Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)

NCT06956729 | Recruiting

• 2 other identifiers: P.I.R-0041-24PR-PI24-00016
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 16

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.

Conditions

Cerebral Palsy

Keywords

Proximal Femoral Guided Growth; Randomized Controlled Trial; Spastic Hip; Hip Dislocation

Outcome Measures

Primary Outcomes (6)

• Migration percentage (MP). Radiological

  Percentage of the femoral head lateral to Perkins line on standardized AP pelvic radiograph. Unit of Measure: Percentage (%)

  Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery

• Pelvic Obliquity (PO). Radiological

  Angle between the horizontal line and the line joining both iliac crests on AP pelvic radiograph. Unit of Measure: Degrees (°)

  Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.

• Migration Percentage Adjusted for Pelvic Obliquity (PAMP). Radiological

  Modified MP accounting for pelvic tilt, measured on AP pelvic radiograph. Unit of Measure: Percentage (%)

  Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.

• Acetabular Index (AI). Radiological

  Angle formed between Hilgenreiner's line and a line along the acetabular roof. Unit of Measure: Degrees (°)

  Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.

• Center-Edge Angle (CEA). Radiological

  Angle between vertical line through femoral head center and a line to lateral acetabular edge. Unit of Measure: Degrees (°)

  Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.

• Hilgenreiner Epiphyseal Angle (HEA). Radiological

  Angle between Hilgenreiner's line and a line along the proximal femoral physis. Unit of Measure: Degrees (°)

  Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.

Secondary Outcomes (28)

• Patient characteristics. Age

  At time of surgery

• Patient characteristics. Sex

  Pre-surgery

• Patient characteristics. Gross Motor Function Classification System level (GMFCS)

  Pre-surgery

• Patient characteristics. Weight

  Pre-surgery

• Patient characteristics. Orthopedic comorbidities

  Pre-surgery

Study Arms (2)

PFGG + Standard Treatment (Experimental Group A)

EXPERIMENTAL

Participants in this arm will receive Proximal Femoral Guided Growth (PFGG) in addition to standard prophylactic treatment for hips at risk of dislocation (HRD). The standard treatment may include adductor tenotomy (percutaneous or open) and psoas tenotomy (intrapelvic or at the lesser trochanter) as indicated. Surgery will be performed under general anesthesia, and postoperative immobilization will follow institutional protocols, including the use of a hip abduction wedge, knee immobilizers, and ankle-foot orthoses (AFO) as required. Follow-up will include standardized clinical, functional, and radiographic assessments at 3 weeks, 6 weeks, 6 months, 12 months, 18 months, and 24 months postoperatively.

Procedure: Proximal Femoral Guided Growth.; Procedure: Standard prophylactic treatment for Hips at Risk of Dislocation.

Standard Treatment Only (Control Group B)

ACTIVE COMPARATOR

Participants in this arm will receive standard prophylactic treatment for HRD without PFGG. This may include adductor and/or psoas tenotomies based on clinical indication, performed under general anesthesia. Postoperative care will be identical to the experimental group, with standard immobilization using a hip abduction wedge, knee immobilizers, and AFOs as needed. The follow-up schedule and outcome assessments will be identical to the experimental group, ensuring consistency in data collection.

Procedure: Standard prophylactic treatment for Hips at Risk of Dislocation.

Interventions

Proximal Femoral Guided Growth. PROCEDURE

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

Also known as: Guided Growth Surgery, Proximal Femoral Epiphysiodesis, Proximal Femoral Hemiepiphysiodesis

PFGG + Standard Treatment (Experimental Group A)

Standard prophylactic treatment for Hips at Risk of Dislocation. PROCEDURE

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.

PFGG + Standard Treatment (Experimental Group A); Standard Treatment Only (Control Group B)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús: lead
• Hospital Sant Joan de Deu: collaborator
• Salamanca University Hospital: collaborator
• Complexo Hospitalario Universitario de A Coruña: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario de Canarias: collaborator
• Hospital Universitario Central de Asturias: collaborator
• Hospital Son Espases: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital Vall d'Hebron: collaborator
• Hospital Universitario Virgen Macarena: collaborator
• Hospital Miguel Servet: collaborator
• Hospital Donostia: collaborator
• Hospitales Universitarios Virgen del Rocío: collaborator
• Complejo Hospitalario de Navarra: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitario Torrecárdenas: collaborator

Study Sites (16)

H. Materno Inf. Teresa Herrera

A Coruña, A Coruña, 15009, Spain

RECRUITING

Hospital Universitario Torrecárdenas Almeria

Almería, Andalusia, 04009, Spain

RECRUITING

H.U. Virgen Macarena Sevilla

Seville, Andalusia, 41009, Spain

RECRUITING

H.U. Virgen Del Rocio

Seville, Andalusia, 41013, Spain

RECRUITING

Ihp-Orthopediatica Sevilla

Seville, Andalusia, 41014, Spain

RECRUITING

H. Universitari Son Espases

Palma, Balearic Islands, 07120, Spain

RECRUITING

H. Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

RECRUITING

H. Sant Joan de Deu

Barcelona, Catalonia, 08950, Spain

RECRUITING

Donostia University Hospital

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

RECRUITING

H. U. Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, 28009, Spain

RECRUITING

Hospital Universitario Ramón Y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Hospital Universitario Doce de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

H.U. Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

H. Univ. de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain

RECRUITING

Related Publications (27)

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• Reimers J. The stability of the hip in children. A radiological study of the results of muscle surgery in cerebral palsy. Acta Orthop Scand Suppl. 1980;184:1-100. doi: 10.3109/ort.1980.51.suppl-184.01. No abstract available.

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• Onimus M, Allamel G, Manzone P, Laurain JM. Prevention of hip dislocation in cerebral palsy by early psoas and adductors tenotomies. J Pediatr Orthop. 1991 Jul-Aug;11(4):432-5. doi: 10.1097/01241398-199107000-00002.

  PMID: 1860938 BACKGROUND

• Lebe M, van Stralen RA, Buddhdev P. Guided Growth of the Proximal Femur for the Management of the 'Hip at Risk' in Children with Cerebral Palsy-A Systematic Review. Children (Basel). 2022 Apr 25;9(5):609. doi: 10.3390/children9050609.

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• Hsu PJ, Wu KW, Lee CC, Lin SC, Kuo KN, Wang TM. Does screw position matter for guided growth in cerebral palsy hips? Bone Joint J. 2020 Sep;102-B(9):1242-1247. doi: 10.1302/0301-620X.102B9.BJJ-2020-0340.R1.

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• Portinaro N, Turati M, Cometto M, Bigoni M, Davids JR, Panou A. Guided Growth of the Proximal Femur for the Management of Hip Dysplasia in Children With Cerebral Palsy. J Pediatr Orthop. 2019 Sep;39(8):e622-e628. doi: 10.1097/BPO.0000000000001069.

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MeSH Terms

Conditions

Cerebral Palsy; Hip Dislocation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• María Galán Olleros, MD

  Hospital Infantil Universitario Niño Jesús, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Galán Olleros, M.D

CONTACT

0034660492192; mgalanolleros@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Orthopedic Surgery and Traumatology.

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: May 4, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data and supporting documentation (Study Protocol and Statistical Analysis Plan) will be available beginning 6 months after the publication of the primary results and will remain accessible for 5 years. Data access will be limited to approved researchers under controlled conditions for statistical purposes only.
• Access Criteria: * The data controller is the Sponsor: SEOP Group (Sociedad Española de Ortopedia Pediátrica). Data will be shared among study centers for statistical purposes only. * Each participant: personal information will be stored in their medical record. Only the principal investigator and collaborators will be able to identify participants, as they will manage the database linking the assigned codes to each individual. Only health authorities or the Ethics Committee will have access to this information, ensuring confidentiality.

Locations

ES (16)