Complications of standard versus long cephalomedullary nails in the treatment of unstable extracapsular proximal femoral fractures: A randomized controlled trial.

AIMS: To compare in a prospective randomized trial the mechanical complications in patients with unstable extracapsular proximal femur fractures without subtrochanteric extension (AO/OTA 31-A2 and 31-A3) METHODS: We prospectively studied 182 patients with unstable extracapsular proximal femur fractures without fractures lines extending more than 3 cm below the lesser trochanter, randomized to receive either a 'standard' (240 mm) nail or a long nail and followed them up for 1 year. RESULTS: We found no difference in the incidence of mechanical or general complications between the two groups, no cut-outs, no fractures of the tip the implant, 1 cut-through and 2 malrotations in the LN group, 2 non-unions that were reoperated, one on each group. The commonest complication was blade lateral migration, 13 (14%) patients in SN and 6 (9%) in the LN. The operating time was shorter in the SN group 51 minutes compared to 67 minutes in the LN group (p=0.000075). The mortality at 1,3 and 12 months in the SN group was of 2%, 6%, 12% while in the LN group was 12%, 18% and 22%. These differences where significative at 1 (p=0.007) and 3 months (p=0.013), but not at 12 months (p=0.075). CONCLUSIONS: We recommend the use of standard nails (240 mm) for this group of fractures, since it does not produce more mechanical complications, and it is faster, cheaper and easier to interlock distally.

Wide-awake surgery in orthopaedics: "Scoping review".

INTRODUCTION: The anaesthetic modality "wide-awake" or "WALANT" (wide awake local anaesthesia not tourniquet) is based on the combination of a local anaesthetic with a vasoconstrictor to reduce bleeding during surgery and to avoid the use of a pneumatic tourniquet. The combination of 1% lidocaine together with 1:100,000 epinephrine is the most commonly used formula. The objective of this work is to carry out a review of the literature about this anaesthetic modality in the field of orthopaedic surgery and traumatology. METHODS: PubMed and Embase databases were consulted with clearly defined operators. Two independent searches were conducted by two investigators, which were combined. Experimental, observational comparative studies, descriptive studies with n> 5 cases and cost studies were included. The individual results of the included studies are described. RESULTS: A total of 8794 entries were collected of which a total of 36 studies were included in the review. A large number of these studies have been published since 2010 and refer almost entirely to hand surgery, with multiple indications applied. There is heterogeneity regarding the type of study design and variables studied, among others. In addition, there is a disparity when defining the methodology of the WALANT technique between the different studies. CONCLUSIONS: This is the first comprehensive and reproducible review of the current state of the WALANT modality. There is great heterogeneity in terms of the study populations, the different comparators, variables studied between the different studies and a lack of precise details regarding the WALANT technique. LEVEL OF EVIDENCE: III, Therapeutic study.

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.

A Systematic Review of Outcome Measures in Orthopaedic Trauma Trials: What Are We Measuring?

Purpose: The objectives of this study are to describe the outcome measures used in orthopaedic fracture care trials, with a particular focus on patient-reported outcome measures (PROMs), and to determine which study characteristics are associated with number of citations. Methods: We retrieved randomized clinical trials on fracture care between 2012 and 2017 from Embase, Medline and CENTRAL databases. Data collected included study characteristics (e.g., region, design, setting, sample size) and outcome measures (e.g., primary variable, measurement perspective, use of PROMs, study results and number of citations). Results: We identified a total of 8,580 articles in the initial search. After title screening, abstract screening and full-text review, we included 416 articles for analysis. 58.4% (243) of the studies clearly defined a primary outcome measure and 56.3% (234) reported sample size justifications for outcome selection. The most common primary outcome reported was a visual analogue scale for pain; used in 21 of the 243 (8.6%) studies that defined a primary outcome. At least one PROM was used in 68.5% (285) of the papers included. Conclusions: A large proportion of studies reporting on PROMs for orthopaedic trauma patients do not provide key information on the outcome selection process; a step of utmost importance in and the designing and reporting of RCTs. There is substantial heterogeneity in the selection of PROMs for fracture care trials, which limits the ability to compare and summarize across studies. Future research in fracture care should strive towards improving the reporting of informative PROMs, with rationale that demonstrates understating of the injury, intervention and patient values. Supplementary Information: The online version contains supplementary material available at 10.1007/s43465-022-00667-8.

A customized percutaneous three-dimensional-printed guide for scaphoid fixation versus a freehand technique: a comparative study.

The aim of this study was to compare the accuracy and reliability of percutaneous fixation of minimally displaced scaphoid fractures using a customized three-dimensional (3-D)-printed guide with a conventional freehand method. A prospective cohort of ten patients underwent scaphoid fixation with the aid of a customized 3-D-printed guide. The final screw position, total surgery time (minutes) and fluoroscopy time (seconds) was compared with a retrospective cohort of ten patients who underwent fixation with a conventional technique. There were no differences in final screw position between both methods. The patients in which the 3-D guide was used had a surgery time reduction of 43% and a fluoroscopy time reduction of 52% compared with the control freehand group. The use of a customized 3-D-printed guide permits a fixation that is as accurate as the standard freehand technique, with reduction in surgical time and intraoperative radiation exposure.Level of evidence: III.

3D printing innovation: New insights into upper extremity surgery planning.

INTRODUCTION: Surgical planning relies on the use of images to develop an action plan prior to the actual surgical intervention. Imaging technology improvement together with the development of specific software to treat three dimensional images has increased the accuracy and capabilities of pre-surgical planning. In addition to this, 3D printing allows us to manufacture customized surgical tools to implement and aid in the success of surgeries. MATERIAL AND METHODS: 3D virtual planning together with 3D printing has been implemented through different approaches in 8 different upper extremity trauma cases. We describe these 8 cases (2 women and 6 men with ages ranging from 16 to 67 years), their specific challenges and management. RESULTS: We show how 3D technology changes the conception, planning and execution of surgery in 8 different cases. In addition, we describe what challenges were faced as well as the various utilities of 3D technology beyond that of anatomical model printing. CONCLUSIONS: The use of 3D technology has improved and enhanced surgical planning. It allows us to view and virtually manipulate fracture fragments prior to surgery. It also enables us to develop customized surgical tools and guides that can increase the accuracy of certain procedures, and help in the management of orthopaedic and trauma lesions. We believe that the use of this technology is beneficial to both the patient and surgeon, since it reduces surgical time and complications giving a better understanding of the injury and its treatment.

Timing and Management of Surgical Site Infections in Patients With Open Fracture Wounds: A Fluid Lavage of Open Wounds Cohort Secondary Analysis.

BACKGROUND: Many studies report on the incidence or prevalence of fracture-related surgical site infections (SSIs) after open fractures; however, few studies report on their timing and management outcomes. To address this gap, we used data from the Fluid Lavage of Open Wounds trial to determine timing of diagnosis, management, and resolution of SSIs. METHODS: All participants included in this analysis had an SSI after an open fracture. Participants were assigned to a group based on the type of SSI as follows: (1) those who developed a superficial SSI and (2) those who had either a deep or organ/space SSI. Descriptive statistics characterized the type, timing, and management of each SSI. RESULTS: Of the 2445 participants in the Fluid Lavage of Open Wounds trial, 325 (13.3%) had an SSI. Superficial SSIs were diagnosed significantly earlier [26.5 days, interquartile range (IQR) 12-48] than deep or organ/space SSIs (53 days, IQR 15-119). Of the 325 patients with SSIs, 174 required operative management and 151 were treated nonoperatively. For SSIs managed operatively, median time for infection resolution was 73 days (IQR 28-165), and on average, 1.73 surgeries (95% confidence interval 1.58-1.88) were needed during the 12 months follow-up. There were 24 cases whose SSIs were not resolved at the time of the final follow-up visit (12 months). CONCLUSIONS: Based on this study's findings and in contradistinction to the Centers for Disease Control and Prevention guidelines, after an open fracture, superficial SSIs were diagnosed at one month and deep/organ/space SSIs at 2 months. This information can allow for earlier infection detection. In addition, the knowledge that approximately 50% of the SSIs in our study required a reoperation and 3 months at a minimum to resolve will assist orthopaedic surgeons when counseling their patients. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

"Can patients learn how to reduce their shoulder dislocation?" A one-year follow-up of the randomized clinical trial between the Boss-Holzach-Matter self-assisted technique and the Spaso method.

OBJECTIVE: The aim of this study was to assess the effectiveness and reproducibility of self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp) method for shoulder dislocation. METHODS: We conducted a follow-up at 1 year from the randomization of 60 patients with shoulder dislocation enrolled in the study "Teaching patients to reduce a shoulder dislocation." Half of these patients had been taught the self-assisted technique, whereas the other half had been treated by a physician's manipulative maneuver for reduction. We surveyed all the enrolled patients to describe recurrence rates and reproducibility for both the techniques without supervision as well as the number of emergency visits. RESULTS: In total, 52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study. The total rate of recurrence was 38.5% (20 patients). For the Sp group, 4 of the 30 patients were lost. There were 9 recurrent patients (30%), and 7 were treated in the emergency department (ED). For the BHM group, 4 of the 30 patients were lost. There were 11 recurrent patients (37%), and 2 were treated in the ED. The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025). CONCLUSION: Teaching the BHM technique to the patients is effective and reproducible without direct supervision. It can decrease the number of visits to the ED and is a valid option to teach the patients at risk of recurrence when not being able to get immediate help. LEVEL OF EVIDENCE: Level I, Therapeutic study.

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials.

An amendment to this paper has been published and can be accessed via the original article.

Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials.

BACKGROUND: In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. METHODS: The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics. RESULTS: We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists. CONCLUSIONS: The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics. TRIAL REGISTRATION: Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).

Mortality Rates of Patients with Proximal Femoral Fracture in a Worldwide Pandemic: Preliminary Results of the Spanish HIP-COVID Observational Study.

BACKGROUND: The outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), in December 2019 in Wuhan, People's Republic of China, has developed into an unprecedented pandemic with enormous pressure on health-care providers around the world. A higher mortality rate has been described in older infected individuals. Patients with hip fracture are a particularly vulnerable population during this pandemic because older age is associated with a higher mortality rate. Our aim was to describe the early mortality rate and demographic variables in a hip fracture sample population in Spain during the coronavirus pandemic. METHODS: This is a multicenter, observational, retrospective, descriptive study. We collected data from 13 major hospitals in Spain from the beginning of the national state of alarm (declared on March 14, 2020, by the Spanish government) until the end of our study period on April 4, 2020. All patients who were ≥65 years of age, presented to the Emergency Department of the participating hospitals during this period with a diagnosis of proximal femoral fracture, and had a minimum follow-up of 10 days were included in the cohort. In addition to mortality, demographic and other potential prognostic variables were also collected. RESULTS: In this study, 136 patients with a hip fracture were included. Of these patients, 124 underwent a surgical procedure and 12 were managed nonoperatively. The total mortality rate was 9.6%. Sixty-two patients were tested for COVID-19, with 23 patients being positive. The mortality rate for these 23 patients was 30.4% (7 of 23 patients) at a mean follow-up of 14 days. The mortality rate was 10.3% (4 of 39) for patients who had been tested and had a negative result and 2.7% (2 of 74) for patients who had not been tested. Of the 12 patients who were managed nonoperatively, 8 (67%) died, whereas, of the 124 patients who were surgically treated, 5 (4%) died. Results differed among centers. CONCLUSIONS: There is a higher mortality rate in patients with a hip fracture and an associated positive test for COVID-19. LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

How Successful Is Antibiotic Treatment for Superficial Surgical Site Infections After Open Fracture? A Fluid Lavage of Open Wounds (FLOW) Cohort Secondary Analysis.

BACKGROUND: Although many studies report the incidence and prevalence of surgical site infections (SSIs) after open fractures, there is limited information on the treatment and subsequent outcomes of superficial SSIs in patients with open fractures. Additionally, clinical studies describing the factors that are associated with persistent infection after nonoperative treatment with antibiotics for patients with superficial SSIs are lacking. QUESTIONS/PURPOSES: Therefore, we asked: (1) What proportion of patients with superficial SSIs after open fracture treatment developed persistent infection after nonoperative treatment (that is, treatment with antibiotics alone)? (2) What risk factors are associated with SSIs that do not resolve with nonoperative (antibiotic) treatment? As a secondary objective, we planned to analyze the microbiological information about participants wound cultures, when these were available, and the proportion of positive cultures for patients whose SSIs were not resolved by antibiotics alone. METHODS: This is a secondary analysis of the Fluid Lavage of Open Wounds (FLOW) trial dataset. The FLOW trial included 2445 patients with operatively managed open fractures. FLOW participants who had a nonoperatively managed superficial SSI diagnosed in the 12 months post-fracture were included in this analysis. Superficial SSIs were diagnosed in 168 participants within 12 months of their fracture. Of these, 83% (139) had their superficial SSI treated with antibiotics alone. Participants were grouped into two categories: (1) 97 participants whose treatment with antibiotics alone resolved the superficial SSI and (2) 42 participants whose treatment with antibiotics alone did not resolve the SSI (defined as undergoing surgical management or the SSI being unresolved at latest follow-up [12-months post-fracture for the FLOW trial]). Of the participants whose treatment with antibiotics alone resolved the SSI, 92% (89 of 97) had complete follow-up, 6% (6 of 97) were lost to follow-up before 12 months, 1% (1 of 97) withdrew consent from the study before 12 months, and 1% (1 of 97) experienced mortality before 12 months. Of the participants whose treatment with antibiotics alone did not resolve the SSI, 90% (38 of 42) had complete follow-up, 7% (3 of 42) were lost to follow-up before 12 months, and 2% (1 of 42) withdrew consent from the study before 12 months. A logistic binary regression analysis was conducted to identify factors associated with persistent infection despite superficial SSI antibiotic treatment. Based on biologic rationale and previous evidence, we identified a priori 13 potential factors (corresponding to 14 levels) to be included in the regression model. RESULTS: The antibiotic treatment resolved the superficial SSI in 70% (97 of 139) of patients and did not resolve the SSI in 30% (42 of 139). After controlling for potential confounding variables, such as age, fracture severity, and time from injury to initial surgical irrigation and débridement, superficial SSIs diagnosed later in follow-up were associated with antibiotics not resolving the SSI (odds ratio 1.05 [95% CI 1.004 to 1.009] for every week of follow-up; p = 0.03). Sex, fracture pattern, and wound size were not associated with antibiotics not resolving the SSI. CONCLUSIONS: Our secondary analysis of prospectively collected FLOW data suggests that antibiotics alone can be an appropriate treatment option when treating superficial SSIs after an open fracture wound, especially when promptly diagnosed. Further research with longer follow-up time is needed to better identify the natural history of superficial SSIs and possibly some dormant or subclinical infections to help clinicians in the treatment decision-making process. LEVEL OF EVIDENCE: Level III, therapeutic study.

Partial Versus Total Trapeziectomy With Interposition Arthroplasty for Trapeziometacarpal Osteoarthritis Grade II to III Eaton-Littler: A Clinical Trial.

Purpose: Total trapeziectomy is the most widely used technique to treat isolated thumb trapeziometacarpal joint osteoarthritis. However, this technique has been associated with proximal migration of the thumb metacarpal, which has led some physicians to consider partial trapeziectomy as a valid alternative. The purpose of this study was to assess whether partial trapeziectomy improves final key pinch strength compared with total trapeziectomy. Methods: We randomized 34 patients with basal thumb osteoarthritis into 2 groups to undergo partial or total trapeziectomy with interposition arthroplasty. Key pinch strength at 12 months was the primary outcome measure. Other variables measured included trapezial space height, range of motion, grip strength, change in key pinch strength, patient-reported outcome measures, and pain. Results: No difference between groups was detected regarding final pinch strength, trapezial space height, grip strength, range of motion, change in pinch strength, patient-reported outcomes (Quick-Disabilities of the Arm, Shoulder, or Hand), or pain. Conclusions: We cannot conclude that partial trapeziectomy provides an advantage over total trapeziectomy at 1 year after surgery. Although trapeziometacarpal space was substantially preserved in the partial trapeziectomy group at 12 months, this difference was not statistically or clinically significant. Type of study/level of evidence: Diagnostic III.

Long-Term Evaluation Following Partial Trapeziectomy and Suspension Arthroplasty for Trapeziometacarpal Osteoarthritis: An Observational Study.

Purpose: Partial trapeziectomy is performed to decrease the risk for first ray collapse. However, the incidence of scaphotrapezoidal (ST) joint osteoarthritis (OA) in the presence of advanced trapeziometacarpal joint OA is around 40%. The purposes of this study were to analyze the progression of the ST joint after partial trapeziectomy and to establish the potential link between radiographic findings and patient outcomes. Methods: We reviewed a series of 22 patients (26 thumbs) with base of the thumb OA who underwent partial trapeziectomy and interposition arthroplasty. Standardized radiographs of the ST joint were classified by 2 independent observers. Measured outcomes were pain, mobility (degrees of abduction, Kapandji score, and anteversion [in centimeters]), force (in kilograms]) and the short version of the Disabilities of the Arm, Shoulder, and Hand questionnaire score. Results: Median follow-up was 8 years. The modified Eaton-Glickel scale was used to rate the degree of ST joint arthritis: 2 thumbs were classified as grade 1, 11 as grade 2, 12 as grade 3, and 1 as grade 4. No parameters analyzed demonstrated a statistically significant correlation between patients' outcomes and joint radiographic arthritis. Conclusions: Our study cannot demonstrate that the radiographic presence of ST arthritis correlates with the patient's main symptoms after partial trapeziectomy. Type of study/level of evidence: Therapeutic IV.

Physical outcome measures: The role of strength and range of motion in orthopaedic research.

Outcome measures are the indispensable mean through which different interventions are compared in research. The increase in volume that orthopaedic research has experienced in the last years has provided an extensive list of outcomes to choose from. Historically, attention has been focused mainly in morbidity as well as physician reported clinical outcomes, however there is a trend towards the use of patient reported outcomes. We intent to review the inherent characteristics and current applicability of two of the most representative physical outcome measures used in orthopaedics: Range of Motion (ROM) and Strength.