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Cerebral PalsyGGSH-MCNCT06956729

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

A study testing Proximal Femoral Guided Growth. and Standard prophylactic treatment for Hips at Risk of Dislocation. in people with Cerebral Palsy, run by Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús at 16 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 8 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Proximal Femoral Guided Growth. and Standard prophylactic treatment for Hips at Risk of Dislocation.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
16 sitesSpain
Study dates
1 Oct 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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%.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

María Galán Olleros, M.D contact

0034660492192

mgalanolleros@gmail.com

16 sites in 1 country

Spain16 sites, 16 recruiting

  • H. Materno Inf. Teresa Herrera

    A Coruña, A Coruña, 15009

    Mª LLANOS RODRÍGUEZ RODRÍGUEZ, M.D., 0034646699322, llanosrguez@yahoo.es

    Recruiting

  • Hospital Universitario Torrecárdenas Almeria

    Almería, Andalusia, 04009

    ANTONIO JIMENEZ CISNEROS, M.D., 0034618260603, antoniojdcgut@gmail.com

    Recruiting

  • H. Sant Joan de Deu

    Barcelona, Catalonia, 08950

    LYDIA DE SENA, M.D., 0034697380112, lydia.sena@sjd.es

    Recruiting

  • Donostia University Hospital

    Donostia / San Sebastian, Gipuzkoa, 20014

    LAURA MONTES MEDINA, M.D., 0034686222741, laura.montesmedina1@gmail.com

    Recruiting

  • H. U. Gregorio Marañón

    Madrid, Madrid, 28007

    ALBERTO ÁLVARO ALONSO, 0034652242247, albalvalo@gmail.com

    Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, 28009

    MARIA GALÁN OLLEROS, M.D., 0034660492192, mgalanolleros@gmail.com

    María Galán, Medicine

    Recruiting

  • Hospital Universitario Ramón Y Cajal

    Madrid, Madrid, 28034

    Mª SOLEDAD DEL CURA VARAS, M.D., 0034653360860, marisoltrauma@gmail.com

    Recruiting

  • Hospital Universitario Doce de Octubre

    Madrid, Madrid, 28041

    MYRIAM VIDART ANCHIA, M.D., 0034620939173, mvanchia@yahoo.es

    Recruiting

  • H.U. Central de Asturias

    Oviedo, Principality of Asturias, 33011

    ARANTZA GADAÑÓN GARCÍA, M.D., 0034 636 31 74 08, a.gadanon@gmail.com

    Recruiting

  • H. Universitari Son Espases

    Palma, Balearic Islands, 07120

    IGNACI SAN PERA TRIGUEROS, 0034686925885, isanpera@gmail.com

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

    JULIO DUART, M.D., 0034619755743, duart.julio@gmail.com

    Recruiting

  • H. Universitario de Salamanca

    Salamanca, Castille and León, 37007

    JORGE LOPEZ OLMEDO, M.D., 0034637729665, jlolmedoCOT@gmail.com

    Recruiting

  • H. Univ. de Canarias

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320

    MARYE MERCE MÉNDEZ OJEDA, M.D., 0034680968886, dramaryemendez@gmail.com

    Recruiting

  • H.U. Virgen Macarena Sevilla

    Seville, Andalusia, 41009

    GLORIA FERNÁNDEZ MORENO, 0034600470149, fermor4@gmail.com

    Recruiting

  • H.U. Virgen Del Rocio

    Seville, Andalusia, 41013

    CARLOS ALFONSO BRAVO, M.D., 0034669329079, carlosal30@hotmail.com

    Recruiting

  • Ihp-Orthopediatica Sevilla

    Seville, Andalusia, 41014

    JOSÉ MANUEL MARTÍNEZ SALAS, 0034658489090, jm_m_s@hotmail.com

    Recruiting

Other trials in Spain

About this study

Official title: Guided Growth in Spastic Hip - Multicenter Study (GGSH-MC)

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:

Read more
  • 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.

Read the 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.

Conditions
Cerebral Palsy
Being tested
Proximal Femoral Guided Growth., Standard prophylactic treatment for Hips at Risk of Dislocation.
Keywords
Proximal Femoral Guided Growth, Randomized Controlled Trial, Spastic Hip, Hip Dislocation
Medical subject headings
Cerebral Palsy, Hip Dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proximal Femoral Guided Growth.Procedure or surgery

    Also called Guided Growth Surgery, Proximal Femoral Epiphysiodesis, Proximal Femoral Hemiepiphysiodesis

    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.Procedure or surgery

    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.

Study groups in NCT06956729
Study groupRoleWhat they receive
PFGG + Standard Treatment (Experimental Group A)ExperimentalParticipants 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.
Receives: Procedure: Proximal Femoral Guided Growth.; Procedure: Standard prophylactic treatment for Hips at Risk of Dislocation.
Standard Treatment Only (Control Group B)Active comparatorParticipants 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.
Receives: Procedure: Standard prophylactic treatment for Hips at Risk of Dislocation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Migration percentage (MP). Radiological

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

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

  2. Pelvic Obliquity (PO). Radiological

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

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

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

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

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

  4. Acetabular Index (AI). Radiological

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

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

  5. Center-Edge Angle (CEA). Radiological

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

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

  6. Hilgenreiner Epiphyseal Angle (HEA). Radiological

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

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

Secondary outcomes (28)

  1. Patient characteristics. Age

    Chronological age of the patient at the time of surgery. Unit of measure: years

    Measured: At time of surgery

  2. Patient characteristics. Sex

    Biological sex of participant. Unit of Measure: Male/Female

    Measured: Pre-surgery

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

    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)

    Measured: Pre-surgery

  4. Patient characteristics. Weight

    Weight of the patient measured using a calibrated scale during the pre-surgical evaluation.

    Unit of measure: kilograms (kg)

    Measured: Pre-surgery

  5. Patient characteristics. Orthopedic comorbidities

    Presence or absence of orthopedic comorbidities such as scoliosis and knee flexion contractures will be assessed.

    Measured: Pre-surgery

  6. Patient characteristics. Respiratory disorders or gastrointestinal issues

    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.

    Measured: Pre-surgery

  7. Patient characteristics. Medication use

    Current use of any medication will be recorded as a categorical variable (yes/no), along with medication type if applicable.

    Measured: Pre-surgery

  8. Clinical variables. Pain

    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)

    Measured: Immediately after surgery; 3 and 6 weeks; 6, 12, 18, and 24 months post-surgery

  9. Clinical variables. Analgesic needs

    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).

    Measured: Immediately after surgery; 3 and 6 weeks; 6, 12, 18, and 24 months post-surgery

  10. Clinical variables. Hip abduction in flexion

    Hip abduction in flexion will be measured in degrees during standardized physical examination. Unit of Measure: Degrees (º)

    Measured: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months

  11. Clinical variables. Hip abduction in extension

    Hip abduction in extension will be measured in degrees during standardized physical examination. Unit of Measure: Degrees (º)

    Measured: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months

  12. Clinical variables. Hip flexion contracture >20°

    Presence or absence of hip flexion contracture greater than 20 degrees will be recorded during physical examination. Yes/no

    Measured: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months

  13. Clinical variables. Galeazzi sign

    The Galeazzi sign will be assessed to detect femoral shortening as a clinical indicator of limb length discrepancy. Presence or absence will be recorded.

    Measured: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months

  14. Clinical variables. Pelvic obliquity

    Pelvic obliquity will be assessed clinically during physical examination and recorded as present or absent.

    Measured: Pre-surgery; at 6 weeks, 6 months, 12, 18, and 24 months

  15. Functional variables

    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)

    Measured: Pre-surgery; 12 and 24 months

  16. Concomitant treatment. Physiotherapy Frequency Per Week

    Frequency of physiotherapy: Number of Physiotherapy Sessions per Week. Sessions per week.

    Measured: At 6 weeks; 6, 12, 18, and 24 months

  17. Concomitant treatment. Orthoses Use

    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.

    Measured: At 6 weeks; 6, 12, 18, and 24 months

  18. Concomitant treatment. Weight-Bearing Activity Time

    Time Spent in Weight-Bearing Activities per Day. Unit of Measure: Minutes per day.

    Measured: At 6 weeks; 6, 12, 18, and 24 months

  19. Concomitant treatment. Participation in Complementary Therapies

    Participation in Complementary Therapies such as Hydrotherapy, hippotherapy, or other specified therapies. Unit of Measure: Yes/No.

    Measured: At 6 weeks; 6, 12, 18, and 24 months

  20. Safety variables and parameters. Clinical complications

    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

    Measured: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery

  21. Safety variables and parameters. Radiological complications

    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

    Measured: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery

  22. Safety variables and parameters. Functional complications

    Intolerance to sitting, supine or lateral positioning, difficulty in perineal care, hygiene, or dressing.

    Unit of Measure of all the above: Participants

    Measured: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery

  23. Safety variables and parameters. Clavien-Dindo-Sink surgical complications classification

    Complications will be classified according to the modified Clavien-Dindo-Sink surgical complications classification. Unit of Measure: Grade (Ordinal)

    Measured: Immediately after surgery; 3 weeks; 6 weeks; 6 months; 12 months; 18 months; 24 months post-surgery

  24. Other variables. Surgical time

    Measured from skin incision to closure, quantified in minutes

    Measured: Perioperative (intraoperative)

  25. Other variables. Postoperative hospital stay

    Measured in days, with the day of surgery as day 0.

    Measured: From surgery to discharge

  26. Other variables. Time to comfortable wheelchair sitting

    Number of days until the patient can sit comfortably in a wheelchair after surgery (day 0), as reported by primary caregivers.

    Measured: At 3 weeks post-surgery

  27. Other variables. Time until pain-free perineal care and hygiene

    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.

    Measured: Assessed at 3 weeks post-surgery

  28. Other variables. Time to initiation of pain-free physiotherapy

    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.

    Measured: Assessed at 3 weeks post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start1 Oct 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956729
Sponsor's protocol ID
P.I.R-0041-24
Other IDs
PR-PI24-00016
Acronym
GGSH-MC
Status last verified
May 2025
First submitted
19 Mar 2025
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant data will be processed in accordance with current data protection legislation, including Organic Law 3/2018, of December 5, on Data Protection and Digital Rights, and the European Regulation (EU) 2016/679 (GDPR). This means that: * The data controller is the Sponsor: SEOP Neuro-Orthopedics Working Group (Spanish Society of Pediatric Orthopedics). Data will be shared among study centers for statistical purposes only. * Personal information is stored in medical records. * Data will not leave the EU and will remain confidential. * Patients may exercise their data rights and file complaints. * Patients' names will not appear in any publications.

Publications

  • 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.

    PubMed 31210072

  • 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.

    PubMed 22336971

  • 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.

    PubMed 21852220

  • 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.

    PubMed 30326758

  • 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.

    PubMed 16978459

  • 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.

    PubMed 19829156

  • 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.

    PubMed 19305274

  • 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.

    PubMed 6029256

  • 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.

    PubMed 954321

  • 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.

    PubMed 6930145

  • 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.

    PubMed 1860938

  • 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.

    PubMed 35626786

  • 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.

    PubMed 32862682

  • 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.

    PubMed 31393306

  • 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.

    PubMed 31425278

Questions about this trial

What is this clinical trial studying?

A study testing Proximal Femoral Guided Growth. and Standard prophylactic treatment for Hips at Risk of Dislocation. in people with Cerebral Palsy, run by Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús at 16 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact María Galán Olleros, M.D (0034660492192, mgalanolleros@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Migration percentage (MP). Radiological (time frame: Pre-surgery; 3 weeks; 6, 12, 18, and 24 months post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06956729, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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