Actively Recruiting

Phase Not Applicable
Age: 2Years - 8Years
All Genders
NCT06118736

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

Age: 2Years - 8Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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