The need for state-of-the-art orthopedic surgical technology in low- to middle income countries : The case of distraction epiphyseolysis for limb lengthening in children with fibular hemimelia in Uzbekistan.

INTRODUCTION: Amongst low- to middle income countries (LMIC), outdated and poorly documented orthopedic interventions may pose patients at risk for complications, serious adverse events (SAE) and unsatisfactory results, contradicting the World Health Organization's (WHO) Safe Surgery mandates. Use cases of conditions managed inadequately in LMIC environments are necessary to increase awareness of stakeholders and overcome deficiencies in collaboration with high-income countries (HIC). MATERIALS AND METHODS: Methodological and clinical experts from the BG Kliniken and the Charité, Berlin, Germany, were invited to investigate established processes for musculoskeletal disorders and injuries in Tashkent, Uzbekistan. Congenital lower leg discrepancy due to fibular hemimelia was recognized as an illustrative example to prove the effectiveness of local treatment guidelines, still relying on distraction epiphyseolysis (chondrodiatasis) via an Ilizarov frame. Routine data from hospital records, images and outpatient follow-up examinations were compared to estimates from a review of studies of limb-lengthening by other techniques. RESULTS: Data from 16 of 49 immature patients (10 males, 6 females, mean age at surgery, 4.2 ± 2.3 years) undergoing chondrodiatasis between 2017 and 2021 showed a mean limb elongation of 2.4 (95% confidence interval [CI], 1.9 to 2.9) cm after a median follow-up of 29 (range, 24 to 36) months. While no complications or SAE were noted, findings are compatible with a risk of 21% under an upper 97.5% confidence limit for null events. No reproducible classification of hemimelia, surgical or general complications, assessment of functional outcomes or health-related quality of life were available. The pooled average length gain from 21 studies on different other interventions with osteotomy enrolling 458 limbs was 5.1 (95% CI, 5.0 to 5.3) cm. CONCLUSIONS OF THE USE CASE: Limb lengthening for hereditary fibular hemimelia in Uzbekistan revealed rather obsolete surgical algorithms, inadequate documentation, and unreliable outcome assessment. Resource limitations notwithstanding, knowledge transfer, implementation of current procedures and hardware, and international collaboration is vital to improve quality of care in this scenario and for the benefit of LMIC in general.

May the 4th be with you: mixed-methods best-evidence synthesis on 4th-generation alumina-zirconia ceramic bearings in total hip arthroplasty.

Purpose: To assess utility, benefits, and risks of 4th-generation alumina-zirconia ceramic pairings in elective total hip arthroplasty (THA). Methods: A comprehensive mixed-methods best-evidence synthesis using data from systematic reviews, randomized controlled trials (RCTs), prospective and retrospective cohort studies, as well as joint replacement registries, was conducted to estimate overall revision and survival rates, periprosthetic infection, bearing fractures, and noise phenomena with 4th-generation alumina-zirconia ceramic versus other tribological couplings in elective THA. The systematic review part across multiple databases was registered with PROSPERO (CRD42023418076), and individual study data were extracted for statistical re-analysis. Results: Twenty overlapping systematic reviews, 7, 17, and 8 references from RCTs, cohort studies, and joint replacement registries form the basis of this work. According to current best evidence, it is (i) 15-33 times more likely that 4th-generation alumina-zirconia pairings avoid a revision for infection than causing a revision for audible noise, (ii) 38-85 times more likely that 4th-generation alumina-zirconia pairings avoid a revision for infection than causing a revision for ceramic head fractures, and (iii) three to six times more likely that 4th-generation alumina-zirconia pairings avoid a revision for infection than cause a revision for ceramic liner fractures. Conclusion: Fourth-generation alumina-zirconia pairings in THA show a favorable benefit-risk ratio, with rare compound-specific adverse events and complications significantly outbalanced by long-term advantages, such as a markedly lower incidence of revision for infection.

[Perceived utility of the inclusion of physician assistants in the surgical process quality and continuing education in Germany : Results of an interprofessional online survey]. / Empfundener Nutzen der Einbindung von Physician Assistants in die chirurgische Prozessqualität und Weiterbildung in Deutschland : Ergebnisse einer interprofessionellen Online-Umfrage.

BACKGROUND: Compared to Anglo-American countries, physician assistants (PA) remain an underrepresented professional group within the German healthcare system. In the surgical disciplines, PAs may relieve the administrative burden of doctors by taking on delegable routine tasks, thus creating time and resources for advanced surgical training. OBJECTIVE: According to interprofessional experts, can the use of PA lead to an optimization of surgical training and a gain in time for surgical qualification in Germany? MATERIAL AND METHODS: After searching for systematic reviews of the current state of knowledge, an online survey was initiated among surgeons and PAs via social networks to determine current and desired clinical areas of activity for PAs in surgery and their future influence on specialist training in Germany. RESULTS: A total of nine systematic reviews were identified, suggesting a beneficial impact of PAs on length of stay, direct costs, and treatment outcomes in surgical scenarios. The online survey included 234 surgeons and 114 PAs. Hospitals with ≥ 90 surgical beds employed PAs far more frequently (65%) than smaller institutions (40%). Although both professional groups are generally highly satisfied with the integration of PAs into clinical workflows, there are gradually different opinions about the preferred spectrum of tasks and duties. DISCUSSION: PAs would like to have greater responsibility in ordering and interpreting diagnostic tests, communicating with patients, and working in the operating theater. Surgeons are concerned that PAs could replace surgical interns and residents. PAs may enrich healthcare in Germany on various levels and can also improve surgical training. The voice and needs of all professional groups must be considered and respected during the upcoming health system reform.

In-hospital mortality after prehospital endotracheal intubation versus alternative methods of airway management in trauma patients. A cohort study from the TraumaRegister DGU®.

PURPOSE: Prehospital airway management in trauma is a key component of care and is associated with particular risks. Endotracheal intubation (ETI) is the gold standard, while extraglottic airway devices (EGAs) are recommended alternatives. There is limited evidence comparing their effectiveness. In this retrospective analysis from the TraumaRegister DGU®, we compared ETI with EGA in prehospital airway management regarding in-hospital mortality in patients with trauma. METHODS: We included cases only from German hospitals with a minimum Abbreviated Injury Scale score ≥ 2 and age ≥ 16 years. All patients without prehospital airway protection were excluded. We performed a multivariate logistic regression to adjust with the outcome measure of hospital mortality. RESULTS: We included n = 10,408 cases of whom 92.5% received ETI and 7.5% EGA. The mean injury severity score was higher in the ETI group (28.8 ± 14.2) than in the EGA group (26.3 ± 14.2), and in-hospital mortality was comparable: ETI 33.0%; EGA 30.7% (27.5 to 33.9). After conducting logistic regression, the odds ratio for mortality in the ETI group was 1.091 (0.87 to 1.37). The standardized mortality ratio was 1.04 (1.01 to 1.07) in the ETI group and 1.1 (1.02 to 1.26) in the EGA group. CONCLUSIONS: There was no significant difference in mortality rates between the use of ETI or EGA, or the ratio of expected versus observed mortality when using ETI.

Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial.

Importance: Fractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence. Objective: To compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS. Design, Setting, and Participants: This randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022. Interventions: Surgical fixation with a Gamma3 IMN or an SHS. Main Outcomes and Measures: The primary outcome was health-related quality of life (HRQOL), measured by the EuroQol-5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score). Results: In this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, -0.03 to 0.07 points; P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, -0.04 to 0.05; P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (ß [SE] , 0.01 [0.05]; P = .82) or previous fracture (ß [SE], 0.01 [0.10]; P = .88) and treatment group. Conclusions and Relevance: This randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip. Trial Registration: ClinicalTrials.gov Identifier: NCT01380444.

[Evidence-based versus expertise-based medicine in orthopedic and trauma surgery : There is nothing more practical than a good theory]. / Evidenzbasierte Medizin versus Erfahrungsmedizin in Orthopädie und Unfallchirurgie : Es gibt nichts Praktischeres als eine gute Theorie.

About a quarter of a century after the introduction of the concept and principles of evidence-based medicine (EbM), some healthcare providers are still adamant that these are incompatible with knowledge gained through experience. Across the surgical disciplines, it is often argued EbM underestimates or neglects the importance of intuition and surgical skills. To put it bluntly, these assumptions are wrong and often characterized by a misunderstanding of the methodology of EbM. Even the best controlled trial cannot be properly interpreted or implemented without clinical reasoning; furthermore, clinicians of all disciplines are obligated to provide care according to the current state of scientific knowledge. In an era of revolutionary biomedical developments, exponential increase of research but incremental innovations, they must become familiar with pragmatic tools to appraise the validity and relevance of clinical study results, and to decide whether there is a need to adapt current beliefs and practices based on the new information. We herein use the recent example of a new medical device for the surgical treatment of rotator cuff tears and subacromial impingement syndrome to illustrate how important it is to interpret data in the context of a precise, answerable question and to combine clinical expertise with methodological principles offered by EbM.

Brace-Free Rehabilitation after Isolated Anterior Cruciate Ligament Reconstruction with Hamstring Tendon Autograft Is Not Inferior to Brace-Based Rehabilitation-A Randomised Controlled Trial.

PURPOSE: The postoperative use of a rehabilitative knee brace after isolated primary anterior cruciate ligament (ACL) reconstruction (ACLR) using a hamstring tendon (HT) autograft is controversial. A knee brace may provide subjective safety but can cause damage if applied incorrectly. The aim of this study is to evaluate the effect of a knee brace on clinical outcomes following isolated ACLR using HT autograft. METHODS: In this prospective randomised trial, 114 adults (32.4 ± 11.5 years, 35.1% women) underwent isolated ACLR using HT autograft after primary ACL rupture. Patients were randomly assigned to wear either a knee brace (n = 58) or no brace (n = 56) for 6 weeks postoperatively. An initial examination was performed preoperatively, and at 6 weeks and 4, 6, and 12 months. The primary endpoint was the subjective International Knee Documentation Committee (IKDC) score to measure participants' subjective perceptions. Secondary endpoints included objective knee function assessed by IKDC, instrumented knee laxity measurements, isokinetic strength tests of the knee extensors and flexors, Lysholm Knee Score, Tegner Activity Score, Anterior Cruciate Ligament-Return to Sport after Injury Score, and quality of life determined by Short Form-36 (SF36). RESULTS: There were no statistically significant or clinically meaningful differences in IKDC scores between the two study groups (3.29, 95% confidence interval (CI) -1.39 to 7.97, p = 0.03 for evidence of non-inferiority of brace-free compared with brace-based rehabilitation). The difference in Lysholm score was 3.20 (95% CI -2.47 to 8.87); the difference in SF36 physical component score 0.09 (95% CI -1.93 to 3.03). In addition, isokinetic testing did not reveal any clinically relevant differences between the groups (n.s.). CONCLUSIONS: Brace-free rehabilitation is non-inferior to a brace-based protocol regarding physical recovery 1 year after isolated ACLR using HT autograft. Consequently, the use of a knee brace might be avoided after such a procedure. LEVEL OF EVIDENCE: Level I, therapeutic study.

Large-scale, pragmatic randomized trials in the era of big data, precision medicine and machine learning. Valid and necessary, or outdated and a waste of resources?

During the past decade, more and more large-scale pragmatic clinical trials have been carried out in orthopedic trauma surgery. This trend is fueled by the common belief that the larger the numbers in a trial, the broader the eligibility criteria, and the less strict the regimentation of local treatment standards by protocol, the more trustworthy the findings would be. However, it must also be taken into account that the precision of an outcome measurement does not depend on the sample size alone, but the homogeneity of the studied population. Consequently, a small trial with stringent entry and assessment criteria may offer similarly precise answers as a large trial with less strict entry and assessment criteria because of the basic mathematical correlation between standard deviation and standard error of the mean. There is now a lively and controversial debate about the role of randomized controlled trials (RCT) in an era of stratified medicine driven by the ever increasing understanding and clinical measurability of molecular pathways, making a certain intervention more effective in patients who show a distinct genetic variant. Cluster and pattern recognition by artificial intelligence (AI) and its methodological variety applied to huge datasets and population-based cohorts further propel the spiral of knowledge. Advanced adaptive RCT concepts like enrichment designs, basket and bucket trials, master protocols etc. were developed to combine classic principles of the scientific method with big data, the latter of which have not arrived yet in trauma care. In spite of all biomedical and methodological achievements made, surprisingly such key questions remain unanswered as a) is a certain treatment causally responsible for making a difference in patient-centered outcomes compared to placebo, a control treatment, or the standard of care, b) do the results of a controlled experiment are relevant enough to change clinical practice, and c) under which conditions and assumptions shall we conduct large-scale pragmatic RCTs, focused confirmatory RCTs, or personalized analyses with or without AI support.

[Interpretation of systematic review articles and meta-analyses : Clinical trials in trauma surgery and orthopedics]. / Interpretation von systematischen Übersichtsarbeiten und Metaanalysen : Klinische Studien in Unfallchirurgie und Orthopädie.

Clinical trials must be planned and interpreted in the context of current best clinical and scientific evidence, undoubtedly provided by systematic reviews and meta-analyses, especially Cochrane Reviews. While many clinicians feel overwhelmed by this complex data source, few visualElements (e.g., the traffic light system of the Cochrane risk of bias [RoB­2] tool, forest plots, etc.), together with indices such as the I2 heterogeneity statistic, allow for a quick appraisal of all critical and necessary qualitative and quantitative information. The effectiveness of different treatment options can indirectly be assessed by methodological advancements like network meta-analyses.Point estimates of percentages are insufficient to describe the utility and value of a proposed novel intervention, which, in orthopedic and trauma surgery, often represents a step innovation. 95% confidence intervals and the so-called fragility index are helpful in determining the ultimate patient benefit.

Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial.

BACKGROUND: Chronic subdural hematoma (cSDH) is the most common complication of mild traumatic brain injury demanding neurosurgery in high-income countries. If undetected and untreated, cSDH may increase intracranial pressure and cause neurological deficiencies. The first-line intervention of choice is burr hole trepanation and hematoma evacuation. However, any third patient may experience rebleeding, demanding craniotomy with excess morbidity. Adjunct endovascular embolization of the frontal and parietal branches of the middle meningeal artery (MMA) is a promising approach to avoid relapse and revision but was hitherto not studied in a randomized trial. METHODS: MEMBRANE is an investigator-initiated, single-center, randomized controlled trial. Male, female, and diverse patients older than 18 years scheduled for surgical evacuation of a first cSDH will be assigned in a 1:1 fashion by block randomization to the intervention (surgery plus endovascular MMA embolization) or the control group (surgery alone). The primary trial endpoint is cSDH recurrence within 3 months of follow-up after surgery. Secondary endpoints comprise neurological deficits assessed by the modified Rankin Scale (mRS) and recurrence- or intervention-associated complications during 3 months of follow-up. Assuming a risk difference of 20% of rebleeding and surgical revision, a power of 80%, and a drop-out rate of 10%, 154 patients will be enrolled onto this trial, employing an adaptive O'Brien-Fleming approach with a planned interim analysis halfway. DISCUSSION: The MEMBRANE trial will provide first clinical experimental evidence on the effectiveness of endovascular embolization of the MMA as an adjunct to surgery to reduce the risk of recurrence after the evacuation of cSDH. TRIAL REGISTRATION: German Clinical Trials Registry (Deutsches Register Klinischer Studien [DRKS]) DRKS00020465. Registered on 18 Nov 2021. CLINICALTRIALS: gov NCT05327933 . Registered on 13 Apr 2022.

Aerosol emission from playing wind instruments and related COVID-19 infection risk during music performance.

The pandemic of COVID-19 led to restrictions in all kinds of music activities. Airborne transmission of SARS-CoV-2 requires risk assessment of wind instrument playing in various situations. Previous studies focused on short-range transmission, whereas long-range transmission risk has not been assessed. The latter requires knowledge of aerosol emission rates from wind instrument playing. We measured aerosol concentrations in a hermetically closed chamber of 20 m3 in an operating theatre as resulting from 20 min standardized wind instrument playing (19 flute, 11 oboe, 1 clarinet, 1 trumpet players). We calculated aerosol emission rates showing uniform distribution for both instrument groups. Aerosol emission from wind instrument playing ranged from 11 ± 288 particles/second (P/s) up to 2535 ± 195 P/s, expectation value ± uncertainty standard deviation. The analysis of aerosol particle size distributions shows that 70-80% of emitted particles had a size of 0.25-0.8 µm and thus are alveolar. Masking the bell with a surgical mask did not reduce aerosol emission. Aerosol emission rates were higher from wind instrument playing than from speaking or breathing. Differences between instrumental groups could not be found but high interindividual variance, as expressed by uniform distribution of aerosol emission rates. Our findings indicate that aerosol emission depends on physiological factors and playing techniques rather than on the type of instrument, in contrast to some previous studies. Based on our results, we present transmission risk calculations for long-range transmission of COVID-19 for three typical woodwind playing situations.

The CRECHE study: testing the urban myth that chocolate Santa Clauses are re-wrapped Easter Bunnies.

OBJECTIVE: To test the urban myth that surplus chocolate Easter Bunnies are re-packaged as Santa Clauses for the following Christmas holiday season. DESIGN: Prospective radiographic cohort study of seasonal chocolate figurines, supplemented by anonymous 5-item questionnaire survey of belief in the re-wrapping myth (Generic Risk Items Noted by Chocolate consumers in Health care settings; GRINCH). SETTING: Two tertiary referral trauma centres in Germany (Berlin and Duisburg). PARTICIPANTS: Eighteen chocolate Easter Bunnies and 15 chocolate Santa Clauses from different manufacturers purchased during 2020; 502 randomly selected people passing through the entrance halls of the two hospitals during 16 September - 12 October 2020. MAIN OUTCOME MEASURES: Whole body computed tomography (WBCT) images of chocolate Easter Bunnies and Santa Clauses assessed by four independent, board-certified radiologists using a visual contour resemblance scale (CRS); survey participants' views on statements related to the re-wrapping myth. RESULTS: Expert examiners clearly distinguished the WBCT images of chocolate Easter Bunnies and Santa Clauses; the mean difference in CRS was 84.2 points (95% CI, 78.5-90.0 points), with excellent inter-observer agreement (mean intra-class correlation coefficient, 0.99; 95% CI, 0.99-1.00). A total of 214 survey participants (43%) disagreed and 145 (29%) agreed with the proposition that seasonal chocolate figurines are re-packaged and re-sold the following season. CONCLUSION: Although about one-third of our survey respondents did not rule out the possibility of seasonal sweets being re-used, WBCT imaging found no similarity between chocolate foil-wrapped Easter and Christmas figurines, providing solid evidence against this urban myth. Chocolate Santa Clauses are unlikely to pose a significant threat to hospital food hygiene requirements. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN16847363 (prospective).