Cerebral Palsy, Hip Dislocation
Conditions
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.
Interventions
PROCEDURETemporary Medial Hemi-epiphysiodesis of the proximal femur
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 group |
| 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 |
| 3-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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline measurements | At the time of enrollment | Other patient related measurements that will be obtained at baseline include * Age * Weight * Height * GMFCS classification * Change in Migration Percentage in the year prior to the adductor tenotomy * Use of tone regulation; Baclofen, Artane, Baclofen pump, Selective Dorsal Rhizotomy (SDR |
Countries
Netherlands
Contacts
Primary ContactMerel Roelen, MD
Backup ContactJaap Tolk, MD PhD
Outcome results
None listed