UK ADAPTIS ACeS Update
44
Audio Transcript Auto-generated
- 00:01 - 00:06
Hello and welcome to a quick UK adaptive study update on behalf of the trial
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management team here at the South Tees Academic
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Centre for surgery or aces for short.
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My name is Steven Liggett,
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a project manager for the centre and one of your contacts for the UK Adaptive study.
- 00:20 - 00:23
We'll start with a couple of recent developments and
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end with a run through the study flow chart
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for a quick refresher of enrollment procedures and follow up.
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The study has received favourable feedback from a recent ethics committee,
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which is great news.
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The protocol and patient information sheet
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required slight amendments to the text,
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however, nothing that affected the design or delivery of the study
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and these documents were resubmitted in the middle of March.
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Once we get the final approval,
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local information packs will be distributed to the investigator sites
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for the local R and D processes. To begin,
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we aim to start scheduling site initiation visits in April,
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and these can be delivered remotely via teams or zoom
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or in the form of short section by section recordings
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that delivery teams might find easier to make time for
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all SI,
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V and training logs will be submitted and reviewed electronically via the Red
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Cap Research Database
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that a A
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are using for this study.
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If you have any questions about these
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recent developments or about the setup timelines,
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then please get in touch via the contacts on the screen.
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Or use the QR code at the bottom to visit the A a
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website
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and to finish here is a quick summary of the trial processes
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were looking for sites to recruit patients over
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21 with a diagnosis of end-stage ankle arthritis
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that require a total ankle replacement or arthroplasty.
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They must be suitable for the infinity with adapts and everlasting ankle system.
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Patients will be provided with an information sheet before consent,
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and consent can be
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given in writing, either via a face to face discussion, email or a letter.
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Initial verbal consent is also allowed,
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but this must be followed up with written consent.
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All of the baseline surgery and post
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surgery data,
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along with the patient reported outcomes
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should be entered onto
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the red cap system,
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and a full list of
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CRFs will be provided in the site files.
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Follow up visits have been designed to try to mirror the routine appointments,
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but research data will need to be collected at six weeks, six months, one year,
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two years and five years
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with X Ray reports required at six months, one year, two years and five years.
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Many thanks for your interest and involvement with UK adap
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sis,
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and we look forward to working with all sites in the very near future.