Trial reportTrials2019
Cast versus functional brace in the rehabilitation of patients with a rupture of the Achilles tendon: statistical analysis plan for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised controlled trial.
Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed, 1 citations in OpenAlex.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundThe incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised trial. METHODS/
designUK STAR is a 1:1, multi-centre, parallel, two-arm, superiority randomised controlled trial. This study aims to evaluate the use of functional bracing compared to plaster cast for the management of acute Achilles tendon rupture in adult patients treated non-operatively. The primary outcome is the Achilles Tendon Rupture Score measured at 9 months after injury and will be estimated based on a linear mixed effects regression model adjusted for the stratification factor (centre) and other key prognostic variables. Secondary outcomes include complications, quality of life and resource use evaluated at 8 weeks and at 3, 6 and 9 months after the injury. Missing data will be summarised and reported by treatment arm. Full details of the planned analysis methods are described in this paper. Further study design details are published in the UK STAR protocol. DISCUSSION: The planned statistical analyses for UK STAR aim to reduce the risk of outcome reporting bias arising from prior data knowledge. Any changes or deviations from the current SAP will be described and justified in the final study report.
trial registrationInternational Standard Randomised Controlled Trial Number Registry, ISRCTN62639639 . Registered on 22 June 2016.
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