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Trial registered on ANZCTR


Registration number
ACTRN12614000884606
Ethics application status
Approved
Date submitted
11/08/2014
Date registered
20/08/2014
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is muscle lengthening or bony surgery better for young children with cerebral palsy who have hip displacement?
Scientific title
Adductor muscle release compared with bony reconstructive surgery for management of hip displacement in young children with cerebral palsy: A randomised clinical trial
Secondary ID [1] 284810 0
nil
Universal Trial Number (UTN)
U1111-1158-0916
Trial acronym
CP-HIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 292191 0
Hip displacement 292192 0
Condition category
Condition code
Musculoskeletal 292528 292528 0 0
Other muscular and skeletal disorders
Neurological 293080 293080 0 0
Other neurological disorders
Surgery 293081 293081 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289599 0
Treatment: Surgery
Comparator / control treatment
Soft tissue relase of the hip adductor muscles:

Soft tissue release surgery will follow a standard surgical protocol as follows:
1. Caudal anaesthetic and morphine 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 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. Phenolisation of the anterior branch of the obturator nerve, using 1ml of 6% phenol to each side.
4. Application of a ‘broomstick’ plaster cast

Soft tissue release surgery takes approximately 60 minutes (including application of broomstick cast)
Control group
Active

Outcomes
Primary outcome [1] 292389 0
Hip migration percentage (MP):

MP is a measure of the proportion of the femoral head that is sitting outside of the acetabulum, expressed as a percentage. A hip x-ray (AP Pelvis) will be taken at each study visit. Participants will be positioned for the x-ray according to a standardised protocol to ensure accurate measurement of migration percentage is possible. MP will be measured directly from the x-ray on-screen and by a standardised method.
Timepoint [1] 292389 0
Baseline
6 months after surgery
12 months after surgery
24 months years after surgery
Secondary outcome [1] 309641 0
Caregiver Priorities and Child Health Index of Life with Disabilitities (CPCHILD):

The participant’s parent/guardian will be asked to complete the CPCHILD questionnaire during their attendance at each study visit. The questionnaire asks carers to consider how each of the listed activities is usually performed by/for their child, to rate how difficult each of these activities were in the previous 2 weeks, and identify the level of assistance that was required to help their child perform the activities.
Timepoint [1] 309641 0
Baseline
3 weeks after surgery
6 months after surgery
12 months after surgery
24 months after surgery
Secondary outcome [2] 309642 0
Paediatric Pain Profile:

The participant’s parent/guardian will be asked to record their child’s pain behaviours using the Paediatric Pain Profile (PPP). The PPP asks parents to use a 20 item scale to rate behaviours from their child that have been identified as being associated with pain.
Timepoint [2] 309642 0
Baseline
Day of discharge
3 weeks after surgery
6 months after surgery
12 months after surgery
24 months after surgery
Secondary outcome [3] 309643 0
Gross Motor Function Measure (GMFM):

The GMFM will be used to measure time to return to baseline function following surgery. The Gross Motor Function Measure (GMFM) was developed to measure change in gross motor function over time in young people with cerebral palsy. The measure covers five dimensions of activity: Lying and Rolling; Sitting; Crawling; Standing; and Walking, Running and Jumping.
Timepoint [3] 309643 0
Baseline
6 months after surgery
12 months after surgery
24 months after surgery
Secondary outcome [4] 309644 0
Safety and adverse events:

Details of adverse events will also be recorded as follows:

Surgical Adverse Events
Blood transfusion: Recorded as required or not. It is expected that only children undergoing VDRO might require transfusion.
Surgical site infection (SSI): SSI will be recorded according to the definitions and classifications of the Center for Disease Control (CDC). Treatment required for SSIs will be recorded, including dressing change, antibiotics (oral or intravenous as an outpatient or inpatient), any readmission, re-operation or removal of hardware required.
Cast issues: If a child develops any adverse events from plaster casting, including skin excoriation, cellulitis and pressure sores, either during admission or during the follow-up period, details will be recorded of management and time to resolution.
Heterotopic Ossification (HO): HO will be classified from pelvic radiographs at each study time point using a system described by Krum and Miller to classify HO after orthopaedic surgery in children with CP. This classification describes HO by both radiographic and clinical criteria. Asymptomatic HO with a lesion of less than half the width of the ipsilateral femoral neck (Classification IA) will not be considered an adverse event.
Delayed union or non-union: Any delay in bone union or non-union evident on the pelvic radiograph will be recorded at follow-up visits. If there is delay in union, time to union will be recorded.
Hardware issues: Symptomatic prominence, hardware failure (breakage) or fracture will be recorded, including management required.

General/Medical Adverse Events:
Respiratory function: Detail will be recorded of any child developing a respiratory tract infection following surgery, including whether the infection resolved prior to discharge, whether an ICU admission was required or whether the child was re-admitted with a respiratory infection after discharge post-surgery.
Urinary Tract Infection: Detail will be recorded of any child developing a urinary tract infection following surgery, including time to resolution.
Severe Vomiting/nausea: Severe nausea of vomiting requiring medication will be recorded.
Severe consitpation: Severe contispation delaying discharge will be recorded, including whether it was resolved prior to discharge

All adverse events will be classified using a modified version of the Clavien-Dindo Classification which has previously been applied to bony surgery for hip displacement in cerebral palsy.
Timepoint [4] 309644 0
Day of discharge
3 weeks after surgery
6 months after surgery
12 months after surgery
24 months after surgery

Eligibility
Key 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.
Minimum age
3 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned, in a 1:1 ratio, to receive either adductor surgery or bony reconstructive surgery. Randomisation will be stratified by GMFCS classification (IV versus V), age (4-6, 7-9 years) and hip migration percentage (31-50%, 51-60%). The randomisation schedule will be entered into a secure, encrypted, web-based database (REDCap) and group allocation will be generated in the presence of the parents/guardian at the time of consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician not directly involved in the analysis of the study results will prepare the randomisation schedule using random permuted blocks with different block sizes to ensure concealment of allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size calculations were based on a retrospective analysis of outcomes for all children aged 3-10 years, GMFCS IV or V, who had STR or VDRO as an index procedure to manage hip displacement at our centre between 2009 and 2011. Hip migration percentage was measured pre-surgery, immediately post-surgery, and at 12 and 24 months post-surgery. Based on this data, and expected admission rates of eligible participants, we aim to recruit 40 children (20 per group). This will give 80% power to detect a difference of at least 0.9 SD in the hip MP at 2 years between the two surgical groups with a two group t-test with a significance level of 0.05. The estimated SD was between 14% and 24%, giving the study an estimated 80% power to detect a difference in hip migration percentage of between 13% and 22% at 2 years.

Intention to treat analysis will be performed. For the primary outcome measure, differences in mean hip migration percentage (MP) between the groups will be estimated, together with 95% confidence intervals. Unpaired t-tests will also be used to assess differences between the groups. A secondary analysis using multivariable linear regression with adjustment for possible differences in baseline confounders will also be undertaken, to obtain more precise estimate of the treatment effect.
Differences in secondary outcomes of pain, gross motoro function (GMFM) and caregiver burden (CPCHILD) will be analysed using parametric statistics (eg t tests) for appropriately distributed outcomes, and non-parametric statistics where outcomes have skewed distributions. If necessary, continuous data outcomes will be log-transformed to obtain a more symmetric distribution.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2787 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 8480 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 289672 0
Charities/Societies/Foundations
Name [1] 289672 0
Murdoch Childrens Research Institute
Address [1] 289672 0
50 Flemington Road
Parkville
Victoria 3052
Country [1] 289672 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
50 Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 288364 0
None
Name [1] 288364 0
Address [1] 288364 0
Country [1] 288364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291409 0
The Royal Children's Hospital
Ethics committee address [1] 291409 0
50 Flemington Road
Parkville
Victoria 3052
Ethics committee country [1] 291409 0
Australia
Date submitted for ethics approval [1] 291409 0
Approval date [1] 291409 0
07/07/2014
Ethics approval number [1] 291409 0
34029C

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49226 0
Prof H Kerr Graham
Address 49226 0
Orthopaedic Department
the Royal Children's Hospital
50 Flemington Road
Parvkille
Victoria 3052
Country 49226 0
Australia
Phone 49226 0
+61 03 93455399
Fax 49226 0
Email 49226 0
kerr.graham@rch.org.au
Contact person for public queries
Name 49227 0
Dr Kate Willoughby
Address 49227 0
Orthopaedic Department
the Royal Children's Hospital
50 Flemington Road
Parvkille
Victoria 3052
Country 49227 0
Australia
Phone 49227 0
+61 03 93454038
Fax 49227 0
Email 49227 0
kate.willoughby@rch.org.au
Contact person for scientific queries
Name 49228 0
Prof H Kerr Graham
Address 49228 0
Orthopaedic Department
the Royal Children's Hospital
50 Flemington Road
Parvkille
Victoria 3052
Country 49228 0
Australia
Phone 49228 0
+61 03 93455399
Fax 49228 0
Email 49228 0
kerr.graham@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing of individual data not included in ethics approval
What supporting documents are/will be available?
No other documents available
Summary results
No Results