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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Palsy, Spastic

Intervention / Treatment
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* Procedure: Hip reconstruction surgery.
* Procedure: Proximal femoral resection
* Procedure: Proximal femoral valgus ostetomy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hip Reconstruction surgery.<br>This group will undergo Hip reconstruction surgery Anterior approach overlying the iliac crest: open reduction and pelvic osteotomy. Lateral approach: derotation-varization osteotomy and shortening of femur and internal fixation. | Procedure: Hip reconstruction surgery.<br>* 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<br>* Other names: Varus derotation shortening ostetomy.;|
| Active Comparator: Proximal femoral resection<br>This group will undergo PFR as described by 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. | Procedure: Proximal femoral resection<br>* 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<br>* Other names: Castle shnider procedure;|
| Active Comparator: Proximal femur valgus osteotomy<br>This group will undergo McHale Procedure.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. | Procedure: Proximal femoral valgus ostetomy<br>* 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<br>* Other names: McHale procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological changes | Plain radiograph x-ray is used to assess the Migration percentage | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | 
| Radiological changes | Plain radiograph x-ray is used to assess Pelvic obliquity | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | 
| Radiological changes | Plain radiograph x-ray is used to asses Acetabular index. | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | 
| Radiological changes | Plain radiograph x-ray is used to assess Femoral head sphericity | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | 
| Radiological changes | Plain radiograph x-ray is used to assess Femoral head deformity. | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | 
| Radiological changes | Plain radiograph x-ray is used to assess Proximal Femoral Migration. | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | 
| Radiological changes | Plain radiograph x-ray is used to assess Heterotrophic ossification | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | 
| Clinical changes | Cp quality of life Questionnaire ( preoperative and postoperative). No minimum or maximum score. Increase score means clinical improvement. | 6 weeks post operative, 3 months postoperative, and 6 months postoperative | 
| Clinical changes | 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. | 6 weeks post operative, 3 months postoperative, and 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRS, Cerebral palsy, McHale, dislocated hip, GMFCS IV, GMFCS V, Hip reconstruction surgery, Proximal femoral resection, valgus osteotomy