Pavlik harness treatment vs monitoring in Graf 2b and 2c hips
Research type
Research Study
Full title
Pavlik harness treatment vs monitoring for treatment of Developmental Dysplasia of the Hip (DDH) in babies diagnosed with Graf type 2 hips
IRAS ID
304944
Contact name
Joanne Dartnell
Contact email
Sponsor organisation
Maidstone and Tunbridge Wells NHS trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Developmental Dysplasia of the Hip (DDH) is a thoroughly manageable condition if treated correctly. While the literature agrees that Pavlik harness treatment is the best means of treatment, there is still a lack of research regarding those patients who have stable but immature Graf type 2b and 2c hips. There are recommendations for how to treat more severe forms, but there is no consensus locally or globally on how to specifically treat type 2b and 2c stable hips.
In the MTW 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 non-invasive, and usually very comfortable, Pavlik harness treatment can result in stress and anxiety for parents, and detracts from caregiving activities such as bathing, needing to adapt feeding and carrying positions, and concern from parents around what they are able to do with their babies.
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 mature on their own with no harness intervention. Babies would be randomised into the a treatment group (harness), or a control group (no harness). Both groups will have an extra scan at 3 weeks post diagnosis, and should a scan in the control group demonstrate that there is no change in maturity of the hips, the baby will be placed in a harness. The extra scans will also be used to determine rate of improvement between the groups. The duration of enrolment for each baby would be a maximum of 15 months.REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0149
Date of REC Opinion
23 Aug 2022
REC opinion
Further Information Favourable Opinion