CPinBOSS

• Research type

  Research Study

• Full title

  Cerebral Palsy in the British Orthopaedic Surgery Surveillance Study

• IRAS ID

  259767

• Contact name

  TIM THEOLOGIS

• Contact email

  Tim.Theologis@ouh.nhs.uk

• Sponsor organisation

  14167

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  Cerebral palsy (CP) is the most common physical disability in childhood.
  Children affected with CP frequently have surgery to improve functional outcome. Diplegia is the form of CP that predominantly affects the legs and restricts the ability to walk. Typically for diplegia, surgery follows an approach which involves several operations performed in a single sitting. This is called single event multi level surgery (SEMLS) and can often take all day to complete. There are major differences between centres that perform SEMLS in terms of patient selection, and choice of the specific surgical interventions.

  The study aims to establish a surveillance cohort of SEMLS surgery patients in the United Kingdom (UK) to determine its efficacy. All patients aged 5-16 years with diplegic CP treated within a UK hospital will be eligible to participate. Patients must have a clinical assessment (Gross Motor Function Classification (GMFCS) Level I-III and a gait analysis report) and will be recommended for SEMLS surgery by the gait analysis team or their treating clinician. Patients who do not pursue surgery will be included in the data collection as part of routine 2 year follow up, their reason for not having surgery will be recorded. This data will be anonymised and uploaded by the clinical team at each participating site onto an online secure database. This is part of a service evaluation. Baseline and follow up data will be collected including: minimal demographic data, GMFCS level, Functional Mobility Scale (FMS), Gait Profile score (GPS) and the latest gait analyses report.

  Within the anonymised surveillance cohort, patients will also be invited to participate in a consented cohort. The routine clinical data will be collected plus these patients will complete patient reported outcome measures at baseline and at follow up time points.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  19/EE/0145

• Date of REC Opinion

  11 Apr 2019

• REC opinion

  Favourable Opinion