[Surgical access route and choice of implant in the region of the clavicle shaft]. / Operative Zugangswege und Implantatwahl im Bereich des Klavikulaschafts.

BACKGROUND: Clavicle fractures are among the most frequent injuries of the shoulder girdle. Nondisplaced fractures are generally treated conservatively, whereas dislocated fractures require surgical reduction and stabilization. A variety of implants and surgical techniques with reliable results are available. While all techniques provide similar healing rates, they share a common disadvantage with the high incidence of implant irritation and correspondingly high rates of second interventions for material removal. OBJECTIVE: The various surgical techniques for clavicle shaft fractures with their specific areas of application as well as advantages and disadvantages are presented. This review also provides an aid for deciding which surgical technique is most appropriate based on the fracture morphology. Furthermore, an overview of current research activities is presented, with a specific focus on new implants which could help to reduce implant irritation. RESULTS AND CONCLUSION: Open superior and anteroinferior plate osteosyntheses each show similar reliable results. The minimally invasive plate osteosynthesis (MIPO) technique offers an alternative for multifragmented fractures as it has a lower complication rate compared to the open procedure. Double plate osteosynthesis using minifragment plates shows promising results with respect to the incidence of implant-related irritation. Larger prospective studies are still pending. Intramedullary nailing offers a good alternative, especially if material removal is planned anyway, e.g., in the pediatric setting.

Routine 6-weeks outpatient visit in patients treated surgically for upper extremity fractures: is it truly necessary?

BACKGROUND: Due to the increasing burden on the heatlhcare system the usefulness of the routinely planned 6-week outpatient visit and radiograph in patients treated surgically for the most common upper extremity fractures, including clavicle, proximal humerus, humeral shaft, olecranon, radial shaft, and distal radius, should be investigated. METHOD: This was a retrospective cohort study of all patients treated surgically for the most common upper extremity fractures between 2019 and 2022 in a level 1 trauma center. The first outcome of interest was the incidence of abnormalities found on the radiograph taken at the 6-week outpatient visit. Abnormalities were defined as all differences between the intraoperative (or direct postoperative) and 6-week radiograph. In case an abnormality was detected, the hospital records were screened to determine its clinical consequence. The clinical consequences were categorized into requiring either additional diagnostics, additional interventions, change of standard postoperative immobilization, weightbearing, or allowed range of motion (ROM). The second outcome of interest was the incidence of deviations from the local standard postoperative treatment and follow-up protocol based on the 6-week outpatient visit as a whole. Deviations were also categorized into either requiring additional diagnostics, additional interventions, change of standard postoperative immobilization, weightbearing, or allowed ROM. RESULTS: A total of 267 patients were included. Abnormalities on radiograph at 6 weeks postoperatively were found in only 10 (3.7%) patients, of which only 4 (1.5%) had clinical implications (in 3 patients extra imaging was required and in 1 patient it was necessary to deviate from standard weightbearing/ROM limitation regimen). The clinical/radiologic findings during the 6-week outpatient visit led to a deviation from standard in only 8 (3.0%) patients. Notably, the majority of these patients experienced symptoms suggestive of complications. CONCLUSION: The routine 6-week outpatient visit and radiograph, after surgery for common upper extremity fractures, rarely has clinical consequences. It should be questioned whether these routine visits are necessary and whether a more selective approach should be considered.

Reverse Shoulder Arthroplasty versus Non-Operative Treatment of Three-Part and Four-Part Proximal Humerus Fractures in the Elderly Patient: A Pooled Analysis and Systematic Review.

Background: The treatment of complex proximal humerus fractures in elderly patients is not yet fully elucidated. Of all treatment options, reverse shoulder arthroplasty (RSA) and non-operative treatment (NOT) appear to provide the best results. Evidence to guide the choice between the two is sparse. Therefore, this review provides an overview of the available evidence on RSA versus NOT. Methods: Studies comparing complex proximal humerus fractures in patients aged >65 years treated either with RSA or NOT were included for systematic review and direct comparison via pooled analysis of patient-rated outcome and range of motion. Indirect comparison of case series and non-comparative studies on either treatment was performed separately. Results: Three comparative studies including 77 patients treated with RSA and 81 treated non-operatively were analysed. The RSA group scored better for both the Constant-Murley score (mean difference 6 points) and DASH score (mean difference 8 points). No differences were detected in ASES, PENN score, pain scores, or range of motion between treatment groups. The most common complications for RSA were infection (3%), nerve injury (2%), and dislocation (2%). Reoperation was required in 5%. In the NOT group, common complications included malunion (42%), osteonecrosis (25%), and non-union (3%); no reoperation was required. Patient satisfaction was equal in both groups. Conclusions: The functional outcomes and range of motion after RSA seemed satisfactory and potentially superior to NOT in elderly patients. Patient satisfaction was comparable despite a high malunion and osteonecrosis rate in the non-operative treatment group, which did not require re-interventions.

Cement augmentation for proximal humerus fractures: a meta-analysis of randomized trials and observational studies.

INTRODUCTION: It is unclear if elderly patients treated with plate osteosynthesis for proximal humerus fractures benefit from cement augmentation. This meta-analysis aims to compare cement augmentation to no augmentation regarding healing, complications, and functional results. METHODS: PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized clinical trials and observational studies. Effect estimates were pooled across studies using random effects models. The primary outcome is overall complication rate. Stratified analyses were performed for types of complication (implant-related or systemic). Secondary outcomes include re-interventions, hospital stay, operation time, functional scores, and general quality of life. RESULTS: Five observational studies and one randomized controlled trial with a total of 541 patients were included. The overall complication rate was significantly lower in the augmented group (15.6% versus 25.4%, OR 0.54 (95%CI 0.33-0.87)). This was caused by a reduction of implant-related complications (10.4% vs. 19.9%, OR 0.49 (95%CI 0.28, 0.88)). No difference in humeral head necrosis was found. Data on re-intervention, hospital stay, and operation time was limited but did not show significant differences. No impact on functional scores and general quality of life was detected. CONCLUSION: This meta-analysis shows that cement augmentation may reduce overall complications, mainly by preventing implant-related complications. No difference was detected regarding need for re-intervention, functional scores, general quality of life, and hospital stay. This is the first meta-analysis on this topic. It remains to be seen whether conclusions will hold when more and better-quality data becomes available.

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.

[Distal radius fracture-tactic and approach]. / Distale Radiusfrakturen ­ Taktik und Zugangswahl.

OBJECTIVE: The aim of surgical treatment is fracture healing with restored alignment, rotation, and joint surface. Stable fixation allows for functional postoperative aftercare. INDICATIONS: Displaced intra- and extra-articular fractures which either could not be adequately reduced or in which a secondary displacement is to expected due to instability criteria. The following factors are considered instability criteria: age > 60 years, female, initial dorsal displacement > 20°, dorsal comminution, radial shortening > 5 mm, palmar displacement. CONTRAINDICATIONS: The only absolute contraindication is if the patient is deemed unfit for surgery due to concerns regarding anesthesia. Old age is a relative contraindication, as it is currently debated whether older patients benefit from the operation. SURGICAL TECHNIQUE: The surgical technique is guided by the fracture pattern. Palmar plating is most commonly performed. If the joint surface needs to be visualized, a dorsal approach (in combination with another approach or alone) or arthroscopically assisted fixation should be chosen. POSTOPERATIVE MANAGEMENT: In general, a functional postoperative regime can be carried out after plate fixation with mobilization without weightbearing. Short-term splinting can provide pain relief. Concomitant ligamentous injuries and fixations, which are not stable enough for functional aftercare (such as k­wires) require a longer period of immobilization. RESULTS: Provided the fracture is reduced correctly, osteosynthesis improves functional outcome. The complication rate ranges between 9 and 15% with the most common complication being tendon irritation/rupture and plate removal. Whether surgical treatment holds the same benefits for patients > 65 years as for younger patients is currently under debate.

Intraoperative imaging in hip arthroplasty: a meta-analysis and systematic review of randomized controlled trials and observational studies.

BACKGROUND: Intraoperative fluoroscopy (IFC) is gaining popularity in total hip arthroplasty (THA), with the aim to achieve better component positioning and therefore eventually reduced revision rates. This meta-analysis investigated the benefit of IFC by comparing it to intraoperative assessment alone. The primary outcome was component positioning and the secondary outcomes included complications and revision rates. METHODS: PubMed, Embase and Cochrane Central Register of Controlled Trials were searched for both randomized clinical trials (RCT) and observational studies. Effect estimates for radiographic cup position, offset/leg length difference and outliers from a safe zone were pooled across studies using random effects models and presented as a weighted odds ratio (OR) with a corresponding 95% confidence interval (95% CI). RESULTS: A total of 10 observational studies involving 1,394 patients were included. No randomized trials were found. IFC showed no significant reduction in acetabular cup position (inclination and anteversion), offset, leg-length discrepancies, revision (none reported) or overall complication rates. CONCLUSION: The current meta-analysis found no differences in cup positioning, offset, leg length discrepancy, the incidence of complications or revision surgery. It should be acknowledged that the included studies were generally performed by experienced surgeons. The benefit of intraoperative fluoroscopy might become more evident at an early phase of the learning curve for this procedure. Therefore, its role has yet to be defined.

Outcomes of acute perilunate injuries-a systematic review.

PURPOSE: The objective of this systematic review was to perform epidemiological as well as clinical, radiological and patient-reported outcome analysis of surgically treated perilunate dislocations and fracture dislocations (PLDs and PLFDs) based on the so far largest pooled patient population to date. MATERIAL AND METHODS: This systematic review was written according to the updated guideline for reporting systematic reviews by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. A comprehensive literature search of Pubmed, Embase, CENTRAL, and CINAHL databases was performed. All studies reporting on complications, radiological, functional and/or patient-reported outcomes of surgically treated acute PLDs and PLFDs with a minimum follow-up of 12 months were included. RESULTS: Twenty-six studies encompassing 550 patients with 553 operatively treated acute perilunate injuries (106 PLDs and 447 PLFDs) were included. The overall postoperative complication rate was 15.0% with secondary reduction loss representing the main contributing factor (10.1%). The overall reoperation rate was 10.4% and the incidence of salvage procedures was 2.8%. The risk for secondary reduction loss was higher for PLD than for PLFD injuries (24.2% vs. 7.0%, relative risk [RR] 3.5, 95% confidence interval [CI] 1.6-7.5). There was a higher overall complication rate for the combined dorsopalmar approach when compared to the isolated dorsal approach (17.4% vs. 8.4%, RR 0.5, 95% CI 0.2-1.0, number needed to treat [NNT] 11.2) and for open surgery versus arthroscopic surgery (17.4% vs. 4.8%, RR 0.3, 95% CI 0.1-0.9, NNT 8.0). A significant correlation was found between radiological osteoarthritis (rOA) and follow-up duration of the individual studies, while functional and patient-rated outcomes were comparable. CONCLUSIONS: Regardless of surgical technique, PLFDs appear to be less susceptible to secondary reduction loss than PLDs. Whenever possible, less invasive (e.g. arthroscopic) surgery should be performed to minimize postoperative complications. The rate of rOA is high and increases significantly with follow-up duration. Interestingly, rOA does not seem to correlate with reduced wrist function nor patient dissatisfaction and the need for salvage surgery is surprisingly rare. LEVEL OF EVIDENCE: Systematic review of level IV studies.

Tranexamic Acid Use in Breast Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: The perioperative use of tranexamic acid (TXA) has become popular among plastic surgeons for a variety of surgical procedures. The aim of this study was to perform a systematic review and meta-analysis on the results reported in the literature regarding the effect of perioperative systemic TXA administration in breast surgery. METHODS: The PubMed, MEDLINE, Embase, CENTRAL, and CINAHL databases were searched for both randomized clinical trials and observational studies. Effect estimates were pooled across studies using random effects models and presented as weighted odds ratio with corresponding 95% confidence interval. RESULTS: A total of five studies encompassing 1139 patients undergoing mastectomy with or without immediate implant or free flap-based breast reconstruction or breast-conserving surgery with or without axillary lymph node dissection were included. Perioperative intravenous administration of TXA significantly reduced the risk for hematoma (7.3% versus 12.9%; OR, 0.43; 95% CI, 0.23 to 0.81) and seroma formation (11.5% versus 19.9%; OR, 0.57; 95% CI, 0.35 to 0.92) in comparison to the control group. In the studies measuring the postoperative drainage amount, the mean difference was 132 mL (95% CI, 220 to 44 mL). No thromboembolic event occurred in either group. The weighted surgical-site infection rate was higher in the control group (3.1% versus 1.5%). However, these data were too sparse to perform comparative meta-analysis. CONCLUSION: Evidence of this study suggests that perioperative administration of TXA significantly reduces the risk for postoperative hematoma and seroma formation in breast surgery, whereas the risk for thromboembolic events and postoperative infection is not increased.

Primary Closure or Secondary Wound Healing of Pin Sites After External Fixator Removal: A Single-Center Blinded Randomized Controlled Trial.

BACKGROUND: The aim of this single-center randomized controlled trial was to compare primary wound closure using a suture with secondary wound healing of pin sites after removal of temporary external fixation. METHODS: This noninferiority trial included all patients who were treated with a temporary external fixator on an upper or lower extremity at 1 institution. The primary outcome was pin-site infection. Secondary outcomes were measured at 2, 6, 12, 24, and 52 weeks and included all other complications, time to pin-site wound healing (in weeks), the most satisfactory pin site as rated by the patient, the visual analog scale (VAS) score for pain, and the Vancouver Scar Scale (VSS). The most proximal pin site was randomly allocated (1:1) to either primary closure or secondary wound healing, and the other pin sites were treated alternately. RESULTS: Seventy patients, providing 241 pin sites, were included between January 1, 2019, and March 1, 2020. A total of 123 pin sites were treated with primary closure and 118, with secondary wound healing. The median age was 55 years (interquartile range, 46 to 67 years), 44% were male, and the median duration of the external fixation was 6 days (interquartile range, 4 to 8 days). There were no pin-site infections in either group. Wound healing was significantly faster in the primary closure group (median of 2 versus 6 weeks, p = 0.013). The VSS and patient satisfaction showed no differences between groups. There was 1 case of fracture-related infection not related to any pin site. CONCLUSIONS: Primary closure of temporary external fixator pin sites did not result in higher infection rates compared with secondary wound healing, and pin sites healed significantly faster after primary closure. Primary closure should therefore be considered in patients treated with a temporary external fixator. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Rib fractures in the elderly population: a systematic review.

BACKGROUND: Multiple rib fractures are associated with significant morbidity and mortality, especially in elderly patients. There is growing interest in surgical stabilization in this subgroup of patients. This systematic review compares conservative treatment to surgical fixation in elderly patients (older than 60 years) with multiple rib fractures. The primary outcome is mortality. Secondary outcomes include hospital and intensive care length of stay (HLOS and ILOS), duration of mechanical ventilation (DMV) and pneumonia rates. METHODS: Multiple databases were searched for comparative studies reporting on conservative versus operative treatment for rib fractures in patients older than 60 years. Both observational studies and randomised clinical trials were considered. RESULTS: Five observational studies (n = 2583) were included. Mortality was lower in operatively treated patients compared to conservative treatment (4% vs. 8%). Pneumonia rate and DMV were similar (5/6% and 5.8/6.5 days) for either treatment modality. Overall ILOS and HLOS of stay were longer in operatively treated patients (6.5 ILOS and 12.7 HLOS vs. 2.7 ILOS and 6.5 ILOS). There were only minimal reports on perioperative complications. Notably, the median number of rib fractures (8.4 vs. 5) and the percentage of flail chest were higher in operatively treated patients (47% vs. 39%). CONCLUSION: It remains unknown to what extent conservative and operative treatment contribute individually to reducing morbidity and mortality in the elderly with multiple rib fractures. To date, the quality of evidence is rather low, thus well-performed comparative observational studies or randomised controlled trials considering all confounders are needed to determine whether operative treatment can improve a patient's outcome.

Validation of the modified AO sternum classification system.

INTRODUCTION: The Arbeitsgemeinschaft für Osteosynthesefragen (AO) foundation along with the Orthopaedic. Trauma Association (OTA) introduced a new classification for sternal fractures in 2018 aiming to provide greater uniformity and clinical utility for the surgical community. A previous validation study identified some critical issues such as the differentiation between type A and B fractures and localization of the fracture either in the manubrium or in the body. Due to the moderate agreement in inter- and intra-observer variability, some modifications were proposed in order to improve the performance of the classification. The aim of this study was to re-assess the inter- and intra-observer variability after adding modifications to the classification. Our hypothesis was that a significative improvement of inter- and intra-observer variability could be achieved. MATERIAL AND METHODS: Twenty computed tomography (CT) scans of patients with sternal fractures were analyzed by six. Junior and six senior surgeons independently. Two assessments were performed with an interval of 6 weeks. The kappa (K) value was calculated in order to assess inter- and intra-observer variability. RESULTS: The overall mean kappa value for inter-observer variability improved from 0.364 to 0.468 (p < 0.001). Inter-observer variability mean for location was 0.573 (SD 0.221) and for type was 0.441 (SD: 0.181). Intra-observer variability showed a mean of 0.703 (SD: 0.153) with a statistic significant improvement when compared to the previous study (mean 0.414, SD: 0.256, p < 0.001). CONCLUSIONS: By modifying the AO/OTA classification of sternal fractures, the inter- and intra-observer variability improved and now shows moderate to substantial agreement.

Natural experiments for orthopaedic trauma research: An introduction.

Natural experiments are observational studies of medical treatments in which treatment allocation is determined by factors outside the control of the investigators, arguably resembling experimental randomisation. Natural experiments in the field of orthopaedic trauma research are scarce. However, they have great potential due to the process governing treatment allocation and the existence of opposing treatment strategies between hospitals or between regions as a result of local education, conviction, or cultural and socio-economic factors. Here, the possibilities and opportunities of natural experiments in the orthopaedic trauma field are discussed. Potential solutions are presented to improve the validity of natural experiments and how to assess the credibility of such studies. Above all, it is meant to spark a discussion about its role within the field of orthopaedic trauma research.

High Percentage of Complications and Re-Operations Following Dynamic Locking Plate Fixation with the Targon® FN for Intracapsular Proximal Femoral Fractures: An Analysis of Risk Factors.

The ideal surgical treatment of femoral neck fractures remains controversial. When treating these fractures with internal fixation, many fixation constructs exist. The primary aim of this study was to evaluate the incidence and specific risk factors associated with complication and re-operation following fixation of intracapsular proximal femoral fractures using the Targon-FN system (B.Braun Melsungen AG). A secondary aim was to identify if lateral prominence of the implant relative to the lateral border of the vastus ridge was a specific risk factor for elective plate removal. Methodically, a retrospective case series was conducted of all consecutive adult patients treated at a single level 1 trauma center in Switzerland for an intracapsular proximal femoral fracture with the Targon-FN. Demographic data were collected. Patients with a follow-up of less than three months were excluded. Complications as well as plate position were recorded. Statistical analysis to identify specific risk factors for re-operation and complications was performed. In result, a total of 72 cases with intracapsular femoral neck fractures were treated with the Targon-FN locking plate system between 2010 and 2017. Thirty-four patients (47.2%) experienced one or more complications. The most common complication was mechanical irritation of the iliotibial band (ITB) (23.6%, n = 17). Complications included intraarticular screw perforation (6.9%, n = 5), avascular necrosis (5.6%, n = 4), non-union (5.6%, n = 4) among others. In total, 46 re-operations were required. Younger age, fracture displacement and time to postoperative weight bearing were identified as risk factors for re-operation. In conclusion, intracapsular femoral neck fractures treated with the Targon-FN system resulted in a high rate of post-operative complication and re-operation. Statistical analysis revealed patient age, fracture displacement, time to postoperative full weight bearing were risk factors for re-operation. The main limitation is the limited number of cases and a short follow-up of less than 12 months in a subgroup of our patients.

How to assess applicability and methodological quality of comparative studies of operative interventions in orthopedic trauma surgery.

PURPOSE: It is challenging to generate and subsequently implement high-quality evidence in surgical practice. A first step would be to grade the strengths and weaknesses of surgical evidence and appraise risk of bias and applicability. Here, we described items that are common to different risk-of-bias tools. We explained how these could be used to assess comparative operative intervention studies in orthopedic trauma surgery, and how these relate to applicability of results. METHODS: We extracted information from the Cochrane risk-of-bias-2 (RoB-2) tool, Risk Of Bias In Non-randomised Studies-of Interventions tool (ROBINS-I), and Methodological Index for Non-Randomized Studies (MINORS) criteria and derived a concisely formulated set of items with signaling questions tailored to operative interventions in orthopedic trauma surgery. RESULTS: The established set contained nine items: population, intervention, comparator, outcome, confounding, missing data and selection bias, intervention status, outcome assessment, and pre-specification of analysis. Each item can be assessed using signaling questions and was explained using good practice examples of operative intervention studies in orthopedic trauma surgery. CONCLUSION: The set of items will be useful to form a first judgment on studies, for example when including them in a systematic review. Existing risk of bias tools can be used for further evaluation of methodological quality. Additionally, the proposed set of items and signaling questions might be a helpful starting point for peer reviewers and clinical readers.

Low-profile dual mini-fragment plating of diaphyseal clavicle fractures. A biomechanical comparative testing.

BACKGROUND: Implant removal rates after clavicle plating are high. Recently, low-profile dual mini-fragment plate constructs have revealed lower implant removal rates following fixation of diaphyseal clavicle fractures. However, they have not been subject to a biomechanical investigation. AIMS: To: (1) investigate thebiomechanical competence of different dual plate designs and (2) compare them against single superoanterior plating. METHODS: Twelve artificial clavicles with a simulated AO/OTA 15.2C unstable diaphyseal clavicle fracture were assigned to 2 groups and instrumented with dual titanium mandible plates as follows: Group 1 - 2.5 mm anterior plus 2.0 mm superior (2.5/2.0); Group 2 - 2.0 mm anterior plus 2.0 mm superior (2.0/2.0). Specimens were cyclically tested to failure under craniocaudal cantilever bending superimposed with torsion around the shaft axis and compared to previous published data acquired using 6 locking superoanterior plates tested under the same conditions (Group 3). FINDINGS: Initial stiffness was highest in Group 1 followed by Group 2 and Group 3, being significantly different between Group 1 and Group 3 (p = 0.020). Displacement after 5000 cycles was biggest in Group 3, followed by Group 2 and Group 1, with significant differences between Group 3 and both Group 1 and Group 2 (p ≤ 0.027). Cycles to failure were highest in Group 3 followed by Group 1 and Group 2, being significantly different between Group 2 and Group 3 (p = 0.004). INTERPRETATION: Low-profile 2.0/2.0 dual plates demonstrated similar initial stiffness compared with single 3.5 mm locking plates, however, they revealed significantly lower resistance to failure. Moreover, low-profile 2.5/2.0 dual plates demonstrated significantly higher initial stiffness and similar resistance to failure compared with single 3.5 mm locking plates and can therefore be considered as their useful alternative for diaphyseal clavicle fracture fixation.

Routine X-Rays after the Osteosynthesis of Distal Radius and Ankle Fractures.

BACKGROUND: The utility of routine x-rays after the osteosynthesis of distal radius fractures and ankle fractures is questionable. We performed a trial to determine whether such x-rays are justified in patients who have undergone standardized imaging with C-arm fluoroscopy during surgery. METHODS: Patients requiring surgery for a distal radius fracture or an ankle fracture were candidates for inclusion in this prospective, randomized, controlled, non-blinded trial. Standardized intraoperative images were obtained with C-arm fluoroscopy and stored at the end of the operation. The next day, patients in the control group underwent imaging with a standard postoperative x-ray, while those in the intervention group did not. The primary endpoint was a change in the treatment plan, defined as additional imaging or a second operation. The secondary endpoints included the range of motion, pain as rated on the Visual Analog Scale, and a functional outcome analysis (PRWE/FAOS). RESULTS: 316 patients were included in the trial (163 in the control group, 153 in the intervention group), of whom 202 (64%) had radius fractures and 114 (36%) had ankle fractures. The treatment plan changed in twelve patients (3.8%; four in the control group and eight in the intervention group), seven of whom (2.2%; three in the control group and four in the intervention group) underwent a second operation. The frequency of changes in the treatment plan and of reoperations was comparable in the two groups (p = 0.36). On follow-up at six weeks and one year, the results with respect to functional outcomes and pain were comparable. CONCLUSION: In this trial, routine postoperative x-rays after the osteosynthesis of distal radial fractures and ankle fractures did not improve the care of patients who had undergone standardized intraoperative imaging.

MIPO vs. intra-medullary nailing for extra-articular distal tibia fractures and the efficacy of intra-operative alignment control: a retrospective cohort of 135 patients.

INTRODUCTION: Definitive treatment of distal extra-articular fractures of the tibia is challenging and both minimal invasive plate osteosynthesis (MIPO) and intramedullary nailing (IMN) are considered to be feasible surgical modalities with their own implant-specific merits and demerits. This retrospective study was designed to compare MIPO versus IMN in terms of fracture healing, complications, functional and radiological outcomes and to assess the efficacy of intra-operative alignment control to reduce the rate of malalignment after definitive fixation of distal extra-articular fractures of the tibia. MATERIALS AND METHODS: All consecutive adult patients with extra-articular distal meta- or diaphyseal tibia fractures that were treated between January 2012 and September 2019 either with MIPO or IMN were included. Outcome measures included fracture healing, complications (infection, malalignment, subsequent surgeries), functional and radiological outcomes. Intra-operative alignment control encompassed bilateral draping of the lower extremities. RESULTS: A total of 135 patients were included out of which 72 patients (53%) were treated with MIPO and 63 patients (47%) underwent IMN. There was a significantly higher incidence of non-union for fractures treated with IMN (13 (22%) vs. 4 (6%), p = 0.04). There was no significant difference between both groups in terms of rotational malalignment (3% vs. 10%) and angular malalignment (4% vs. 5%). A significantly higher rate of infection was found after MIPO after correction of significant differences in baseline characteristics. No differences were found in subsequent surgeries or functional outcomes. CONCLUSION: Both MIPO and IMN are reliable surgical techniques. IMN is associated with higher rates of non-union, whereas MIPO results in a higher risk for infection. The incidence of malalignment was surprisingly low endorsing the utility of the intra-operative alignment control.