Actively Recruiting
GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
Led by Erasmus Medical Center · Updated on 2024-10-08
84
Participants Needed
5
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) level IV or V
- Age between 2 and 8 years
- At least one hip with abduction in flexion of 40 degrees or less
- Migration percentage of 30-50%
- Head shaft angle greater than 145 degrees
You will not qualify if you...
- Not fit for surgery
- History of bony hip surgery on the affected hip
- Severe acetabular dysplasia defined as a gothic arch, an incongruent joint, or an acetabular index greater than 30 degrees consistent with A2 and A3 acetabular deformity according to Robin and Graham on adequate radiographs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
2
UMC Groningen
Groningen, Netherlands
Actively Recruiting
3
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
4
Sint Maartenskliniek
Nijmegen, Netherlands
Not Yet Recruiting
5
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
Research Team
M
Merel Roelen, MD
CONTACT
J
Jaap Tolk, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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