Guided Growth Technique Use In Treatment Of Hip Sublaxation In CP Childern

NCT ID: NCT06983353

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the change in femoral neck-shaft angle (coxa valga) following transphyseal screw insertion in children with CP.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The hip is one of the most common involved joint in cerebral palsy. Hip displacement occurs in more than 33% of children with cerebral palsy, with a higher prevalence in nonambulatory children. Hip displacement in this population is typically progressive. Hip dislocation can result in pain and difficulty with sitting and perineal care. Hip Surveillance in Children with Cerebral Palsy.

Traditional surgical management, typically reserved for hips with a migration percentage of 40% or more, includes hip reconstruction involving soft tissue releases, femoral and pelvic osteotomies. These procedures are associated with significant perioperative morbidity, including pain; increased blood loss; and lengthy anesthetic and inpatient recovery times, often complicated with peri-operative infections. With improved surgical techniques, orthopedic implants and enhanced postoperative pathways, weightbearing can be resumed shortly after surgery; however, traditional treatment commonly included a period of non-weight-bearing, with some surgeons preferring to augment their reconstruction with a hip spica or abduction brace .

Guided growth procedures are well established in the treatment for the gradual correction of angular and rotational limb deformities in children. Anterior hemiepiphysiodesis of the distal femur has been shown to be effective in the treatment of fixed flexion deformity of the knee when compared to traditional osteotomies. shows intra-operative radiographs of this minimally invasive technique, which has been recently applied to the proximal femoral physis for various conditions. By placing a screw over the physis on the medial side, the tethering that occurs on the medial side will result in progressive varus of the proximal femur. It is understood that this manipulation of the proximal femoral anatomy can alter the course of secondary acetabular dysplasia .Furthermore, it is recognized that guided growth procedures of the proximal femoral physis can be carried out as day case procedures, require a shorter operating time and allow for immediate weight bearing/standing when performed in non-ambulatory patients.

Type of the study: Prospective cohort study Study Setting: Assiut University Hospitals, Department of Orthopaedics and Traumatology

Preoperative assessment :

A-Clinical for GMFCS B- Radiological AP and Lateral pelvis for the migration percentage (MP), head/neck-shaft angle (HSA/NSA) and acetabular index (AI) Procedure: Insertion of a transphyseal fully threaded cannulated screw at proper size across the infromedial proximal femoral physis under fluoroscopic guidance +/- soft tissue release , Abductor brace , hip spicca , and ankle foot orthosis .

* Postoperative Care:
* Weight-bearing as tolerated.
* Physical therapy to improve hip abductor strength and range of motion.
* Regular follow-up at 1.5, 3, 6, 12, and 24 months and uptill .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy (CP) Guided Growth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transphyseal screw

transphyseal screw in proximal femoral physis

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* children aged 3-12 yrs diagnosed with CP ( GMFCS level l\_lV )
* Neck-Shaft angle \>150
* early hip sub laxation ( migration percentage \< 50% )

Exclusion Criteria

* Sever hip sub laxation ( migration percentage\> 50 % )
* Children below 3 yrs and above 12
* Pathological bone
* medical contraindications to surgery
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mohamed Adel Fathy Abdel aleem

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Adel Fathy Abdel aleem

doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut university hospital

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

mohamed adel fathy, residant

Role: CONTACT

01006775249

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31425278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35626786 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

guided growth in cp childern

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.