In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial.

BACKGROUND: Extremity fractures are common, and most are managed operatively; however, despite successful reduction, up to half of patients report persistent post-surgical pain. Furthermore, psychological factors such as stress, distress, anxiety, depression, catastrophizing, and fear-avoidance behaviors have been associated with the development of chronic pain. The purpose of this pilot study was to examine the feasibility of a randomized controlled trial to determine the effect of in-person cognitive behavioral therapy (CBT) vs. usual care on persistent post-surgical pain among patients with a surgically managed extremity fracture. METHODS: Eligible patients were randomized to either in-person CBT or usual care. We used four criteria to judge the composite measure of feasibility: 1) successful implementation of CBT at each clinical site, 2) 40 patients recruited within 6 months, 3) treatment compliance in a minimum 36 of 40 participants (90%), and 4) 32 of 40 participants (80%) achieving follow-up at one year. The primary clinical outcome was persistent post-surgical pain at one year after surgery. RESULTS: Only two of the four participating sites were able to implement the CBT regimen due to difficulties with identifying certified therapists who had the capacity to accommodate additional patients into their schedule within the required timeframe (i.e., 8 weeks of their fracture). Given the challenges associated with CBT implementation, only one site was able to actively recruit patients. This site screened 86 patients and enrolled 3 patients (3.5%) over a period of three months. Participants were unable to comply with the in-person CBT, with no participants attending an in-person CBT session. Follow-up at one year could not be assessed as the pilot study was stopped early, three months into the study, due to failure to achieve the other three feasibility criteria. CONCLUSION: Our pilot trial failed to demonstrate the feasibility of a trial of in-person CBT versus usual care to prevent persistent pain after surgical repair of traumatic long-bone fractures and re-enforces the importance of establishing feasibility before embarking on definitive trials. Protocol modifications to address the identified barriers include the delivery of our intervention as a therapist-guided, remote CBT program. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier NCT03196258); Registered June 22, 2017, https://clinicaltrials.gov/ct2/show/NCT03196258.

Change in Gustilo-Anderson classification at time of surgery does not increase risk for surgical site infection in patients with open fractures: A secondary analysis of a multicenter, prospective randomized controlled trial.

Introduction: Open fractures represent a major source of morbidity. Surgical site infections (SSIs) after open fractures are associated with a high rate of reoperations and hospitalizations, which are associated with a lower health-related quality of life. Early antibiotic delivery, typically chosen through an assessment of the size and contamination of the wound, has been shown to be an effective technique to reduce the risk of SSI in open fractures. The Gustilo-Anderson classification (GAC) was devised as a grading system of open fractures after a complete operative debridement of the wound had been undertaken but is commonly used preoperatively to help with the choice of initial antibiotics. Incorrect preoperative GAC, leading to less aggressive initial management, may influence the risk of SSI after open fracture. The objectives of this study were to determine (1) how often the GAC changed from the initial to definitive grading, (2) the injury and patient characteristics associated with increases and decreases of the GAC, and (3) whether a change in GAC was associated with an increased risk of SSI. Methods: Using data from the FLOW trial, a large multicenter randomized study, we used descriptive statistics to quantify how frequently the GAC changed from the initial to definitive grading. We used regression models to determine which injury and patient characteristics were associated with increases and decreases in GAC and whether a change in GAC was associated with SSI. Results: Of the 2420 participants included, 305 participants had their preoperative GAC change (12.6%). The factors associated with upgrading the GAC (from preoperative score to the definitive assessment) included fracture sites other than the tibia, bone loss at presentation, width of wound, length of wound, and skin loss at presentation. However, initial misclassification of type III fractures as type II fractures was not associated with an increased risk of SSI (P = 0.14). Conclusions: When treating patients with open fracture wounds, surgeons should consider that 12% of all injuries may initially be misclassified when using the GAC, particularly fractures that have bone loss at presentation or those located in sites different than the tibia. However, even in misclassified fractures, it did not seem to increase the risk of SSI.

Outcomes of arthroscopic-assisted lateral tibial plateau fixation: a systematic review.

PURPOSE: The purpose of this study is to evaluate and summarize the current literature on outcomes of arthroscopic-assisted tibial plateau fixation (AATPF) when applied for only lateral tibial plateau fractures. METHODS: A comprehensive search of nine databases was conducted: ClinicalTrials.gov, Cochrane Library via Wiley, Embase and MEDLINE via Ovid, Global Index Medicus, PubMed, Scopus, SPORTDiscus via EBSCO, and Web of Science Core Collection. The study was performed in concordance with PRISMA guidelines. Studies eligible for inclusions included Schatzker I-III lateral tibial plateau fractures with a minimum of 6-month follow-up. Data extraction was performed by two authors independently using a predesigned form. RESULTS: A total of 17 studies, 7 prospective and 10 retrospective, including 565 patients (age 15-82 years old) treated with AATPF were included in this review with follow-up ranging from 6 to 138 months. All 10 studies that used categorical functional outcomes demonstrated excellent/very good or good outcomes in > 90% of patients. When compared to patients managed with the traditional open reduction internal fixation (ORIF), patients treated with AATPF had statistically significantly better range of motion mean difference [5.21° (95% CI - 2.50 to 12.92, p < 0.0001)], lower blood loss [66.19 mL (95% confidence interval (CI) 32.54-99.84 mL, p < 0.0001)], shorter hospital stay [- 1.41 days (95% CI - 3.39 to 0.58 days, p < 0.0001)], better Hospital Special Surgery score [11.31 (95% CI 6.49-16.12, p < 0.0001)], and higher Rasmussen radiographic score [1.26 (95% CI - 0.72 to 3.23, p < 0.0001)]. CONCLUSION: AATPF is a promising treatment of lateral tibial plateau fractures with some advantages over the traditional ORIF. LEVEL OF EVIDENCE: Therapeutic Level III.

Association of Patient-Level and Hospital-Level Factors With Timely Fracture Care by Race.

Importance: Racial disparities in treatment benchmarks have been documented among older patients with hip fractures. However, these studies were limited to patient-level evaluations. Objective: To assess whether disparities in meeting fracture care time-to-surgery benchmarks exist at the patient level or at the hospital or institutional level using high-quality multicenter prospectively collected data; the study hypothesis was that disparities at the hospital-level reflecting structural health systems issues would be detected. Design, Setting, and Participants: This cohort study was a secondary analysis of prospectively collected data in the PREP-IT (Program of Randomized trials to Evaluate Preoperative antiseptic skin solutions in orthopaedic Trauma) program from 23 sites throughout North America. The PREP-IT trials enrolled patients from 2018 to 2021, and patients were followed for 1-year. All patients with hip and femur fractures enrolled in the PREP-IT program were included in analysis. Data were analyzed April to September 2022. Exposures: Patient-level and hospital-level race, ethnicity, and insurance status. Main Outcomes and Measures: Primary outcome measure was time to surgery based on 24-hour time-to-surgery benchmarks. Multilevel multivariate regression models were used to evaluate the association of race, ethnicity, and insurance status with time to surgery. The reported odds ratios (ORs) were per 10% change in insurance coverage or racial composition at the hospital level. Results: A total of 2565 patients with a mean (SD) age of 64.5 (20.4) years (1129 [44.0%] men; mean [SD] body mass index, 27.3 [14.9]; 83 [3.2%] Asian, 343 [13.4%] Black, 2112 [82.3%] White, 28 [1.1%] other) were included in analysis. Of these patients, 834 (32.5%) were employed and 2367 (92.2%) had insurance; 1015 (39.6%) had sustained a femur fracture, with a mean (SD) injury severity score of 10.4 (5.8). Five hundred ninety-six patients (23.2%) did not meet the 24-hour time-to-operating-room benchmark. After controlling for patient-level characteristics, there was an independent association between missing the 24-hour benchmark and hospital population insurance coverage (OR, 0.94; 95% CI, 0.89-0.98; P = .005) and the interaction term between hospital population insurance coverage and racial composition (OR, 1.03; 95% CI, 1.01-1.05; P = .03). There was no association between patient race and delay beyond 24-hour benchmarks (OR, 0.96; 95% CI, 0.72-1.29; P = .79). Conclusions and Relevance: In this cohort study, patients who sought care from an institution with a greater proportion of patients with racial or ethnic minority status or who were uninsured were more likely to experience delays greater than the 24-hour benchmarks regardless of the individual patient race; institutions that treat a less diverse patient population appeared to be more resilient to the mix of insurance status in their patient population and were more likely to meet time-to-surgery benchmarks, regardless of patient insurance status or population-based insurance mix. While it is unsurprising that increased delays were associated with underfunded institutions, the association between institutional-level racial disparity and surgical delays implies structural health systems bias.

A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan.

BACKGROUND: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. METHODS AND DESIGN: The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. RESULTS: The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.

High Rates of Imminent Subsequent Fracture After Femoral Neck Fracture in the Elderly.

BACKGROUND: Fragility fractures of the hip are known to be followed frequently by subsequent fragility fractures, including second hip fractures. Data on subsequent fractures are available for aggregated index femoral neck and intertrochanteric femoral fractures, grouped generically as hip fractures, but not specifically for femoral neck fractures. There is increasing recognition that a subsequent fracture often occurs early after a hip fracture in the elderly, creating an emphasis on the concept of "imminent fracture risk." Since 2000, there have been many reports on the care gap in interventions after a fragility fracture, with concern regarding the slow uptake of appropriate systemic treatments designed to prevent a subsequent fracture in high-risk patients. METHODS: As planned a priori, we performed an analysis of subsequent fractures after an index femoral neck fracture in 2 prospective clinical trials involving 2,520 patients from 90 sites on 5 continents. We recorded the incidence and time of occurrence of all secondary fragility fractures as well as the reported use of bone-protective medication in all subjects. RESULTS: In the 24 months following the index femoral neck fracture, 226 (9.0%) of 2,520 patients sustained at least 1 subsequent fragility fracture, including 113 hip fractures (4.5%). The median interval from the index fracture to a subsequent fracture was approximately 9.0 months. Only 25.2% (634) of the 2,520 patients reported using bone-protective medications at any time during follow-up. Female patients, those with nondisplaced index fractures, and those treated with arthroplasty, were more likely to have received protective medication. CONCLUSIONS: Subsequent fractures, including second hip fractures, occurred frequently and early following an index femoral neck fracture in 2 large global cohorts. Interventions to prevent a subsequent fracture were instituted in only 1 of 4 patients, even though a focused directive was included in both study protocols. LEVEL OF EVIDENCE: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.

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.

Intimate Partner Violence During Recovery from an Orthopaedic Injury: An Exploratory, Prospective, Multicenter, Observational Cohort Study.

BACKGROUND: Orthopaedic injuries may lead to an increased incidence of intimate partner violence (IPV) during recovery as people dependent on others' help are at a higher risk for abuse. Additionally, there is a lack of understanding of how IPV affects injury recovery. In women being treated for an orthopaedic injury, we aimed to determine the number of new IPV disclosures in the 12 months after an injury and to explore the impact of IPV on recovery. METHODS: We enrolled 250 female participants from 6 orthopaedic fracture clinics in Canada, the Netherlands, Spain, and Finland. IPV disclosure and clinical outcomes were assessed at the initial visit and during the 12-month follow-up period. RESULTS: Of 250 participants, 81 (32.4% [95% confidence interval (CI), 26.6% to 38.2%]) had a history of IPV in their lifetime and disclosed this at their initial orthopaedic clinic appointment. Twenty-one participants (12.4% [95% CI, 7.5% to 17.8%]) who did not disclose abuse at the initial visit disclosed IPV during the follow-up. In our a priori unadjusted analysis, disclosure of IPV at the initial appointment or a subsequent follow-up appointment was associated with a 32% lower likelihood of returning to a pre-injury level of function with no restrictions regarding responsibilities at home (hazard ratio, 0.68 [95% CI, 0.46 to 0.99]; p = 0.046). Participants disclosing IPV had lower health-related quality of life on the EuroQol-5 Dimensions (EQ-5D) at the 6-month-follow-up, with adjusted mean differences of -5.3 (95% CI, -10.2 to -0.4, p = 0.04) for the visual analog scale and -0.06 (95% CI, -0.11 to -0.01; p = 0.02) for the Function Index. They also had lower Function Index scores at the final 12-month follow-up visit, with an adjusted mean difference of -0.06 (95% CI, -0.10 to -0.02; p = 0.006). CONCLUSIONS: A surprisingly high percentage of women disclosed IPV within 12 months after the injury. Our exploratory results suggest that women who disclose IPV may have lower health-related quality of life. This study supports the need to optimize orthopaedic clinics to provide appropriate support for asking about and assisting individuals who experienced IPV. Additional research is warranted to further explore these findings. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Subspecialty Fellowship Training Is Not Associated With Better Outcomes in Fixation of Low-Energy Femoral Neck Fractures-An Analysis of the Fixation Using Alternative Implants for the Treatment of Hip Fractures Database.

OBJECTIVES: To compare risk of reoperation for femoral neck fracture patients undergoing fixation with cancellous screws (CSs) or sliding hip screws based on surgeon fellowship (trauma-fellowship-trained vs. non-trauma-fellowship-trained). DESIGN: Retrospective review of Fixation using Alternative Implants for the Treatment of Hip fractures data. SETTING: Eighty-one centers across 8 countries. PATIENTS/PARTICIPANTS: Eight hundred nineteen patients ≥50 years old with low-energy hip fractures requiring surgical fixation. INTERVENTION: Patients were randomized to CS or sliding hip screw group in the initial dataset. MAIN OUTCOME MEASUREMENTS: The primary outcome was risk of reoperation. Secondary outcomes included death, serious adverse events, radiographic healing, discharge disposition, and use of ambulatory devices postoperatively. RESULTS: There was no difference in risk of reoperation between the 2 surgeon groups (P > 0.05). Patients treated by orthopaedic trauma surgeons were more likely to be overweight/obese and have major medical comorbidities (P < 0.05). There was a higher risk of serious adverse events, higher likelihood of radiographic healing, and higher odds of discharge to a facility for patients treated by trauma-fellowship-trained surgeons (P < 0.05). CONCLUSIONS: Based on these data, risk of reoperation for low-energy femoral neck fracture fixation is equivalent regardless of fellowship training. The higher likelihood of radiographic healing noted in the trauma-trained group does not seem to have a major clinical implication because it did not affect risk of reoperation between the 2 groups. Patient-specific factors present preinjury, such as body habitus and medical comorbidities, may account for the lower odds of discharge to home and higher risk of postoperative medical complications for patients treated by orthopaedic trauma surgeons. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures

Background: Tibial shaft fractures are the most common long-bone injury, with a reported annual incidence of more than 75 000 in the United States. This study aimed to determine whether patients with tibial fractures managed with intramedullary nails experience a lower rate of reoperation if treated at higher-volume hospitals, or by higher-volume or more experienced surgeons. Methods: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) was a multicentre randomized clinical trial comparing reamed and nonreamed intramedullary nailing on rates of reoperation to promote fracture union, treat infection or preserve the limb in patients with open and closed fractures of the tibial shaft. Using data from SPRINT, we quantified centre and surgeon volumes into quintiles. We performed analyses adjusted for type of fracture (open v. closed), type of injury (isolated v. multitrauma), gender and age for the primary outcome of reoperation using multivariable logistic regression. Results: There were no significant differences in the odds of reoperation between high- and low-volume centres (p = 0.9). Overall, surgeon volume significantly affected the odds of reoperation (p = 0.03). The odds of reoperation among patients treated by moderate-volume surgeons were 50% less than those among patients treated by verylow-volume surgeons (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.28­0.88), and the odds of reoperation among patients treated by high-volume surgeons were 47% less than those among patients treated by very-low-volume surgeons (OR 0.53, 95% CI 0.30­0.93). Conclusion: There appears to be no significant additional patient benefit in treatment by a higher-volume centre for intramedullary fixation of tibial shaft fractures. Additional research on the effects of surgical and clinical site volume in tibial shaft fracture management is needed to confirm this finding. The odds of reoperation were higher in patients treated by very-low-volume surgeons; this finding may be used to optimize the results of tibial shaft fracture management. Clinical trial registration: ClinicalTrials.gov, NCT00038129

Contexte: La fracture de la diaphyse tibiale est la plus commune des fractures des os longs, avec une incidence annuelle déclarée de plus 75 000 cas aux États-Unis. Cette étude visait à déterminer si les patients traités par enclouage intramédullaire pour une fracture du tibia sont moins souvent réopérés quand l'intervention est effectuée dans des établissements qui traitent de plus forts volumes de cas ou par des chirurgiens opérant un plus fort volume de cas ou plus expérimentés. Méthodes: L'étude SPRINT (Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures) est un essai clinique multicentrique randomisé qui a comparé l'effet de l'enclouage alésé c. non alésé sur le taux des réinterventions visant à promouvoir la consolidation osseuse de la fracture, à traiter une infection ou à préserver le membre chez des patients victimes de fractures fermées ou ouvertes de la diaphyse tibiale. À partir des données de l'étude SPRINT, nous avons classé les établissements et les chirurgiens en quintiles selon les volumes de cas traités. Nous avons effectué des analyses ajustées en fonction du type de fracture (ouverte c. fermée), du type de blessure (isolée c. polytraumatisme), du sexe et de l'âge, pour établir le taux de réintervention (paramètre principal), en utilisant la régression logistique multivariée. Résultats: On n'a noté aucune différence significative quant au risque de réintervention entre les centres qui traitaient des volumes élevés c. bas (p = 0,9). Dans l'ensemble le volume d'opérations des chirurgiens a significativement influé sur le risque de réintervention (p = 0,03). Le risque de réintervention chez les patients traités par des chirurgiens dont le volume d'interventions était moyen était de 50 % de moins que chez les patients traités par des chirurgiens dont le volume était très bas (risque relatif [RR] 0,50, intervalle de confiance [IC] à 95 % 0,28­0,88) et le risque de réintervention chez les patients traités par des chirurgiens dont le volume était très élevé était de 47 % de moins que chez les patients traités par des chirurgiens dont le volume était très bas (RR 0,53, IC à 95 % 0,30­0,93). Conclusion: Il ne semble y avoir aucun bienfait additionnel significatif au fait d'être opéré dans un centre où le volume d'interventions pour enclouage intramédullaire des fractures de la diaphyse tibiale est élevé. Il faudra approfondir la recherche sur les effets du volume chirurgical et de l'expérience clinique des établissements pour confirmer cette observation. Le risque de réintervention a été plus élevé chez les patients traités par des chirurgiens dont le volume d'interventions était très bas; cette observation pourrait être utilisée pour optimiser l'issue du traitement des fractures de la diaphyse tibiale. Enregistrement de l'essai clinique : ClinicalTrials. gov, NCT00038129.

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.

Heterotopic Ossification Following Arthroplasty for Femoral Neck Fracture.

BACKGROUND: Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we aimed to (1) determine the prevalence of HO following total hip arthroplasty (THA) for femoral neck fracture in patients ≥50 years of age, (2) identify whether HO is associated with an increased risk of revision surgery within 24 months after the fracture, and (3) determine the impact of HO on functional outcomes. METHODS: We performed a multivariable Cox regression analysis using revision surgery as the dependent variable and HO as the independent variable. We compared Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between participants with and those without HO at 24 months. RESULTS: Of 1,441 participants in the study, 287 (19.9%) developed HO within 24 months. HO was not associated with subsequent revision surgery. Grade-III HO was associated with statistically significant and clinically relevant deterioration in the total WOMAC score, which was mainly related to the function component of the score, compared with grade I or II. CONCLUSIONS: The impact of grade-III HO on the functional outcomes and quality of life after THA for hip fracture is clinically important, and HO prophylaxis for selected high-risk patients may be appropriate. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study.

BACKGROUND: Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures. METHODS: Two orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported. RESULTS: All five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants. CONCLUSIONS: These results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated. TRIAL REGISTRATION: ClincialTrials.gov , number NCT03385304 . Registered December 28, 2017.

Prognostic factors for predicting health-related quality of life after intramedullary nailing of tibial fractures: a randomized controlled trial.

AIMS: Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery. METHODS: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) trial examined adults with an open or closed tibial shaft fracture who were treated with either reamed or unreamed intramedullary nails. HRQoL was assessed at hospital discharge (for pre-injury level) and at 12 months post-fracture using the Short Musculoskeletal Functional Assessment (SMFA) Dysfunction, SMFA Bother, 36-Item Short Form 36 (SF-36) Physical, and SF-36 Mental Component scores. We used multiple linear regression analysis to determine if baseline and surgical factors, as well as post-intervention procedures within one year of fracture, were associated with these HRQoL outcomes. Significance was set at p < 0.01. We hypothesize that, irrespective of the four measures used, prognosis is guided by both modifiable and non-modifiable factors and that patients do not return to their pre-injury level of function, nor HRQoL. RESULTS: For patient and surgical factors, only pre-injury quality of life and isolated fracture showed a statistical effect on all four HRQoL outcomes, while high-energy injury mechanism, smoking, and race or ethnicity, demonstrated statistical significance for three of the four HRQoL outcomes. Patients who did not require reoperation in response to infection, the need for bone grafts, and/or the need for implant exchanges had statistically superior HRQoL outcomes than those who did require intervention within one year after initial tibial fracture nailing. CONCLUSION: We identified several baseline patient factors, surgical factors, and post-intervention procedures within one year after intramedullary nailing of a tibial shaft fracture that may influence a patient's HRQoL.Cite this article: Bone Jt Open 2021;2(1):22-32.

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients.

PURPOSE: Femoral neck fractures in young patients are typically managed with internal fixation using either cancellous screws or a sliding hip screw (SHS). Although fixation preserves the hip joint, patients are still at risk of complications and poor clinical outcomes which lead to diminished function and health related quality of life (HRQL). The Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) pilot randomized controlled factorial trial evaluated the effect of surgical fixation (cancellous screws vs. SHS) and vitamin D supplementation vs. placebo on patient-reported function and HRQL. METHODS: Patients between the ages of 18-60 years with a femoral neck fracture requiring surgical fixation were eligible. Eligible patients were randomized to receive either a sliding hip screw or cancellous screws for fracture fixation AND vitamin D3 4,000 IU or placebo daily for 6 months. Patient-reported function (Hip Outcome Score) and HRQL (Short Form-12) were assessed at standardized time points in the 12 months following their fixation surgery. Patient-reported function and HRQL were summarized using means, SD, and 95% confidence intervals (CIs), or percentages and counts. Longitudinal data analysis with mixed models was used to explore the effect of treatment group and time on the patient-reported function and HRQL. RESULTS: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6- and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment. CONCLUSIONS: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional efforts to improve the outcomes of these challenging injuries are still needed. LEVEL OF EVIDENCE: Therapeutic Level II.

Optimal Technical Factors During Operative Management of Low-Energy Femoral Neck Fractures.

OBJECTIVE: To determine if cancellous screw (CS) and sliding hip screw (SHS) technical factors during low-energy femoral neck fracture fixation affects a 24-month revision surgery rate and health-related quality of life (HRQL). DESIGN: Prospective randomized controlled study. SETTING: International, multicenter. PATIENTS: Eight hundred ninety-eight femoral neck fracture patients age 50 years and older. INTERVENTION: Patients were randomized to fracture stabilization with either CSs or a SHS device as part of the Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH) trial. CS technical factors analyzed included screw diameter, short versus long screw threads, screw number and formation, screw orientation, and washer use. SHS technical factors studied were side plate length, supplemental screw use, lag screw position, and tip-apex distance. MAIN OUTCOME MEASUREMENTS: Revision surgeries within 24 months to promote fracture healing, relieve pain, treat infection, or improve function. In addition, HRQL measures were collected, including the SF-12 Physical Component Score and Western Ontario and McMaster Universities Osteoarthritis Index. RESULTS: The 3-screw inverted triangle pattern had a significantly lower revision surgery rate than a 3-screw triangle formation (P = 0.004). No other CS or SHS technical factors were predictive of revision surgery or affected a patient's HRQL (P > 0.05). CONCLUSIONS: A 3-screw inverted triangle pattern was superior to a 3-screw triangle formation. However, injury and patient factors such as fracture displacement, age, smoking status and sex play a more significant role in clinical outcomes for low-energy femoral neck fracture treatment. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

What Factors Increase Revision Surgery Risk When Treating Displaced Femoral Neck Fractures With Arthroplasty: A Secondary Analysis of the HEALTH Trial.

OBJECTIVES: HEALTH was a randomized controlled trial comparing total hip arthroplasty with hemiarthroplasty in low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome. No significant short-term differences between treatment arms were observed. The primary objective of this secondary HEALTH trial analysis was to determine if any patient and surgical factors were associated with increased risk of revision surgery within 24 months after hip fracture. METHODS: We analyzed 9 potential factors chosen a priori that could be associated with revision surgery. The factors included age, body mass index, major comorbidities, independent ambulation, type of surgical approach, length of operation, use of femoral cement, femoral head size, and degree of femoral stem offset. Our statistical analysis was a multivariable Cox regression using reoperation within 24 months of index surgery as the dependent variable. RESULTS: Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months. None of the studied factors were found to be predictors of revision surgery (P > 0.05). CONCLUSION: Both total and partial hip replacements are successful procedures in low-energy displaced femoral neck fracture patients. We were unable to identify any patient or surgeon-controlled factors that significantly increased the need for revision surgery in our elderly and predominately female patient population. One should not generalize our findings to an active physiologically younger femoral neck fracture population. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Arthroplasty Versus Internal Fixation for the Treatment of Undisplaced Femoral Neck Fractures: A Retrospective Cohort Study.

OBJECTIVE: To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs). DESIGN: Retrospective cohort study. SETTING: Secondary data analysis of 2 multinational randomized controlled trials. PARTICIPANTS: Patients aged 50 years or older with a FNF. INTERVENTION: Arthroplasty (n = 1441), including total hip arthroplasty and hemiarthroplasty, performed for a displaced FNF versus internal fixation (n = 734), including sliding hip screw or multiple cancellous screws, performed for an undisplaced FNF. MAIN OUTCOME MEASUREMENT: The primary outcome was mortality within 24 months of injury. Secondary outcomes included reoperation and health-related quality of life. RESULTS: The 24-month mortality rate was 15.0% (n = 327). Arthroplasty was associated with a significant reduction in the odds of mortality [adjusted odds ratio (aOR): 0.56, 95% confidence interval (CI): 0.44-0.72, P < 0.01] compared with treatment with internal fixation. 11.4% (n = 248) of the study patients required reoperation within 24 months of injury. The odds of reoperation were 59% lower with arthroplasty treatment than with internal fixation (aOR: 0.41, 95% CI: 0.32-0.55, P < 0.01). The 24-month SF-12 physical component scores were 2.7 points higher in arthroplasty patients compared with internal fixation patients (95% CI: 1.6-3.8, P < 0.01). CONCLUSIONS: Our findings suggest arthroplasty for a FNF may reduce the risk of mortality and reoperation compared with internal fixation of undisplaced fractures. This finding is counter to many current surgical practices but consistent with a mounting body of evidence. Before widespread adoption of arthroplasty for undisplaced fractures, these results should be confirmed in a definitive comparative trial. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Predictors of Long-Term Pain After Hip Arthroplasty in Patients With Femoral Neck Fractures: A Cohort Study.

OBJECTIVES: To identify factors associated with the development of prolonged pain after hip fracture surgery. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Eighty hospitals in 10 countries. PATIENTS/PARTICIPANTS: One thousand four hundred forty-one hip fracture patients in the HEALTH trial. INTERVENTIONS: Total hip arthroplasty or hemiarthroplasty. MAIN OUTCOME MEASURES: Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty. RESULTS: Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%). CONCLUSIONS: Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.