Trial reportTrials2014
Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study.
Trial report in Trials, 2014. 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 14 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Ultrasound and shockwave therapy for acute fractures in adults.The Cochrane database of systematic reviews · 2023Pooled it
- Pooled it
- Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials.BMJ (Clinical research ed.) · 2017Pooled it
- Ultrasound and shockwave therapy for acute fractures in adults.The Cochrane database of systematic reviews · 2014Pooled it
- Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial.BMJ (Clinical research ed.) · 2016Trial
- Time to consider fracture nonunion an orphan disease? An update into pathophysiology, epidemiology and therapeutic solutions.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025Review
- Radiographic Humerus Union Measurement (RHUM) Demonstrates High Inter- and Intraobserver Reliability in Assessing Humeral Shaft Fracture Healing.HSS journal : the musculoskeletal journal of Hospital for Special Surgery · 2020Article
- Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients.Pilot and feasibility studies · 2019Article
- Inhibitory effects of low intensity pulsed ultrasound on osteoclastogenesis induced in vitro by breast cancer cells.Journal of experimental & clinical cancer research : CR · 2018Article
- [Effectiveness of pulsed ultrasound on bone fracture healing speed-up].Der Unfallchirurg · 2017Article
- Cochrane in CORR (®): Ultrasound and Shockwave Therapy for Acute Fractures in Adults (Review).Clinical orthopaedics and related research · 2016Review
- Low-intensity continuous ultrasound triggers effective bisphosphonate anticancer activity in breast cancer.Scientific reports · 2015Article
- Constructing the toolbox: Patient-specific genetic factors of altered fracture healing.Genes & diseases · 2014Article
- Radiographic union score for tibia fractures predicts success with operative treatment of tibial nonunion.Journal of clinical orthopaedics and traumaArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundThe role of low-intensity pulsed ultrasound (LIPUS) in the management of fractures remains controversial. The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively.
methodsWe conducted a multicenter, concealed, blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS or a sham device. All participating centers were located in Canada and site investigators were orthopedic surgeons specializing in trauma surgery. The goals of our pilot study were to determine recruitment rates in individual centers, investigators' ability to adhere to study protocol and data collection procedures, our ability to achieve close to 100% follow-up rates, and the degree to which patients were compliant with treatment. Patients were followed for one year and a committee (blinded to allocation) adjudicated all outcomes. The committee adjudicators were experienced (10 or more years in practice) orthopedic surgeons with formal research training, specializing in trauma surgery.
resultsOur overall rate of recruitment was approximately 0.8 patients per center per month and site investigators successfully adhered to the study protocol and procedures. Our rate of follow-up at one year was 84%. Patient compliance, measured by an internal timer in the study devices, revealed that 39 (76%) of the patients were fully compliant and 12 (24%) demonstrated a greater than 50% compliance. Based on patient feedback regarding excessive questionnaire burden, we conducted an analysis using data from another tibial fracture trial that revealed the Short Musculoskeletal Function Assessment (SMFA) dysfunction index offered no important advantages over the SF-36 Physical Component Summary (PCS) score. No device-related adverse events were reported.
conclusionsOur pilot study identified key issues that might have rendered a definitive trial unfeasible. By modifying our protocol to address these challenges we have enhanced the feasibility of a definitive trial to explore the effect of LIPUS on tibial fracture healing.
trial registrationThe TRUST definitive trial was registered at ClinicalTrials.gov on 21 April 2008 (identifier: NCT00667849).
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What OpenQuestion holds
Registered trials
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.