9 Clinical Trials for Various Conditions
The purpose of this phase 2 randomized control trial will be to evaluate the effect of glucose-insulin-potassium (GIK) therapy in the setting of lower extremity trauma to reduce short- and long-term muscle damage, acute rhabdomyolysis, and acute kidney injury. The study will consist of 40 patients with femur or tibial shaft fractures randomized to the GIK arm (using a well-described systemic GIK protocol; n = 20) or the control arm (using isotonic saline; n = 20). The use of systemic GIK is expected to decrease the overall amount of lower extremity muscle cell death and result in improved muscle function in the postoperative period. Additionally, the investigators hypothesize that GIK will lead to less severe rhabdomyolysis and a concomitant decrease in the incidence of AKI that results from the byproducts of muscle cell death.
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 shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5). The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study
The purpose of this study is to evaluate both genotypic differences and differences in local gene expression in individuals who develop acute traumatic compartment syndrome relative to control patients with at-risk lower extremity fractures who do not develop compartment syndrome.
The investigators will compare intramedullary nailing of open and closed tibia shaft fractures with carbon fiber implant versus titanium implant in a Level I trauma setting.
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.
Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required. Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment
The objective is to determine the effect of vitamin D3 supplementation on fracture healing at 3 months.
The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.