GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Temporary Medial Hemi-epiphysiodesis of the proximal femur.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Hip Dislocation. Basic parameters: 2 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Temporary Medial Hemi-epiphysiodesis of the proximal femur
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Primary outcome measures
- Treatment failure [Time frame: from enrollment to the end of study (8 years)]
Secondary outcome measures (5)
- Radiographic parameters [Time frame: from enrollment to the end of study (8 years)]
- 3-dimensional shape analysis of proximal femur [Time frame: directly postoperative, at 2-year follow-up and at 5-year follow-up]
- CPChild questionnaire [Time frame: from enrollment to the end of study (8 years)]
- CPG questionnaire [Time frame: from enrollment to the end of study (8 years)]
- Secondary surgical interventions other than bony procedure [Time frame: from enrollment to the end of study (8 years)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 5 centers
- Amsterdam UMC — Amsterdam
- UMC Groningen — Groningen
- Maastricht UMC — Maastricht
- Sint Maartenskliniek — Nijmegen
- Erasmus MC — Rotterdam
Publications
- van Stralen RA, Roelen MCR, Moerman S, Witbreuk MMEH, Witlox MA, Ten Ham A, Eygendaal D, Reijman M, Tolk JJ. GUIDANCE study: guided growth of the proximal femur to prevent further hip migration in patients with cerebral palsy-study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Dec 11;14(12):e091073. doi: 10.1136/bmjopen-2024-091073. PMID 39663160
Identifiers
NCT: NCT06118736 · PanamaID 10082