GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-8
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Spastic CP
GMFCS level IV-V
Aged 2-8 years
At least one hip with an abduction in flexion ≤ 40 degrees
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Procedure/SurgeryTemporary Medial Hemi-epiphysiodesis of the proximal femur
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femurExperimental treatment 1 intervention
Group B: Adductor tenotomyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Treatment failure
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
Time frame
from enrollment to the end of study (8 years)Secondary outcomes
1
Radiographic parameters
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
Time frame
from enrollment to the end of study (8 years)2
3-dimensional shape analysis of proximal femur
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.
Time frame
directly postoperative, at 2-year follow-up and at 5-year follow-up3
CPChild questionnaire
\"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.
Time frame
from enrollment to the end of study (8 years)4
CPG questionnaire
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.
Time frame
from enrollment to the end of study (8 years)Other outcomes
1
Baseline measurements
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
Time frame
At the time of enrollmentSponsors and contacts
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Source ClinicalTrials.gov