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

Primary Purpose

Cerebral Palsy, Spastic

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hip reconstruction surgery.
Proximal femoral resection
Proximal femoral valgus ostetomy
Sponsored by
Muhammad Ayoub
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral palsy, McHale, dislocated hip, GMFCS IV, GMFCS V, Hip reconstruction surgery, HRS, Proximal femoral resection, valgus osteotomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Hip Reconstruction surgery.

Proximal femoral resection

Proximal femur valgus osteotomy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Radiological changes
Plain radiograph x-ray is used to assess the Migration percentage
Radiological changes
Plain radiograph x-ray is used to assess Pelvic obliquity
Radiological changes
Plain radiograph x-ray is used to asses Acetabular index.
Radiological changes
Plain radiograph x-ray is used to assess Femoral head sphericity
Radiological changes
Plain radiograph x-ray is used to assess Femoral head deformity.
Radiological changes
Plain radiograph x-ray is used to assess Proximal Femoral Migration.
Radiological changes
Plain radiograph x-ray is used to assess Heterotrophic ossification
Clinical changes
Cp quality of life Questionnaire ( preoperative and postoperative). No minimum or maximum score. Increase score means clinical improvement.
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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2022
Last Updated
June 3, 2023
Sponsor
Muhammad Ayoub
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1. Study Identification

Unique Protocol Identification Number
NCT05593887
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
March 26, 2024 (Anticipated)
Study Completion Date
September 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhammad Ayoub

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral palsy, McHale, dislocated hip, GMFCS IV, GMFCS V, Hip reconstruction surgery, HRS, Proximal femoral resection, valgus osteotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hip Reconstruction surgery.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Proximal femoral resection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Proximal femur valgus osteotomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hip reconstruction surgery.
Other Intervention Name(s)
Varus derotation shortening ostetomy.
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Proximal femoral resection
Other Intervention Name(s)
Castle shnider procedure
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Proximal femoral valgus ostetomy
Other Intervention Name(s)
McHale procedure
Intervention Description
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
Primary Outcome Measure Information:
Title
Radiological changes
Description
Plain radiograph x-ray is used to assess the Migration percentage
Time Frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Title
Radiological changes
Description
Plain radiograph x-ray is used to assess Pelvic obliquity
Time Frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Title
Radiological changes
Description
Plain radiograph x-ray is used to asses Acetabular index.
Time Frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Title
Radiological changes
Description
Plain radiograph x-ray is used to assess Femoral head sphericity
Time Frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Title
Radiological changes
Description
Plain radiograph x-ray is used to assess Femoral head deformity.
Time Frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Title
Radiological changes
Description
Plain radiograph x-ray is used to assess Proximal Femoral Migration.
Time Frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Title
Radiological changes
Description
Plain radiograph x-ray is used to assess Heterotrophic ossification
Time Frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Title
Clinical changes
Description
Cp quality of life Questionnaire ( preoperative and postoperative). No minimum or maximum score. Increase score means clinical improvement.
Time Frame
6 weeks post operative, 3 months postoperative, and 6 months postoperative
Title
Clinical changes
Description
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.
Time Frame
6 weeks post operative, 3 months postoperative, and 6 months postoperative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Ayoub, Master
Phone
+201093949792
Email
Muhammad_ayoub@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Baraka, MD
Phone
+201001058858
Email
Mostafa.baraka@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mootaz Thakeb, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of medicine
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11539
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16534712
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.
Results Reference
background
PubMed Identifier
31169645
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.
Results Reference
background
PubMed Identifier
27440567
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.
Results Reference
background
PubMed Identifier
19055594
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.
Results Reference
background
PubMed Identifier
24968787
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.
Results Reference
background
PubMed Identifier
33380203
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.
Results Reference
background
PubMed Identifier
31663909
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.
Results Reference
background
PubMed Identifier
24788508
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.
Results Reference
background
PubMed Identifier
34943303
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.
Results Reference
background
PubMed Identifier
2358491
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.
Results Reference
background
PubMed Identifier
25788307
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.
Results Reference
background
PubMed Identifier
15715691
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.
Results Reference
background
PubMed Identifier
12237214
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.
Results Reference
background
PubMed Identifier
29735134
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.
Results Reference
background

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

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