Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05593887
Status:
RECRUITING
Last Update Posted:
2023-06-06
First Post:
2022-10-17
Brief Title:
Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy A Comparison of Three Procedures
Sponsor:
Muhammad Ayoub
Organization:
Ain Shams University
Study Overview
Official Title:
Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy A Comparison of Three Procedures
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor functional deficits eg 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
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 andor functional deficits eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None