A study to find out whether gradually stopping brace treatment or stopping it all at once is better for babies with hip dysplasia

The WINDY study- Weaning in INfant hip Dysplasia- a randomised multicentre feasibility study of weaning of brace treatment versus immediate cessation for developmental dysplasia of the hip

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11590338

Enrollment

Registered

2025-05-02

Start date

2025-11-01

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The strategy for discontinuing Pavlik harness treatment in infants under 6 months with Developmental Dysplasia of the Hip (DDH) following successful Pavlik harness use. Musculoskeletal Diseases

Interventions

This is a multicentre, open-label, randomised controlled feasibility trial comparing two approaches to ending Pavlik harness treatment in infants with developmental dysplasia of the hip (DDH). Followi

Eligibility

Sex/Gender

All

Age

1 Days to 6 Months

Inclusion criteria

Inclusion criteria: 1. The infant has commenced Pavlik harness treatment under 6 months of age 2. The infant has completed a period of full-time Pavlik harness wear 3. Alpha angle is at least 60 degrees at the time of randomisation 4. The parent or legal guardian is willing and able to provide informed consent for participation

Exclusion criteria

Exclusion criteria: 1. The infant has, or is suspected to have, a neuromuscular condition 2. The parent or legal guardian is unable to adhere to the study procedures or complete the questionnaires 3. The parent or legal guardian is unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
Acceptability of trial design measured using the monthly recruitment rate per centre and the percentage of eligible infants randomised at the end of the 6-month recruitment period.	—

Secondary

Measure	Time frame
1. Parental engagement measured using self-reported compliance questionnaires and EMBRACE completion rates at baseline, 2, 4, and 6 weeks post-randomisation 2. Reliability of the EMBRACE measured using floor and ceiling effects, test-retest reliability (Intraclass Correlation Coefficient), and Cronbach’s alpha at 2 and 4 weeks post-randomisation 3. Validity of the EMBRACE measured using correlation with visual analogue scale (VAS) scores at baseline, 2, 4, and 6 weeks post-randomisation 4. Acceptability of the EMBRACE measured using the average time taken to complete the questionnaire and percentage of missing data at baseline, 2, 4, and 6 weeks post-randomisation 5. Accessibility of Smart4NIPE data measured using the availability of routinely collected clinical data at baseline 6. Accuracy and completeness of Smart4NIPE data measured using a comparison of the data points recorded in Smart4NIPE with those entered into REDCap at baseline 7. Acetabular dysplasia measured using the most recent routine ultrasound or radiograph (BSCOS core measurement set or acetabular index) at 12 weeks post-randomisation 8. Reintervention rate measured using the clinician-reported requirement for further bracing or surgery at 12 weeks post-randomisation 9. Impact on the family unit measured using EMBRACE questionnaire scores at baseline, 2, 4, and 6 weeks post-randomisation 10. Hospital attendances related to DDH measured using the recording of the number of appointments from randomisation to 12 weeks 11. Adverse events measured using data recording any clinician-reported foreseeable or serious adverse events throughout the 12-week follow-up period	—

Measure

Time frame

1. Parental engagement measured using self-reported compliance questionnaires and EMBRACE completion rates at baseline, 2, 4, and 6 weeks post-randomisation 2. Reliability of the EMBRACE measured using floor and ceiling effects, test-retest reliability (Intraclass Correlation Coefficient), and Cronbach’s alpha at 2 and 4 weeks post-randomisation 3. Validity of the EMBRACE measured using correlation with visual analogue scale (VAS) scores at baseline, 2, 4, and 6 weeks post-randomisation 4. Acceptability of the EMBRACE measured using the average time taken to complete the questionnaire and percentage of missing data at baseline, 2, 4, and 6 weeks post-randomisation 5. Accessibility of Smart4NIPE data measured using the availability of routinely collected clinical data at baseline 6. Accuracy and completeness of Smart4NIPE data measured using a comparison of the data points recorded in Smart4NIPE with those entered into REDCap at baseline 7. Acetabular dysplasia measured using the most recent routine ultrasound or radiograph (BSCOS core measurement set or acetabular index) at 12 weeks post-randomisation 8. Reintervention rate measured using the clinician-reported requirement for further bracing or surgery at 12 weeks post-randomisation 9. Impact on the family unit measured using EMBRACE questionnaire scores at baseline, 2, 4, and 6 weeks post-randomisation 10. Hospital attendances related to DDH measured using the recording of the number of appointments from randomisation to 12 weeks 11. Adverse events measured using data recording any clinician-reported foreseeable or serious adverse events throughout the 12-week follow-up period

—

Countries

England, United Kingdom, Wales

Contacts

Public ContactJoanna Craven

Joanna.Craven@liverpool.ac.uk+44 (0)151 795 0500

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026