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

NCT05593887 | Recruiting

• 1 other identifier: cp dislocated hip
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral palsy; McHale; dislocated hip; GMFCS IV; GMFCS V; Hip reconstruction surgery; HRS; Proximal femoral resection; valgus osteotomy

Outcome Measures

Primary Outcomes (9)

• 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

• Radiological changes

  Plain radiograph x-ray is used to assess Pelvic obliquity

  Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative

• Radiological changes

  Plain radiograph x-ray is used to asses Acetabular index.

  Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative

• 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

• 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

• 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

• Radiological changes

  Plain radiograph x-ray is used to assess Heterotrophic ossification

  Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative

• 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

• 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

Study Arms (3)

Hip Reconstruction surgery.

ACTIVE COMPARATOR

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.

Procedure: Hip reconstruction surgery.

Proximal femoral resection

ACTIVE COMPARATOR

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.

Procedure: Proximal femoral resection

Proximal femur valgus osteotomy

ACTIVE COMPARATOR

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.

Procedure: Proximal femoral valgus ostetomy

Interventions

Hip reconstruction surgery. PROCEDURE

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

Also known as: Varus derotation shortening ostetomy.

Hip Reconstruction surgery.

Proximal femoral resection PROCEDURE

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

Also known as: Castle shnider procedure

Proximal femoral resection

Proximal femoral valgus ostetomy 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

Also known as: McHale procedure

Proximal femur valgus osteotomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammad Ayoub: lead

Study Sites (1)

Faculty of medicine

Cairo, Abbasia, 11539, Egypt

RECRUITING

Related Publications (14)

• 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.

  PMID: 16534712 BACKGROUND

• 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.

  PMID: 31169645 BACKGROUND

• 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.

  PMID: 27440567 BACKGROUND

• 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.

  PMID: 19055594 BACKGROUND

• 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.

  PMID: 24968787 BACKGROUND

• 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.

  PMID: 33380203 BACKGROUND

• 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.

  PMID: 31663909 BACKGROUND

• 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.

  PMID: 24788508 BACKGROUND

• 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.

  PMID: 34943303 BACKGROUND

• 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.

  PMID: 2358491 BACKGROUND

• 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.

  PMID: 25788307 BACKGROUND

• 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.

  PMID: 15715691 BACKGROUND

• 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.

  PMID: 12237214 BACKGROUND

• 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.

  PMID: 29735134 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hip Dislocation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Mootaz Thakeb, MD

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Muhammad Ayoub, Master

CONTACT

+201093949792; Muhammad_ayoub@outlook.com

Mostafa Baraka, MD

CONTACT

+201001058858; Mostafa.baraka@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 26, 2022
• Study Start: October 18, 2022
• Primary Completion: October 26, 2025
• Study Completion: October 26, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)