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NOT YET RECRUITING
NCT07847619
NA

8 vs 12 Weeks: A Pavlik Harness Trial

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

Developmental dysplasia of the hip is the most common bone and joint condition in babies. It is usually treated with a harness that holds the hips in a safe position so they can develop normally. After the hip is confirmed to be in the correct position, babies are commonly kept in the harness for up to 12 weeks or more. While effective, wearing a harness for this length of time can be challenging for families. It can make everyday care such as feeding, bathing and dressing more difficult, and add stress during an important time for bonding. This trial compares two treatment options: 8 versus 12 weeks of harness wear. The 8-week option is being tested because research has shown that most hips appear normal on ultrasound by this point. The main measure of success is whether the hip looks normal on x-ray two years after treatment. Families will also be asked about their experience and treatment-related problems. If the shorter option is as effective as the longer option, many babies could spend less time in brace, reducing burden without compromising outcomes. Because this trial is embedded in routine care, results can be put into practice quickly and guide care for babies across Ontario and beyond.

Official title: Optimising Post-Centring Pavlik Time in Infant DDH: A Non-Inferiority RCT of 8 vs 12 Weeks

Key Details

Gender

All

Age Range

0 Months - 6 Months

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2027-01

Completion Date

2030-03

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DEVICE

Pavlik Harness

The intervention is the duration of Pavlik harness use after sonographic centring. The Pavlik harness itself is unchanged: a commercially available soft brace positioning the hips in flexion and abduction to maintain reduction. No modifications are introduced to fitting technique, wear schedule, caregiver education, skin checks, or monitoring. All care follows the existing SickKids protocol used in routine practice. The harness is worn full time (24 hours/day initially), with allowance for up to 1 hour/day removal for hygiene after 5 weeks of treatment.

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada