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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur | Experimental | Standard care + intervention |
|
| Adductor tenotomy | No Intervention | Standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary Medial Hemi-epiphysiodesis of the proximal femur | Procedure | Temporary Medial Hemi-epiphysiodesis of the proximal femur |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | The Primary study outcome is treatment failure, defined as:
| from enrollment to the end of study (8 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline measurements | Other patient related measurements that will be obtained at baseline include
| At the time of enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merel Roelen, MD | Contact | +31639173455 | m.roelen@erasmusmc.nl | |
| Jaap Tolk, MD PhD | Contact | j.tolk@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jaap Tolk, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Not yet recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39663160 | Derived | 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. |
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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.
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.
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| 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:
| 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. | 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. | 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:
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:
| from enrollment to the end of study (8 years) |
| UMC Groningen | Recruiting | Groningen | Netherlands |
|
| Maastricht UMC | Recruiting | Maastricht | Netherlands |
|
| Sint Maartenskliniek | Not yet recruiting | Nijmegen | Netherlands |
|
| Erasmus MC | Recruiting | Rotterdam | Netherlands |
|
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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