Clinical trial NCT06956729: Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)
Official title: Guided Growth in Spastic Hip - Multicenter Study (GGSH-MC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Proximal Femoral Guided Growth
Randomized Controlled Trial
Spastic Hip
Hip Dislocation
Lead sponsor: Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
name: Salamanca University Hospital
name: Complexo Hospitalario Universitario de A Coruña
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario de Canarias
name: Hospital Universitario Central de Asturias
name: Hospital Son Espases
name: Hospital Universitario 12 de Octubre
name: Hospital Vall d'Hebron
name: Hospital Universitario Virgen Macarena
name: Hospital Miguel Servet
name: Hospital Donostia
name: Hospitales Universitarios Virgen del Rocío
name: Complejo Hospitalario de Navarra
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario Torrecárdenas
First posted: 2025-05-04
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Migration percentage (MP). Radiological
timeFrame: Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery
measure: Pelvic Obliquity (PO). Radiological
timeFrame: Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.
measure: Migration Percentage Adjusted for Pelvic Obliquity (PAMP). Radiological
timeFrame: Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.
measure: Acetabular Index (AI). Radiological
timeFrame: Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.
measure: Center-Edge Angle (CEA). Radiological
timeFrame: Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.
measure: Hilgenreiner Epiphyseal Angle (HEA). Radiological
timeFrame: Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery.
Secondary outcomes:
measure: Patient characteristics. Age
timeFrame: At time of surgery
measure: Patient characteristics. Sex
timeFrame: Pre-surgery
measure: Patient characteristics. Gross Motor Function Classification System level (GMFCS)
timeFrame: Pre-surgery
measure: Patient characteristics. Weight
timeFrame: Pre-surgery
measure: Patient characteristics. Orthopedic comorbidities
timeFrame: Pre-surgery
measure: Patient characteristics. Respiratory disorders or gastrointestinal issues
timeFrame: Pre-surgery
measure: Patient characteristics. Medication use
timeFrame: Pre-surgery
measure: Clinical variables. Pain
timeFrame: Immediately after surgery; 3 and 6 weeks; 6, 12, 18, and 24 months post-surgery
measure: Clinical variables. Analgesic needs
timeFrame: Immediately after surgery; 3 and 6 weeks; 6, 12, 18, and 24 months post-surgery
measure: Clinical variables. Hip abduction in flexion
timeFrame: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months
measure: Clinical variables. Hip abduction in extension
timeFrame: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months
measure: Clinical variables. Hip flexion contracture >20°
timeFrame: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months
measure: Clinical variables. Galeazzi sign
timeFrame: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months
measure: Clinical variables. Pelvic obliquity
timeFrame: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months
measure: Functional variables
timeFrame: Pre-surgery; 12 and 24 months
measure: Concomitant treatment. Physiotherapy Frequency Per Week
timeFrame: At 6 weeks; 6, 12, 18, and 24 months
measure: Concomitant treatment. Orthoses Use
timeFrame: At 6 weeks; 6, 12, 18, and 24 months
measure: Concomitant treatment. Weight-Bearing Activity Time
timeFrame: At 6 weeks; 6, 12, 18, and 24 months
measure: Concomitant treatment. Participation in Complementary Therapies
timeFrame: At 6 weeks; 6, 12, 18, and 24 months
measure: Safety variables and parameters. Clinical complications
timeFrame: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery
measure: Safety variables and parameters. Radiological complications
timeFrame: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery
measure: Safety variables and parameters. Functional complications
timeFrame: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery
measure: Safety variables and parameters. Clavien-Dindo-Sink surgical complications classification
timeFrame: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery
measure: Other variables. Surgical time
timeFrame: Perioperative (intraoperative)
measure: Other variables. Postoperative hospital stay
timeFrame: From surgery to discharge
measure: Other variables. Time to comfortable wheelchair sitting
timeFrame: At 3 weeks post-surgery
measure: Other variables. Time until pain-free perineal care and hygiene
timeFrame: Assessed at 3 weeks post-surgery
measure: Other variables. Time to initiation of pain-free physiotherapy
timeFrame: Assessed at 3 weeks post-surgery
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas Almeria
state: Andalucía
city: Sevilla
country: Spain
facility: H.U. Virgen Macarena Sevilla
state: Andalucía
city: Sevilla
country: Spain
facility: H.U. Virgen Del Rocio
state: Andalucía
city: Sevilla
country: Spain
facility: Ihp-Orthopediatica Sevilla
state: Andalucía
city: Salamanca
country: Spain
facility: H. Universitario de Salamanca
state: Castilla y Leon
city: Barcelona
country: Spain
facility: H. Sant Joan de Deu
state: Cataluña
city: Donostia
country: Spain
facility: Donostia University Hospital
state: Gipuzkoa
city: Palma
country: Spain
facility: H. Universitari Son Espases
state: Illes Balears
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Oviedo
country: Spain
facility: H.U. Central de Asturias
state: Principado de Asturias
city: Santa Cruz de Tenerife,
country: Spain
facility: H. Univ. de Canarias
state: Santa Cruz de Tenerife
city: A Coruña
country: Spain
facility: H. Materno Inf. Teresa Herrera
city: Madrid
country: Spain
facility: H. U. Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Universitario Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
Study officials:
affiliation: Hospital Infantil Universitario Niño Jesús, Madrid
name: María Galán Olleros, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiapekos N, Brostrom E, Hagglund G, Astrand P. Primary surgery to prevent hip dislocation in children with cerebral palsy in Sweden: a minimum 5-year follow-up by the national surveillance program (CPUP). Acta Orthop. 2019 Oct;90(5):495-500. doi: 10.1080/17453674.2019.1627116. Epub 2019 Jun 18.
citation: Shore BJ, Yu X, Desai S, Selber P, Wolfe R, Graham HK. Adductor surgery to prevent hip displacement in children with cerebral palsy: the predictive role of the Gross Motor Function Classification System. J Bone Joint Surg Am. 2012 Feb 15;94(4):326-34. doi: 10.2106/JBJS.J.02003.
citation: Hwang M, Kuroda MM, Tann B, Gaebler-Spira DJ. Measuring care and comfort in children with cerebral palsy: the care and comfort caregiver questionnaire. PM R. 2011 Oct;3(10):912-9. doi: 10.1016/j.pmrj.2011.05.017.
citation: Hagglund G, Goldring M, Hermanson M, Rodby-Bousquet E. Pelvic obliquity and measurement of hip displacement in children with cerebral palsy. Acta Orthop. 2018 Dec;89(6):652-655. doi: 10.1080/17453674.2018.1519104. Epub 2018 Oct 17.
citation: Narayanan UG, Fehlings D, Weir S, Knights S, Kiran S, Campbell K. Initial development and validation of the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD). Dev Med Child Neurol. 2006 Oct;48(10):804-12. doi: 10.1017/S0012162206001745.
citation: Birkenmaier C, Jorysz G, Jansson V, Heimkes B. Normal development of the hip: a geometrical analysis based on planimetric radiography. J Pediatr Orthop B. 2010 Jan;19(1):1-8. doi: 10.1097/BPB.0b013e32832f5aeb.
citation: Foroohar A, McCarthy JJ, Yucha D, Clarke S, Brey J. Head-shaft angle measurement in children with cerebral palsy. J Pediatr Orthop. 2009 Apr-May;29(3):248-50. doi: 10.1097/BPO.0b013e31819bceee.
citation: Southwick WO. Osteotomy through the lesser trochanter for slipped capital femoral epiphysis. J Bone Joint Surg Am. 1967 Jul;49(5):807-35. No abstract available.
citation: Tonnis D. Normal values of the hip joint for the evaluation of X-rays in children and adults. Clin Orthop Relat Res. 1976 Sep;(119):39-47.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hsieh HC, Wang TM, Kuo KN, Huang SC, Wu KW. Guided Growth Improves Coxa Valga and Hip Subluxation in Children with Cerebral Palsy. Clin Orthop Relat Res. 2019 Nov;477(11):2568-2576. doi: 10.1097/CORR.0000000000000903.
citation: Lee WC, Kao HK, Yang WE, Ho PC, Chang CH. Guided Growth of the Proximal Femur for Hip Displacement in Children With Cerebral Palsy. J Pediatr Orthop. 2016 Jul-Aug;36(5):511-5. doi: 10.1097/BPO.0000000000000480.
citation: Chou PC, Huang YC, Hsueh CJ, Lin JG, Chu HY. Retrospective study using MRI to measure depths of acupuncture points in neck and shoulder region. BMJ Open. 2015 Jul 29;5(7):e007819. doi: 10.1136/bmjopen-2015-007819.
citation: Shaw KA, Hire JM, Cearley DM. Salvage Treatment Options for Painful Hip Dislocations in Nonambulatory Cerebral Palsy Patients. J Am Acad Orthop Surg. 2020 May 1;28(9):363-375. doi: 10.5435/JAAOS-D-19-00349.
citation: Shore BJ, Graham HK. Management of Moderate to Severe Hip Displacement in Nonambulatory Children with Cerebral Palsy. JBJS Rev. 2017 Dec;5(12):e4. doi: 10.2106/JBJS.RVW.17.00027. No abstract available.
citation: Shrader MW, Wimberly L, Thompson R. Hip Surveillance in Children With Cerebral Palsy. J Am Acad Orthop Surg. 2019 Oct 15;27(20):760-768. doi: 10.5435/JAAOS-D-18-00184.
citation: Hagglund G, Andersson S, Duppe H, Lauge-Pedersen H, Nordmark E, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy. The first ten years of a population-based prevention programme. J Bone Joint Surg Br. 2005 Jan;87(1):95-101.
citation: Ramstad K, Jahnsen RB, Terjesen T. Severe hip displacement reduces health-related quality of life in children with cerebral palsy. Acta Orthop. 2017 Apr;88(2):205-210. doi: 10.1080/17453674.2016.1262685. Epub 2016 Nov 28.
citation: Wawrzuta J, Willoughby KL, Molesworth C, Ang SG, Shore BJ, Thomason P, Graham HK. Hip health at skeletal maturity: a population-based study of young adults with cerebral palsy. Dev Med Child Neurol. 2016 Dec;58(12):1273-1280. doi: 10.1111/dmcn.13171. Epub 2016 Jun 17.
citation: Jung NH, Pereira B, Nehring I, Brix O, Bernius P, Schroeder SA, Kluger GJ, Koehler T, Beyerlein A, Weir S, von Kries R, Narayanan UG, Berweck S, Mall V. Does hip displacement influence health-related quality of life in children with cerebral palsy? Dev Neurorehabil. 2014 Dec;17(6):420-5. doi: 10.3109/17518423.2014.941116. Epub 2014 Jul 24.
citation: Cornell MS. The hip in cerebral palsy. Dev Med Child Neurol. 1995 Jan;37(1):3-18. doi: 10.1111/j.1469-8749.1995.tb11928.x. No abstract available.
citation: Bagg MR, Farber J, Miller F. Long-term follow-up of hip subluxation in cerebral palsy patients. J Pediatr Orthop. 1993 Jan-Feb;13(1):32-6. doi: 10.1097/01241398-199301000-00007.
citation: Kerr Graham H, Selber P. Musculoskeletal aspects of cerebral palsy. J Bone Joint Surg Br. 2003 Mar;85(2):157-66. doi: 10.1302/0301-620x.85b2.14066. No abstract available.