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Not yet recruiting NCT06983353

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

No phase Interventional Cerebral Palsy (CP) Guided Growth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transphyseal screw.
Who it may be relevant to
Registry conditions: Cerebral Palsy (CP), Guided Growth. Basic parameters: 3 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Transphyseal Screw Guided Growth Technique for Correction of Coxa Valga in Cerebral Palsy Children With Hip Sublaxation A Pilot Study

Overview

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

Detailed description

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 .

Interventions

  • Device transphyseal screw
    transphyseal screw in proximal femoral physis

Primary outcome measures

  • Change in femoral neck-shaft angle (measured on anteroposterior pelvic radiographs). [Time frame: - Regular follow-up at 1.5, 3, 6, 12, and 24 months .]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut university hospital — Asyut

Publications

  • 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. PMID 31425278
  • 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. PMID 35626786

Identifiers

NCT: NCT06983353 · guided growth in cp childern

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗