Skin Antisepsis before Surgical Fixation of Extremity Fractures.

BACKGROUND: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults.

BACKGROUND: The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied. METHODS: We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years of age or older who were undergoing surgery for hip fracture at 46 U.S. and Canadian hospitals. Patients were randomly assigned in a 1:1 ratio to receive spinal or general anesthesia. The primary outcome was a composite of death or an inability to walk approximately 10 ft (3 m) independently or with a walker or cane at 60 days after randomization. Secondary outcomes included death within 60 days, delirium, time to discharge, and ambulation at 60 days. RESULTS: A total of 1600 patients were enrolled; 795 were assigned to receive spinal anesthesia and 805 to receive general anesthesia. The mean age was 78 years, and 67.0% of the patients were women. A total of 666 patients (83.8%) assigned to spinal anesthesia and 769 patients (95.5%) assigned to general anesthesia received their assigned anesthesia. Among patients in the modified intention-to-treat population for whom data were available, the composite primary outcome occurred in 132 of 712 patients (18.5%) in the spinal anesthesia group and 132 of 733 (18.0%) in the general anesthesia group (relative risk, 1.03; 95% confidence interval [CI], 0.84 to 1.27; P = 0.83). An inability to walk independently at 60 days was reported in 104 of 684 patients (15.2%) and 101 of 702 patients (14.4%), respectively (relative risk, 1.06; 95% CI, 0.82 to 1.36), and death within 60 days occurred in 30 of 768 (3.9%) and 32 of 784 (4.1%), respectively (relative risk, 0.97; 95% CI, 0.59 to 1.57). Delirium occurred in 130 of 633 patients (20.5%) in the spinal anesthesia group and in 124 of 629 (19.7%) in the general anesthesia group (relative risk, 1.04; 95% CI, 0.84 to 1.30). CONCLUSIONS: Spinal anesthesia for hip-fracture surgery in older adults was not superior to general anesthesia with respect to survival and recovery of ambulation at 60 days. The incidence of postoperative delirium was similar with the two types of anesthesia. (Funded by the Patient-Centered Outcomes Research Institute; REGAIN ClinicalTrials.gov number, NCT02507505.).

Long-term Outcomes with Spinal versus General Anesthesia for Hip Fracture Surgery: A Randomized Trial.

BACKGROUND: The effects of spinal versus general anesthesia on long-term outcomes have not been well studied. This study tested the hypothesis that spinal anesthesia is associated with better long-term survival and functional recovery than general anesthesia. METHODS: A prespecified analysis was conducted of long-term outcomes of a completed randomized superiority trial that compared spinal anesthesia versus general anesthesia for hip fracture repair. Participants included previously ambulatory patients 50 yr of age or older at 46 U.S. and Canadian hospitals. Patients were randomized 1:1 to spinal or general anesthesia, stratified by sex, fracture type, and study site. Outcome assessors and investigators involved in the data analysis were masked to the treatment arm. Outcomes included survival at up to 365 days after randomization (primary); recovery of ambulation among 365-day survivors; and composite endpoints for death or new inability to ambulate and death or new nursing home residence at 365 days. Patients were included in the analysis as randomized. RESULTS: A total of 1,600 patients were enrolled between February 12, 2016, and February 18, 2021; 795 were assigned to spinal anesthesia, and 805 were assigned to general anesthesia. Among 1,599 patients who underwent surgery, vital status information at or beyond the final study interview (conducted at approximately 365 days after randomization) was available for 1,427 (89.2%). Survival did not differ by treatment arm; at 365 days after randomization, there were 98 deaths in patients assigned to spinal anesthesia versus 92 deaths in patients assigned to general anesthesia (hazard ratio, 1.08; 95% CI, 0.81 to 1.44, P = 0.59). Recovery of ambulation among patients who survived a year did not differ by type of anesthesia (adjusted odds ratio for spinal vs. general, 0.87; 95% CI, 0.67 to 1.14; P = 0.31). Other outcomes did not differ by treatment arm. CONCLUSIONS: Long-term outcomes were similar with spinal versus general anesthesia.

Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial.

BACKGROUND: The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported. OBJECTIVE: To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia. DESIGN: Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505). SETTING: 46 U.S. and Canadian hospitals. PARTICIPANTS: Patients aged 50 years or older undergoing hip fracture surgery. INTERVENTION: Spinal or general anesthesia. MEASUREMENTS: Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care. RESULTS: A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups. LIMITATION: Missing outcome data and multiple outcomes assessed. CONCLUSION: Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute.

Outcomes with spinal versus general anesthesia for patients with and without preoperative cognitive impairment: Secondary analysis of a randomized clinical trial.

INTRODUCTION: The effect of spinal versus general anesthesia on the risk of postoperative delirium or other outcomes for patients with or without cognitive impairment (including dementia) is unknown. METHODS: Post hoc secondary analysis of a multicenter pragmatic trial comparing spinal versus general anesthesia for adults aged 50 years or older undergoing hip fracture surgery. RESULTS: Among patients randomized to spinal versus general anesthesia, new or worsened delirium occurred in 100/295 (33.9%) versus 107/283 (37.8%; odds ratio [OR] 0.85; 95% confidence interval [CI] 0.60 to 1.19) among persons with cognitive impairment and 70/432 (16.2%) versus 71/445 (16.0%) among persons without cognitive impairment (OR 1.02; 95% CI 0.71 to 1.47, p = 0.46 for interaction). Delirium severity, in-hospital complications, and 60-day functional recovery did not differ by anesthesia type in patients with or without cognitive impairment. DISCUSSION: Anesthesia type is not associated with differences in delirium and functional outcomes among persons with or without cognitive impairment.

Engaging patients as partners in a multicentre trial of spinal versus general anaesthesia for older adults.

Engaging patients-defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them-as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

Operative vs. Nonoperative Treatment of Isolated Humeral Shaft Fractures: A Prospective Cohort Study.

The purpose was to compare plate and screw fixation (open reduction internal fixation [ORIF]) and functional bracing (FB) of isolated humeral shaft fractures with treatment and patient-based outcomes. We performed a prospective trial of ORIF v. FB at 12 centers. Surgeons counseled patients on treatment options and a patient centered decision was made. We enrolled 179 patients, of which 6-month data was analyzed for 102 (39 female; 63 male). Forty-five were treated with ORIF and 57 with FB. We found no difference in the disability of the arm, shoulder and hand (DASH) score, visual analogue score (VAS) or elbow range of motion (ROM) at 6 months. However, 11% of the FB group developed nonunion. Complications in the ORIF group included a 2% infection and nonunion rate and 13% iatrogenic radial nerve dysfunction (RND). ORIF can be expected to result in higher union rates with the inherent risks of infection and RND. Finally, at 6 months, both groups demonstrated higher DASH scores than population norms, indicating a lack of full recovery. (Journal of Surgical Orthopaedic Advances 30(2):067-072, 2021).

Is There a Critical Radiographic Angle That Portends Poor Functional Outcome Scores in Nonoperative Treatment of Isolated Humeral Shaft Fractures?

Our purpose was to evaluate radiographic alignment of nonoperatively treated humerus fractures and determine if there is a critical angle associated with worse outcomes. All patients with humeral shaft fractures that were prospectively followed as part of a larger multicenter trial were reviewed. These patients were selected for nonoperative management based on shared decision making. There were 80 patients that healed with adequate data. The receiver operating characteristic (ROC) had best fit with a sagittal radiographic angle of 10° (AUC: 0.731) and coronal angle of 15° (AUC: 0.580) at 1-year follow-up. We found increased or worse disabilities of the arm, shoulder and hand (DASH) scores with > 10° sagittal alignment or > 15° of coronal alignment. Poor DASH scores were observed at angles lower than previously accepted for nonoperative treatment. These findings are useful in decision making and patient guidance. (Journal of Surgical Orthopaedic Advances 30(2):073-077, 2021).

How High Can You Go?: Retrograde Nailing of Proximal Femur Fractures.

There are no data-supported recommendations on how proximal is too proximal for retrograde nailing (RGN). At six level 1 trauma centers, patients with femur fractures within the proximal one-third of the femur treated with RGN were included. This article describes a proximal segment capture ratio (PSCR) and nail segment capture ratio to evaluate RGN of proximal fractures. The study included 107 patients. The average follow-up was 44 weeks. There were two nonunions and three malunions. There was no significant difference between PSCR of 0.3 or less and need for secondary procedures or time to full weight bearing (p>.05). In this study, a smaller (< 0.3) PSCR was not associated with an increased number of complications. A higher Orthopaedic Trauma Association classification was predictive of malunion and increased time to union. These data demonstrate that retrograde nailing is safe and effective for the treatment of supraisthmal femur fractures.

Life Interrupted: The Trauma Caregiver Experience.

Traumatic injury frequently leads to an abrupt change in physical and psychological functioning; informal caregivers play a significant role in the recovery process in the hospital and at home. The purpose of this study was to describe the range of stressors and burdens experienced by orthopedic trauma family caregivers in the acute care setting, as well as responses and strategies employed. Qualitative, in-depth interviews were conducted in the hospital with 12 family caregivers of severely injured orthopedic trauma patients. Interviews were audiotaped, transcribed, and analyzed to identify the range of experiences and common themes. Data were organized into 4 categories: stressors and needs; barriers; resources; and response. Stressors and barriers included the confusion and turmoil of life in the hospital, exposure to tragedy, difficulty obtaining and understanding information, and a sense that the family was not considered an integral part of the care plan. Factors influencing caregiver coping included access to the patient, provider communication, caregiver internal and external resources, and the presence of staff assisting in negotiation of the complex and unfamiliar hospital system. Understanding the caregiver experience enables nursing providers to build trust and offer effective support and guidance; caregiver-centered systems of information from admission to discharge may facilitate adaptation and improved caregiving.

Early Acetabular Fracture Repair Through an Anterior Approach Is Associated With Increased Blood Loss.

OBJECTIVES: To determine whether the timing of acetabular fracture fixation through an anterior approach influences estimated and calculated perioperative blood loss. DESIGN: Retrospective cohort study. SETTING: Level 1 trauma center from 2013 to 2021. PATIENT SELECTION CRITERIA: Patients aged ≥18 years treated with acetabular fracture fixation through an anterior-based approach. OUTCOME MEASURES AND COMPARISONS: The primary outcome was calculated blood loss (CBL). Secondary outcomes were estimated blood loss reported by surgeon and anesthesia, and blood transfusion requirements. Comparisons of blood loss were made at discrete postinjury time thresholds (24, 36, and 48 hours) and on a continuous basis. RESULTS: One hundred eight patients were studied. The mean age was 65 years, and 73% of patients were male. Earlier fixation of acetabular fractures resulted in greater CBL and estimated blood loss (surgeon and anesthesia) compared with later fixation when analyzed on a continuum and at specific time points (24, 36, and 48 hours). Mean CBL in patients treated earlier (<48 hours, 2539 ± 1194 mL) was significantly greater than those treated later (≥48 hours, 1625 ± 909 mL; P < 0.001). Fracture repair before 48 hours postinjury was associated with a 3 times greater risk of >2000 mL of CBL ( P = 0.006). This did not result in differences in transfusion rates between groups at 24 hours ( P = 0.518), 36 hours ( P = 1.000), or 48 hours ( P = 0.779). CONCLUSIONS: Delaying fixation of acetabular fractures treated through an anterior approach for 48 hours postinjury may significantly reduce perioperative blood loss. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Impact of Anesthesia selection on Post-Op Pain Management in Operatively treated Hip Fractures.

OBJECTIVES: To determine if the use of Peripheral Nerve Block (PNB) versus Local Infiltration Analgesia (LIA) for hip fracture patients, affected opioid consumption in the early post-operative period. DESIGN: Retrospective cohort study SETTING: Two level 1 trauma centers PATIENTS/INTERVENTION: 588 patients with surgically treated AO/OTA 31A and 31B fractures between February 2016-October 2017 were included. 415 (70.6%) received general anesthesia (GA) alone, 152 received GA plus perioperative PNB (25.9%), and 21 had GA plus LIA intra-operatively (3.6%). Median age was 82 years; predominantly female (67%) and AO/OTA 31A fractures (55.37%). MAIN OUTCOME MEASURES: Morphine Milligram Equivalents (MME) at 24 and 48 hours postoperatively, length of stay (LOS) and the occurrence of any complication after surgery RESULTS: The PNB cohort was less likely to use any opioid than the GA group at 24 and 48 hours postoperatively (OR: 0.36, 95% CI: 0.22-0.61 and OR: 0.56, 95% CI: 0.35-0.89 respectively). LOS ≥ 10 days had 3.24 times the odds of 24- and 48-hour opioid administration compared to LOS ≤ 10 days (OR: 3.24, 95% CI 1.11-9.42; OR: 2.98, 95% CI 1.38-6.41, respectively). The most common complication was post-operative delirium, with PNB more likely to present with any complication compared to GA (OR= 1.88, 95% CI 1.09-3.26). There was no difference when comparing LIA to general anesthesia. CONCLUSIONS: Our findings suggest PNB for hip fracture can help limit the use of post-operative opioids with adequate pain relief. Regional analgesia does not seem to avoid complications such as delirium.

High Complication Rate After Percutaneous Screw Fixation for Valgus-Impacted Femoral Neck Fractures Without Sagittal Malalignment.

OBJECTIVES: To evaluate the rate of reoperation in patients without sagittal plane malalignment who underwent percutaneous screw fixation of a valgus-impacted femoral neck fracture. DESIGN: Retrospective case series. SETTING: Two Level 1 academic trauma centers. PATIENTS AND INTERVENTION: Two hundred seven patients >50 years of age with valgus-impacted femoral neck fractures treated with at least 3 large-diameter (>6.5 mm) cancellous screws from 2013 to 2019. Patients were excluded if there was a sagittal plane fracture deformity. MAIN OUTCOME MEASUREMENTS: The primary outcome was reoperation. Secondary outcomes considered "major complications" included: avascular necrosis, varus collapse or implant cutout, nonunion, deep infection, and hematoma requiring reoperation. Surgical fixation strategies (screw configuration, aim) and implant type (partial vs. fully threaded cancellous screws) were secondarily compared. RESULTS: Average patient age was 77 years, and median clinical follow-up was 658 days. Thirty-one patients (15%) required reoperation, and the major complication rate was 17.3% (36 complications in 33 patients). Logistic regression analysis demonstrated a higher risk of reoperation with constructs consisting of all partially threaded screws (17.0%) compared with the use of at least 1 fully threaded screw (7.5%) when an inverted triangle configuration was used (odds ratio, 2.50; 95% CI, 0.81-7.77). CONCLUSIONS: This study demonstrated a relatively high rate of reoperation and major complications in patients with valgus-impacted femoral neck fractures without sagittal malalignment treated with in situ percutaneous screw fixation. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Local administration of vancomycin powder in orthopaedic fracture surgery: current practice and trends.

Objectives: Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system-level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods: Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results: A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions: Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of Evidence: Prognostic-III.

Pragmatic design and inclusion of patient-partner representatives improves participant experience in clinical research.

Objectives: Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. Methods: At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Results: Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Conclusions: Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.

Effects of Spinal Anesthesia in Geriatric Hip Fracture: A Propensity-Matched Study.

OBJECTIVES: To identify whether anesthesia type is associated with surgical outcomes in geriatric patients undergoing operative treatment for a hip fracture. DESIGN: Retrospective database review of prospectively collected data. PATIENTS: Patients included in the American College of Surgeons National Surgical Quality Improvement Program database. All included patients were 65-89 years of age and had a hip fracture treated with internal fixation, arthroplasty, or intramedullary device. Patients were excluded for open, pathologic, stress-related, or periprosthetic hip fractures. INTERVENTION: Use of spinal anesthesia (SA) or general anesthesia (GA). MAIN OUTCOME MEASUREMENTS: Complications, mortality, and discharge destination. RESULTS: A total of 23,649 cases met inclusion and exclusion criteria and were successfully matched using propensity score matching: 15,766 GA and 7883 SA. The odds of sustaining a complication were 21% lower in the SA group compared with those in the GA group (odds ratio SA/GA 0.791; 95% confidence interval, 0.747-0.838). The 30-day mortality rate was not correlated with SA or GA choice. Patients who underwent SA were significantly more likely to be discharged to home (odds ratio SA/GA 1.65; 95% confidence interval, 1.531-1.773). CONCLUSIONS: No mortality difference exists between patients undergoing SA and those undergoing GA for hip fracture surgery. For patients undergoing hip fracture surgery with SA, there is lower 30-day complication profile and higher discharge to home rate compared with those undergoing GA. Both anesthesia modalities may be acceptable. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Early Advanced Weight-Bearing After Periarticular Fractures: A Randomized Trial Comparing Antigravity Treadmill Therapy Versus Standard of Care.

SUMMARY: In current clinical practice, weight-bearing is typically restricted for up to 12 weeks after definitive fixation of lower extremity periarticular fractures. However, muscle atrophy resulting from restricting weight-bearing has a deleterious effect on bone healing and overall limb function. Antigravity treadmill therapy may improve recovery by allowing patients to safely load the limb during therapy, thereby reducing the negative consequences of prolonged non-weight-bearing while avoiding complications associated with premature return to full weight-bearing. This article describes a multicenter randomized controlled trial comparing outcomes after a 10-week antigravity treadmill therapy program versus standard of care in adult patients with periarticular fractures of the knee and distal tibia. The primary hypothesis is that, compared with patients receiving standard of care, patients receiving antigravity treadmill therapy will report better function 6 months after definitive treatment.

The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7-121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.

Wound care practices after orthopaedic trauma surgery are highly variable and not evidence based.

OBJECTIVE: Given the tremendous medical, social and financial costs of surgical site infections, the pressure to minimize these complications has been mounting. There remains a substantial gap in evidence-based practice for postoperative wound care after orthopaedic trauma surgery. The purpose of this study is to determine what standards are currently in practice for postoperative wound management. METHODS: A 16-question web-based survey was published on the Orthopaedic Trauma Association website and disseminated to members through the association's quarterly email. The survey gathered data on postoperative wound care practices; specifically, when wound checks are performed, and when providers allow patients to get the incisions wet. RESULTS: 102 Orthopaedic surgeons completed the survey. Ninety-one percent were trauma fellowship trained, and 95% worked at either a Level I (76%) or Level II (19%) trauma center. There were over 100 different proposed protocols captured by the survey. The majority of surgeons (54%) perform a wound check within the first three days after surgery. Additionally, half of surgeons (50%) do not permit patients to get their incisions wet until sutures and staples are removed. CONCLUSION: Wound care routines following surgical management of orthopaedic trauma injuries are highly variable. Diverse protocols are performed at the discretion of the treating surgeon without scientific basis. This study defines immense variability in one aspect of peri-operative care that could play an important role in surgical site infections and provides a foundation for future studies to explore the potential influence of standardized wound care routines on post-operative infections and wound healing.

The Fate of Patients After a Staged Nonunion Procedure for Known Infection.

OBJECTIVES: To determine the factors associated with successful union and eradication of infection in the setting of staged procedures to treat obviously infected nonunions of long bones. We hypothesize that patients with positive intraoperative cultures obtained at the time of definitive surgery for infected nonunions are more likely to have persistent nonunion than those with negative cultures. DESIGN: Multicenter retrospective review. SETTING: Eight academic Level 1 trauma centers. PATIENTS/PARTICIPANTS: Patients who underwent staged management for obviously infected nonunion of a long bone. MAIN OUTCOME MEASUREMENTS: For each patient, initial fracture management, management of retained implants, number of debridements, grafting, bacteriology, antibiotic course, bone defect management, soft-tissue coverage, and definitive surgery performed were reviewed. RESULTS: A total of 134 patients were treated with staged procedures for obviously infected nonunion of a long bone (mean age 49 years, 60% open fractures, and mean follow-up 22 months). During definitive procedures, 120 patients had intraoperative cultures taken with 43% having positive cultures. For culture-positive patients, 41 patients achieved eventual union and 10 had persistent nonunion. Of 69 culture-negative patients, 66 achieved eventual union and 3 had persistent nonunion. The number of patients with union versus persistent nonunion was statistically significant between culture-positive and culture-negative groups (P = 0.015). CONCLUSIONS: Management of infected nonunion in long bones with staged treatments before definitive fixation are beneficial but ultimately less effective when performed in the setting of positive bacterial cultures at the time of definitive management. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.