NCT06118736 GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
| NCT ID | NCT06118736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2024-03-06 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jaap Tolk, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06118736 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 8 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06118736 currently recruiting?
Yes, NCT06118736 is actively recruiting participants. Contact the research team at m.roelen@erasmusmc.nl for enrollment information.
Where is the NCT06118736 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Groningen, Netherlands, Maastricht, Netherlands, Nijmegen, Netherlands and 1 additional location.
Who is sponsoring the NCT06118736 clinical trial?
NCT06118736 is sponsored by Erasmus Medical Center. The principal investigator is Jaap Tolk, MD, PhD at Erasmus Medical Center. The trial plans to enroll 84 participants.
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