Temporary Medial Hemi-epiphysiodesis of the proximal femur
ProcedureTemporary Medial Hemi-epiphysiodesis of the proximal femur
NCT Number: NCT06118736
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.
Interested in participating?
Request Info2 year–8 year
All sexes
Interventional
Not applicable
Amsterdam UMC, Amsterdam, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Time frame: from enrollment to the end of study (8 years)
The Primary study outcome is treatment failure, defined as:
Time frame: 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
Time frame: 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:
Time frame: 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.
Time frame: 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.
Time frame: 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:
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:
Time frame: At the time of enrollment
Other patient related measurements that will be obtained at baseline include
Contact information is provided by the study sponsor or research team.
Erasmus Medical Center
Other
Acronym: GUIDANCE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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