Journal of orthopaedic trauma
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Reliable clinical orthopaedic trauma research is important and necessary to guide orthopaedic surgeons and their patients to best practices and expected outcomes. Currently, most fracture care is guided by suboptimal clinical research. ⋯ Although each fracture trial comes with its own set of obstacles, the trial can be successful with proper expertise, study planning, and study design. The purpose of this article is to present the rationale, methodology, and implementation strategies to successfully complete a large fracture trial.
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Parathyroid hormone is a well-known regulator of calcium metabolism in the body. It binds to osteoblasts and assists in the regulation of bone turnover. Changes in parathyroid hormone levels have been documented in pathologic states such as osteoporosis, and fluxes are also noted during healing of fractures. ⋯ Parathyroid hormone, as a systemic mediator of calcium and bone metabolism, is a good candidate. Much research has been accomplished in animal models examining the role of parathyroid hormone in fracture healing. Although further research is required, especially in human fracture patients, early indicators are that parathyroid hormone may play a role in accelerating fracture healing in healthy patients and in reducing rates of fracture nonunion in compromised patients or tissue beds.
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Low-intensity pulsed ultrasound (LIPUS) is a relatively new technique for the acceleration of fracture healing in fresh fractures and nonunions. It has a frequency of 1.5 MHz, a signal burst width of 200 micros, a signal repetition frequency of 1 kHz, and an intensity of 30 mW/cm2. In 1994 and 1997, two milestone double-blind randomized controlled trials revealed the benefits of LIPUS for the acceleration of fracture healing in the tibia and radius. ⋯ For delayed union and nonunion, the overall success rate of LIPUS therapy is approximately 67% (humerus), 90% (radius/radius-ulna), 82% (femur), and 87% (tibia/tibia-fibula). LIPUS likely has the ability to enhance maturation of the callus in distraction osteogenesis and reduce the healing index. The critical role of LIPUS for fracture healing is still unknown because of the heterogeneity of results in clinical trials for fresh fractures and the lack of controlled trials for delayed unions and nonunions.
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The measurement of clinical outcomes in trauma research is often problematic in that it is subjective and currently no feasible gold standard evaluation is available. Consequently, observed trial results are partly dependent on which outcome measure is used. Precise and useful estimates of treatment effects can only be obtained when using reliable, valid, and responsive instruments for measuring fracture healing. ⋯ In contrast, patient-assessed measures have been designed specifically for investigational purposes and measure health on various domains. Some of them have been validated extensively. Critically evaluating established clinician-based assessments and integrating those found to be valid with patient-assessed outcomes into a composite measure of fracture healing constitute major future challenges.
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Selecting the most appropriate outcome measures can be especially burdensome in trials studying fracture healing, because the process of fracture healing is subjective and without a gold standard. Although a wide variety of radiographic modalities are available, plain radiography remains the most common approach for healing assessment. ⋯ In this article, we provide an overview of the most commonly used radiographic and clinical criteria for defining fracture healing. The validity and reliability of alternative approaches is also discussed.