GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
- Conditions
- Hip DislocationCerebral Palsy
- Interventions
- Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur
- Registration Number
- NCT06118736
- Lead Sponsor
- Erasmus Medical Center
- Brief 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.
The investigators objective is 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- Spastic CP
- GMFCS level IV-V
- Aged 2-8 years
- At least one hip with an abduction in flexion ≤ 40 degrees
- Migration percentage of 30-50%
- Head shaft angle > 145
- Not fit for surgery
- History of bony hip surgery to the affected hip
- Severe acetabular dysplasia defined as a gothic arch, an incongruent joint or an acetabular index > 30 degrees, consistent with A2 and A3 acetabular deformity according to Robin and Graham in an adequately performed radiographs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur Temporary Medial Hemi-epiphysiodesis of the proximal femur Standard care + intervention
- Primary Outcome Measures
Name Time Method Treatment failure from enrollment to the end of study (8 years) The Primary study outcome is treatment failure, defined as:
* Need for secondary bony hip surgery to the affected hip or progression to hip migration \> 50% at 5-year follow-up . An indication for secondary bony surgery will be defined as;
* Migration percentage \> 50% at a minimum of 1 year after surgery, OR
* An increased migration \> 10% in 1 year during follow-up
* Increase in Acetabular index to \> 30 degrees or an increase of more than 5 degrees during follow-up
- Secondary Outcome Measures
Name Time Method Radiographic parameters from enrollment to the end of study (8 years) Standardized conventional radiographs, AP and Lauenstein view (frog leg lateral) Pelvic radiographs will be performed according to the standardized protocol as defined by AACPDM
* Migration percentage (%), change in migration percentage per treatment arm (on baseline and follow-up)
* Head Shaft angle (HSA) in degrees
* Acetabular index
* Melbourne hip classification
* Pelvic obliquity
* Positioning of the hemi epiphysiodesis screw in the intervention group3-dimensional shape analysis of proximal femur directly postoperative, at 2-year follow-up and at 5-year follow-up CT-scans of the hip will be performed in the intervention group directly postoperative, at 2-year follow-up and 5-year follow-up. On these scans the following measurements will be performed:
* Positioning of the hemi epiphysiodesis screw
* 3-dimensional proximal femoral shape analysis regarding (change in) sphericity, congruency and head-neck orientation will be performed in patients at 2-year follow-up and at 5-year follow-up.
* The direction of migration of the hip and acetabular morphology will be determined according to the method described by Brunner et al.
* Sphericity of the femoral head will be determined by the Mose technique.CPChild questionnaire from enrollment to the end of study (8 years) \"Caregivers Priorities and Child Health Index of Life with Disabilities\"
The CPCHILD™ is a parent completed questionnaire and was developed to help clinicians to identify areas that are impairing a child's quality of life, determine what is most important to the child and caregiver, and monitor the child's progress in a way that is meaningful to the family.
Minimum value is 0 and maximum value is 100, the higher the score the better the outcome.CPG questionnaire from enrollment to the end of study (8 years) CPG = \"Checklist Pijn Gedrag\" (Dutch for Checklist Pain behaviour) A mean pain score will be calculated.
A minimum value of 0 with a maximum value of 10. Higher scores mean more pain.Secondary surgical interventions other than bony procedure from enrollment to the end of study (8 years) Screw revision ▪ The following will be used as indications for screw revision in the intervention group throughout the study period:
* \< 1 thread of the screw remaining in the epiphysis, and
* HSA \> 100 degrees
Repeated soft tissue release.
▪ The following will be used as indications for repeated soft tissue releases (adductor and/or psoas tenotomy) in both the intervention and control group throughout the study period:
* Abduction \< 30 degrees, and
* No indication for bony surgery
Trial Locations
- Locations (5)
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Maastricht UMC
🇳🇱Maastricht, Netherlands
Sint Maartenskliniek
🇳🇱Nijmegen, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands