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

NCT04101903 | Active Not Recruiting

• 2 other identifiers: 19IR05RP-PG-0616-20006
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (1)

• Clinical Importance of referrals

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

  2 weeks following hip check

Secondary Outcomes (12)

• Number of appropriate referrals per GP practice

  Within 2 years of hip check

• Number of Late diagnoses

  Within 2 years of hip check

• Consequences of Late diagnoses

  Within 2 years of hip check

• Volume of referrals

  Within 2 years of hip check

• Timeliness of referrals

  Within 2 years of hip check

Study Arms (2)

Diagnostic Aid

EXPERIMENTAL

The experimental group will use the trial diagnostic aid for all 6-week infant hip checks

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.

Interventions

The 6-week Hip Checklist DIAGNOSTIC_TEST

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

Diagnostic Aid

Eligibility Criteria

• Age: 6 Weeks - 11 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• University College, London: collaborator
• University of Bedfordshire: collaborator
• King's College London: collaborator
• Steps Charity Worldwide: collaborator
• Longrove Surgery: collaborator

Study Sites (1)

Rise Group Practice

London, N19 3YU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33268429 DERIVED

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 24, 2019
• Study Start: March 6, 2020
• Primary Completion: June 30, 2025
• Study Completion (Estimated): February 15, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)