An interventional study of Temporary Medial Hemi-epiphysiodesis of the proximal femur in Cerebral Palsy and Hip Dislocation, sponsored by Erasmus Medical Center. Recruiting at 5 sites in Netherlands. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 84 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Standard care + intervention
Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur
Standard care
Temporary Medial Hemi-epiphysiodesis of the proximal femur
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)
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)
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-up
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)
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)
Secondary surgical interventions other than bony procedure
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
Time frame: from enrollment to the end of study (8 years)
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 enrollment
Plan to share: Yes — Individual de-identified participant data that underlie the results from the GUIDANCE study and the study protocol will be shared if requested. Data will be available beginning 12 months and ending 5 years following publication of this paper. Data will be available for researchers who provide a methodologically sound scientific proposal, which has been approved by an ethical committee. Proof of the latter should be provided. Analyses should achieve the aims as reported in the approved proposal. Proposals for data should be directed to the corresponding author.
Supporting information: Study protocol
Time frame: Data will be available beginning 12 months and ending 5 years following publication of this paper
Access criteria: Data will be available for researchers who provide a methodologically sound scientific proposal, which has been approved by an ethical committee. Proof of the latter should be provided. Analyses should achieve the aims as reported in the approved proposal.
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Apr 2029, 61 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 61 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
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