To determine whether guided growth of the proximal femur decreases the risk of further hip migration and need for further surgery in cerebral palsy patients.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Need for secondary (bony) surgery and/or progression to a migration percentage
of > 50%.
Secondary outcome
- Change in migration percentage
- Head shaft angle
- Complication rate
- Screw revision rate
- CP - child questionnaire
Background summary
In recent literature, the potential of guided growth of the proximal femur to
modify hip growth in patients with cerebral palsy has been shown. Using medial
hemi-epiphysiodesis of the proximal femur (TMH-PF) morphology of hips at risk
of symptomatic (sub)luxation in cerebral palsy (CP) can be changed, aiming to
reduce further hip migration and the need for more invasive surgical treatment
modalities. Further research is necessary to assess if the results of TMH-PF in
combination with adductor tenotomies are significantly better than the results
of the current standard of care; adductor tenotomies alone.
Study objective
To determine whether guided growth of the proximal femur decreases the risk of
further hip migration and need for further surgery in cerebral palsy patients.
Study design
Multicentre, randomized, controlled trial.
Intervention
The intervention group undergoes an adductor tenotomy combined with temporary
medial hemi-epiphysiodese of the proximal femur. The control group undergoes an
adductor tenotomy alone.
Study burden and risks
- Both groups of patients will undergo surgery in accordance with the current
standard of care.
- Both groups will have the same clinic appointments, including physical
examination and radiological follow-up, in accordance with the current standard
of care.
- Patients will be asked to fill out a CP - child preoperatively as well as at
the 6 week postoperative mark and at the 1 year postoperative appointment [7].
- The group of patients undergoing TMH-PF will have additional surgical risks:
Risk of infection, the need for screw revision. However, they might also
benefit from the advantages of this technique in the form of preventing
secondary bony surgery.
- All patients will undergo a low-dose CT scan directly postoperatively, at 2
years postoperatively and at 5 years postoperatively to assess 3-dimensional
morphological changes of the hip.
Dr Molewaterplein 40
Rotterdam 3015 GB
NL
Dr Molewaterplein 40
Rotterdam 3015 GB
NL
Listed location countries
Age
Inclusion criteria
- Spastic CP
- GMFCS level IV-V
- Aged 2-8 years
- Abduction in flexion <= 40 degrees
- Migration percentage of 30-50%
- Head shaft angle > 145 degrees
Exclusion criteria
- Not fit for surgery
- History of bony hip surgery to the affected hip
- Severe acetabular dysplasia defined as a gothic arch, a incongruent joint or
an acetabular index > 30 degrees, consistent with A2 and A3 acetabular
deformity according to Robin and Graham
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL84133.078.24 |