GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
GUIDANCE
1 other identifier
interventional
84
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
March 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
October 8, 2024
October 1, 2024
5.1 years
October 25, 2023
October 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment failure
The Primary study outcome is treatment failure, defined as: * Need for secondary bony hip surgery to the affected hip or progression to hip migration \> 50% at 5-year follow-up . An indication for secondary bony surgery will be defined as; * Migration percentage \> 50% at a minimum of 1 year after surgery, OR * An increased migration \> 10% in 1 year during follow-up * Increase in Acetabular index to \> 30 degrees or an increase of more than 5 degrees during follow-up
from enrollment to the end of study (8 years)
Secondary Outcomes (5)
Radiographic parameters
from enrollment to the end of study (8 years)
3-dimensional shape analysis of proximal femur
directly postoperative, at 2-year follow-up and at 5-year follow-up
CPChild questionnaire
from enrollment to the end of study (8 years)
CPG questionnaire
from enrollment to the end of study (8 years)
Secondary surgical interventions other than bony procedure
from enrollment to the end of study (8 years)
Other Outcomes (1)
Baseline measurements
At the time of enrollment
Study Arms (2)
Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur
EXPERIMENTALStandard care + intervention
Adductor tenotomy
NO INTERVENTIONStandard care
Interventions
Temporary Medial Hemi-epiphysiodesis of the proximal femur
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Amsterdam UMC
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
Maastricht UMC
Maastricht, Netherlands
Sint Maartenskliniek
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Related Publications (1)
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: 39663160DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaap Tolk, MD, PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD candidate
Study Record Dates
First Submitted
October 25, 2023
First Posted
November 7, 2023
Study Start
March 6, 2024
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
December 1, 2030
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning 12 months and ending 5 years following publication of this paper
- Access Criteria
- Data will be available for researchers who provide a methodologically sound scientific proposal, which has been approved by an ethical committee. Proof of the latter should be provided. Analyses should achieve the aims as reported in the approved proposal.
Individual de-identified participant data that underlie the results from the GUIDANCE study and the study protocol will be shared if requested. Data will be available beginning 12 months and ending 5 years following publication of this paper. Data will be available for researchers who provide a methodologically sound scientific proposal, which has been approved by an ethical committee. Proof of the latter should be provided. Analyses should achieve the aims as reported in the approved proposal. Proposals for data should be directed to the corresponding author.