Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)

Pain intensity at 12-hour intervals during the 48 hours following definitive fixation surgery. Abstracted from medical record and supplemented by participant pain logs. At least one time point will be assessed using the Multidimensional Post Surgical Pain Scale in order to study multiple pain dimensions.

Pain intensity at 12-hour intervals between study enrollment and definitive fixation surgery. Abstracted from medical record and supplemented by participant pain logs.

Defined as the hospitalization during which the definitive fixation occurs. Length of stay for all other study injury related hospitalizations will also be abstracted.

Will include nonunion, wound closure complications, bleeding complications (particularly perioperative bleeding due to loss of platelet function and gastrointestinal bleeding), as well as pain treatment related adverse effects. These include nausea, vomiting, constipation, sedation, pruritis, respiratory depression, somnolence, dizziness, headaches, coordination problems, peripheral edema, blurred vision, gastrointestinal symptoms and irritation, renal impairment, platelet inhibition, angioedema, and post operative delirium. Adverse effects and complications will be assessed by both patient report of symptoms during the period between enrollment and 48 hours post definitive fixation, and by clinical survey of symptoms during index hospitalization and at discharge from additional surgical admissions up to definitive fixation.

The SMFA (Short Musculoskeletal Function Assessment) is a shorter version of the 101-item Musculoskeletal Function Assessment (MFA) questionnaire. The SMFA is a 46-item questionnaire consisting of the dysfunction index and the bother index. The dysfunction index has 34 items for assessment of patient function, while the bother index consists of 12 items designed to detect how much patients are bothered by functional items. The SMFA has been evaluated for reliability, validity and responsiveness in trauma populations. To be assessed at 6 and 12 months.

The generic health status will be measured by the VR-12 instrument from which a VR-6D can be computed for the purpose of a cost-utility analysis. The VR-12 is a multipurpose self-administered generic measure of health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The instrument produces a physical health and mental health summary measure. To be assessed at 6 and 12 months.

The presence of depressive symptoms will be measured using the nine item depression scale of the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a well validated tool for assisting clinicians in diagnosing depression. There are two components of the PHQ-9: (1) assessing symptoms and functional impairment to make a tentative depression diagnosis, and (2) deriving a severity score. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). To be assessed at 12 months.

PTSD will be measured using the standard PTSD Checklist (PCL), a 17-item measure that elicits responses for each of the DSM-IV disorders that comprise the diagnostic criteria for PTSD (intrusive, avoidant, and arousal symptoms). The psychometric properties of the PCL have been well established and it is the most widely used measure of PTSD. Both civilian and military versions are available. The military version will be used for all those patients on active duty at the time of their injury. To be assessed at 12 months.

Costs for the index hospitalization and subsequent hospitalizations (within one year) will be derived using hospital bills, outpatient bills and professional fees. Hospital costs will be calculated from charges at the revenue center/cost department line level using cost-to-charge ratios (CCRs) computed from the hospital-specific Medicare Cost Reports. Billing data will be supplemented or imputed by identifying medical resource utilization as documented in study case report forms, categorizing resources using standard medical billing codes, and assigning costs based on Medicare fee schedules. Of particular interest will be resource utilization and costs associated with the index hospital admission, surgical procedures for bone grafting and nonunion, subsequent admissions for complications, and post-operative follow-up care.

Fracture severity will be measured using standard of care CT scans. In severe fractures, this image will be obtained after application of a temporary joint spanning external fixator. Thus, the fracture severity analysis will be based on fractured distal tibias with limb alignment provisionally controlled. After definitive fracture reconstruction, a second CT scan will be obtained at the 3 month follow up time point, for assessment of chronic contact stress challenge. The second CT scan will be obtained for all patients for whom it is standard of care.

Fracture classification will be obtained using radiographs of the patient's injured ankle at presentation and after each surgical intervention according to standard of care practice. These radiographs will be used for clinical care, to classify the fractures, and at follow-up to assess outcome. Radiographs will be obtained at the time of initial hospital evaluation, immediately following treatment and at follow up clinic visits according to standard of care. Final clinical assessments and radiographs will be obtained as close to 12 months as routine practice allows. At practices where patients are routinely followed for more than 12 months and 24 month clinical assessments and radiographs will be conducted, at which point all study-related activities will be completed. A subset of 60 patients, identified prospectively, will provide an additional CT 3 months following definitive fixation, and will provide a final set of radiographs 24 months following definitive fixation.