Pavlik Harness Treatment vs Monitoring for Treatment of Developmental Dysplasia of the Hip (DDH) in Babies Diagnosed With Graf Type 2 Hips

NCT07111858 | Recruiting

• 1 other identifier: 304944
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Developmental Dysplasia of the Hip (DDH) is thoroughly manageable if treated correctly. While the standard treatment is using a Pavlik harness, there is not enough research regarding those patients who have stable but immature Graf type 2b and 2c hips and whether a harness is needed. At Maidstone and Tunbridge Wells NHS Trust, all babies who present with Graf type 2b and 2c hip dysplasia are treated using a Pavlik harness, which is worn 24 hours a day for up to 12 weeks. Although the harness is usually very comfortable, it can result in stress and anxiety for parents, and may make caregiving activities such as bathing, feeding and carrying more difficult. Our aim is to run a feasibility trial, recruiting babies with type 2b and 2c hip dysplasia, to determine whether there is any difference in a group which is treated with Pavlik harnessing, or whether these hips do in fact mature on their own. We would like to ensure that Pavlik harness treatment is indeed necessary in these groups. Babies randomised to the comparator group with type 2b and 2c hips would be treated using a Pavlik Harness and following the usual protocol with ultrasound scans at 3 weeks, 8 weeks and 12 weeks post start of treatment, and harness duration is determined by the scan at 8 weeks. Babies randomised to the Intervention group would be monitored via ultrasound scans at 3 weeks, 6 weeks, 8 weeks and 12 weeks post diagnosis, and should it be determined that their hips are not maturing spontaneously, they will be placed in a harness immediately, and follow the treatment-group protocol. Since the scans are done so frequently, and their hips are stable, there is no risk to these babies. Babies in both groups would have x-rays at 9 months and 15 months to determine longer-term outcome. The trial will last for 15 months after diagnosis for each patient, and the end-point of the study would be on achieving a 15-month x-ray for the last recruited patient. Patients will be informed of the results of the study.

Conditions

Developmental Hip Dysplasia

Keywords

DDH

Outcome Measures

Primary Outcomes (2)

• Ultrasound

  An alpha angle of 60 degrees using Graf Classification needs to be obtained to denote a normal hip

  12 weeks after baseline scan

• Ultrasound

  Alpha angle of 60 degrees needs to be obtained using the Graf classification in order to denote a normal hip

  12 weeks after initial scan

Secondary Outcomes (2)

• Parenting Stress Index

  3 weeks after baseline scan

• X Ray

  9 months and 15 months of age

Study Arms (2)

Pavlik Harness Treatment

NO INTERVENTION

This is usual care with a Pavlik Harness

Watchful waiting and regular ultrasound scans

EXPERIMENTAL

Watchful waiting, with ultrasound scans every 3 weeks

Other: Watchful waiting with supportive care

Interventions

Watchful waiting with supportive care OTHER

Usual care is Pavlik Harness Treatment. Watchful waiting with ongoing ultrasound scans is the intervention in this study to determine whether the hip matures without the use of the Pavlik Harness

Watchful waiting and regular ultrasound scans

Eligibility Criteria

• Age: 0 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants from birth to 16 weeks with Graf type 2b or 2c hip dysplasia on ultrasound

You may not qualify if:

• associated neuromuscular, genetic or neurological condition which may complicate the course of treatment
• babies who have unstable hips on clinical examination

Sponsors & Collaborators

• Maidstone & Tunbridge Wells NHS Trust: lead
• Canterbury Christ Church University: collaborator

Study Sites (1)

Maidstone and Tunbridge Wells NHS trust

Royal Tunbridge Wells, United Kingdom

RECRUITING

Related Publications (3)

• Pollet V, Sakkers R, Beek E, et al. Abduction bracing versus natural history in hip dysplasia: multicenter randomized trial. J Child Orthop 2016;10:S30-S31

  BACKGROUND

• Bracken J, Ditchfield M. Ultrasonography in developmental dysplasia of the hip: what have we learned? Pediatr Radiol. 2012 Dec;42(12):1418-31. doi: 10.1007/s00247-012-2429-8. Epub 2012 Sep 2.

  PMID: 22940710 BACKGROUND

• Abidin, R. R. (1995). Parenting Stress Index. Lutz, Florida: Psychological Assessment Resources, Inc.

  BACKGROUND

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

Watchful Waiting; Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Nicole Hilburn, PhD

CONTACT

+447982027154; nicole.hilburn@canterbury.ac.uk

Joanne Dartnell, Consultant Orthopaedic Surgeon

CONTACT

jo.dartnell@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 2, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)