ArticleWorld journal of orthopedics2022
Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review.
Article in World journal of orthopedics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Predictors of Increased Fragility Index Scores in Surgical Randomized Controlled Trials: An Umbrella Review.World journal of surgery · 2023Pooled it
- Recurring low statistical robustness in orthopaedic surgery: A systematic review of 84 fragility index studies.Journal of experimental orthopaedics · 2025Review
- The Statistical Fragility of Lateral Extra-articular Tenodesis Research: A Systematic Review.Orthopaedic journal of sports medicine · 2024Article
- The Fragility of Landmark Randomized Controlled Trials in the Plastic Surgery Literature.Plastic and reconstructive surgery. Global open · 2024Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite recent meta-analyses of randomized controlled trials (RCTs), there remains no consensus regarding the preferred surgical treatment for humeral shaft fractures. The fragility index (FI) is an emerging tool used to evaluate the robustness of RCTs by quantifying the number of participants in a study group that would need to switch outcomes in order to reverse the study conclusions.
aimTo investigate the fragility index of randomized control trials assessing outcomes of operative fixation in proximal humerus fractures.
methodsWe completed a systematic review of RCTs evaluating the surgical treatment of humeral shaft fractures. Inclusion criteria included: articles published in English; patients randomized and allotted in 1:1 ratio to 2 parallel arms; and dichotomous outcome variables. The FI was calculated for total complications, each complication individually, and secondary surgeries using the Fisher exact test, as previously published.
resultsFifteen RCTs were included in the analysis comparing open reduction plate osteosynthesis with dynamic compression plate or locking compression plate, intramedullary nail, and minimally invasive plate osteosynthesis. The median FI was 0 for all parameters analyzed. Regarding individual outcomes, the FI was 0 for 81/91 (89%) of outcomes. The FI exceeded the number lost to follow up in only 2/91 (2%) outcomes.
conclusionThe FI shows that data from RCTs regarding operative treatment of humeral shaft fractures are fragile and does not demonstrate superiority of any particular surgical technique.
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Registered trials
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