Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures.

OBJECTIVES: Evaluate if nonoperative or operative treatment of displaced clavicle fractures delivers reduced rates of nonunion and improved Disability of the Arm, Shoulder, and Hand (DASH) scores. DESIGN: Multicenter, prospective, observational. SETTING: Seven Level 1 Trauma Centers in the United States. PATIENT SELECTION CRITERIA: Adults with closed, displaced (100% displacement/shortened >1.5 cm) midshaft clavicle fractures (Orthopaedic Trauma Association 15.2) were treated nonoperatively, with plates and screw fixation, or with intramedullary fixation from 2003 to 2018. OUTCOME MEASURES AND COMPARISONS: DASH scores (2, 6 weeks, 3, 6, 12, and 24 months), reoperation, and nonunion were compared between the nonoperative, plate fixation, and intramedullary fixation groups. RESULTS: Four hundred twelve patients were enrolled, with 203 undergoing plate fixation, 26 receiving intramedullary fixation, and 183 treated nonoperatively. The average age of the nonoperative group was 40.1 (range 18-79) years versus 35.8 (range 18-74) in the plate group and 39.3 (range 19-56) in the intramedullary fixation group (P = 0.06). One hundred forty (76.5%) patients in the nonoperative group were male compared with 154 (75.9%) in the plate group and 18 (69.2%) in the intramedullary fixation group (P = 0.69). All groups showed similar DASH scores at 2 weeks, 12 months, and 24 months (P > 0.05). Plate fixation demonstrated better DASH scores (median = 20.8) than nonoperative (median = 28.3) at 6 weeks (P = 0.04). Intramedullary fixation had poorer DASH scores at 6 weeks, 3 months, and 6 months than plate fixation and worse DASH scores than nonoperative at 6 months (P < 0.05). The nonunion rate for nonoperative treatment (14.6%) was significantly higher than the plate group (0%) (P < 0.001). CONCLUSIONS: Operative treatment of displaced clavicle fractures provided lower rates of nonunion than nonoperative treatment. Except at 6 weeks, no difference was observed in DASH scores between plate fixation and nonoperative treatment. Intramedullary fixation resulted in worse DASH scores than plate fixation at 6 weeks, 3 months, and 6 months and worse DASH scores than nonoperative at 6 months. Implant removal was the leading reason for reoperation in the plate and intramedullary fixation groups, whereas surgery for nonunion was the primary reason for surgery in the nonoperative group. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Midshaft clavicle fractures: is anterior plating an acceptable alternative to superior plating?

PURPOSE: The purpose of this study was to determine whether anterior plating is better tolerated than superior plating for midshaft clavicle fractures. METHODS: This was a prospective non-randomized observational cohort study following operative vs. non-operative management of clavicle fractures from 2003 to 2018 at 7 level 1 academic trauma centers in the USA. The subset of patients treated with plate and screws is the basis for this comparative study. Adults aged 18-85 with closed clavicle fractures displaced over 100% or shortened by more than 1.5 cm were eligible for enrollment. Patients were followed for 2 years following enrollment. Allowable fixation methods at the discretion of the surgeon consisted of anterior-inferior or superior plating. A total of 412 patients were enrolled. Of these, 192 patients received either superior or anterior plating for a displaced clavicle fracture with complete documented prospective research forms capturing type of plating technique. The primary outcome measure was hardware removal (HWR). Secondary outcomes were Disability of the Arm Shoulder and Hand (DASH) score and Visual Analog Pain (VAP) score, and satisfaction score (1 = high satisfaction; 5 = low satisfaction). RESULTS: There was no difference in HWR rates (7.1% superior 9/127; 6.2% anterior 4/65, p = 0.81), VAP score (mean 1.5 SD 1.0 superior; mean 1.7 SD 0.6 anterior, p = 0.21), DASH score (mean 7.5 SD 12.4 superior; mean 5.2 SD 15.2 anterior; p = 0.18) or satisfaction score (mean 1.6 SD 1.0 superior; mean 1.7 SD 0.60 anterior, p = 0.18). CONCLUSION: There is no difference in HWR rates or functional outcomes when using a superior vs. anterior plating technique.

Posttraumatic Patellar Osteomyelitis due to Raoultella ornithinolytica: A Case Report.

CASE: A 59-year-old woman sustained a comminuted patellar fracture after a fall from standing. The injury was treated with open reduction and internal fixation 7 days from initial injury. Seven weeks postoperatively, she developed a swollen, painful, and draining knee. Workup demonstrated Raoultella ornithinolytica. She underwent surgical debridement and antibiotic treatment. CONCLUSION: This is an unusual presentation of patellar osteomyelitis with R. ornithinolytica. Early identification, treatment with appropriate antimicrobial therapy, and consideration of surgical debridement are important in patients presenting with pain, swelling, and erythema after surgery.

Bone Health Management in Elective Orthopaedic Surgery: A Claims-Based Observational Study.

Introduction: There are limited data on the management of bone health, including bone mineral density (BMD) evaluation and osteoporosis (OP) treatment, in patients undergoing elective orthopaedic surgeries. Methods: This was a retrospective cohort study using administrative claims data from Symphony Health, PatientSource for patients aged ≥50 years with documented kyphoplasty/vertebroplasty (KP/VP), total knee arthroplasty (TKA), and total hip arthroplasty (THA). Risk stratification to identify patients at very high risk for fracture (VHRFx) was based on clinical practice guideline recommendations to the extent information on variables of interest were available from the claims database. Results: A total of 251 919 patients met inclusion criteria: KP/VP (31 018), TKA (149 849), and THA (71 052). The majority were female (80.3%) with a mean (SD) age of 68.5 (7.5) years. Patients undergoing KP/VP were older and had a greater comorbidity burden associated with risk for falls, mobility issues, muscle weakness, and respiratory and cardiovascular diseases. In the 6 months before surgery, 11.8% of patients were tested and/or received treatment for OP. Patients undergoing KP/VP were more likely to be tested and/or treated (17.5%) than patients undergoing TKA (11.0%) or THA (10.9%). Overall, men had a lower rate of testing and/or treatment than women (4.6% vs 13.5%). In the 12 months before surgery, patients with an OP diagnosis and at VHRFx (30.8%) had a higher rate of treatment and/or testing than those without OP (11.5%), or those without OP but with a fracture in the year preceding surgery (10.2%). Conclusions: Bone health management is suboptimal in patients undergoing elective orthopaedic surgeries and is worse in men than in women. Proper management of OP before and after surgery may improve outcomes.

Serology and Comorbidities in Patients With Fracture Nonunion: A Multicenter Evaluation of 640 Patients.

INTRODUCTION: This multicenter cohort study investigated the association of serology and comorbid conditions with septic and aseptic nonunion. METHODS: From January 1, 2011, to December 31, 2017, consecutive individuals surgically treated for nonunion were identified from seven centers. Nonunion-type, comorbid conditions and serology were assessed. RESULTS: A total of 640 individuals were included. 57% were male with a mean age of 49 years. Nonunion sites included tibia (35.2%), femur (25.6%), humerus (20.3%), and other less frequent bones (18.9%). The type of nonunion included septic (17.7%) and aseptic (82.3%). Within aseptic, nonvascular (86.5%) and vascular (13.5%) nonunion were seen. Rates of smoking, alcohol abuse, and diabetes mellitus were higher in our nonunion cohort compared with population norms. Coronary artery disease and tobacco use were associated with septic nonunion (P < 0.05). Diphosphonates were associated with vascular nonunion (P < 0.05). Serologically, increased erythrocyte sedimentation rate, C-reactive protein, parathyroid hormone, red cell distribution width, mean platelet volume (MPV), and platelets and decreased absolute lymphocyte count, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and albumin were associated with septic nonunion while lower calcium was associated with nonvascular nonunion (P < 0.05). The presence of four or more of increased erythrocyte sedimentation rate, C-reactive protein, or red cell distribution width; decreased albumin; and age younger than 65 years carried an 89% positive predictive value for infection. Hypovitaminosis D was seen less frequently than reported in the general population, whereas anemia was more common. However, aside from hematologic and inflammatory indices, no other serology was abnormal more than 25% of the time. DISCUSSION: Abnormal serology and comorbid conditions, including smoking, alcohol abuse, and diabetes mellitus, are seen in nonunion; however, serologic abnormalities may be less common than previously thought. Septic nonunion is associated with inflammation, younger age, and malnourishment. Based on the observed frequency of abnormality, routine laboratory work is not recommended for nonunion assessment; however, specific focused serology may help determine the presence of septic nonunion.

Does negative pressure wound therapy reduce the odds of infection and improve health-related quality of life in patients with open fractures?

AIMS: To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. METHODS: Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury. RESULTS: After applying inverse probability treatment weighting to adjust for the influence of injury characteristics on type of dressing used, 1,322 participants were assessed. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.52-times higher in patients who received NPWT compared to those who received a standard wound dressing (95% confidence interval (CI) 1.84 to 11.12; p = 0.001). Overall, 1,040 participants were included in our HRQoL analysis, and those treated with NPWT had statistically significantly lower mean SF-12 PCS post-fracture (p < 0.001). These differences did not reach the minimally important difference for the SF-12 PCS. CONCLUSION: Our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management within 12 months post-fracture. Due to possible residual confounding with the worst cases being treated with NPWT, we are unable to determine if NPWT has a negative effect or is simply a marker of worse injuries or poor access to early soft-tissue coverage. Regardless, our results suggest that the use of this treatment requires further evaluation. Cite this article: Bone Jt Open 2022;3(3):189-195.

The effect of time to irrigation and debridement on the rate of reoperation in open fractures : a propensity score-based analysis of the Fluid Lavage of Open Wounds (FLOW) study.

AIMS: Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and debridement (I&D) and the development of subsequent deep infection has not been established in the literature. Traditionally, I&D of an open fracture has been recommended within six hours of injury based on animal studies from the 1970s, however the clinical basis for this remains unclear. Using data from a multicentre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound I&D (within six hours of injury vs beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open limb fractures requiring surgical treatment. METHODS: To adjust for the influence of patient and injury characteristics on the timing of I&D, a propensity score was developed from the dataset. Propensity-adjusted regression allowed for a matched cohort analysis within the study population to determine if early irrigation put patients independently at risk for reoperation, while controlling for confounding factors. Results were reported as odds ratios (ORs), 95% confidence intervals (CIs), and p-values. All analyses were conducted using STATA 14. RESULTS: In total, 2,286 of 2,447 patients randomized to the trial from 41 orthopaedic trauma centres across five countries had complete data regarding time to I&D. Prior to matching, the patients managed with early I&D had a higher proportion requiring reoperation for infection or healing complications (17% vs 13%; p = 0.019), however this does not account for selection bias of more severe injuries preferentially being treated earlier. When accounting for propensity matching, early irrigation was not associated with reoperation (OR 0.71 (95% CI 0.47 to 1.07); p = 0.73). CONCLUSION: When accounting for other variables, late irrigation does not independently increase risk of reoperation. Cite this article: Bone Joint J 2021;103-B(6):1055-1062.

Effect of Tourniquet Use During Surgical Treatment of Open Fractures.

BACKGROUND: We sought to evaluate whether tourniquet use, with the resultant ischemia and reperfusion, during surgical treatment of an open lower-extremity fracture was associated with an increased risk of complications. METHODS: This is a retrospective cohort study of 1,351 patients who had an open lower-extremity fracture at or distal to the proximal aspect of the tibia and who participated in the FLOW (Fluid Lavage of Open Wounds) trial. The independent variable was intraoperative tourniquet use, and the primary outcome measures were adjudicated unplanned reoperation within 1 year of the injury and adjudicated nonoperative wound complications. RESULTS: Unplanned reoperation and nonoperative wound complications were roughly even between the no-tourniquet (18.7% and 19.1%, respectively) and tourniquet groups (17.8% and 20.8%) (p = 0.78 and p = 0.52). Following matching, as determined by model interactions, tourniquet use was a significant predictor of unplanned reoperation in Gustilo Type-IIIA (odds ratio, 3.60; 95% confidence interval, 1.16 to 11.78) and IIIB fractures (odds ratio, 16.61; 95% confidence interval, 2.15 to 355.40). CONCLUSIONS: The present study showed that tourniquet use did not influence the likelihood of complications following surgical treatment of an open lower-extremity fracture. However, in cases of severe open fractures, tourniquet use was associated with increased odds of unplanned reoperation; surgeons should be cautious with regard to tourniquet use in this setting. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Low Adherence to Recommended Guidelines for Open Fracture Antibiotic Prophylaxis.

BACKGROUND: Prompt administration of antibiotics is a critical component of open fracture treatment. Traditional antibiotic recommendations have been a first-generation cephalosporin for Gustilo Type-I and Type-II open fractures, with the addition of an aminoglycoside for Type-III fractures and penicillin for soil contamination. However, concerns over changing bacterial patterns and the side effects of aminoglycosides have led to interest in other regimens. The purpose of the present study was to describe the adherence to current prophylactic antibiotic guidelines. METHODS: We evaluated the antibiotic-prescribing practices of 24 centers in the U.S. and Canada that were participating in 2 randomized controlled trials of skin-preparation solutions for open fractures. A total of 1,234 patients were evaluated. RESULTS: All patients received antibiotics on the day of admission. The most commonly prescribed antibiotic regimen was cefazolin monotherapy (53.6%). Among patients with Type-I and Type-II fractures, there was 61.1% compliance with cefazolin monotherapy. In contrast, only 17.2% of patients with Type-III fractures received the recommended cefazolin and aminoglycoside therapy, with an additional 6.7% receiving piperacillin/tazobactam. CONCLUSIONS: There is moderate adherence to the traditional antibiotic treatment guidelines for Gustilo Type-I and Type-II fractures and low adherence for Type-III fractures. Given the divergence between current practice patterns and prior recommendations, high-quality studies are needed to determine the most appropriate prophylactic protocol.

The Dislocated Hip on CT Scan: An Argument for the Initial Pelvic Radiograph in Trauma Patients.

This study evaluated the frequency in which a hip dislocation is first diagnosed by computed tomography (CT) scan. A retrospective review was conducted of orthopaedic trauma patients presenting with hip dislocation to a Level 1 trauma center over three years. We recorded whether the patient first received pelvic radiograph (PXR) or CT scan of the pelvis, if the patient underwent closed reduction of the hip prior to CT scan, and if repeat pelvis CT scan was done. Of 83 hip dislocations, 64 patients were sent to CT scanner dislocated; 19 patients first had PXR and underwent closed reduction of the hip prior to CT scan. By obtaining a PXR, reducing the hip prior to CT, the incidence of repeat CT scan decreased from 37% to 11% (p = 0.046). By diagnosing hip dislocation, reducing prior to CT scan, repeat scans can be reduced, thus decreasing cost and radiation exposure to patients. (Journal of Surgical Orthopaedic Advances 29(1):4345, 2020).

Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.

Secondary Fracture Prevention: Consensus Clinical Recommendations from a Multistakeholder Coalition.

Osteoporosis-related fractures are undertreated, due in part to misinformation about recommended approaches to patient care and discrepancies among treatment guidelines. To help bridge this gap and improve patient outcomes, the American Society for Bone and Mineral Research assembled a multistakeholder coalition to develop clinical recommendations for the optimal prevention of secondary fractureamong people aged 65 years and older with a hip or vertebral fracture. The coalition developed 13 recommendations (7 primary and 6 secondary) strongly supported by the empirical literature. The coalition recommends increased communication with patients regarding fracture risk, mortality and morbidity outcomes, and fracture risk reduction. Risk assessment (including fall history) should occur at regular intervals with referral to physical and/or occupational therapy as appropriate. Oral, intravenous, andsubcutaneous pharmacotherapies are efficaciousandcanreduce risk of future fracture.Patientsneededucation,however, about thebenefitsandrisks of both treatment and not receiving treatment. Oral bisphosphonates alendronate and risedronate are first-line options and are generally well tolerated; otherwise, intravenous zoledronic acid and subcutaneous denosumab can be considered. Anabolic agents are expensive butmay be beneficial for selected patients at high risk.Optimal duration of pharmacotherapy is unknown but because the risk for second fractures is highest in the earlypost-fractureperiod,prompt treatment is recommended.Adequate dietary or supplemental vitaminDand calciumintake shouldbe assured. Individuals beingtreatedfor osteoporosis shouldbe reevaluated for fracture risk routinely, includingvia patienteducationabout osteoporosisandfracturesandmonitoringfor adverse treatment effects.Patients shouldbestronglyencouraged to avoid tobacco, consume alcohol inmoderation atmost, and engage in regular exercise and fall prevention strategies. Finally, referral to endocrinologists or other osteoporosis specialists may be warranted for individuals who experience repeated fracture or bone loss and those with complicating comorbidities (eg, hyperparathyroidism, chronic kidney disease).

Secondary Fracture Prevention: Consensus Clinical Recommendations from a Multistakeholder Coalition.

Osteoporosis-related fractures are undertreated, due in part to misinformation about recommended approaches to patient care and discrepancies among treatment guidelines. To help bridge this gap and improve patient outcomes, the American Society for Bone and Mineral Research assembled a multistakeholder coalition to develop clinical recommendations for the optimal prevention of secondary fracture among people aged 65 years and older with a hip or vertebral fracture. The coalition developed 13 recommendations (7 primary and 6 secondary) strongly supported by the empirical literature. The coalition recommends increased communication with patients regarding fracture risk, mortality and morbidity outcomes, and fracture risk reduction. Risk assessment (including fall history) should occur at regular intervals with referral to physical and/or occupational therapy as appropriate. Oral, intravenous, and subcutaneous pharmacotherapies are efficacious and can reduce risk of future fracture. Patients need education, however, about the benefits and risks of both treatment and not receiving treatment. Oral bisphosphonates alendronate and risedronate are first-line options and are generally well tolerated; otherwise, intravenous zoledronic acid and subcutaneous denosumab can be considered. Anabolic agents are expensive but may be beneficial for selected patients at high risk. Optimal duration of pharmacotherapy is unknown but because the risk for second fractures is highest in the early post-fracture period, prompt treatment is recommended. Adequate dietary or supplemental vitamin D and calcium intake should be assured. Individuals being treated for osteoporosis should be reevaluated for fracture risk routinely, including via patient education about osteoporosis and fractures and monitoring for adverse treatment effects. Patients should be strongly encouraged to avoid tobacco, consume alcohol in moderation at most, and engage in regular exercise and fall prevention strategies. Finally, referral to endocrinologists or other osteoporosis specialists may be warranted for individuals who experience repeated fracture or bone loss and those with complicating comorbidities (eg, hyperparathyroidism, chronic kidney disease). © 2019 American Society for Bone and Mineral Research.

Use of Bone Health Evaluation in Orthopedic Surgery: 2019 ISCD Official Position.

This position development conference (PDC) Task Force examined the assessment of bone status in orthopedic surgery patients. Key questions included which orthopedic surgery patients should be evaluated for poor bone health prior to surgery and which subsets of patients are at high risk for poor bone health and adverse outcomes. Second, the reliability and validity of using bone densitometry techniques and measurement of specific geometries around the hip and knee before and after arthroplasty was determined. Finally, the use of computed tomography (CT) attenuation coefficients (Hounsfield units) to estimate bone quality at anatomic locations where orthopedic surgery is performed including femur, tibia, shoulder, wrist, and ankle were reviewed. The literature review identified 665 articles of which 198 met inclusion exclusion criteria and were selected based on reporting of methodology, reliability, or validity results. We recommend that the orthopedic surgeon be aware of established ISCD guidelines for determining who should have additional screening for osteoporosis. Patients with inflammatory arthritis, chronic corticosteroid use, chronic renal disease, and those with history of fracture after age 50 are at high risk of osteoporosis and adverse events from surgery and should have dual energy X-ray absorptiometry (DXA) screening before surgery. In addition to standard DXA, bone mineral density (BMD) measurement along the femur and proximal tibia is reliable and valid around implants and can provide valuable information regarding bone remodeling and identification of loosening. Attention to positioning, selection of regions of interest, and use of special techniques and software is required. Plain radiographs and CT provide simple, reliable methods to classify the shape of the proximal femur and to predict osteoporosis; these include the Dorr Classification, Cortical Index, and critical thickness. Correlation of these indices to central BMD is moderate to good. Many patients undergoing orthopedic surgery have had preoperative CT which can be utilized to assess regional quality of bone. The simplest method available on most picture archiving and communications systems is to simply measure a regions of interest and determine the mean Hounsfield units. This method has excellent reliability throughout the skeleton and has moderate correlation to DXA based on BMD. The prediction of outcome and correlation to mechanical strength of fixation of a screw or implant is unknown.

Bone Health Optimization: Beyond Own the Bone: AOA Critical Issues.

Worldwide, osteoporosis management is in crisis because of inadequate delivery of care, competing guidelines, and confusing recommendations. Additionally, patients are not readily accepting the diagnosis of poor bone health and often are noncompliant with treatment recommendations. Secondary fracture prevention, through a program such as Own the Bone, has improved the diagnosis and medical management after a fragility fracture. In patients who undergo elective orthopaedic procedures, osteoporosis is common and adversely affects outcomes. Bone health optimization is the process of bone status assessment, identification and correction of metabolic deficits, and initiation of treatment, when appropriate, for skeletal structural deficits. The principles of bone health optimization are similar to those of secondary fracture prevention and can be initiated by all orthopaedic surgeons. Patients who are ≥50 years of age should be assessed for osteoporosis risk and, if they are in a high-risk group, bone density should be measured. All patients should be counseled to consume adequate vitamin D and calcium and to discontinue use of any toxins (e.g., tobacco products and excessive alcohol consumption). Patients who meet the criteria for pharmaceutical therapy for osteoporosis should consider delaying surgery for a minimum of 3 months, if feasible, and begin medication treatment. Orthopaedic surgeons need to assume a greater role in the care of bone health for our patients.

Wound Surface Area as a Risk Factor for Flap Complications among Patients with Open Fractures.

BACKGROUND: Soft-tissue complications often dictate the success of limb salvage and the overall outcome of open fractures. Based on prior work at the R Adams Cowley Shock Trauma Center, the authors hypothesize that wounds larger than 200 cm are associated with a greater likelihood of both flap-related reoperation and wound complications among patients requiring soft-tissue reconstruction with a rotational flap or free tissue transfer. METHODS: This study was a secondary analysis of Fluid Lavage in Open Wounds trial data that included all patients who received a rotational or free tissue flap transfer for an open fracture. The primary outcome was flap-related reoperation within 12 months of injury. The secondary outcome was wound complication, which included events treated operatively or nonoperatively. Multivariable logistic regression was used to assess the association between wound size and outcomes, adjusting for confounders. RESULTS: Seventeen percent of the 112 patients required a flap-related reoperation. A wound size greater than 200 cm(2) was not associated with reoperation in an unadjusted model (p = 0.64) or adjusting for Gustilo type (p = 0.70). The sample had an overall wound complication rate of 47.3 percent. Patients with a wound size of greater than 200 cm(2) were three times more likely to experience wound complications (OR, 3.05; 95 percent CI, 1.08 to 8.62; p = 0.04) when adjusting for moderate to severe wound contamination and wound closure in the operating room. CONCLUSION: The findings of this study demonstrate that wound surface area is an integral determinant for wound complication following soft-tissue flap treatment, but found no association between wound surface area and flap-related reoperation rates. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Factors Associated With Revision Surgery After Internal Fixation of Hip Fractures.

BACKGROUND: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. METHODS: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. RESULTS: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (for every 5-point increase) (HR 1.19, 95% CI 1.02-1.39; P = 0.027), displaced fracture (HR 2.16, 95% CI 1.44-3.23; P < 0.001), unacceptable quality of implant placement (HR 2.70, 95% CI 1.59-4.55; P < 0.001), and smokers treated with cancellous screws versus smokers treated with a sliding hip screw (HR 2.94, 95% CI 1.35-6.25; P = 0.006). Additionally, for every 10-year decrease in age, participants experienced an average increased risk of 39% for hardware removal. CONCLUSIONS: Results of this study may inform future research by identifying high-risk patients who may be better treated with arthroplasty and may benefit from adjuncts to care (HR 1.39, 95% CI 1.05-1.85; P = 0.020). LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Are large clinical trials in orthopaedic trauma justified?

BACKGROUND: The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. METHODS: The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. RESULTS: The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04; RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). CONCLUSIONS: Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. TRIAL REGISTRATION: NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

Factors Associated With Health-Related Quality of Life in Patients With Open Fractures.

OBJECTIVES: To analyze FLOW data to identify baseline patient, injury, fracture, and treatment factors associated with lower health-related quality of life (HRQoL) at 12-month postfracture. DESIGN: Prognostic study using data from a prospective randomized controlled trial. SETTING: Thirty-one clinical centers in the United States, Canada, Australia, and India. PATIENTS/PARTICIPANTS: One thousand four hundred twenty-seven patients with open fracture from the FLOW trial with complete 12-month Short Form-12 (SF-12) follow-up assessment and no missing data for selected baseline factors. INTERVENTION: Not applicable. MAIN OUTCOME MEASUREMENT: Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 at 12-month postfracture. RESULTS: One thousand four hundred twenty-seven patients were included in the SF-12 PCS and MCS linear regression models. Smoking, lower preinjury SF-12 PCS and MCS, and work-related injuries were significantly associated with lower SF-12 PCS and MCS at 12-month postfracture. A lower extremity fracture and a wound that was not closed at initial irrigation and debridement were significantly associated with lower 12-month SF-12 PCS but not MCS. Only the adjusted mean difference for lower extremity fractures approached the minimally important difference for the SF-12 PCS. CONCLUSIONS: We identified a number of statistically significant baseline factors associated with lower HRQoL; however, only the presence of a lower extremity fracture approached clinical significance. More research is needed to quantify the impact of these factors on patients and to determine whether changes to modifiable factors at baseline will lead to clinically significant improvements in HRQoL after open fractures. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Medical Team Training Improves Team Performance: AOA Critical Issues.

Effective teamwork and communication can decrease medical errors in environments where the culture of safety is enhanced. Health care can benefit from programs that are based on teamwork, as in other high-stress industries (e.g., aviation), with crew resource management programs, simulator use, and utilization of checklists. Medical team training (MTT) with a strong leadership commitment was used at our institution to focus specifically on creating open, yet structured, communication in operating rooms. Training included the 3 phases of the World Health Organization protocol to organize communication and briefings: preoperative verification, preincision briefing, and debriefing at or near the end of the surgical case. This training program led to measured improvements in job satisfaction and compliance with checklist tasks, and identified opportunities to improve training sessions. MTT provides the potential for sustainable change and a positive impact on the environment of the operating room.