BackgroundThe 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... Show moreBackgroundThe 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 analysisThis 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.DiscussionThe 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. Show less
Beeres, F.J.P.; Diwersi, N.; Houwert, M.R.; Link, B.C.; Heng, M.; Knobe, M.; ... ; Wall, B.J.M. van de 2021
Background: There is no consensus on the optimal operative technique for humeral shaft fractures. This meta-analysis aims to compare minimal-invasive plate osteosynthesis (MIPO) with open reduction... Show moreBackground: There is no consensus on the optimal operative technique for humeral shaft fractures. This meta-analysis aims to compare minimal-invasive plate osteosynthesis (MIPO) with open reduction internal fixation (ORIF) for humeral shaft fractures regarding non-union, re-intervention, radial nerve palsy, time to union, operation duration and functional outcomes.Methods: PubMed/Medline/Embase/CENTRAL/CINAHL were searched for both randomized clinical trials (RCT) and observational studies comparing MIPO with ORIF for humeral shaft fractures. Effect estimates were pooled across studies using random effects models and presented as weighted odds ratio (OR), risk difference (RD), mean difference (MD) and standardized mean difference (SMD) with corresponding 95% confidence interval (95%CI). Subgroup analysis was performed stratified by study design (RCTs and observational studies). Results: A total of two RCT's (98 patients) and seven observational studies (263 patients) were included. The effect estimates obtained from observational studies and RCT's were similar in direction and magnitude. MIPO carries a lower risk for non-union (RD: 5%; OR 0.3, 95% CI 0.1-0.9) and secondary radial nerve palsy (RD 5%; OR 0.3, 95%CI 0.1- 0.9). Nerve function eventually restored spontaneously in all patients in both groups.Results were inconclusive regarding re-intervention (RD 7%; OR: 0.7, 95%CI 0.2-1.9), infection (RD 4%; OR 0.4, 95%CI 0.1-1.5), time to union (MD -1 week, 95%CI -3 - 1) and operation duration (MD -13 minutes, 95%CI -38.9 - 11.9). Functional shoulder scores (SMD 0.01, 95%CI -0.3 - 0.3) and elbow scores (SMD 0.01, 95%CI -0.3 - 0.3) were similar for the different operative techniques.Conclusion: MIPO has a lower risk for non-union than ORIF for the treatment of humeral shaft fractures. Radial nerve palsy secondary to operation is a temporary issue resolving in all patients in both treatment groups. Although both treatment options are viable, the general balance leans towards MIPO having more favorable outcomes. (C) 2020 Elsevier Ltd. All rights reserved. Show less
