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
The strategy for discontinuing Pavlik harness treatment in infants under 6 months with Developmental Dysplasia of the Hip (DDH) following successful Pavlik harness use.
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). Following informed consent, participants are randomly allocated in a 1:1 ratio to one of two arms using a secure web-based system (REDCap), stratified by site. The intervention arm involves weaning, defined as wearing the Pavlik harness at night only (minimum 10 hours per night) for four weeks following the completion of full-time use. The control arm involves immediate cessation of the Pavlik harness with no further brace use.
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
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