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19/84 Surgical treatment for severe stable slipped capital femoral epiphysis (SCFE) in children

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question: Is acute correction of deformity more clinically and cost-effective than a strategy of pinning in-situ with later correction if required for the treatment of severe stable SCFE?

  1. Intervention: Acute correction of deformity (open reduction), applicants to define and justify chosen technique.
  2. Patient/target group: Children with diagnosed severe stable SCFE, to be defined by applicants.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: In hospital.
  4. Comparator: Pinning in situ accepting deformity, with subsequent interventions should symptoms warrant - applicants to define procedure used.
  5. Study design: A pragmatic randomised controlled trial and in-trial assessment of cost-effectiveness. There should be an internal pilot phase to test the ability to recruit and randomise (including acceptability to patients and parents/carers). Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: Pain and hip function measured using the PROMIS Mobility score.
    Other outcomes: Quality of life. Incidence of secondary procedures, adverse events including avascular necrosis (AVN); cost-effectiveness; educational attainment.
  7. Minimum duration of follow-up: 2 years.
    Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale:

A slipped capital femoral epiphysis (or SCFE) is a rare condition but one of the most important paediatric and adolescent hip disorders encountered in medical practice – it is the most common reason for hip replacement surgery in both adolescence and early adulthood. Obesity is the most important risk factor for SCFE, with evidence of a causal association. With obesity rates amongst school age children increasing, the British Society Children’s Orthopaedic Surgery (BSCOS) have prioritised the area as requiring urgent research.

Treatment options depend on the severity and classification of the slip. Treatment of mild-to-moderate slips usually involves percutaneous in situ fixation, without correction of the deformity. For severe slips, treatment options include correcting the deformity (open reduction and fixation at the growth plate), or accepting the deformity (in-situ fixation with cannulated screws or Kirschner wires) and a strategy of later corrective surgery if the child is symptomatic. Uncertainty exists around which surgery offers the best outcome due to the dearth of high quality evidence. The HTA Programme therefore wishes to commission the trial outlined above.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 4th December 2019. Applications will be considered by the HTA Funding Committee at its meeting in January.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May.

Applications received after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email: htacommissioning@nihr.ac.uk

Telephone: Commissioning Funding Committee 02380 595510