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Recruiting Not applicable

Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures

NCT05593887 · tracked via the Priya Life Science Egypt tracker
Sponsor
Muhammad Ayoub
Phase
Not applicable
Started
2022-10-18
Last updated
2025-08-11

Condition(s) studied

Cerebral Palsy, Spastic

Investigational drug(s) / intervention(s)

Hip reconstruction surgery.Proximal femoral resectionProximal femoral valgus ostetomy

Hip reconstruction surgery.: This group will undergo Hip reconstruction surgery Anterior approach overlying the iliac crest: open reduction, pelvic osteotomy and pelvic osteotomy. Lateral approach: derotation-varization osteotomy and shortening of femur, internal fixation

Proximal femoral resection: Resection of the proximal part of the femur below the level of the lesser trochanter by 2 to 3 cm and constructed a capsular flap across the acetabulum. The quadriceps muscle will be sutured around the resected end of the femur

Proximal femoral valgus ostetomy: The patient is positioned in the lateral decubitus Position A straight incision is cantered over the greater trochanter and extends proximally. Head and neck are resected. A closing wedge, shortening, valgus-producing osteotomy of 40 to 50 degrees is marked just below the lesser trochanter and fixed by a plate

Study summary

Cerebral palsy (CP) is characterized by a fixed lesion that affects the neurological system during development. Pathologic hip conditions, such as subluxation or dislocation, are of great concern in non-ambulatory CP patients. Complete hip dislocations are commonly encountered in non-ambulatory CP patients and this can be quite problematic if pain is experienced or when sitting, balance, posture, or hygiene become affected.

The management of this patient population includes both reconstructive surgery, which aimed to center the dislocated femoral head into the acetabulum, and salvage surgeries, which are performed to reduce associated pain and/or functional deficits (e.g., sitting problems).

There are many options for salvage management of dislocated hips in CP patients, including proximal femoral resection (PFR) either with or without cartilage capping, proximal femoral valgus osteotomy, hip arthrodesis, and prosthetic hip arthroplasty.

To date, there is no conclusive evidence to determine which option is superior compared to the others in terms of efficacy and postoperative complications in CP patients due to the lack of a comparison group and the small number of included patients. Furthermore, the decision to take reconstructive vs. salvage procedures is still a matter of debate in the literature.

Therefore, this study is being conducted to compare outcomes between PFR, reconstructive hip surgery, and proximal femur valgus osteotomy in terms of clinical improvement (Including pain) and complications

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Lesion: neglected deformed dislocated hip (Deformed head Group B, C, and D according to Rutz classification modified from MCPHCS ) * Non-ambulatory: as defined by GMFCS level IV and V Exclusion Criteria: * Ambulatory patients * patients underwent any previous hip bony procedures. * Non-deformed Femoral head Group A according to Rutz classification * Neuromuscular hip dislocation other than cp.

Primary outcome measure(s)

  • Radiological changes — Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
    Plain radiograph x-ray is used to assess the Migration percentage
  • Radiological changes — Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
    Plain radiograph x-ray is used to assess Pelvic obliquity
  • Radiological changes — Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
    Plain radiograph x-ray is used to asses Acetabular index.
  • Radiological changes — Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
    Plain radiograph x-ray is used to assess Femoral head sphericity
  • Radiological changes — Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
    Plain radiograph x-ray is used to assess Femoral head deformity.
  • Radiological changes — Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
    Plain radiograph x-ray is used to assess Proximal Femoral Migration.
  • Radiological changes — Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
    Plain radiograph x-ray is used to assess Heterotrophic ossification
  • Clinical changes — 6 weeks post operative, 3 months postoperative, and 6 months postoperative
    Cp quality of life Questionnaire ( preoperative and postoperative). No minimum or maximum score. Increase score means clinical improvement.
  • Clinical changes — 6 weeks post operative, 3 months postoperative, and 6 months postoperative
    Non-communicating children's pain checklist - revised ( preoperative and postoperative).score equals or more than 7 indicates that the child is in pain. Increase score means more severe pain.

Trial sites (1)

FacilityCityRegionStatus
Faculty of medicine Cairo Abbasia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05593887 on ClinicalTrials.gov ↗ ← All trials in Egypt