Trial reportTrials2011
The impact of clinical data on the evaluation of tibial fracture healing.
Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00667849 (Trial to Evaluate UltraSound in the Treatment of Tibial Fractures), which is not on this map. Cited by 8 papers, 2 of them syntheses 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.
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The socioeconomic impact of orthopaedic trauma: A systematic review and meta-analysis.PloS one · 2020Pooled it
- Ultrasound and shockwave therapy for acute fractures in adults.The Cochrane database of systematic reviews · 2014Pooled it
- From episodic imaging to real-time sensor monitoring: translational advances in assessing fracture healing dynamics.Journal of orthopaedic translation · 2026Review
- The Life of a Fracture: Biologic Progression, Healing Gone Awry, and Evaluation of Union.JBJS reviews · 2020Review
- Radiologic evaluation of fracture healing.Skeletal radiology · 2019Review
- Can Clinical and Surgical Parameters Be Combined to Predict How Long It Will Take a Tibia Fracture to Heal? A Prospective Multicentre Observational Study: The FRACTING Study.BioMed research international · 2018Observational
- A Cross-Lingual Mobile Medical Communication System Prototype for Foreigners and Subjects with Speech, Hearing, and Mental Disabilities Based on Pictograms.Computational and mathematical methods in medicine · 2017Article
- Radiographic union score for hip substantially improves agreement between surgeons and radiologists.BMC musculoskeletal disorders · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundRadiographic healing is a common outcome measure in orthopedic trials and adjudication by outcome assessors is often conducted on the basis of plain films alone. The degree to which this process reflects clinical practice, in which both plain films and clinical notes are available, is uncertain. We explored the effect of adding clinical notes to radiographs in the adjudication process of a feasibility trial of tibial shaft fractures.
methodsRadiographic and clinical data from a multicenter randomized controlled trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. At the completion of the trial, serial radiographs (anteroposterior and lateral) were independently evaluated for progression of fracture healing, defined as bridging of at least 3 of 4 cortices, by an adjudication committee comprised of 3 blinded orthopaedic trauma surgeons. Immediately after determination of radiographic time to healing, each surgeon was provided with clinical notes associated with each radiographic follow up visit and asked to re-visit their initial impression. Consensus was achieved for both adjudications. We calculated the percentage of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of clinical notes and their relative influence on the committee's decisions.
results47 of 51 patients were determined to have healed radiographically during the trial follow-up period, and consideration of clinical notes resulted in a change of 40% (19 of 47) of time to healing consensus decisions; however, revised decisions were equally likely to support an earlier or a later time to healing. Clinical notes that resulted in a change to either a 'healed' or a 'not healed' decision contained significantly more comments of either pain resolution or deterioration, respectively, resumption of or failure to resume weightbearing, or either return or no return to work/pre-injury activities (p < 0.001).
conclusionsThe addition of clinical notes to the adjudication of radiographic fracture healing changed the outcome decision in a substantial number of cases. Orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing in order to enhance the generalizability of their results.
trial registrationThe TRUST trial was registered [ID NCT00667849] at http://clinicaltrials.gov/ct2/show/NCT00667849.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.