The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.
This study is one of three separate studies of the Bioventus Observational Non-interventional EXOGEN Studies (BONES) program. Eligibility for each study is determined by fractured bone.
Dose and duration of bisphosphonate therapy will increase the likelihood that patients experience delayed healing of non-union fractures.
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
This study is to determine the composition of bone graft harvested using the RIA system in 16 orthopaedic trauma patients between age 19 and 65 who have sustained a fracture or non-union requiring bone grafting. The patients will be followed to assess clinical outcomes and associated pain.
The purpose of this multi-center study is to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established (appendicular skeletal) non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.
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.
To define a serum protein-based diagnostic for the progression and failure of fracture healing, through the identification of a set of serum proteins that appear at early times of biological healing and show a specific correlation with later radiological and functional signs used to define delayed healing and non-union.
The purpose of the study is to determine whether vitamin D supplementation in patients with hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with fractures of the humerus, femur, or tibia. The central hypothesis of the study is that vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the risk of nonunion compared to placebo treatment.