940 Clinical Trials for Various Conditions
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.
Fractures, Bone
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are: Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels? Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.
Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
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.
Fractures, Bone, Trauma Injury
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.
Opioid Use, Fractures, Bone, Trauma
The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.
Hip Fractures
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.
Bone Fracture, Fresh Fracture
The goal of this clinical trial is to compare photobiomodulation therapy (PBMT) in addition to standard of care in the treatment of tibial and metatarsal bone stress injuries in a military training setting. Participants will all receive usual care and also be randomized to either active or sham photobiomodulation therapy. Effectiveness will be assessed based on time to return to duty and measures of pain and function. * Participants will receive care for a maximum of 6 weeks. * Participants will have follow-up through 4 months (or graduation/dismissal from training, whichever comes first).
Metatarsal Stress Fracture, Stress Fracture of Tibia
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture. Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.
Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue leading to bone fragility (i.e., weakness) and an increased risk for fracture. Bone strength is a critical factor in a bone's ability to resist fracture and is clearly an important outcome in studies of osteoporosis. The current standard for assessing bone health and diagnosing osteoporosis is to use dual-energy x-ray absorptiometry (DXA) to quantify the areal bone mineral density (BMD), typically at the hip and spine. However, DXA-derived BMD has limited discriminatory accuracy for distinguishing individuals that experience fragility fracture from those who do not. One well known limitation of DXA-derived BMD is that it does not adequately assay bone strength. There is a critical unmet need to identify persons more accurately with diminished bone strength who are at high risk of experiencing a fragility fracture in order to determine an appropriate therapy. A potential new diagnostic approach to assess skeletal health and improve osteoporosis diagnosis is the use of Cortical Bone Mechanics Technology (CBMT). CBMT leverages multifrequency vibration analysis to conduct a noninvasive, dynamic 3-point bending test that makes direct, mechanical measurements of ulnar cortical bone. Data indicates that CBMT-derived ulnar flexural rigidity accurately estimates ulnar whole bone strength and provides information about cortical bone that is unique and independent of DXA-derived BMD. However, the clinical utility of CBMT-derived flexural rigidity has not yet been demonstrated. The investigators have designed a clinical study to assess the accuracy of CBMT-derived ulnar flexural rigidity in discriminating post-menopausal women who have suffered a fragility fracture from those who have not. These data will be compared to DXA-derived peripheral and central measures of BMD obtained from the same subjects.
Osteoporosis, Osteopenia or Osteoporosis, Osteoporosis, Postmenopausal, Osteoporosis Risk, Osteoporotic Fractures, Fragility Fracture, Bone Fracture
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
Type 1 Diabetes, Osteopenia, Bone Loss, Fractures, Bone
Serum lactate has been utilized as a standard in guiding management of orthopedic injuries. Elevated preoperative lactate has been associated with a higher likelihood of postoperative complications. However, lactate's role in guiding operative timing in non-critical long-bone fractures has not been previously explored. This study investigates lactate's role in guiding surgical timing and predicting complications secondary to delayed definitive correction in non-critical long-bone fractures with Injury Severity Score \<16.
Lactate Blood Increase, Trauma Blunt, Trauma, Secondary, Injury Traumatic
The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.
Fracture of Radius and Ulna
The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds. Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.
Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents, Fractures, Bone, Extremity Fracture Lower, Extremity Fractures Upper
The aim of this project is to assess the effectiveness of the IlluminOss pelvic implants in patients with pelvic metastatic disease presenting with pain, risk of pathologic fracture, non-displaced or minimally displaced pathologic fracture of the pelvis, and geriatric patients with pelvic fragility fractures. Results from this study will be used to confirm preliminary clinically and possibly statistically significant reductions in pain and improvements in function among these patients.
Cancer Metastatic, Trauma, Pathologic Fracture
This research study is being done to measure bone health in living kidney donors and compare them to non-kidney donors to learn if living kidney donors have a higher risk of bone fractures (breaks) after kidney donation. Certain chemicals in the body that help maintain bone health were shown to have changed after kidney donation in living donors, whether or not these changes lead to a decrease in bone quality and increase the risk of fractures is not known. The purpose of this study is to compare the bone health of living kidney donors, with the bone health of non-kidney donors. This information will be helpful in informing future kidney donors of the risks of donation and in creating treatments to help prevent these complications.
Renal Transplant Donor of Left Kidney, Renal Transplant Donor of Right Kidney
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.
Fractures, Bone
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.
Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited, Fracture, Tibial, Fracture of Femur, Fracture Arm
Administration of ultrasound guided peripheral nerve blocks is a procedural skill set that falls within the scope of Emergency Medicine practice. Extrapolating evidence from Anesthesia and Orthopedic literature (which shows decreased post-operative opioid use by surgical patients who receive regional anesthesia as part of their pre and perioperative pain management strategy) the investigators believe that early administration of regional anesthesia for long bone fractures by providers in the ED may have an as of yet unidentified positive impact on long term opioid use. If this is indeed found to be the case, early administration of regional anesthesia for extremity fractures would represent an area of focus for ED providers in the national effort by the medical community to combat opioid abuse.
Bone Fracture, Opioid Use, Opioid Dependence
The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.
Pain, Acute
This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a common treatment for tibia shaft fractures in adults. The study group will have a bone graft applied to the open cortex of the fracture. The bone graft will be composed of the intramedullary reamings, which are a byproduct produced when the intramedullary canal is reamed in preparation for insertion of the IMN.
Tibial Fractures, Nonunion of Fracture, Delayed Union of Fracture
This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). It is hypothesized that by 6 months, the number of subjects with successful bone healing will be greater in the BHA-treated group compared to subjects treated with standard of care alone. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of infection.
Tibial Fractures
The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.
Metabolic Bone Disease, Transplant-Related Disorder, Secondary Osteoporosis
The goal of this translational study is to establish a newly emerging CT-based tool for the characterization of changes in bone micro-architecture and assessment of their implications for fracture-risk in a population of COPD patients at risk for osteoporosis. The tool will be suitable and generalizable across emerging CT scanners from different vendors, and it will provide a more structurally-based assessment of osteoporosis and bone loss than is provided by simple bone density measures. The study will characterize the impact of different COPD-related factors on bone structure, and their implications for fracture-risk, leading to the development of a COPD-specific model for assessment of fracture-risk that will utilize patient-specific demographic, clinical and radiographic data, and CT BMD at the spine, as well as bone structural measures at the hip and/or ankle.
Pulmonary Disease, Chronic Obstructive, Osteoporosis
Osteoporosis is a common disease among elderly people, which leads to an increased bone fracture risk. Bone fractures can greatly reduce quality of life and increase age-related problems including reduced life expectancy. In clinical practice, a bone mineral density (BMD) scan using dual-energy X-ray absorptiometry (DEXA) is used for diagnosing osteoporosis. However, DEXA does not always accurately predict who will develop fractures and who will not. This is because bone mineral density alone does not capture all of the factors that contribute to bone strength. One factor bone mineral density does not measure is trabecular microarchitecture of bone (structure of bone). Our goal in this study is to use a specialized CT scan called Dual-Energy CT (DECT) to capture information about the trabecular (spongy) bone in the vertebra of the lower (lumbar) spine. Research has shown that this kind of information helps in predicting bone strength in bone specimens. The investigator will use this information to develop a method to more accurately predict which patients are likely to experience fractures of the lumbar vertebra. These are the most common type of fractures associated with osteoporosis. The participant is being asked to participate in this research study because a physician is treating the participant for osteoporosis and the participant has met the initial criteria to participate in the study. Participation in this study involves having a DECT scan, as well as a DEXA scan if the participant has not had one recently (within two months). Research studies include only those individuals who choose to take part. Please take time to make a decision. Please ask the study doctor or the study staff to explain any words or information that are not understood. The participant may also want to discuss it with family members, friends or other health care providers.
Osteoporosis
This pilot study will evaluate the feasibility of implementing an intervention in the home setting that is specifically designed to coach and mentor caregivers as they assist individuals with Alzheimer's disease and related dementia (ADRD) who have fractured a hip to perform everyday activities and engage in more physical activity.
Fractures, Bone, Dementia
The objective of this study is to determine whether a new minimally invasive method for in vivo measurement of cortical bone tissue properties can identify those who are at risk for fragility fractures of the hip and radius. The investigators hypothesis is that women with fragility fractures of the hip and radius have altered cortical bone tissue properties compared to non-fracture controls independent of standard clinical tests, such as bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).
Distal Radius Fracture, Osteoporosis, Hip Fractures
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
Open tíbia Fracture With Sub-segmental Bone Loss
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization. The initiation of the adjunctive treatment is to begin within 11 days of surgical stabilization.
Bimalleolar Ankle Fractures
This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.
Fracture of Shaft of Radius and/or Ulna, Metaphyseal Fracture of Bone of Upper Limb, Fracture of Upper Limb, Level Unspecified
The goal of this study is to perform the first fracture reduction clinical trial with a potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term care population.
Osteoporotic Fractures, Osteoporosis, Postmenopausal