GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
NCT ID: NCT06118736
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2024-03-06
2030-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur
Standard care + intervention
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Adductor tenotomy
Standard care
No interventions assigned to this group
Interventions
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Temporary Medial Hemi-epiphysiodesis of the proximal femur
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
8 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Merel Roelen
MD, PhD candidate
Principal Investigators
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Jaap Tolk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Amsterdam UMC
Amsterdam, , Netherlands
UMC Groningen
Groningen, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Sint Maartenskliniek
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Melinda Witbreuk, MD PhD
Role: primary
Sophie Moerman, MD PhD
Role: primary
Adhiambo Witlox, MD PhD
Role: primary
Arno ten Ham, MD
Role: primary
Merel Roelen, MD
Role: primary
Jaap Tolk, MD PhD
Role: backup
Renee van Stralen, MD
Role: backup
References
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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.
Other Identifiers
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PanamaID 10082
Identifier Type: -
Identifier Source: org_study_id
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