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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Katie Ridsdale
k.ridsdale@sheffield.ac.uk


Miss Elizabeth Swaby
e.a.swaby@sheffield.ac.uk


Mr Ashley Cole
ashley.cole4@nhs.net


Study Location:

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Be Part of Research - Trial Details - BASIS 2

BASIS 2

Recruiting

Open to: All Genders

Age: 10 Years - 18 Years

Medical Conditions

Deforming dorsopathies


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Scoliosis is when the backbone curves to the side. If the curve gets too big,children may need to have spinal surgery. Scoliosis gets worse during childhood growth spurts. To try to prevent the curve needing surgery,children wear a back brace to hold the spine in position. The BASIS study is an ongoing study,comparing children who wear a ‘full time’ back brace for 23 hours per day (the ‘standard’ treatment),to a newer brace that is just worn at night. The BASIS study is trying to find out if a night-time only brace is as good as full-time bracing. Once children finish growing,the traditional belief has been that scoliosis will not get bigger. However,we know that in a third of affected adolescents,the curve gets bigger in the months after the brace is removed – so some doctors now recommend that braces are worn for longer.

The BASIS 2 study will invite participants from the BASIS study to be part of an additional study,where they will either wear the brace for an extra 6 months after the end of growth,or remove the brace at the end of growth. The follow-up visits,x-rays and questionnaires will be the same as already planned in the BASIS study,with the addition of one hand x-ray which some hospitals already do as standard care to look at the ‘growth plates’ to assess if there is any evidence of growth remaining. The scoliosis will be monitored closely to see how it changes until 2 years after the end of growth.

A survey of 44 participants already in the BASIS study revealed that 20 (45%) had no current preference regarding continuing brace wear,15 (35%) preferred an extra 6 months in brace and 9 (20%) preferred to stop wearing the brace at maturity. We are working with our adolescent participants,to maximise their involvement in BASIS 2. The results will be shared,using multimedia and social media,with the help of our participant advocates,to gain maximum reach throughout the scoliosis community. The results will also be presented to spinal surgeons at national and international meetings,published in a scientific journal and publicised through the Scoliosis Association UK (website and social media).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 May 2024 30 Apr 2030

Interventional

Interventional type: Device;



You can take part if:



You may not be able to take part if:


None


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cardiff & Vale University Lhb
    Woodland House
    maes-y-coed Road
    Cardiff
    CF14 4HH
  • Sheffield Children's Hospital
    Western Bank
    Sheffield
    South Yorkshire
    S10 2TH
  • The James Cook University Hospital
    Marton Road
    Middlesbrough
    Cleveland
    TS4 3BW
  • The Royal National Orthopaedic Hospital (stanmore)
    Brockley Hill
    Stanmore
    Middlesex
    HA7 4LP
  • Royal Orthopaedic Hospital
    The Woodlands
    bristol Road South
    northfield
    Birmingham
    West Midlands
    B31 2AP

Katie Ridsdale
k.ridsdale@sheffield.ac.uk


Mr Ashley Cole
ashley.cole4@nhs.net


Miss Elizabeth Swaby
e.a.swaby@sheffield.ac.uk



The study is sponsored by SHEFFIELD CHILDREN'S NHS FOUNDATION TRUST and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) .




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for Trial ID: CPMS 62323

Last updated 11 February 2025

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