Cerebral Palsy, Spastic Clinical Trial
Official title:
Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures
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
Status | Recruiting |
Enrollment | 51 |
Est. completion date | September 26, 2024 |
Est. primary completion date | March 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of medicine | Cairo | Abbasia |
Lead Sponsor | Collaborator |
---|---|
Muhammad Ayoub |
Egypt,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Radiological changes | Plain radiograph x-ray is used to assess Pelvic obliquity | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | |
Primary | Radiological changes | Plain radiograph x-ray is used to asses Acetabular index. | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Radiological changes | Plain radiograph x-ray is used to assess Heterotrophic ossification | Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative | |
Primary | 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 | |
Primary | 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 |
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