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Active, Not Recruiting

NCT Number: NCT04101903

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Developmental Dysplasia of the Hip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

6 week–11 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rise Group Practice

London, N19 3YU, United Kingdom

About this study

  • Objectives:
  • To determine whether the use of a check list for the 6-week hip check can (i) reduce the number of clinically insignificant referrals from primary to secondary care, and (ii) reduce the number of Developmental dysplasia of the hip (DDH) diagnosed beyond the age of 12 weeks.
  • To determine the cost-effectiveness of this intervention considering a life time horizon.
  • To conduct an integrated qualitative and quantitative process evaluation in order to: understand the participants' experience with the intervention; identify how the intervention affects general practitioners' capability, opportunity and motivation in relation to the 6-week check; study how the intervention is implemented; and investigate how contextual factors affect uptake of the intervention.
  • Type of trial: Phase III, cluster randomised controlled trial
  • Trial design and methods: This trial incorporates (i) 4-months internal pilot in order to confirm realistic recruitment targets; (ii) process evaluation encompassing qualitative research on changing physician referral behaviour and on normalising the intervention in practice; and (iii) health economic evaluation.
  • Trial duration per participant: 24 months
  • Planned trial sites: 172 GP practices in England. Half will be randomised to the experimental arm (using the diagnostic aid) and half to the control arm (standard of care 6 week hip check)
  • Total number of participants planned: 172 GP practices will be randomised (with an average of 110 infants recruited across the trial period per practice).
  • Main inclusion criteria:
  • Inclusion: GP practices registered in England and who carry out the 6-week hip check as part of their routine work - these practices must be using either EMIS or System One clinical computer systems

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • General practices (GP) registered in England and who carry out the 6-week infant hip check as part of their routine work.
  • Practice using either EMIS or SystemOne clinical computer systems
  • General practitioners recording all 6 week baby hip examination on their computer template
  • GPs willing to give informed consent to (a) being randomized, (b) willing to undergo observations, interviews and questionnaires and (c)collaborating secondary care facilities releasing data about all infants undergoing the 6-week hip check GP practices during the duration of the randomised controlled trial.
  • GPs conducting the 6 week check must agree to view the training video on the examination of babies' hips at 6 weeks at baseline
  • In the study practice, infants who are eligible for this study will be those presenting to any of the practices if aged <11 weeks when the 6-week check is done in the GP practice.

Exclusion criteria

  • Any GP practice that is to close down within 12 months of when the first patient would be recruited in this practice.
  • Parents/carers aged under 18

Treatment and study plan

The 6-week Hip Checklist

Diagnostic Test

Comprehensive 9-item structured guide to aid in correct diagnosis of developmental dysplasia of the hip.

Primary outcomes

  1. Clinical Importance of referrals

    Time frame: 2 weeks following hip check

    Number of referred hips that are considered clinically insignificant (referrals resulting in reassurance and discharge from secondary care).

Secondary outcomes

  1. Number of appropriate referrals per GP practice

    Time frame: Within 2 years of hip check

    Number of referred infants with a hip deemed clinically significant (any hip of an infant that warrants treatment, evaluation and/or monitored by secondary care specialist.

  2. Number of Late diagnoses

    Time frame: Within 2 years of hip check

    Cases of developmental dysplasia of the hip that is diagnosed by a specialist secondary care facility at age 3-24 months.

  3. Consequences of Late diagnoses

    Time frame: Within 2 years of hip check

    How the late diagnoses of developmental dysplasia of the hip affects the patients treatment. For example, whether they need more treatment than if it were to be detected early.

  4. Volume of referrals

    Time frame: Within 2 years of hip check

    Total number of patients referred to secondary care in trial period

  5. Timeliness of referrals

    Time frame: Within 2 years of hip check

    Number of days from general practitioner referral to consultation with orthopaedic specialist

  6. Incremental costs of using aid

    Time frame: Within 2 years of hip check

    Costs associated with using aid per clinically insignificant referral avoided, per late diagnosis avoided, per quality of life in years gained and the net monetary benefit of using the tool.

  7. Incidence of developmental dysplasia of the hip

    Time frame: Within 2 years of hip check

    Clinically significant cases of developmental hip dysplasia in the entire study period (any hip of an infant that warrants treatment, evaluation and/or monitored by specialist secondary care facility.

  8. Impact of the intervention on general practitioner behaviour

    Time frame: Within 2 years of hip check

    GP behaviour in relation to 6-week hip check to be measured based on 14 domains of the adapted theoretical domains framework questionnaire. The 14 domains include knowledge, skills, social/professional role and identity, beliefs about capabilities, optimism, beliefs about consequences, reinforcement, intentions, goals, memory/attention and decision processes, environmental context and resources, social influences, emotion and behavioural regulation. Per domain the scale ranges from 1-10 of scoring (with 1 being the lowest and 10 the highest of agreement with the statements indicated).

  9. Parent/Carer general worry at present

    Time frame: Within 2 weeks of hip check

    As measured by Spielberger State-Trait Anxiety Inventory 6-items short form. This comprises of 6 statements to be answered on a scale of 1 to 4 with 4 being the highest measure of anxiety.

  10. Parent/Carer worry related to developmental dysplasia of the hip

    Time frame: Within 2 weeks of hip check

    As measured by Infant Hip Worries Inventory. This comprises of 12 statements to be answered on a scale of 1 to 5, with 1 being the lowest and 5 the highest.

  11. Parent/Carer satisfaction with the trial intervention

    Time frame: Within 2 weeks of hip check

    As measured by EUROPEP Dimensions of care subscale. This comprises of 23 statements to be answered on a scale of 1 to 5, with 1 being the lowest possible rating and 5 the highest.

  12. Parent/Carer acceptability of trial intervention

    Time frame: Within 2 weeks of hip check

    As measured by qualitative interviews

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Collaborators

  • King's College London
  • Longrove Surgery
  • Steps Charity Worldwide
  • University College, London
  • University of Bedfordshire

Registry information

Official study title

Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice: Controlled Randomised Trial

Acronym: HipDyS

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Sep 24, 2019
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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