Developmental Dysplasia of the HipHipDySNCT04101903
Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice
A study testing The 6-week Hip Checklist in people with Developmental Dysplasia of the Hip, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 11 weeks
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- The 6-week Hip Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2020to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice: Controlled Randomised Trial
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.
Read the detailed description
- 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
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- The 6-week Hip Checklist
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 6-week Hip ChecklistDiagnostic test
Comprehensive 9-item structured guide to aid in correct diagnosis of developmental dysplasia of the hip.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Aid | Experimental | The experimental group will use the trial diagnostic aid for all 6-week infant hip checks Receives: Diagnostic Test: The 6-week Hip Checklist |
| Standard of Care | No intervention | The control group will assess infants according to standard practice, during the 6-week hip check. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Importance of referrals
Number of referred hips that are considered clinically insignificant (referrals resulting in reassurance and discharge from secondary care).
Measured: 2 weeks following hip check
Secondary outcomes (12)
Number of appropriate referrals per GP practice
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.
Measured: Within 2 years of hip check
Number of Late diagnoses
Cases of developmental dysplasia of the hip that is diagnosed by a specialist secondary care facility at age 3-24 months.
Measured: Within 2 years of hip check
Consequences of Late diagnoses
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.
Measured: Within 2 years of hip check
Volume of referrals
Total number of patients referred to secondary care in trial period
Measured: Within 2 years of hip check
Timeliness of referrals
Number of days from general practitioner referral to consultation with orthopaedic specialist
Measured: Within 2 years of hip check
Incremental costs of using aid
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.
Measured: Within 2 years of hip check
Incidence of developmental dysplasia of the hip
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.
Measured: Within 2 years of hip check
Impact of the intervention on general practitioner behaviour
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).
Measured: Within 2 years of hip check
Parent/Carer general worry at present
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.
Measured: Within 2 weeks of hip check
Parent/Carer worry related to developmental dysplasia of the hip
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.
Measured: Within 2 weeks of hip check
Parent/Carer satisfaction with the trial intervention
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.
Measured: Within 2 weeks of hip check
Parent/Carer acceptability of trial intervention
As measured by qualitative interviews
Measured: Within 2 weeks of hip check
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start6 Mar 2020
- Primary completion30 Jun 2025
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, University of Bedfordshire, King's College London, Steps Charity Worldwide, Longrove Surgery
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101903
- Sponsor's protocol ID
- 19IR05
- Other IDs
- RP-PG-0616-20006
- Acronym
- HipDyS
- Status last verified
- Jan 2026
- First submitted
- 17 Sep 2019
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be used for publication.
Publications
Roposch A, Warsame K, Chater A, Green J, Hunter R, Wood J, Freemantle N, Nazareth I. Study protocol for evaluation of aid to diagnosis for developmental dysplasia of the hip in general practice: controlled trial randomised by practice. BMJ Open. 2020 Dec 2;10(12):e041837. doi: 10.1136/bmjopen-2020-041837.
PubMed 33268429
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice: Controlled Randomised Trial
- ClinicalTrials.gov ID
- NCT04101903
- Acronym / sponsor ID
- HipDyS / 19IR05
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College, London, University of Bedfordshire, King's College London, Steps Charity Worldwide, Longrove Surgery
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Aid | Experimental | Diagnostic Test: The 6-week Hip ChecklistThe experimental group will use the trial diagnostic aid for all 6-week infant hip checks |
| Standard of Care | No intervention | –The control group will assess infants according to standard practice, during the 6-week hip check. |
Who may qualify
- Ages
- 6 to 11 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 6-week Hip ChecklistComprehensive 9-item structured guide to aid in correct diagnosis of developmental dysplasia of the hip. | Diagnostic test | Diagnostic Aid |
Primary outcome
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).
12 secondary outcomes
Number of appropriate referrals per GP practice
Time frame: Within 2 years of hip check
Number of Late diagnoses
Time frame: Within 2 years of hip check
Consequences of Late diagnoses
Time frame: Within 2 years of hip check
Volume of referrals
Time frame: Within 2 years of hip check
Timeliness of referrals
Time frame: Within 2 years of hip check
Incremental costs of using aid
Time frame: Within 2 years of hip check
Incidence of developmental dysplasia of the hip
Time frame: Within 2 years of hip check
Impact of the intervention on general practitioner behaviour
Time frame: Within 2 years of hip check
Parent/Carer general worry at present
Time frame: Within 2 weeks of hip check
Parent/Carer worry related to developmental dysplasia of the hip
Time frame: Within 2 weeks of hip check
Parent/Carer satisfaction with the trial intervention
Time frame: Within 2 weeks of hip check
Parent/Carer acceptability of trial intervention
Time frame: Within 2 weeks of hip check
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 33268429Roposch A, Warsame K, Chater A, Green J, Hunter R, Wood J, Freemantle N, Nazareth I. Study protocol for evaluation of aid to diagnosis for developmental dysplasia of the hip in general practice: controlled trial randomised by practice. BMJ Open. 2020 Dec 2;10(12):e041837. doi: 10.1136/bmjopen-2020-041837.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be used for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 6-week Hip Checklist in people with Developmental Dysplasia of the Hip, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Importance of referrals (time frame: 2 weeks following hip check). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.