Guided growth treatment for hip issues in children with cerebral palsy
GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
NA · Erasmus Medical Center · NCT06118736
This study is testing a new way to help children with cerebral palsy grow their hips properly to prevent dislocations and reduce the need for major surgeries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 2 Years to 8 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 5 sites (Amsterdam and 4 other locations) |
| Trial ID | NCT06118736 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of temporary medial hemi-epiphysiodesis of the proximal femur to modify hip growth in children with spastic cerebral palsy. The goal is to reduce the risk of hip dislocation and the need for more invasive surgeries by assessing the outcomes of this intervention compared to the current standard care of adductor tenotomies alone. Children aged 2-8 years with specific hip conditions will be enrolled to evaluate the impact of this guided growth approach on hip migration.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-8 years with spastic cerebral palsy, GMFCS level IV-V, and specific hip conditions.
Not a fit: Patients who are not fit for surgery or have a history of bony hip surgery to the affected hip may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for more invasive surgeries in children with cerebral palsy and improve their quality of life.
How similar studies have performed: Other studies have shown promising results with guided growth techniques in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spastic CP * GMFCS level IV-V * Aged 2-8 years * At least one hip with an abduction in flexion ≤ 40 degrees * Migration percentage of 30-50% * Head shaft angle \> 145 Exclusion Criteria: * 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
Where this trial is running
Amsterdam and 4 other locations
- Amsterdam UMC — Amsterdam, Netherlands (NOT_YET_RECRUITING)
- UMC Groningen — Groningen, Netherlands (RECRUITING)
- Maastricht UMC — Maastricht, Netherlands (RECRUITING)
- Sint Maartenskliniek — Nijmegen, Netherlands (NOT_YET_RECRUITING)
- Erasmus MC — Rotterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Jaap Tolk, MD, PhD — Erasmus Medical Center
- Study coordinator: Merel Roelen, MD
- Email: m.roelen@erasmusmc.nl
- Phone: +31639173455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Hip Dislocation