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NCT Number: NCT06118736

GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients

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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Key information

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary Medial Hemi-epiphysiodesis of the proximal femur

Procedure

Temporary Medial Hemi-epiphysiodesis of the proximal femur

Primary outcomes

  1. 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 > 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

Secondary outcomes

  1. Radiographic parameters

    Time frame: from enrollment to the end of study (8 years)

    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
  2. 3-dimensional shape analysis of proximal femur

    Time frame: directly postoperative, at 2-year follow-up and at 5-year follow-up

    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.
  3. CPChild questionnaire

    Time frame: from enrollment to the end of study (8 years)

    "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.

  4. CPG questionnaire

    Time frame: from enrollment to the end of study (8 years)

    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.

  5. Secondary surgical interventions other than bony procedure

    Time frame: from enrollment to the end of study (8 years)

    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

Other outcomes

  1. Baseline measurements

    Time frame: At the time of enrollment

    Other patient related measurements that will be obtained at baseline include

    • Age
    • Weight
    • Height
    • GMFCS classification
    • Change in Migration Percentage in the year prior to the adductor tenotomy
    • Use of tone regulation; Baclofen, Artane, Baclofen pump, Selective Dorsal Rhizotomy (SDR

Study contacts

Contact information is provided by the study sponsor or research team.

Jaap Tolk, MD PhD

CONTACT

[email protected]

Merel Roelen, MD

CONTACT

[email protected]

+31639173455

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: GUIDANCE

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 7, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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