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Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice

Study acronym: HipDyS
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Jun 30, 2024 to Jun 30, 2025
    • Study completion date: Jun 2025 to Feb 15, 2027
    v7
  2. Minor Primary completion date changed from estimate of Jun 2024 to Jun 30, 2024v6
  3. Minor Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: estimated 152 to confirmed 172
    • Study sites: 2 to 1
    • Study completion date: Jun 2024 to Jun 2025
    • Study description revised
  4. Notable Primary and study completion dates: Mar 2023 to Jun 2024
    • Study description shortened, about 7 words
    • Study sites revised (2)
    • Eligibility criteria shortened, about 3 words
    v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2019 to Mar 6, 2020
    • Study sites: 0 to 2
    • Collaborators revised (5)
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Developmental dysplasia of the hip (DDH) is one of the most common inborn diseases. Early diagnosis of this condition is very important and it can be harmful both to miss DDH and label normal infants as having DDH. Why DDH can be missed or labelled to normal children is not well understood but can be related to the doctor's knowledge, skill and the way the hip consultation is conducted. This research aims to help overcome these issues and proposes the use of a diagnostic aid (checklist) for DDH in general practices (GP). The Investigator will divide general practices (GP) in England into two groups. One group will use our checklist for all hip checks they carry out. The other group will work as they usually do, without the aid. The study wishes to compare if GPs who use the checklist will do better in identifying babies with DDH than those who do not use our checklist. The Investigator will also evaluate whether using the checklist reduces costs for families around trips to doctors or hospitals, and costs to the NHS (National Health Service). In addition The Investigators will interview general practitioners, health visitors and carers of infants to elicit their perceptions about the intervention. The study will include GPs registered in England who carry out the 6-week hip check and agree to being randomised and to hospitals releasing data on infants they had examined during the study period. Practices planning to close within 12 months of the start of the study are not eligible. Eligible infants will be identified by general practice patient registers and infants will be invited to attend a 6-week check at their local practices, the research sites. The study plans to include a total of 152 practices in this study and will collaborate with 15 NIHR (National Institute of Health Research) CRNs (Clinical Research Network) to recruit GP practices with efficient and existing infrastructure.
Trial Details
NCT Number NCT04101903
Lead Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators: University College, London, University of Bedfordshire, King's College London, Steps Charity Worldwide, Longrove Surgery
Conditions
(from sponsor)
Developmental Dysplasia of the Hip
Related terms Developmental Dysplasia of the Hip
Enrollment 172 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov