Clinical trial NCT05593887: Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures
Official title: Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Cerebral palsy
McHale
dislocated hip
GMFCS IV
GMFCS V
Hip reconstruction surgery
HRS
Proximal femoral resection
valgus osteotomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Radiological changes
timeFrame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
measure: Radiological changes
timeFrame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
measure: Radiological changes
timeFrame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
measure: Radiological changes
timeFrame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
measure: Radiological changes
timeFrame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
measure: Radiological changes
timeFrame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
measure: Radiological changes
timeFrame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
measure: Clinical changes
timeFrame: 6 weeks post operative, 3 months postoperative, and 6 months postoperative
measure: Clinical changes
timeFrame: 6 weeks post operative, 3 months postoperative, and 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
state: Abbasia
Study officials:
affiliation: Ain Shams University
name: Mootaz Thakeb, MD
role: STUDY_CHAIR
References:
citation: Terjesen T. Development of the hip joints in unoperated children with cerebral palsy: a radiographic study of 76 patients. Acta Orthop. 2006 Feb;77(1):125-31. doi: 10.1080/17453670610045803.
citation: Lins LAB, Watkins CJ, Shore BJ. Natural History of Spastic Hip Disease. J Pediatr Orthop. 2019 Jul;39(Issue 6, Supplement 1 Suppl 1):S33-S37. doi: 10.1097/BPO.0000000000001347.
citation: DiFazio R, Shore B, Vessey JA, Miller PE, Snyder BD. Effect of Hip Reconstructive Surgery on Health-Related Quality of Life of Non-Ambulatory Children with Cerebral Palsy. J Bone Joint Surg Am. 2016 Jul 20;98(14):1190-8. doi: 10.2106/JBJS.15.01063.
citation: Robin J, Graham HK, Baker R, Selber P, Simpson P, Symons S, Thomason P. A classification system for hip disease in cerebral palsy. Dev Med Child Neurol. 2009 Mar;51(3):183-92. doi: 10.1111/j.1469-8749.2008.03129.x. Epub 2008 Dec 3.
citation: Braatz F, Eidemuller A, Klotz MC, Beckmann NA, Wolf SI, Dreher T. Hip reconstruction surgery is successful in restoring joint congruity in patients with cerebral palsy: long-term outcome. Int Orthop. 2014 Nov;38(11):2237-43. doi: 10.1007/s00264-014-2379-x. Epub 2014 Jun 27.
citation: Min JJ, Kwon SS, Sung KH, Lee KM, Chung CY, Park MS. Remodelling of femoral head deformity after hip reconstructive surgery in patients with cerebral palsy. Bone Joint J. 2021 Jan;103-B(1):198-203. doi: 10.1302/0301-620X.103B1.BJJ-2020-1339.R1.
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