Let's Agree to Disagree on Operative versus Nonoperative (LADON) treatment for proximal humerus fractures: Study protocol for an international multicenter prospective cohort study.

BACKGROUND: The proximal humerus fracture is a common injury, but the optimal management is much debated. The decision for operative or nonoperative treatment is strongly influenced by patient specific factors, regional and cultural differences and the preference of the patient and treating surgeon. The aim of this study is to compare operative and nonoperative treatment of proximal humerus fractures for those patients for whom there is disagreement about optimal management. METHODS AND ANALYSIS: This protocol describes an international multicenter prospective cohort study, in which all patients of 18 years and older presenting within three weeks after injury with a radiographically diagnosed displaced proximal humerus fracture can be included. Based on patient characteristics and radiographic images several clinical experts advise on the preferred treatment option. In case of disagreement among the experts, the patient can be included in the study. The actual treatment that will be delivered is at the discretion of the treating physician. The primary outcome is the QuickDash score at 12 months. Propensity score matching will be used to control for potential confounding of the relation between treatment modality and QuickDash scores. DISCUSSION: The LADON study is an international multicenter prospective cohort study with a relatively new methodological study design. This study is a "natural experiment" meaning patients receive standard local treatment and surgeons perform standard local procedures, therefore high participation rates of patients and surgeons are expected. Patients are only included after expert panel evaluation, when there is proven disagreement between experts, which makes this a unique study design. Through this inclusion process, we create two comparable groups whom received different treatments and where expert disagree about the already initiated treatment. Since we are zooming in on this particular patient group, confounding will be largely mitigated. Internationally the treatment of proximal humerus fractures are still much debated and differs much per country and hospital. This observational study with a natural experiment design will create insight into which treatment modality is to be preferred for patients in whom there is disagreement about the optimal treatment strategy. TRIAL REGISTRATION: Registered in Netherlands trial register NL9357 and Swiss trial register CH 2020-00961; https://clinicaltrials.gov/.

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

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