Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)
NCT ID: NCT06956729
Last Updated: 2025-05-04
Study Results
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Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2024-10-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PFGG + Standard Treatment (Experimental Group A)
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.
Proximal 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
Standard 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.
Standard Treatment Only (Control Group B)
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.
Standard 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.
Interventions
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Proximal 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
Standard 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 neuromuscular conditions other than CP.
* Children with high surgical/anesthetic risk.
* Documented history of reconstructive or palliative hip surgery.
3 Years
8 Years
ALL
No
Sponsors
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Hospital Sant Joan de Deu
OTHER
Salamanca University Hospital
OTHER
Complexo Hospitalario Universitario de A Coruña
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario de Canarias
OTHER
Hospital Universitario Central de Asturias
OTHER
Hospital Son Espases
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital Vall d'Hebron
OTHER
Hospital Universitario Virgen Macarena
OTHER
Hospital Miguel Servet
OTHER
Hospital Donostia
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
Complejo Hospitalario de Navarra
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario Torrecárdenas
OTHER
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
OTHER
Responsible Party
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María Galán Olleros
Specialist in Orthopedic Surgery and Traumatology.
Principal Investigators
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María Galán Olleros, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Infantil Universitario Niño Jesús, Madrid
Locations
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H. Materno Inf. Teresa Herrera
A Coruña, A Coruña, Spain
Hospital Universitario Torrecárdenas Almeria
Almería, Andalusia, Spain
H.U. Virgen Macarena Sevilla
Seville, Andalusia, Spain
H.U. Virgen Del Rocio
Seville, Andalusia, Spain
Ihp-Orthopediatica Sevilla
Seville, Andalusia, Spain
H. Universitari Son Espases
Palma, Balearic Islands, Spain
H. Universitario de Salamanca
Salamanca, Castille and León, Spain
H. Sant Joan de Deu
Barcelona, Catalonia, Spain
Donostia University Hospital
Donostia / San Sebastian, Gipuzkoa, Spain
H. U. Gregorio Marañón
Madrid, Madrid, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Spain
Hospital Universitario Ramón Y Cajal
Madrid, Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
H.U. Central de Asturias
Oviedo, Principality of Asturias, Spain
H. Univ. de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PR-PI24-00016
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
P.I.R-0041-24
Identifier Type: -
Identifier Source: org_study_id
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