Cerebral Palsy
Conditions
Keywords
Proximal Femoral Guided Growth, Randomized Controlled Trial, Spastic Hip, Hip Dislocation
Brief summary
The Guided Growth in Spastic Hip Multicenter Study (GGSH-MC) is a prospective, multicenter, randomized controlled trial that aims to evaluate the mid-term outcomes of Proximal Femoral Guided Growth (PFGG) in children with spastic cerebral palsy (CP) and hips at risk of dislocation (HRD). Hip dislocation is a common and severe complication in children with CP, especially those who are non-ambulatory, with a reported risk of 70-90%. The trial includes children aged 3 to 8 years with spastic CP and HRD, defined by a migration percentage (MP) between 30% and 60%. Participants will be cluster-randomized by center into two parallel groups: * Experimental Group: Standard prophylactic treatment for HRD + PFGG * Control Group: Standard prophylactic treatment for HRD only PFGG involves insertion of a fully threaded cannulated screw across the lateral cortex and proximal femoral epiphysis under fluoroscopic guidance, with the aim of modulating growth to improve hip containment. All patients will also receive standard soft tissue surgery (adductor and/or psoas tenotomies), as clinically indicated. Follow-up will include clinical, radiographic, and functional assessments at 3 and 6 weeks, and at 6, 12, 18, and 24 months post-intervention. The study will include a 1-year inclusion period and a 2-year follow-up, concluding in October 2027. Primary outcome measures include radiographic indicators of hip displacement. Secondary outcomes include functional scores, complication rates, and need for further surgery. A total of 42 participants (21 per group) will provide 80% power to detect significant differences at a 0.05 significance level. Analyses will be performed using intention-to-treat principles, with subgroup and multivariate analyses to explore modifying factors.
Detailed description
Cerebral palsy (CP) is the leading cause of severe physical disability in childhood, with a prevalence of 1.6 per 1,000 live births in developed countries. Spastic CP, affecting 75% of patients, often leads to progressive musculoskeletal deformities due to muscle imbalance, particularly around the hip joint. Hip dysplasia is the second most common deformity, and if untreated, can progress to dislocation, especially in non-ambulatory children (GMFCS IV-V), where risk exceeds 70%. Hip displacement in CP is attributed to spasticity of the adductors and flexors, growth-related deformities such as coxa valga and acetabular dysplasia, and limited weight-bearing. These changes can impair function, sitting tolerance, hygiene, and quality of life. Current strategies emphasize surveillance and early intervention for hips at risk of dislocation (HRD), including soft tissue surgery. However, recurrence remains high, and reconstructive surgery, while effective, is invasive and associated with significant morbidity. Proximal Femoral Guided Growth (PFGG) is a minimally invasive technique involving medial hemiepiphysiodesis with a cannulated screw to modulate proximal femoral growth and improve containment. Though early outcomes are promising, prospective multicenter evidence is limited. This study is a prospective, multicenter, randomized controlled trial using cluster randomization by center to compare PFGG + standard treatment versus standard treatment alone. Children aged 3-8 years with spastic CP and HRD (MP 30-60%) will be included. The primary outcome is radiographic containment. Secondary outcomes include functional scores, pain, complications, and reintervention rates. Follow-up spans 24 months. All surgeries follow a standardized protocol. Postoperative care includes early mobilization, use of hip abduction wedge, and physical therapy. Sample size is calculated for 80% power to detect a difference in dislocation rates, requiring 42 subjects. Data will be collected using standardized CRFs and managed centrally under SEOP oversight. Adverse events will be systematically recorded. The study has IRB approval and complies with ISO 14155, GDPR, and the Helsinki Declaration. Funding is provided by the 2023 EPOS Research Grant (€10,000). Results will be published regardless of outcome.
Interventions
PROCEDUREProximal Femoral Guided Growth.
Proximal Femoral Guided Growth (PFGG) is performed under general anesthesia with the patient in a supine position on a radiolucent table. The surgical field is prepared from the abdomen to the feet. Anatomical landmarks on the femur and femoral neck are marked to guide the procedure. A smooth guidewire (4.0-7.0 mm) is introduced parallel to the table and advanced to the lateral quarter of the femoral neck. A 1-2 cm incision is made along the lateral femur, allowing access to the vastus lateralis muscle. Fluoroscopic control is used to ensure precise guidewire placement in the proximal femoral epiphysis in both anteroposterior (AP) and lateral views. The lateral cortex is drilled, and a fully threaded cannulated screw is inserted, ensuring at least three threads reach the epiphysis for effective growth modulation. Final fluoroscopic verification is performed to confirm proper screw placement and rule out joint penetration. Continuous fluoroscopy is used if necessary. The guidewire is r
PROCEDUREStandard prophylactic treatment for Hips at Risk of Dislocation.
Both groups will receive standard prophylactic treatment for HRD, which consists of soft tissue release procedures based on clinical indication and functional level (GMFCS classification): Adductor Tenotomy - Percutaneous or open technique, depending on contracture severity. Psoas Tenotomy - Intrapelvic approach for GMFCS levels I-III and IV (ambulatory). Lesser trochanter approach for GMFCS levels IV-V (non-ambulatory). Additional tenotomies may be performed as needed, targeting muscles contributing to hip displacement and contractures. Botulinum toxin type A may be administered to specific muscle groups if clinically indicated. Postoperative immobilization includes: Hip abduction wedge Knee immobilizers in extension Ankle-foot orthoses (AFOs), based on individual patient needs The goal of this intervention is to reduce spastic muscle imbalance, improve hip stability, and delay or prevent hip dislocation in children with spastic CP and HRD.
Sponsors
Hospital Sant Joan de Deu
Salamanca University Hospital
Complexo Hospitalario Universitario de A Coruña
Hospital General Universitario Gregorio Marañon
Hospital Universitario de Canarias
Hospital Universitario Central de Asturias
Hospital Son Espases
Hospital Universitario 12 de Octubre
Hospital Vall d'Hebron
Hospital Universitario Virgen Macarena
Hospital Miguel Servet
Hospital Donostia
Hospitales Universitarios Virgen del Rocío
Complejo Hospitalario de Navarra
Hospital Universitario Ramon y Cajal
Hospital Universitario Torrecárdenas
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Functional outcome evaluators and data analysts will be blinded to group allocation. Although radiographic assessors cannot be fully blinded due to visible hardware, they will be independent and follow standardized protocols to ensure objectivity. Treating surgeons and caregivers will not be blinded due to the nature of the intervention.
Intervention model description
This study is a prospective, multicenter, randomized controlled trial (RCT) with two parallel groups, using cluster randomization to minimize inter-center variability in surgical techniques and postoperative care. Centers are assigned to either the experimental group (PFGG + standard prophylactic treatment) or the control group (standard prophylactic treatment alone). Conducted across specialized pediatric orthopedic centers, the study includes a one-year enrollment period, followed by a 24-month structured follow-up with standardized clinical and radiographic assessments at 3 weeks, 6 weeks, 6, 12, 18, and 24 months. The intervention is single-blinded, ensuring radiographic assessors and outcome evaluators remain unaware of group allocation to reduce bias. Data will be analyzed using intention-to-treat principles to account for any deviations from the assigned interventions.
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 3 to 8 years. * Diagnosis of predominantly spastic cerebral palsy (CP). * Any functional level according to the GMFCS. * Hips at risk of dislocation (HRD), unilateral or bilateral, defined by a migration percentage (MP) between 30% and 60%.
Exclusion criteria
* Children with predominantly hypotonic or dystonic types of CP. * Children with neuromuscular conditions other than CP. * Children with high surgical/anesthetic risk. * Documented history of reconstructive or palliative hip surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migration percentage (MP). Radiological | Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery | Percentage of the femoral head lateral to Perkins line on standardized AP pelvic radiograph. Unit of Measure: Percentage (%) |
| Pelvic Obliquity (PO). Radiological | Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery. | Angle between the horizontal line and the line joining both iliac crests on AP pelvic radiograph. Unit of Measure: Degrees (°) |
| Migration Percentage Adjusted for Pelvic Obliquity (PAMP). Radiological | Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery. | Modified MP accounting for pelvic tilt, measured on AP pelvic radiograph. Unit of Measure: Percentage (%) |
| Acetabular Index (AI). Radiological | Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery. | Angle formed between Hilgenreiner's line and a line along the acetabular roof. Unit of Measure: Degrees (°) |
| Center-Edge Angle (CEA). Radiological | Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery. | Angle between vertical line through femoral head center and a line to lateral acetabular edge. Unit of Measure: Degrees (°) |
| Hilgenreiner Epiphyseal Angle (HEA). Radiological | Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery. | Angle between Hilgenreiner's line and a line along the proximal femoral physis. Unit of Measure: Degrees (°) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient characteristics. Gross Motor Function Classification System level (GMFCS) | Pre-surgery | GMFCS level will be recorded to classify gross motor function. The GMFCS has five levels (I to V), with higher levels indicating more severe motor impairment. Unit of measure: scale (I to V) |
| Patient characteristics. Weight | Pre-surgery | Weight of the patient measured using a calibrated scale during the pre-surgical evaluation. Unit of measure: kilograms (kg) |
| Patient characteristics. Orthopedic comorbidities | Pre-surgery | Presence or absence of orthopedic comorbidities such as scoliosis and knee flexion contractures will be assessed. |
| Patient characteristics. Respiratory disorders or gastrointestinal issues | Pre-surgery | Presence or absence of relevant medical comorbidities, including epilepsy, respiratory disorders (e.g., obstructive sleep apnea, tracheostomy), and gastrointestinal disorders (e.g., gastrostomy), will be recorded. |
| Patient characteristics. Medication use | Pre-surgery | Current use of any medication will be recorded as a categorical variable (yes/no), along with medication type if applicable. |
| Clinical variables. Pain | Immediately after surgery; 3 and 6 weeks; 6, 12, 18, and 24 months post-surgery | Pain will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from no pain to worst imaginable pain. Higher scores indicate greater pain intensity. Unit of measure: scale (0-10) |
| Clinical variables. Analgesic needs | Immediately after surgery; 3 and 6 weeks; 6, 12, 18, and 24 months post-surgery | Analgesic requirements will be recorded based on caregiver reports. Categorical: first-line analgesics (e.g., Ibuprofen, Paracetamol \[Acetaminophen\], Metamizole), second-line analgesics (e.g., mild opioids like Tramadol), or third-line analgesics (e.g., strong opioids such as morphine and fentanyl). |
| Clinical variables. Pelvic obliquity | Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months | Pelvic obliquity will be assessed clinically during physical examination and recorded as present or absent. |
| Functional variables | Pre-surgery; 12 and 24 months | The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire will be completed. It is a validated measure of health-related quality of life for children with severe disabilities. Units on a scale (0-100; higher = better) |
| Concomitant treatment. Physiotherapy Frequency Per Week | At 6 weeks; 6, 12, 18, and 24 months | Frequency of physiotherapy: Number of Physiotherapy Sessions per Week. Sessions per week. |
| Concomitant treatment. Orthoses Use | At 6 weeks; 6, 12, 18, and 24 months | Use of orthoses: Number of hours per day the participant uses orthotic devices (e.g., hip abduction orthoses, scoliosis braces. Unit of Measure: Hours per day. |
| Clinical variables. Galeazzi sign | Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months | The Galeazzi sign will be assessed to detect femoral shortening as a clinical indicator of limb length discrepancy. Presence or absence will be recorded. |
| Concomitant treatment. Participation in Complementary Therapies | At 6 weeks; 6, 12, 18, and 24 months | Participation in Complementary Therapies such as Hydrotherapy, hippotherapy, or other specified therapies. Unit of Measure: Yes/No. |
| Safety variables and parameters. Clinical complications | Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery | Wound dehiscence, hematoma, superficial or deep infection. New symptoms not present before surgery will also be evaluated, such as pain, hip mobility limitations or stiffness, insomnia, constipation, irritability, etc. Unit of Measure of all the above: Participants |
| Safety variables and parameters. Radiological complications | Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery | Loosening of epiphyseal screws, peri-implant fracture, implant breakage, progression of hip displacement, avascular necrosis of the femoral head, chondrolysis, etc. Unit of Measure: Number of participants |
| Safety variables and parameters. Functional complications | Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery | Intolerance to sitting, supine or lateral positioning, difficulty in perineal care, hygiene, or dressing. Unit of Measure of all the above: Participants |
| Safety variables and parameters. Clavien-Dindo-Sink surgical complications classification | Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery | Complications will be classified according to the modified Clavien-Dindo-Sink surgical complications classification. Unit of Measure: Grade (Ordinal) |
| Other variables. Surgical time | Perioperative (intraoperative) | Measured from skin incision to closure, quantified in minutes |
| Other variables. Postoperative hospital stay | From surgery to discharge | Measured in days, with the day of surgery as day 0. |
| Other variables. Time to comfortable wheelchair sitting | At 3 weeks post-surgery | Number of days until the patient can sit comfortably in a wheelchair after surgery (day 0), as reported by primary caregivers. |
| Other variables. Time until pain-free perineal care and hygiene | Assessed at 3 weeks post-surgery | Number of days until the patient can perform perineal care and hygiene without pain post-surgery (day 0), reported by primary caregivers during follow-up. |
| Other variables. Time to initiation of pain-free physiotherapy | Assessed at 3 weeks post-surgery | Number of days from the surgical intervention (day 0) until the patient can begin physiotherapy without pain, as reported by primary caregivers during follow-up visits. |
| Concomitant treatment. Weight-Bearing Activity Time | At 6 weeks; 6, 12, 18, and 24 months | Time Spent in Weight-Bearing Activities per Day. Unit of Measure: Minutes per day. |
| Clinical variables. Hip abduction in flexion | Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months | Hip abduction in flexion will be measured in degrees during standardized physical examination. Unit of Measure: Degrees (º) |
| Clinical variables. Hip abduction in extension | Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months | Hip abduction in extension will be measured in degrees during standardized physical examination. Unit of Measure: Degrees (º) |
| Clinical variables. Hip flexion contracture >20° | Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months | Presence or absence of hip flexion contracture greater than 20 degrees will be recorded during physical examination. Yes/no |
| Patient characteristics. Age | At time of surgery | Chronological age of the patient at the time of surgery. Unit of measure: years |
| Patient characteristics. Sex | Pre-surgery | Biological sex of participant. Unit of Measure: Male/Female |
Countries
Spain
Contacts
Primary ContactMaría Galán Olleros, M.D
Outcome results
None listed