GUIDANCE: GUIDed Growth of the Proximal Femur to Prevent Further Hip migrAtion iN CErebral Palsy Patients

• Sponsor: Erasmus Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06118736
• Collaborator: (none)
• Enrollment: 84
• Arms: 2
• Anticipated Duration (Months): 83

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Hip Dislocation	Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: GUIDed Growth of the Proximal Femur to Prevent Further Hip migrAtion iN CErebral Palsy Patients
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur Standard care + intervention	Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur; Temporary Medial Hemi-epiphysiodesis of the proximal femur
No Intervention: Adductor tenotomy Standard care

Outcome Measures

Primary Outcome Measures

1. Treatment failure [5 years follow up]

   Need for secondary bony hip surgery or progression of hip migration >50%

Secondary Outcome Measures

1. 3-dimensional proximal femoral shape analysis [at 2-year follow-up and at 5-year follow-up]

   varus/valgus and anteversion/retroversion

2. CPChild questionnaire [5 year follow up]

   minimum value 0, maximum value 100, higher score means better outcome, " Caregivers Priorities and Child Health Index of Life with Disabilities"

3. CPG questionnaire [5 year follow up]

   minimum value 0, maximum value 10, higher scores mean more pain, ' checklist pijngedrag'

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Erasmus Medical Center

Investigators

• Principal Investigator: Jaap Tolk, MD, PhD, Erasmus Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merel Roelen, MD, PhD candidate, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT06118736
• Other Study ID Numbers: PanamaID 10082
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hip Dislocation; Cerebral Palsy

Study Results

No Results Posted as of Nov 7, 2023