Topic: Children, surgery, orthopaedics
Conditions
Interventions
A total of 636 children aged 3 ? 13 months with a dislocated hip in the absence of the proximal femoral ossific nucleus will be recruited (318 in each arm). They will be stratified at randomisaton by
Sponsors
Southampton University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 3 to 13 months with either: 1.1. New diagnosis of developmental displacement of the hip 1.2. Failed splintage up to 12 weeks of age 2. Children who require surgical reduction of the hip (open or closed) 3. Children who are fit for surgery the decision to include in the study will be entirely at the discretion of the operating surgeon 4. Parents willing to give consent to treatment, complete questionnaires and follow-up
Exclusion criteria
Exclusion criteria: 1. Children older than 13 months 2. Children with neurological or syndromic teratologic dislocation of the hip 3. Children who have had previous surgical treatment for hip dysplasia 4. Children with an existing AVN 5. Children with existing ossific nucleus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of avascular necrosis (AVN grade II to IV); Timepoint(s): Post Surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health economic evaluation; Timepoint(s): 6 months post surgery 2. Need for second surgery (subluxation, dysplasia, AVN); Timepoint(s): Follow-up visits (post surgery) 3. Quality of life for child; Timepoint(s): Ongoing post surgery (age 2-5 years) 4. Quality of life for main carer; Timepoint(s): Ongoing post surgery (age 2-5 years) | — |
Countries
United Kingdom
Outcome results
None listed