluations related to gait function of the participants included in the preliminary study before training and after 8 weeks of training.

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.

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.

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.

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).

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