Cerebral PalsyGUIDANCENCT06118736
GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
A study testing Temporary Medial Hemi-epiphysiodesis of the proximal femur in people with Cerebral Palsy and Hip Dislocation, run by Erasmus Medical Center at 5 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Cerebral Palsy, Hip Dislocation
- What is being tested?
- Temporary Medial Hemi-epiphysiodesis of the proximal femur
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesNetherlands
- Study dates
- 6 Mar 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jaap Tolk, MD PhD contact
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Not yet recruiting
Amsterdam UMC
Amsterdam
Melinda Witbreuk, MD PhD
- Recruiting
UMC Groningen
Groningen
Sophie Moerman, MD PhD
- Recruiting
Maastricht UMC
Maastricht
Adhiambo Witlox, MD PhD
- Not yet recruiting
Sint Maartenskliniek
Nijmegen
Arno ten Ham, MD
- Recruiting
Erasmus MC
Rotterdam
Merel Roelen, MD
Jaap Tolk, MD PhD
About this study
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.
- Conditions
- Cerebral Palsy, Hip Dislocation
- Being tested
- Temporary Medial Hemi-epiphysiodesis of the proximal femur
- Medical subject headings
- Cerebral Palsy, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Medial Hemi-epiphysiodesis of the proximal femurProcedure or surgery
Temporary Medial Hemi-epiphysiodesis of the proximal femur
| Study group | Role | What they receive |
|---|---|---|
| Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur | Experimental | Standard care + intervention Receives: Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur |
| Adductor tenotomy | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment to the end of study (8 years)
Secondary outcomes (5)
Radiographic parameters
Standardized conventional radiographs, AP and Lauenstein view (frog leg lateral) Pelvic radiographs will be performed according to the standardized protocol as defined by AACPDM
- Migration percentage (%), change in migration percentage per treatment arm (on baseline and follow-up)
- Head Shaft angle (HSA) in degrees
- Acetabular index
- Melbourne hip classification
- Pelvic obliquity
- Positioning of the hemi epiphysiodesis screw in the intervention group
Measured: from enrollment to the end of study (8 years)
3-dimensional shape analysis of proximal femur
CT-scans of the hip will be performed in the intervention group directly postoperative, at 2-year follow-up and 5-year follow-up. On these scans the following measurements will be performed:
- Positioning of the hemi epiphysiodesis screw
- 3-dimensional proximal femoral shape analysis regarding (change in) sphericity, congruency and head-neck orientation will be performed in patients at 2-year follow-up and at 5-year follow-up.
- The direction of migration of the hip and acetabular morphology will be determined according to the method described by Brunner et al.
- Sphericity of the femoral head will be determined by the Mose technique.
Measured: directly postoperative, at 2-year follow-up and at 5-year follow-up
CPChild questionnaire
\"Caregivers Priorities and Child Health Index of Life with Disabilities\"
The CPCHILD™ is a parent completed questionnaire and was developed to help clinicians to identify areas that are impairing a child's quality of life, determine what is most important to the child and caregiver, and monitor the child's progress in a way that is meaningful to the family.
Minimum value is 0 and maximum value is 100, the higher the score the better the outcome.
Measured: from enrollment to the end of study (8 years)
CPG questionnaire
CPG = \"Checklist Pijn Gedrag\" (Dutch for Checklist Pain behaviour) A mean pain score will be calculated.
A minimum value of 0 with a maximum value of 10. Higher scores mean more pain.
Measured: from enrollment to the end of study (8 years)
Secondary surgical interventions other than bony procedure
Screw revision ▪ The following will be used as indications for screw revision in the intervention group throughout the study period:
- \< 1 thread of the screw remaining in the epiphysis, and
- HSA \> 100 degrees
Repeated soft tissue release.
▪ The following will be used as indications for repeated soft tissue releases (adductor and/or psoas tenotomy) in both the intervention and control group throughout the study period:
- Abduction \< 30 degrees, and
- No indication for bony surgery
Measured: from enrollment to the end of study (8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start6 Mar 2024
- Primary completionApr 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merel Roelen, Erasmus Medical Center
- Investigators
- Jaap Tolk, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118736
- Sponsor's protocol ID
- PanamaID 10082
- Acronym
- GUIDANCE
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 39663160
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
- ClinicalTrials.gov ID
- NCT06118736
- Acronym / sponsor ID
- GUIDANCE / PanamaID 10082
- Conditions
- Cerebral Palsy, Hip Dislocation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur | Experimental | Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femurStandard care + intervention |
| Adductor tenotomy | No intervention | –Standard care |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary Medial Hemi-epiphysiodesis of the proximal femurTemporary Medial Hemi-epiphysiodesis of the proximal femur | Procedure or surgery | Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur |
Primary outcome
Treatment failure
Time frame: from enrollment to the end of study (8 years)
The Primary study outcome is treatment failure, defined as: * Need for secondary bony hip surgery to the affected hip or progression to hip migration \&gt; 50% at 5-year follow-up . An indication for secondary bony surgery will be defined as; * Migration percentage \&gt; 50% at a minimum of 1 year after surgery, OR * An increased migration \&gt; 10% in 1 year during follow-up * Increase in Acetabular index to \&gt; 30 degrees or an increase of more than 5 degrees during follow-up
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 39663160van 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaap Tolk, MD PhD contact
Jaap Tolk, MD, PhD principal investigator
Erasmus Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Medial Hemi-epiphysiodesis of the proximal femur in people with Cerebral Palsy and Hip Dislocation, run by Erasmus Medical Center at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merel Roelen, MD (+31639173455, m.roelen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: from enrollment to the end of study (8 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.