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

Cerebral Palsy, Spastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593887
• Other study ID #: cp dislocated hip
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: September 26, 2024

Study information

• Verified date: June 2023
• Source: Ain Shams University
• Contact: Muhammad Ayoub, Master
• Phone: +201093949792
• Email: Muhammad_ayoub[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Hip Dislocation
• Paralysis

Intervention

Procedure:
• Hip 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
• Proximal 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
• Proximal 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

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Muhammad Ayoub

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

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. — View Citation

Breau LM, McGrath PJ, Camfield CS, Finley GA. Psychometric properties of the non-communicating children's pain checklist-revised. Pain. 2002 Sep;99(1-2):349-57. doi: 10.1016/s0304-3959(02)00179-3. — View Citation

Dartnell J, Gough M, Paterson JM, Norman-Taylor F. Proximal femoral resection without post-operative traction for the painful dislocated hip in young patients with cerebral palsy: a review of 79 cases. Bone Joint J. 2014 May;96-B(5):701-6. doi: 10.1302/0301-620X.96B5.32963. — View 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. — View Citation

Horsch A, Hahne F, Ghandour M, Platzer H, Alimusaj M, Putz C. Radiological Outcomes of Femoral Head Resection in Patients with Cerebral Palsy: A Retrospective Comparative Study of Two Surgical Procedures. Children (Basel). 2021 Dec 1;8(12):1105. doi: 10.3390/children8121105. — View 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. — View Citation

McHale KA, Bagg M, Nason SS. Treatment of the chronically dislocated hip in adolescents with cerebral palsy with femoral head resection and subtrochanteric valgus osteotomy. J Pediatr Orthop. 1990 Jul-Aug;10(4):504-9. — View 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. — View 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. — View Citation

Rutz E, Vavken P, Camathias C, Haase C, Junemann S, Brunner R. Long-term results and outcome predictors in one-stage hip reconstruction in children with cerebral palsy. J Bone Joint Surg Am. 2015 Mar 18;97(6):500-6. doi: 10.2106/JBJS.N.00676. — View Citation

Shaw KA, Hire JM, Cearley DM. Salvage Treatment Options for Painful Hip Dislocations in Nonambulatory Cerebral Palsy Patients. J Am Acad Orthop Surg. 2020 May 1;28(9):363-375. doi: 10.5435/JAAOS-D-19-00349. — View Citation

Shrader MW, Andrisevic EM, Belthur MV, White GR, Boan C, Wood W. Inter- and Intraobserver Reliability of Pelvic Obliquity Measurement Methods in Patients With Cerebral Palsy. Spine Deform. 2018 May-Jun;6(3):257-262. doi: 10.1016/j.jspd.2017.10.001. — View 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. — View Citation

Waters E, Maher E, Salmon L, Reddihough D, Boyd R. Development of a condition-specific measure of quality of life for children with cerebral palsy: empirical thematic data reported by parents and children. Child Care Health Dev. 2005 Mar;31(2):127-35. doi: 10.1111/j.1365-2214.2004.00476.x. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

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