Let's Agree to Disagree on Operative Versus Nonoperative Treatment for Distal Radius Fractures in Older People: Protocol for a Prospective International Multicenter Cohort Study.

BACKGROUND: Distal radius fractures are the most frequently encountered fractures in Western societies, typically affecting patients aged 50 years and older. Although this is a common injury, the best treatment for these fractures in older patients is still under debate. OBJECTIVE: This prospective study aims to compare the outcome of operatively and nonoperatively treated distal radius fractures in the older population. Only patients with distal radius fractures for which equipoise regarding the optimal treatment exists will be included. METHODS: This prospective international multicenter observational cohort study will be designed as a natural experiment. Natural experiments are observational studies in which treatment allocation is determined by factors outside the control of the investigators but also (largely) independent of patient characteristics. Patients aged 65 years and older with an acute distal radius fracture will be considered for inclusion. Treatment allocation (operative vs nonoperative) will be based on the local preferences of the treating hospital either in Switzerland or the Netherlands. Hence, the process governing treatment allocation resembles that of randomization. Patients will be identified after treatment has been initiated. Based on the radiographs and baseline information of the patient, an expert panel of 6 certified trauma surgeons from 2 regions will provide their treatment recommendation. Only patients for whom the experts disagree on treatment recommendations will ultimately be included in the study (ie, for whom there is a clinical equipoise). For these patients, both operative and nonoperative treatment of distal radius fractures are viable, and treatment choice is predominantly determined by personal or local preference. The primary outcome will be the Patient-Rated Wrist Evaluation score at 12 weeks. Secondary outcomes will include the Physical Activity Score for the Elderly, the EQ questionnaire, pain, the living situation, range of motion, complications, and radiological outcomes. By including outcomes such as living situation and the Physical Activity Score for the Elderly, which are not relevant for younger cohorts, valuable information to tailor treatment to the needs of the older population can be gained. According to the sample size collection, which was based on the minimal important clinical difference of the Patient-Rated Wrist Evaluation, 92 patients will have to be included, with at least 46 patients in each treatment group. RESULTS: Enrollment began in July 2023 and is expected to continue until summer 2024. The final follow-up will be 2 years after the last patient is included. CONCLUSIONS: Although many trials on this topic have previously been published, there remains an ongoing debate regarding the optimal treatment for distal radius fractures in older patients. This observational study, which will use a fairly new methodological study design, will provide further information on treatment outcomes for older patients with distal radius fractures for which to date equipoise exists regarding the optimal treatment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52917.

A natural experiment study: Low-profile double plating versus single plating techniques in midshaft clavicle fractures-Study protocol.

BACKGROUND: Single plate osteosynthesis is commonly employed when performing surgical stabilization of midshaft clavicle fractures. In recent years, a smaller structural low-profile double plating technique has been described as a possible solution for the high removal rates associated with single plating. A previous meta-analysis has demonstrated that low-profile double plating attains the same healing rates as single plating without a higher chance of fracture-related infections. This meta-analysis, however, was based on relatively small studies. Therefore, a multicentre prospective natural experiment was designed using natural variation in treatment regimens and geographical location of the trauma as treatment allocation mechanism to compare both treatments on a larger scale. This manuscript describes its protocol. MATERIAL & METHODS: Patients (≥16 years) with primary midshaft clavicle fractures that are eligible for operative treatment will be included. Treatment allocation will be determined by the geographical location of the accident and local hospital providing treatment. In two centres, single plating is the treatment of choice for these patients. In two others, low-profile double plating has become the standard treatment. For the low-profile double plating group, one superiorly positioned VariAx 2.0mm and one anterior VariAx 2.4mm or 2.7mm plate will be used. For the single plating group, the standard locally available implant will be used. A total of 336 patients will be included. The primary outcome of interest is re-intervention. Secondary outcomes include complications, operative time, length of incision, functional scores (DASH, EQ-5D-DL, VAS-Pain/Satisfaction) and cost-effectiveness. DISCUSSION: This study will determine whether low-profile double plating has significant clinical and cost-effective benefits over single plating techniques in midshaft clavicle fractures. The study will also give insight in the performance of a natural experiment study design for orthopedic trauma research. TRIAL REGISTRATION: This study has been registered on ClincialTrials.gov, identifier NCT05579873.

Surgery goes EPA (Entrustable Professional Activity) - how a strikingly easy to use app revolutionizes assessments of clinical skills in surgical training.

OBJECTIVE: Entrustable Professional Activities (EPAs) are increasingly being used in competency-based medical education approaches. A general lack of time in clinical settings, however, prevents supervisors from providing their trainees with adequate feedback. With a willingness for more administrative tasks being low in both trainees and educators, the authors developed a radical user-friendly mobile application based on the EPA concept called "Surg-prEPAred". DESIGN: Surg-prEPAred is designed to collect micro-assessment data for building competency profiles for surgical residents according to their curriculum. The goal of Surg-prEPAred is to facilitate the performance and documentation of workplace-based assessments. Through aggregated data the app generates a personalized competency profile for every trainee. During a pilot run of 4 months, followed by ongoing usage of the application with a total duration of 9 months (August 2019 to April 2020), 32 residents and 33 consultants made daily use of the application as a rating tool. Every rating included knowledge, skills and professional attitudes of the trainees. Before the initiation of the App and after the 9-month trial period trainees and supervisors where both sent questionnaires to evaluate the user friendliness and effectiveness of the App. RESULTS: Five hundred ten App based assessments were generated. Out of 40 pre-defined EPAs, 36 were assessed. 15 trainees and 16 supervisors returned the questionnaires and stated the surg-prEPAred App as very valuable, effective and feasible to evaluate trainees in a clinical setting providing residents with an individual competence portfolio to receive precision medical education. CONCLUSIONS: The authors expectation is that the Surg-prEPAred App will contribute to an improvement of quality of medical education and thus to the quality of patient care and safety. In the future the goal is to have the App become an integral part of the official Swiss surgical curriculum accepted by the Swiss professional surgical society.

Low profile dual plating for mid-shaft clavicle fractures: a meta-analysis and systematic review of observational studies.

INTRODUCTION: Low profile dual plate fixation using two mini fragment plates (< 2.7 mm thickness) is a relatively new technique and alternative to single plating for treating midshaft clavicle fractures. To date, no meta-analysis has been performed comparing these two techniques. Therefore, a systematic review and meta-analysis of observational studies and randomized clinical trials was performed comparing single plating to low profile dual plating for midshaft clavicle fractures. METHODS: PubMed/Medline/Embase/CENTRAL/CINAHL were searched for both randomized clinical trials (RCT) and observational studies comparing both treatments. Effect estimates were pooled across studies using random effects models. The primary outcome is overall complication rate and re-intervention rate. Secondary outcomes include healing, operation duration and functional scores. RESULTS: Low profile dual plating has favourable outcomes regarding overall complication rate (8.1% vs. 22.5%, OR 0.3, 95% CI 0.2-0.7, I2 = 16%, p = 0.007) and re-intervention rate (6.1% vs. 16.1%, OR 0.3, 95% CI 0.1-0.9, I2 = 25%, p = 0.02). The largest contributing factor behind these differences was the high incidence of implant related complaints in the single plating group (4.7% vs. 11.6%, OR 0.4, 95% CI 0.2-0.9, I2 = 0%, p = 0.02). The use of low profile dual plating does not have a detrimental effect on healing with union being attained in 99% compared to 97.4% in the single plating group (OR 1.8, 95% CI 0.3-10.7, I = 0%, p = 0.5). Data on operating time and functional results is limited. CONCLUSION: This meta-analysis shows that dual plating low profile plates for midshaft clavicle fractures is a safe procedure attaining the same union rates seen in patients treated with single plating. In addition, it seems to have a lower overall complication and re-intervention rate, mostly driven by the lower incidence of implant related complaints. Low profile dual plating, however, is a fairly new technique and should be further explored in respect to more differentiated endpoints to test whether these first findings are valid. LEVEL OF EVIDENCE: III.

Is there a need for standardized postoperative X-rays after operative treatment of clavicular fractures?

PURPOSE: In most hospitals, acquiring postoperative X-rays after operative treatment of a fracture is the standard. Its value, however, after operative treatment for clavicular fractures is questionable. The aim of this study was to evaluate how often there is a change in treatment plan due to the postoperative X-ray after operative treatment of clavicular fractures when intra-operative images were acquired. METHODS: This was a retrospective cohort study performed in a level I trauma center. All consecutive patients treated surgically for clavicular fractures between 2014 and 2018 were included. The primary outcome was any deviation from the standard postoperative protocol resulting from the routine postoperative X-ray taken within the first 72 h after surgery. Secondary outcomes included all other complications and re-interventions performed during follow-up of patients with at least 6-month follow-up. RESULTS: In total, 241 patients were included in the study with a mean age of 42 years (SD 17). Only one patient had an abnormality on postoperative X-ray necessitating additional CT-scanning. No additional re-interventions or deviations from standard postoperative protocol were required. For secondary analyses, 187 patients were available. Seven patients had a late implant associated infection: one was detected at the time of implant removal and six during revision for non-union. Six patients had aseptic complications: four with non-union and two with implant failure. One-hundred and seven patients had an implant removal due to irritation after consolidation. CONCLUSION: Routinely performing postoperative X-rays after osteosynthesis for clavicular fractures seems unnecessary. Refraining from performing unnecessary radiographs will decrease exposure to radiation and likely have a beneficial effect on costs, length of hospital stay as well as healthcare consumption. This study was performed in a single center; therefore, it remains to be seen whether the findings are reproducible in another setting.

Cement augmentation for trochanteric femur fractures: A meta-analysis of randomized clinical trials and observational studies.

INTRODUCTION: To date, it is unclear what the clinical benefit of cement augmentation in fixation for trochanteric fractures is. The aim of this meta-analysis is to compare cement augmentation to no augmentation in fixation of trochanteric femur fractures in the elderly patients (>65 years) following low energy trauma. METHODS: PubMed/Medline/Embase/CENTRAL/CINAHL were searched for both randomized clinical trials (RCT) and observational studies comparing both treatments. Effect estimates were pooled across studies using random effects models. Subgroup analysis was performed stratified by study design (RCTs and observational studies). The primary outcome is overall complication rate. Secondary outcomes include re-operation rate, mortality, operation duration, hospital stay, general quality of life, radiologic measures and functional hip scores. RESULTS: A total of four RCT's (437 patients) and three observational studies (293 patients) were included. The effect estimates of RCTs were equal to those obtained from observational studies. Cement augmentation has a significantly lower overall complication rate (28.3% versus 47.2%) with an odds ratio (OR) of 0.3 (95%CI 0.1-0.7). The occurrence of device/fracture related complications was the largest contributing factor to this higher overall complication rate in the non-augmented group (19.9% versus 6.0%, OR 0.2, 95%CI 0.1-0.6). Cement augmentation also carries a lower risk for re-interventions (OR 0.2, 95%CI 0.1-0.7) and shortens the hospital stay with 2 days (95%CI -2.2 to -0.5 days). The mean operation time was 7 minutes longer in the augmented group (95%CI 1.3-12.9). Radiological scores (lag screw/blade sliding mean difference -3.1mm, 95%CI -4.6 to -1.7, varus deviation mean difference -6.15°, 95%CI; -7.4 to -4.9) and functional scores (standardized mean difference 0.31, 95%CI 0.0-0.6) were in favor of cement augmentation. Mortality was equal in both groups (OR 0.7, 95%CI 0.4-1.3) and cement related complications were rare. CONCLUSION: Cement augmentation in fixation of trochanteric femoral fractures leads to fewer complications, re-operations and shorter hospital stay at the expense of a slightly longer operation duration. Cementation related complications occur rarely and mortality is equal between treatment groups. Based on these results, cement augmentation should be considered for trochanteric fractures in elderly patients.

ORIF versus MIPO for humeral shaft fractures: a meta-analysis and systematic review of randomized clinical trials and observational studies.

BACKGROUND: There is no consensus on the optimal operative technique for humeral shaft fractures. This meta-analysis aims to compare minimal-invasive plate osteosynthesis (MIPO) with open reduction internal fixation (ORIF) for humeral shaft fractures regarding non-union, re-intervention, radial nerve palsy, time to union, operation duration and functional outcomes. METHODS: PubMed/Medline/Embase/CENTRAL/CINAHL were searched for both randomized clinical trials (RCT) and observational studies comparing MIPO with ORIF for humeral shaft fractures. Effect estimates were pooled across studies using random effects models and presented as weighted odds ratio (OR), risk difference (RD), mean difference (MD) and standardized mean difference (SMD) with corresponding 95% confidence interval (95%CI). Subgroup analysis was performed stratified by study design (RCTs and observational studies). RESULTS: A total of two RCT's (98 patients) and seven observational studies (263 patients) were included. The effect estimates obtained from observational studies and RCT's were similar in direction and magnitude. MIPO carries a lower risk for non-union (RD: 5%; OR 0.3, 95% CI 0.1-0.9) and secondary radial nerve palsy (RD 5%; OR 0.3, 95%CI 0.1- 0.9). Nerve function eventually restored spontaneously in all patients in both groups. Results were inconclusive regarding re-intervention (RD 7%; OR: 0.7, 95%CI 0.2-1.9), infection (RD 4%; OR 0.4, 95%CI 0.1-1.5), time to union (MD -1 week, 95%CI -3 - 1) and operation duration (MD -13 minutes, 95%CI -38.9 - 11.9). Functional shoulder scores (SMD 0.01, 95%CI -0.3 - 0.3) and elbow scores (SMD 0.01, 95%CI -0.3 - 0.3) were similar for the different operative techniques. CONCLUSION: MIPO has a lower risk for non-union than ORIF for the treatment of humeral shaft fractures. Radial nerve palsy secondary to operation is a temporary issue resolving in all patients in both treatment groups. Although both treatment options are viable, the general balance leans towards MIPO having more favorable outcomes.