None listed
Conditions
Brief summary
This study aims to find out if muscle lengthening surgery or bone surgery is more successful for improving hip displacement in young children with cerebral palsy (CP) who have severe hip displacement. Hip displacement refers to the ‘ball’ (femoral head) of the hip joint moving out of the ‘socket’ (acetabulum) and is common amongst children with CP. Hip displacement can lead to changes in shape of the hip joint, degeneration of the joint, loss of function and eventual pain. In severe cases, or when untreated, displacement can lead to complete dislocation of the hip. Studies have demonstrated that the success of surgery to lengthen tight hip muscles (soft tissue release, or STR) has a limited effect. This surgery is most unsuccessful for children who are not able to walk independently. Up to 86% of these children go on to require further surgery or develop severe hip displacement. The surgical alternative to STR is invasive surgery to change the shape of the hip (varus derotation osteotomy, or VDRO). It has been thought that the earlier the age at which VDRO is done, the higher the chance that it will need to be repeated in the future. At present, efforts are made to delay this surgery in young children by using STR as a ‘temporising’ measure. Previous studies suggest that VDRO is likely to be more successful than STR in managing hip displacement, but it is less clear what the impacts are on factors such as burden of care, parent satisfaction and quality of life. This study will compare the effects of STR and VDRO surgery. To find out the effect of each surgery on hip displacement, the primary outcome measure will be Migration Percentage, a reliable measure of hip displacement that can be taken from a standard hip xray. Impact on factors such as comfort, burden of care and quality of life will be measured through a reliable parent-report questionnaire. All outcome measures will be assessed at baseline, 3 months after surgery (12 weeks) and then at 6, 12 and 24 months after surgery.
Interventions
Varus derotation osteotomy (VDRO) of the proximal femur:
Bony reconstructive surgery will be by VDRO and will follow a standard surgical protocol as follows:
1. Epidural anaesthesia with a dosing regimen individualised to each child – as per current practice
2. Careful examination of hip abduction range under anaesthesia and bilateral open lengthening of the adductor longus, adductor brevis, gracilis and psoas muscles, through a groin skin crease incision, until there is at least 60 degrees of
Varus derotation osteotomy (VDRO) of the proximal femur: Bony reconstructive surgery will be by VDRO and will follow a standard surgical protocol as follows: 1. Epidural anaesthesia with a dosing regimen individualised to each child – as per current practice 2. Careful examination of hip abduction range under anaesthesia and bilateral open lengthening of the adductor longus, adductor brevis, gracilis and psoas muscles, through a groin skin crease incision, until there is at least 60 degrees of abduction in each hip, and symmetric abduction is restored. 3. Bilateral femoral VDRO will be performed via a lateral approach, using a 90 or 100 degree blade plate for stable internal fixation, aiming for a neck shaft angle of between 90 and 100 degrees, with derotation to 10 degrees of anteversion. Bilateral VDROs, performed by a team of 2 surgeons, takes approximately 90 minutes.
Sponsors
The Royal Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of cerebral palsy and be registered with the Victorian Cerebral Palsy Register, 2. Non-ambulant, with gross motor function classified at level IV or V by the GMFCS, 3. Aged between 3 and 10 years at the time of surgery, 4. Hip migration between 30 and 100% in one or both hips at the time of randomisation, 5. Hip abduction <40 degrees in one or both hips at the time of randomisation, and 6. A recommendation from the treating Orthopaedic Surgeon to proceed to surgery for management of hip displacement.
Exclusion criteria
1. Unfit to undergo a general anaesthetic 2. Unsuitable on medical and surgical grounds for either adductor surgery or bony reconstructive surgery, including a generalised bleeding disorder, severe osteopenia or a history of insufficiency fractures, or a history of severe, recurrent respiratory infection.
Outcome results
None listed