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.).

Outcomes Following Intramedullary Nailing of Select Periarticular Distal Tibia Fractures.

Intramedullary nailing (IMN) of periarticular distal tibia fractures may offer advantages compared to plating. This study aims to report on the outcomes of select periarticular distal tibia fractures treated with IMN. Patients over 17 years of age that underwent IMN for extraarticular distal tibia fractures (Osteosynthesefragen/Orthopaedic Trauma Association [AO/OTA] 43-A), partial articular with associated segmental shaft component (43-B), and simple intraarticular (43-C1/2) at a Level I trauma center were included. The primary outcome was physical function (PF) and pain interference (PI) assessed via Patient-Reported Outcomes Measurement Information System (PROMIS). Secondary outcomes included reoperation, nonunion, infection, and malalignment. Eighty-four patients with > 12 months follow up were included. Mean PROMIS PI and PF scores were 55.5 and 45.0, respectively. The rate of nonunion and deep infection each were 8%. Eighty-four percent of patients achieved normal alignment. There were no differences detected in clinical outcomes between patients with intraarticular injuries compared with those with extraarticular fractures. Satisfactory clinical, radiographic, and patient-reported outcomes can be expected following treatment of extraarticular and simple intraarticular distal tibia fractures with IMN. (Journal of Surgical Orthopaedic Advances 32(4):246-251, 2023).

Intramedullary Nail Fixation of Intra-articular and Extra-articular Proximal Tibia Fractures.

Recent studies suggest advantages to intramedullary nailing (IMN) of extra-articular proximal tibia fractures compared to plating. To our knowledge, no studies have evaluated IMN treatment of proximal tibia fractures with simple articular extension. We sought to compare rate of reoperation, malalignment, and patient-reported outcomes in patients with intra-articular versus extra-articular proximal tibia fractures treated via IMN. This retrospective cohort study compared patients that underwent IMN of extra-articular proximal tibia fractures (AO/OTA 41A2 and A3; n = 33) to simple intra-articular fractures (AO/OTA 41C1 and C2; n = 20) with minimum 12-month follow-up. With the numbers available, no significant differences were detected between the extra- and intra-articular groups for unplanned reoperation (9/33 vs. 2/20, p = 0.18), infection (4/33 vs. 1/20, p = 0.64), nonunion (4/33 vs. 2/20, p > 0.99), or malunion (5/30 vs. 3/19, p > 0.99). IMN of simple intra-articular proximal tibial fractures is a reasonable treatment strategy that may be desirable in certain clinical situations. (Journal of Surgical Orthopaedic Advances 30(1):055-060, 2021).

Retrograde intramedullary nailing below a hip arthroplasty prosthesis: a viable fixation option for periprosthetic and interprosthetic femur fractures.

BACKGROUND: Periprosthetic femur fractures (PPFF) distal to a femoral stem are traditionally treated with open reduction and internal fixation (ORIF) with plate and screws. To our knowledge, no studies exist comparing outcomes following ORIF vs retrograde intramedullary nails (RIMN) for this injury. METHODS: This is a retrospective comparison of PPFFs distal to a femoral stem treated by ORIF (n = 17) vs RIMN (n = 13). The primary outcome was unplanned re-operation. RESULTS: There was no difference in unplanned re-operation (17.6 vs 23.1%, p > 0.99), infection, nonunion, refracture, and alignment between groups. The RIMN group had shorter surgical time (89 vs 157 min, p < 0.01), less blood loss (137 vs 291 ml, p = 0.03), and greater obesity. CONCLUSION: RIMN is a potential option for operative fixation of PPFF distal to a femoral stem worthy of additional study.

Abdominopelvic bleed rate on admission CT correlates with mortality and transfusion needs in the setting of blunt pelvic fractures: a single institution pilot study.

PURPOSE: The objectives of this study were to calculate the total volumetric rate of abdominopelvic bleeding in patients with acute pelvic fractures and examine the relationships between the bleeding rate, patient outcomes, and required patient interventions. METHODS: This was a retrospective cohort study which included 29 patients from a 4-year period (May 2013 to May 2017). Patients with acute pelvic fractures and active bleeding detected on CT with two phases of imaging were included. Software was used to measure the volume of active bleeding on arterial and parenchymal phases. The active bleeding rate was calculated by dividing the change in active bleeding volume by the time between the two phases. The total volumetric bleed rate from all sites was then computed. Clinical variables were compared between survivors and non-survivors. RESULTS: Overall mortality in this cohort was 21% (n = 6). The mean abdominopelvic volumetric bleed rate in non-survivors was much greater than survivors (40.7 cc/min vs. 5.7 cc/min; p < 0.01). Ninety-six percent of survivors had an abdominopelvic bleed rate < 20 cc/min compared to 33% of non-survivors. An abdominopelvic bleed rate > 20 cc/min was associated with a mortality rate of 80% while a rate of < 20 cc/min was associated with a 92% survival rate. The mean pelvic hematoma volume was greater in non-survivors compared to survivors (1854 cc vs. 746 cc; p < 0.01). There was a positive association between hematoma volume and units of blood transfused (rs = 0.4, n = 29, p = 0.04). CONCLUSION: An abdominopelvic bleeding rate > 20 cc/min was associated with a high risk of mortality.

The effect of pH versus base deficit on organ failure in trauma patients.

BACKGROUND: Base deficit (BD) calculations are affected by trauma-related changes in circulating concentrations of anions after injury. In contrast, pH is a direct measurement that corresponds to hypoperfusion. We hypothesized that changes in pH would more closely correspond to organ dysfunction compared with changes in BD. MATERIALS AND METHODS: BD and pH values were collected for the first 48 h after injury from a retrospective cohort of 74 multiply injured adult patients who were admitted to the surgical intensive care unit for a minimum of 1 wk. Mean and extreme (minimum pH and maximum BD) values of pH and BD were determined for day 1 (0-24 h) and for day 2 (24-48 h) after injury. Organ dysfunction was measured by averaging daily sequential organ failure assessment scores over the entire duration of intensive care unit admission. BD and pH values were compared with mean modified sequential organ failure assessment scores by univariate and multivariate linear regression. RESULTS: Organ dysfunction corresponded more closely with changes in pH compared with those in BD. Minimum pH and maximum BD showed better correspondence to organ dysfunction compared with mean values. Minimum pH values at 24-48 h had the highest univariate (r(2) = 0.43) correspondence to organ dysfunction. In contrast, mean BD values at 24-48 h showed no correspondence (r(2) = 0.07) to organ dysfunction. Multivariate analysis demonstrated that 24-48 h of minimum pH had the highest numerical effect on organ dysfunction. CONCLUSIONS: Correspondence between organ dysfunction and BD deteriorated in contrast to increasing correspondence between organ dysfunction and pH measured within 48 h after injury.

Tissue damage volume predicts organ dysfunction and inflammation after injury.

BACKGROUND: Multiply injured patients (MIPs) are at risk to develop multiple-organ failure (MOF) and prolonged systemic inflammation response syndrome (SIRS). It is difficult to predict which MIPs are at the highest risk to develop these complications. We have developed a novel method that quantifies the distribution and physical magnitude of all injuries identified on admission computed tomography scanning called the Tissue Damage Volume (TDV) score. We explored how individualized TDV scores corresponded to MOF and SIRS. MATERIALS AND METHODS: A retrospective study on 74 MIPs measured mechanical TDV by calculating injury volumes on admission computed tomography scans of all injuries in the head/neck, chest, abdomen, and pelvis. Regional and total TDV scores were compared between patients that did or did not develop MOF or sustained SIRS. The magnitude of organ dysfunction was also stratified by the magnitude of TDV. RESULTS: Mean total and pelvic TDV scores were significantly increased in patients who developed MOF. Mean total, chest, and abdominal TDV scores were increased in patients who developed sustained SIRS. The magnitude of organ dysfunction was significantly higher in patients who sustained large volume injuries in the pelvis or abdomen, and in patients who sustained injuries in at least three anatomic regions. CONCLUSIONS: A novel index that quantifies the magnitude and distribution of mechanical tissue damage volume is a patient-specific index that can be used to identify patients who have sustained injury patterns that predict progression to MOF and SIRS. The preliminary methods will need refinement and prospective validation.

Update on Venous Thromboembolism in Orthopaedic Trauma Surgery.

Venous thromboembolism (VTE) is a notable contributor to the morbidity and mortality of patients with orthopaedic trauma. Several associations have published guidelines on VTE prophylaxis, with a strong predilection toward low-molecular-weight heparin for chemoprophylaxis. However, previous recommendations may be revisited because recent high-level evidence demonstrated aspirin to be noninferior to low-molecular-weight heparin in preventing serious complications of VTE. Direct oral anticoagulants are emerging as safe alternatives to injectable medication and may offer improved patient compliance. There is no consensus on postinjury duration of chemoprophylaxis as an outpatient. Mechanical prophylaxis remains an important adjunctive VTE preventive measure for inpatients with pelvis and extremity fractures. Proteomics and novel laboratory measurements may be able to predict high-risk patients and detect early thrombus formation. Despite high-quality prospective research over the past decade, we still have much to learn about patient- and injury-specific risk factors.

Skeletal Traction for Isolated Femur Fractures Does Not Reduce Opioid Consumption.

OBJECTIVES: Isolated femoral shaft fractures can be treated preoperatively with skeletal traction (TXN) or maintenance of a position of comfort (COMF). The goal of this retrospective review was to determine whether preoperative opioid consumption differs significantly between these forms of treatment. DESIGN: Case-control retrospective study. SETTING: Two academic Level 1 trauma centers. PATIENT SELECTION CRITERIA: Patients presenting to the emergency department with isolated OTA/AO 32A-C femoral shaft fractures from 2017 to 2020. OUTCOME MEASURES AND COMPARISONS: The primary outcome was preoperative opioid consumption (morphine milligram equivalents) comparing patients treated with application of TXN or placed in a position of COMF. RESULTS: Two hundred and twenty patients were studied (COMF n = 167, TXN n = 53). Multivariate regression analysis revealed significantly greater preoperative opioid consumption in the emergency department for the TXN group compared with COMF (2.6 more morphine milligram equivalents [confidence interval, 0.23-4.96], P = 0.031). There was no difference in preoperative opioid consumption between groups on the hospital floor ( P = 0.811) nor during the entire preoperative course ( P = 0.486). The total preoperative rate of opioid consumption (morphine milligram equivalents/hour) did not differ ( P = 0.825). CONCLUSIONS: Patients with isolated femoral shaft fractures treated preoperatively with skeletal traction consumed more opioids in the emergency department compared with patients treated in a position of comfort, but no difference in opioid consumption was observed between groups for the entire preoperative course. A position of comfort may be considered as an acceptable alternative to skeletal traction for patients with isolated femur fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The local and systemic effects of immune function on fracture healing.

The immune system plays an integral role in the regulation of cellular processes responsible for fracture healing. Local and systemic influences on fracture healing correlate in many ways with fracture-related outcomes, including soft tissue healing quality and fracture union rates. Impaired soft tissue healing, restricted perfusion of a fracture site, and infection also in turn affect the immune response to fracture injury. Modern techniques used to investigate the relationship between immune system function and fracture healing include precision medicine, using vast quantities of data to interpret broad patterns of inflammatory response. Early data from the PRECISE trial have demonstrated distinct patterns of inflammatory response in polytrauma patients, which thereby directly and indirectly regulate the fracture healing response. The clearly demonstrated linkage between immune function and fracture healing suggests that modulation of immune function has significant potential as a therapeutic target that can be used to enhance fracture healing.

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.

Work Productivity Loss After Minimally Displaced Complete Lateral Compression Pelvis Fractures.

OBJECTIVE: To quantify work impairment and economic losses due to lost employment, lost work time (absenteeism), and lost productivity while working (presenteeism) after a lateral compression pelvic ring fracture. Secondarily, productivity loss of patients treated with surgical fixation versus nonoperative management was compared. DESIGN: Secondary analysis of a prospective, multicenter trial. SETTING: Two level I academic trauma centers. PATIENT SELECTION CRITERIA: Adult patients with a lateral compression pelvic fracture (OTA/AO 61-B1/B2) with a complete posterior pelvic ring fracture and less than 10 mm of initial displacement. Excluded were patients who were not working or non-ambulatory before their pelvis fracture or who had a concomitant spinal cord injury. OUTCOME MEASURES AND COMPARISONS: Work impairment, including hours lost to unemployment, absenteeism, and presenteeism, measured by Work Productivity and Activity Impairment assessments in the year after injury. Results after non-operative and operative treatment were compared. RESULTS: Of the 64 included patients, forty-seven percent (30/64) were treated with surgical fixation, and 53% (30/64) with nonoperative management. 63% returned to work within 1 year of injury. Workers lost an average of 67% of a 2080-hour average work year, corresponding with $56,276 in lost economic productivity. Of the 1395 total hours lost, 87% was due to unemployment, 3% to absenteeism, and 10% to presenteeism. Surgical fixation was associated with 27% fewer lost hours (1155 vs. 1583, P = 0.005) and prevented $17,266 in average lost economic productivity per patient compared with nonoperative management. CONCLUSIONS: Lateral compression pelvic fractures are associated with a substantial economic impact on patients and society. Surgical fixation reduces work impairment and the corresponding economic burden. LEVEL OF EVIDENCE: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Risk-stratified thromboprophylaxis effects of aspirin versus low-molecular-weight heparin in orthopedic trauma patients: A secondary analysis of the PREVENT CLOT trial.

BACKGROUND: The PREVENT CLOT trial concluded that thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin (LMWH) in preventing death after orthopedic trauma. However, it was unclear if these results applied to patients at highest risk of thrombosis. Therefore, we assessed if the effect of aspirin versus LMWH differed based on patients' baseline risk of venous thromboembolism (VTE). METHODS: The PREVENT CLOT trial enrolled 12,211 adult patients with fractures. This secondary analysis stratified the study population into VTE risk quartiles: low (<1%) to high (>10%) using the Caprini score. We assessed stratum-specific treatment effects using the win ratio method, in which each patient assigned to aspirin was paired with each assigned to LMWH. In each pair, we compared outcomes hierarchically, starting with death, then pulmonary embolism, deep vein thrombosis, and bleeding. The secondary outcome added patients' medication satisfaction as a fifth composite component. RESULTS: In the high-risk quartile (n = 3052), 80% had femur fracture, pelvic, or acetabular fractures. Thoracic (47%) and head (37%) injuries were also common. In the low risk quartile (n = 3053), most patients had a tibia fracture (67%), 5% had a thoracic injury, and less than 1% had head or spinal injuries. Among high risk patients, thromboembolic events did not differ statistically between aspirin and LMWH (win ratio, 0.94; 95% confidence interval [CI], 0.82-1.08, p = 0.42). This result was consistent in the low (win ratio, 1.15; 95% CI, 0.90-1.47, p = 0.27), low-medium (win ratio, 1.05; 95% CI, 0.85-1.29, p = 0.68), and medium-high risk quartiles (win ratio, 0.94; 95% CI, 0.80-1.11, p = 0.48). When medication satisfaction was considered, favorable outcomes were 68% more likely with aspirin (win ratio, 1.68; 95% CI, 1.60-1.77; p < 0.001). CONCLUSION: Thromboembolic outcomes were similar with aspirin or LMWH, even among patients at highest risk of VTE. Aspirin was favored if medication satisfaction was also considered. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

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.

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.

Risk factors for complications within 30 days of operatively fixed periprosthetic femur fractures.

Background: With a rising number of periprosthetic femur fractures (PPFFs) each year, the primary objective of our study was to quantify risk factors that predict complications following operative treatment of PPFFs. Methods: A retrospective cohort study of 231 patients with a periprosthetic femur fracture was conducted at an Academic, Level 1 Trauma Center. The main outcome measurement of interest was complications, as defined by the ACS-NSQIP, within 30 days of surgery. Results: 56 patients had 96 complications. Bivariate analyses revealed ASA score, preoperative ambulatory status, length of stay, discharge disposition, time from admission to surgery, length of surgery, perioperative change in hemoglobin, Charlson comorbidity index, cerebral vascular accident/transient ischemic attack, chronic obstructive pulmonary disease, diabetes mellitus, and receipt of a blood transfusion were associated with development of a complication (p < 0.1). Multivariate logistic regression showed length of stay (OR 1.11, 95% CI 1.03-1.19; p = 0.006), receipt of a blood transfusion (OR 2.48, 95% CI 1.14-5.42; p = 0.02), and diabetes mellitus (OR 2.17, 95% CI 1.03-4.56; p = 0.04) remained independently predictive of complication. Conclusions: Length of stay, receipt of a blood transfusion, and diabetes were associated with increased perioperative risk for developing a complication following operative treatment of periprosthetic femur fractures. Methods to decrease length of stay or transfusion rates may mitigate complication risk in these patients. Level of Evidence: Prognostic, Level III.

Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients (PRECISE STUDY).

SUMMARY: Optimal timing and procedure selection that define staged treatment strategies can affect outcomes dramatically and remain an area of major debate in the treatment of multiply injured orthopaedic trauma patients. Decisions regarding timing and choice of orthopaedic procedure(s) are currently based on the physiologic condition of the patient, resource availability, and the expected magnitude of the intervention. Surgical decision-making algorithms rarely rely on precision-type data that account for demographics, magnitude of injury, and the physiologic/immunologic response to injury on a patient-specific basis. This study is a multicenter prospective investigation that will work toward developing a precision medicine approach to managing multiply injured patients by incorporating patient-specific indices that quantify (1) mechanical tissue damage volume; (2) cumulative hypoperfusion; (3) immunologic response; and (4) demographics. These indices will formulate a precision injury signature, unique to each patient, which will be explored for correspondence to outcomes and response to surgical interventions. The impact of the timing and magnitude of initial and staged surgical interventions on patient-specific physiologic and immunologic responses will be evaluated and described. The primary goal of the study will be the development of data-driven models that will inform clinical decision-making tools that can be used to predict outcomes and guide intervention decisions.

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.

Is Immediate Weight-Bearing Safe After Single Implant Fixation of Elderly Distal Femur Fractures?

OBJECTIVES: To compare early complications in elderly patients with extra-articular distal femur fractures (DFFs) allowed to weight-bear as tolerated (WBAT) immediately versus patients prescribed initial touchdown weight-bearing (TDWB). DESIGN: Retrospective cohort study. SETTING: Level 1 academic trauma center. PATIENTS: One hundred thirty-five patients 60 years or older who underwent surgical fixation of an extra-articular DFF, including the OTA/AO fracture classification of 33-A1-3, and periprosthetic fractures with a stable knee prosthesis (Lewis and Rorabeck type I or II) with at least 6 months follow-up. INTERVENTION: Immediate WBAT or TDWB after surgical fixation of an extra-articular DFF with either an intramedullary nail or locked plate. MAIN OUTCOME MEASUREMENTS: The primary outcome was a major adverse event within the first 6 months, defined as (1) early fixation failure or change in alignment leading to reoperation, (2) nonunion, or (3) deep infection. Secondary outcomes included postoperative inpatient length of stay, discharge disposition (secondary facility vs. home), malunion, mortality, and patient-reported outcomes. RESULTS: The rate of early adverse events requiring reoperation was similar between the WBAT group (6, 10.7%) and the TDWB group (15, 19.0%; P = 0.23). There was no difference between groups with respect to length of stay, discharge disposition, malunion, and patient-reported outcomes. CONCLUSIONS: This study supports allowing carefully selected elderly patients, based on surgeon preference, to immediately weight-bear after operative fixation of an extra-articular DFF regardless of implant choice. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Predictors of Improved Early Clinical Outcomes After Elective Implant Removal.

OBJECTIVES: To determine preoperative factors predictive of improvement in pain and function after elective implant removal. We hypothesized that patients undergoing orthopaedic implant removal to relieve pain would have significant improvements in both pain and function. DESIGN: Prospective cohort study. SETTING: Level I Trauma Center. PATIENTS/PARTICIPANTS: One hundred eighty-nine patients were enrolled after consenting for orthopaedic implant removal to address residual pain. One hundred sixty-three were available for 3-month follow-up. MAIN OUTCOME MEASUREMENT: Preoperative and postoperative outcome measures including Patient Reported Outcomes Measurement Information System (PROMIS) scores were compared. Preoperative scores, surgeon prediction of pain improvement, and palpable implants were analyzed as predictors of outcomes. RESULTS: Median PROMIS physical function and pain interference scores and visual analogue scale significantly improved by 6, 8, and 2 points, respectively (P < 0.001 for all). Worse preinjury scores predicted improvement in respective postoperative outcomes (P < 0.001 for all). Surgeon prediction of improvement was associated with improved PROMIS pain interference (P = 0.005), patient subjective assessment of pain improvement (P = 0.03), and subjective percent of pain remaining at 3 months (P = 0.02). Implant superficial palpability was not predictive for any postoperative outcomes. CONCLUSIONS: Although the primary indication for implant removal in this population was pain relief, many patients also had a clinically relevant improvement in physical function. In addition, patients who start with worse global indices of pain and function are more likely to improve after implant removal. This suggests that implant-related pain directly contributes to global dysfunction. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.