Rabies post-exposure prophylaxis in the emergency department: A monocentric retrospective observational study.

BACKGROUND: Emergency departments (ED) are frequently visited after suspected rabies exposure (SRE) and the potential need for rabies post-exposure prophylaxis (R-PEP). However, data on the number of visits, patients' demographics, travel history and the medical treatment is still rare. Therefore, the aim of this study was to assess the number of R-PEP and the appropriateness of medical management including wound treatment, vaccination regime and immunoglobulin application following SRE in a university hospital ED. METHOD: We conducted a monocentric retrospective observational study on emergency patients treated in the ED of the LMU University Hospital, Ludwig-Maximilians-University Munich, Germany, between June 1st, 2023 and January 31st, 2024. Patients requiring post-exposure prophylaxis due to SRE abroad or in Germany were included. Demographic data, travel history, clinical findings, wound treatment, and R-PEP vaccination regimen were recorded. RESULTS: During the observation period of 245 days 43 patients presented to our ED for R-PEP. There was a total of 51 presentation appointments, as 5 patients returned for further treatment. Most patients (27, 52.9 %) presented at the ED on a Saturday, Sunday, or a public holiday. 17 (39.5 %) patients had a category II exposure, and 26 (60.5 %) had a category III exposure. In our ED, there were 28 (55.0 %) active vaccinations and 23 (45.0 %) both active and passive vaccinations. CONCLUSIONS: Our data show that patients frequently present for R-PEP in ED. Therefore, there is a high need for education on indication for R-PEP and for implementation of precise R-PEP treatment guidelines in daily clinical practice.

[Motives of patients presenting independently at the emergency department-a prospective monocentric observational study]. / Beweggründe von Patienten, die sich selbständig in der Notaufnahme vorstellen ­ eine prospektive monozentrische Beobachtungsstudie.

BACKGROUND: In the ongoing professional, societal, and political discussion, the hypothesis is repeatedly put forward that a large portion of patients who independently visit the emergency department could also be treated in other care settings such as by a general practitioner, the statutory medical on-call service, or in emergency clinics. Various reasons are cited for why these alternative care settings are not utilized in these cases. OBJECTIVES: This study investigates the motives of patients who presented independently at the emergency department, as well as the socio-demographic parameters of this study cohort. MATERIALS AND METHODS: The survey was carried out as part of a prospective monocentric observational study of internal medicine patients at a university emergency department. RESULTS: A total of 1086 patients were included in the study. In total, 33% of the study participants visited the emergency department based on a physician's recommendation or referral instead of opting for an alternative care option. The main reason for visiting the emergency department was the subjectively assessed urgency of their symptoms. Among the patients who presented independently at the emergency department, 28% required further inpatient care during the course of treatment. Awareness of alternative care pathways, such as utilizing emergency medical services, seeking care from the statutory medical on-call service, or visiting an emergency clinic, was low. CONCLUSIONS: Emergency departments remain an important point of contact for patients who present there independently, without being brought by emergency medical services. The motives behind why patients choose a visit to the emergency department over treatment in an alternative care setting vary. If alternatives are to be used instead of emergency departments, structures first need to be established or expanded.

Neutrophil Gene Expression Patterns in Multiple Trauma Patients Indicate Distinct Clinical Outcomes.

INTRODUCTION: Patients after polytrauma suffer from posttraumatic immune system dysregulation and multiple organ dysfunction. Genome-wide microarray profiling in monocytes revealed a regulatory network of inflammatory markers around the transcription factor AP-1 in severely injured patients. Recent research focuses on the role of neutrophils in posttraumatic inflammation. The aim of this study was, therefore, to evaluate the impact of this inflammatory network in neutrophils. MATERIALS AND METHODS: Blood sampling and neutrophil separation were performed on admission of the patient and at 6 h, 12 h, 24 h, 48 h, and 72 h after trauma. Neutrophil expression levels of the target genes c-Jun, c-Fos, BCL2A, MMP-9, TIMP-1, ETS-2, IL-1ß, and MIP-1ß were quantified by RT-qPCR. Patients were assorted into groups according to distinct clinical parameters like massive transfusion (>10 RBC units/24 h), injury severity (ISS), 90-d survival, and the presence of traumatic brain injury (defined by ICI on head CT). Statistics were calculated by Mann-Whitney Rank-Sum Test, Receiver Operating Curves, and binary multiple logistic regression. RESULTS: Forty severely injured patients (mean ISS 36 ± 14) were included. BCL2A, MMP-9, TIMP-1, and ETS2 levels showed a significant correlation to 90-d-survival in the early posttraumatic period (6 h-24 h). Furthermore, differential BCL2A, IL-1ß, MIP-1ß, and MMP-9 regulation was observed in patients requiring massive transfusion. We could further show a significant TIMP-1 response in trauma PMN associated with traumatic brain injury. CONCLUSIONS: This study of seriously injured patients highlights very early posttraumatic transcriptional changes in PMNs, which were clearly associated with posttraumatic events and outcomes.

Propensity Score-Matched Analysis of Arthroscopically Assisted Ankle Facture Treatment Versus Conventional Treatment.

BACKGROUND: The aim of this study was to assess the prospective, longitudinal outcome after arthroscopically assisted open reduction and internal fixation (AORIF) and to compare the results with open reduction and internal fixation (ORIF) in complex ankle fractures. METHODS: Acute, closed, bimalleolar equivalent, bimalleolar, or trimalleolar ankle fractures were included. The AORIF cohort was enrolled prospectively. The ORIF group was identified from a retrospective database. The same inclusion and exclusion criteria were applied. The only difference was the additional arthroscopy in the AORIF cohort. The patient-reported outcome measurement (PROM) following AORIF was assessed at 1 and 4 years of follow-up using the Olerud and Molander Ankle Score (OMAS) and Tegner activity scale (TAS). The AORIF cohort was propensity score matched (nearest-neighbor matching) to the ORIF database. The OMAS and Foot and Ankle Ability Measure (FAAM) were compared between the resulting groups. Nonparametric statistics were applied; values are presented as median (interquartile range). Twenty-six AORIF patients had a prospective 4-year follow-up. RESULTS: No significant differences (1 year vs 4 years) were identified for the OMAS (90 [10] vs 90 [11]) and TAS (4 [2] vs 5 [2]). The severity of the cartilage lesions (International Cartilage Repair Society [ICRS] grade <4 vs ICRS of 4) had no significant influence on the PROMs. Twenty-five patients per cohort (AORIF vs ORIF) were matched. The OMAS (90 [13] vs 75 [40]; P = .008) and FAAM Activities of Daily Living (ADL; 96 [11] vs 88 [30]; P = .034) revealed significantly better outcomes for AORIF. More patients in the AORIF cohort returned to sport (96% vs 77%; P = .035), with a higher FAAM Sports score (88 [37] vs 56 [47]; P = .008). CONCLUSION: AORIF for complex ankle fractures led to consistently good to excellent results. The propensity score-matched analysis revealed a significantly better outcome 4 years after surgery for AORIF compared with ORIF. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Polytrauma in Older Adults Leads to Significantly Increased TIMP-1 Levels in the Early Posttraumatic Period.

BACKGROUND: Patients after polytrauma regularly suffer from posttraumatic immune system destabilization, which closely influences the further clinical development. Increasing age has recently been identified as an isolated risk factor for an adverse outcome after major trauma. Higher rates and intensity of acute inflammation following severe injury suggest that deregulated inflammation may contribute to these higher rates of posttraumatic morbidity and mortality in older adults. MMP-9 and TIMP-1 have been found to play a major role in posttraumatic immune disorder in a previous genome-wide mRNA analysis. OBJECTIVE: The aim of this study was to evaluate the differences in serum protein dynamics in older and younger polytraumatized adults. METHODS: Blood samples were drawn immediately within 90 minutes after trauma and subsequently after 6, 12, 24, 48, and 72 h. Serum levels of TIMP-1 and MMP-9 were quantified using ELISA. Age groups were divided according to a cutoff of 60 years. RESULTS: 60 polytrauma patients (ISS > 16) were included (<60 years, n = 49; ≥60 years, n = 49; ≥60 years, n = 11). Serum TIMP-1 and MMP-9 levels showed a highly significant serum dynamic in young and old polytrauma patients (p < 0.001). Patients ≥ 60 years showed significantly higher overall TIMP-1 levels (p < 0.001). Patients ≥ 60 years showed significantly higher overall TIMP-1 levels (p = 0.008). TIMP-1 levels showed a significant maximum after 72 h in the older study population. MMP-9 levels were nonsignificantly higher during the whole observational period in older polytrauma patients when compared to younger patients. CONCLUSION: The posttraumatic immune response is characterized by significantly higher TIMP-1 levels in older polytrauma patients. This significant association between TIMP-1 levels and patients' age indicates a more extensive immune dysregulation following major trauma in older adults.

Arthroscopically Assisted Treatment of Complex Ankle Fractures: Intra-articular Findings and 1-Year Follow-Up.

Especially after complex ankle fractures, patients regularly suffer from residual symptoms, presumably due to occult intra-articular injuries. The aim of this study was to evaluate the intra-articular lesions, identify fractures specifically at risk for these, and assess the results after arthroscopically assisted open reduction and internal fixation of complex ankle fractures after 1 year. The primary outcome was the American Orthopedic Foot and Ankle Society (AOFAS) hindfoot score. Secondary outcome parameters were the Olerud and Molander Ankle Score (OMAS), Tegner activity scale, arthroscopic findings, functional assessment, and complications. Thirty-two patients (56% female) were enrolled. Chondral lesions were detected in 91%. Full-thickness lesions treated by microfracturing were observed in 0% of unimalleolar, 43% of bimalleolar, and 40% of trimalleolar fractures. After 1 year, the median (interquartile range) AOFAS was 94 (9) and OMAS was 90 (10) for all patients. When analyzing factors possibly influencing the outcome, age, sex, smoking, grading for surgical procedures according to the American Society of Anesthesiologists, fracture type (uni-, bi-, or trimalleolar), severity of chondral lesions graded according to the International Cartilage Repair Society (grade <4 versus grade 4), and syndesmotic instability had no significant influence on the outcome. The only variable significantly influencing the AOFAS (p = .004) and OMAS (p < .001) was body mass index (BMI; rs = -0.522 and -0.606, respectively), with a higher BMI resulting in inferior outcome scores. Complications were observed in 3 patients, 2 with superficial skin necrosis at the posterolateral incision and 1 nonunion of the medial malleolus. Taken together, these data show that intra-articular injuries were common in ankle fractures. Bi- and trimalleolar fractures were particularly at risk for full-thickness lesions. A higher BMI tended to result in inferior outcome scores. Arthroscopically assisted open reduction and internal fixation led to good to excellent results in all but 1 patient.

Selenium and Selenoprotein P Deficiency Correlates With Complications and Adverse Outcome After Major Trauma.

BACKGROUND: A declining selenium (Se) status constitutes a characteristic of critical illness and may affect disease course and survival. The dynamics of trauma-induced changes in biomarkers of Se status are poorly characterized, and an association with multiple organ failure (MOF) and mortality can be hypothesized. It was the aim of this study to investigate Se and selenoprotein P (SELENOP) concentrations in major trauma patients during the early posttraumatic period. PATIENTS AND METHODS: Twenty-four patients after major trauma (ISS ≥16) were included at our level one trauma center. Se supplementation ever during the 90-day observation period was defined as an exclusion criterion. Serum samples were drawn within less than 60 min after trauma, and after 6 h, 12 h, 24 h, 48 h, and 72 h. Serum Se was analyzed by X-ray fluorescence and SELENOP concentrations by ELISA. The data were correlated to clinical parameters, occurrence of MOF defined by MOF and APACHE II score, lung injury defined by Horowitz index and clinical outcome (90-days survival). RESULTS: Serum Se and SELENOP concentrations of the trauma patients were significantly below the average of healthy European subjects (mean ±SD; Se, 41.2±8.1 vs. 84.7±23.3 µg/L, P < 0.001; SePP, 1.5±0.3 vs. 4.3±1.0 mg/L, P < 0.001). A strong deficit was present already at the first time point (Se; 33.6±10.5 µg/L, SELENOP: 1.4±0.5 mg/L). The clinical scores collectively showed an inverse relation between health status and Se biomarkers. Patients who did not survive the 90-day observation period exhibited significantly lower initial post-trauma Se status than the surviving patients (mean±SD; Se, 24.7±7.2 vs. 39.2±8.4 µg/L, P<0.05; SePP, 1.1±0.4 vs. 1.6±0.4 mg/L, P<0.05). CONCLUSION: Very low Se and SELENOP concentrations occur fast after major trauma and are associated with poor survival odds. These findings support the notion that early Se substitution may constitute a meaningful adjuvant treatment strategy in trauma patients.

Comparison of arthroscopic to open tibiotalocalcaneal arthrodesis in high-risk patients.

BACKGROUND: Open tibiotalocalcaneal arthrodesis (TTCA) is associated to high complication rates, which led to the development of arthroscopic techniques. Aim was to compare complication rates of open to arthroscopic TTCA in high-risk patients. METHODS: Single-center, retrospective case-control study. Patients were selected from the authors' TTCA database. Eligible were high-risk patients receiving arthroscopic-, or open TTCA retrospectively suitable for arthroscopic TTCA. Primary outcome were major complications. RESULTS: Eight open and 15 arthroscopic TTCAs were included. Three open and 4 arthroscopic TTCAs presented preoperative plantar ulceration. Fusion rates were similar (75% vs. 67%; p=0.679). Major complications occurred in 63% of open (80% surgical-site-infections (SSI)) and 33% of arthroscopic (100% non-unions) TTCA. Preoperative plantar ulceration did not affect major SSI in open TTCA (67% vs. 60%) but resulted in a significant increase of non-union rates for arthroscopic TTCA (75% vs. 18%; p=0.039). In patients without plantar ulceration the union-rate was 80% for both, open and arthroscopic TTCA. CONCLUSION: Arthroscopic TTCA drastically reduced major SSI. Patients without preexisting ulceration had excellent union-rates for open and arthroscopic TTCA.

Influence of age and level of activity on the applicability of a walker orthosis - a prospective study in different cohorts of healthy volunteers.

BACKGROUND: Walker orthosis are frequently prescribed as they are removable to allow wound control, body care and physiotherapy and are adaptable to the soft tissue conditions. The prerequisite for successful treatment with any walker orthosis is a correct use by the patient. Therefore, the aim of this study was to investigate patients' handling of a commonly used walker. METHODS: Prospective observational study analyzing the applicability of a walker orthosis in different cohorts with varying age and level of activity. Volunteers were recruited from a mountain-biking-team (Sport), a cardiovascular-health-sports-group (Cardio) and a retirement home (Senior). The correct application was assessed following initial training (t0) and one week later (t1). Outcome parameters were an Application Score, strap tightness, vertical heel lift-off and subjective judgement of correct application. RESULTS: Thirty-three volunteers, 11 Sports group (31 ± 7a), 12 Cardio group (59 ± 11a), 10 Senior group, (82 ± 5a) were enrolled. No differences for any parameter could be observed between t0 and t1. Age showed a moderate correlation for all outcome parameters and the cohort influenced all variables. The Senior group presented significant inferior results to the Sport- and Cardio group for the Application Score (p = 0.002-p < 0.001) and strap tightness (p < 0.001). Heel lift-off was significantly inferior in the Cardio- and Senior- compared to the Sport group (p = 0.003-p < 0.001). 14% in the Sport-, 4% in the Cardio- and 83% in the Senior group achieved less than 9 points in the Application Score - which was considered insufficient. However, out of these 90% believed the application to be correct. CONCLUSIONS: The elderly cohort living in a retirement home demonstrated an impaired handling of the walker orthosis. Further, participants were incapable to self-assess the correct handling. These aspects should be respected when initiating treatment with a walker orthosis. TRIAL REGISTRATION: Retrospectively registered on the 16th of February 2018: # DRKS00013728 on DRKS.

Development of an accelerated functional rehabilitation protocol following minimal invasive Achilles tendon repair.

PURPOSE: Surgical repair after acute Achilles tendon rupture leads to lower re-rupture rates than non-surgical treatment. After open repair, early functional rehabilitation improves outcome, but there are risks of infection and poor wound healing. Minimal invasive surgery reduces these risks; however, there are concerns about its stability. Consequently, physicians may have reservations about adopting functional rehabilitation. There is still no consensus about the post-operative treatment after minimal invasive repair. The aim of this study was to define the most effective and safe post-operative rehabilitation protocol following minimal invasive repair. METHODS: A systematic literature search in Embase, MEDLINE and Cochrane Library for prospective trials reporting on early functional rehabilitation after minimal invasive repair was performed. Seven studies were included. RESULTS: One randomized controlled trail, one prospective comparative and five prospective non-comparative studies were identified. Four studies performed full weight bearing, all demonstrating good functional results, an early return to work/sports and high satisfaction. One study allowed early mobilization leading to excellent subjective and objective results. The only randomized controlled trial performed the most accelerated protocol demonstrating a superior functional outcome and fewer complications after immediate full weight bearing combined with free ankle mobilization. The non-comparative study reported high satisfaction, good functional results and an early return to work/sports following combined treatment. CONCLUSION: Immediate weight bearing in a functional brace, together with early mobilization, is safe and has superior outcome following minimally invasive repair of Achilles tendon rupture. Our recommended treatment protocol provides quality assurance for the patient and reliability for the attending physician. LEVEL OF EVIDENCE: II.

Functional treatment for fractures to the base of the 5th metatarsal - influence of fracture location and fracture characteristics.

BACKGROUND: Fractures to the base of the fifth metatarsal are common, but their treatment remains controversial. Especially for Lawrence and Botte (L&B) type II fractures, there is conflicting evidence and consequently no consensus. Further, many authors consider displacement, articular involvement, and number of fragments an indication for surgery, although evidence is missing. The aim of this study was to evaluate the outcome of functional treatment for all L&B type I and II fractures. Of special interest were the influence of (1) the fracture location (L&B type I vs. II) and (2) the fracture characteristics (displacement, intra-articular involvement, communition) on the subjective outcome. METHODS: Retrospective registry study with a prospective follow-up. Patients with an acute, isolated, epi-metaphyseal fracture to the fifth metatarsal bone (L&B type I and II) treated by full weightbearing with a minimum follow-up of 6 months were included. Fracture location (L&B type I and II) and characteristics (displacement <2 mm or >2 mm, intra-articular involvement, and number of fragments) were assessed. Outcome parameters were return to work, return to sports, VAS-FA, and SF-12. The influence of the fracture (1) location and (2) -characteristics on these parameters was tested. RESULTS: Thirty-nine patients (40 ± 15 years, 56% female) were enrolled with a mean follow-up of 22 ± 10 months. L&B type I fractures occurred in 59%, type II in 41%. Thirty-one percent of all fractures were dislocated, 74% intra-articular, and 41% multi-fragmentary. Patients returned to work after 17 ± 12 days, to sports after 53 ± 22 days. The VAS-FA score at the final follow-up was 96 ± 4, SF-12 PCS score 57 ± 5 and MCS score 51 ± 8. No complications were reported, no patient required surgery. None of the assessed outcome parameters differed significantly between (1) the different fracture locations (L&B type I vs. II) or (2) the different fracture characteristics (displacement, intra-articular involvement, and number of fragments). CONCLUSIONS: (1) Both, L&B I and II fractures featured excellent results with immediate full weightbearing. Consequently, L&B type I and II fractures should be summarized as epi-metaphyseal fractures. (2) Fracture displacement, articular involvement, and number of fragments did not influence the outcome. Therefore, functional treatment should be recommended for all epi-metaphyseal fractures.

Significant Cytokine mRNA Expression Changes Immediately after Initiation of Cardiopulmonary Resuscitation.

INTRODUCTION: The purpose of this study was to evaluate immediate immunological changes following cardiopulmonary resuscitation (CPR). mRNA expression levels of selected immunomodulatory cytokines in out-of-hospital cardiac arrest (OHCA) survivors were detected and correlated to clinical parameter. METHODS: OHCA survivors with sustained unconsciousness after return of spontaneous circulation (ROSC) were included. PAXgene whole blood samples were drawn immediately after initiation of CPR and subsequently after 6 h, 12 h, 24 h, 48 h, and 72 h. TNF-alpha, IL-8, IL-10, and IL-1ra mRNA levels were quantified by RT-qPCR and compared to multiple organ failure, 30-day survival, and the induction of therapeutic hypothermia (TH). RESULTS: 25 patients (63 ± 15 years) were enrolled presenting a characteristic time-dependent cytokine profile in the early postresuscitation period. High initial TNF-alpha and IL-8 mRNA levels were followed by a significant decrease. IL-1ra mRNA levels significantly increased beginning after 6 h. Nonsurvivors showed significantly higher IL-8 mRNA levels immediately after CPR. TH induced significantly higher IL-1ra mRNA levels compared to normothermia. CONCLUSION: Significant mRNA cytokine expression changes are already detectable immediately after initiation of CPR. These expressional changes are significantly different depending on 30-day survival. TH seems to attenuate proinflammatory immune reaction by a significant increase of IL-1ra mRNA levels. This trial is registered with DRKS00012940.

Diagnosis of Musculus Gastrocnemius Tightness - Key Factors for the Clinical Examination.

Common foot and ankle pathologies have been linked to isolated Musculus gastrocnemius tightness (MGT). Various examination techniques have been described to assess MGT. Still, a standardized examination procedure is missing. Literature argues for weightbearing examination but the degree of knee flexion needed to eliminate the restraining effect of the M. gastrocnemius on ankle dorsiflexion (ADF) is unknown. This manuscript investigates the effect of knee flexion on ankle dorsiflexion and provides a detailed description of a standardized examination protocol. Examination on 20 healthy individuals revealed, that 20° of knee flexion is sufficient to fully eliminate the influence of the M. gastrocnemius on ADF. This builds the prerequisite for a standardized examination for MGT. Non-weightbearing and weightbearing examination of ADF has to be conducted with the knee fully extended and at least 20° flexed. Two investigators should conduct non-weightbearing testing with the subject in supine position. In order to obtain reliable results, the axis of the fibula should be marked. One examiner can conduct weightbearing examination with the subject in lunge stance. Isolated MGT is present if ADF is impaired with the knee fully extended and knee flexion results in a significant ADF increase. The herein presented standardized examination is the prerequisite for future studies aiming at establishing norm values.

Ankle dorsiflexion: what is normal? Development of a decision pathway for diagnosing impaired ankle dorsiflexion and M. gastrocnemius tightness.

INTRODUCTION: Impaired ankle dorsiflexion (ADF) is known to increase forefoot pressure, which is associated to various pathologies affecting the foot and ankle. M. gastrocnemius tightness (MGT) is its most common cause. Up to date we are missing a standardized examination procedure, norm values, and a valid decision pathway to diagnose impaired ADF and MGT. The aim of this study was to define norm values for ADF using a standardized examination procedure. These were used to define a decision pathway to diagnose impaired ADF and MGT. MATERIALS AND METHODS: 64 young, asymptomatic subjects were examined. Based on a standardized examination procedure, bilateral ADF, both with the knee extended and flexed, non-weight bearing and weight bearing, was assessed by three investigators. Inter-rater test reliability and norm values for ADF were calculated. Side differences were analyzed. ADF differences between the knee extended and flexed were calculated. RESULTS: The standardized examination procedure revealed high ICC values (0.876-0.915). ADF values with the knee extended for the left/right limb were 22.7° ± 5.9° [95 % CI 21.2°-24.3°]/23.4° ± 6.5° [95 % CI 21.7°-25.1°] non-weight bearing and 33.3° ± 5.5° [95 % CI 31.9°-34.7°]/33.6° ± 5.6° [95 % CI 32.1°-35.0°] weight bearing. Physiological side differences with the knee extended were <6° (95 % CI). Knee flexion resulted in an approximate ADF increase of 10°. CONCLUSIONS: Based on an extensive systematic approach, physiological values for ADF were assessed in a large asymptomatic population. This allowed the definition of a decision pathway to diagnose impaired ADF and MGT. Patients presenting with pathologies associated with impaired ADF should be examined according to the herein presented examination protocol. This systematic approach provides a consistent definition of impaired ADF and MGT, which is the prerequisite to study the effectiveness of treatment strategies for MGT.

The value of arthroscopy in the treatment of complex ankle fractures - a protocol of a randomised controlled trial.

BACKGROUND: An anatomical reconstruction of the ankle congruity is the important prerequisite in the operative treatment of acute ankle fractures. Despite anatomic restoration patients regularly suffer from residual symptoms after these fractures. There is growing evidence, that a poor outcome is related to the concomitant traumatic intra-articular pathology. By supplementary ankle arthroscopy anatomic reduction can be confirmed and associated intra-articular injuries can be treated. Nevertheless, the vast majority of complex ankle fractures are managed by open reduction and internal fixation (ORIF) only. Up to now, the effectiveness of arthroscopically assisted fracture treatment (AORIF) has not been conclusively determined. Therefore, a prospective randomised study is needed to sufficiently evaluate the effect of AORIF compared to ORIF in complex ankle fractures. METHODS/DESIGN: We perform a randomised controlled trial at Munich University Clinic enrolling patients (18-65 years) with an acute ankle fracture (AO 44 A2, A3, B2, B3, C1 - C3 according to AO classification system). Patients meeting the inclusion criteria are randomised to either intervention group (AORIF, n = 37) or comparison group (ORIF, n = 37). Exclusion criteria are fractures classified as AO type 44 A1 or B1, pilon or plafond-variant injury or open fractures. Primary outcome is the AOFAS Score (American Orthopaedic Foot and Ankle Society). Secondary outcome parameter are JSSF Score (Japanese Society of Surgery of the Foot), Olerud and Molander Score, Karlsson Score, Tegner Activity Scale, SF-12, radiographic analysis, arthroscopic findings of intra-articular lesions, functional assessments, time to return to work/sports and complications. This study protocol is accordant to the SPIRIT 2013 recommendation. Statistical analysis will be performed using SPSS 22.0 (IBM). DISCUSSION: The subjective and functional outcome of complex ankle fractures is regularly unsatisfying. As these injuries are very common it is essential to improve the postoperative results. Potentially, arthroscopically assisted fracture treatment can significantly improve the outcome by addressing the intra-articular pathologies. Given the absolute lack of studies comparing AORIF to ORIF in complex ankle fractures, this randomised controlled trail is urgently needed to evaluate the effectiveness of additional arthroscopy. TRIAL REGISTRATION: ClinicalTrials.gov reference: NCT02449096 (Trial registration date: April 7th, 2015).