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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05593887
Enrollment
51
Registered
2022-10-26
Start date
2022-10-18
Completion date
2025-10-26
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral palsy, McHale, dislocated hip, GMFCS IV, GMFCS V, Hip reconstruction surgery, HRS, Proximal femoral resection, valgus osteotomy

Brief 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

Detailed description

Hip displacement is common in non-ambulatory patients with cerebral palsy (CP) of Gross Motor Function Classification System (GMFCS) levels IV and V. CP is a permanent disorder affecting movement and posture that causes activity limitations due to nonprogressive injury to the fetal or immature infant brain. Owing to the primary abnormalities of CP, such as spasticity and muscle imbalance, hip displacement progresses and is usually detected around the age of five to seven years old. If left untreated, progressive hip displacement eventually causes pain, pelvic obliquity, difficulty with sitting, and hinders hygiene. Neglected dislocation leads to femoral head deformity and it is assessed with the use of the revised version of the MCPHCS (Melbourne Cerebral Palsy Hip Classification system). The MCPHCS is a radiographic classification system that includes joint congruency and alignment as well as acetabular and femoral head deformity. Previous studies have shown that reduction of displacement through hip reconstructive surgery (HRS), which includes femoral varus and de-rotational osteotomy (FVDO), with or without pelvic osteotomies, relieves both pain frequency and intensity . It has been found however that hip joint congruity after HRS improves even if the initial presentation of a CP hip seems irreversible. There are many options for salvage management of dislocated hips in CP patients, including proximal femoral resection (FHR) either with or without cartilage capping, which is known as femoral head cap plastic surgery (FCP), and proximal femoral valgus osteotomy. Noteworthy, pain and muscular spasm are frequent postoperative complaints during the early postoperative period, particularly before the benefits of FCP and FHR can be witnessed. Thus, a number of management strategies can be used to control these symptoms, including the use of analgesics, anxiolytics, or skin traction. Horsch et al in their study found that the postoperative outcomes of FHR and FCP are similar in terms of telescoping, heterotopic ossification, and complication. Traditionally, resection arthroplasty has been considered as an option for palliative treatment of a CP hip with femoral head destruction. However, there are no clear-cut indications for resection arthroplasty for a deformed femoral head. The procedure described by McHale in 1990 entails femoral head and neck resection, valgus-producing subtrochanteric osteotomy to reposition the leg relative to the trunk, and advancement of the lesser trochanter into the acetabulum by attaching ligamentum teres to the intact iliopsoas. 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, the small number of included patients, and the short follow-up periods. Therefore, A prospective study will be conducted to compare outcomes between Proximal femoral resection (Castle Schneider), Valgus osteotomy (McHale procedure), and Reconstructive hip procedure (VDO + Pelvic osteotomy) as regards post-operative clinical and radiological changes and postoperative complications that include pain, proximal migration, stiffness, and Heterotrophic ossifications.

Interventions

PROCEDUREHip 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

PROCEDUREProximal 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

PROCEDUREProximal 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

Sponsors

Muhammad Ayoub
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Radiological changesImmediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperativePlain radiograph x-ray is used to assess the Migration percentage
Clinical changes6 weeks post operative, 3 months postoperative, and 6 months postoperativeCp quality of life Questionnaire ( preoperative and postoperative). No minimum or maximum score. Increase score means clinical improvement.

Countries

Egypt

Contacts

Primary ContactMuhammad Ayoub, Master
Muhammad_ayoub@outlook.com+201093949792
Backup ContactMostafa Baraka, MD
Mostafa.baraka@hotmail.com+201001058858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026