Journal of orthopaedic trauma
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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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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.
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Comparative Study
Locked plating of distal femur fractures leads to inconsistent and asymmetric callus formation.
Locked plating constructs may be too stiff to reliably promote secondary bone healing. This study used a novel imaging technique to quantify periosteal callus formation of distal femur fractures stabilized with locking plates. It investigated the effects of cortex-to-plate distance, bridging span, and implant material on periosteal callus formation. ⋯ Stabilization of distal femur fractures with periarticular locking plates can cause inconsistent and asymmetric formation of periosteal callus. A larger bridge span only minimally improves callus formation. The more flexible titanium plates enhanced callus formation compared with stainless steel plates.
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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.