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.
None
associated neuromuscular, genetic or neurological condition which may complicate the course of treatment
babies who have unstable hips on clinical examination
Parallel
Watchful waiting with supportive care
Other interventionUsual 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
Ultrasound
An alpha angle of 60 degrees using Graf Classification needs to be obtained to denote a normal hip
Ultrasound
Alpha angle of 60 degrees needs to be obtained using the Graf classification in order to denote a normal hip
Parenting Stress Index
Questionnaire to determine stress levels of parents whose babies are in the harness and non-harness groups
X Ray
X ray to determine Acetabular Index at 9 months and and 15 months of age to determine whether the hip is normal once the baby starts weightbearing
Click on the lead sponsor to view all of their trials.
Maidstone & Tunbridge Wells NHS Trust
Lead sponsor
Canterbury Christ Church University
Collaborator
