Cerebral Palsy, SpasticNCT05593887
Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures
A study testing Hip reconstruction surgery., Proximal femoral resection and Proximal femoral valgus ostetomy in people with Cerebral Palsy, Spastic, run by Muhammad Ayoub at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Hip reconstruction surgery., Proximal femoral resection and Proximal femoral valgus ostetomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2022to 26 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read more
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
Read the 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.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Hip reconstruction surgery., Proximal femoral resection, Proximal femoral valgus ostetomy
- Keywords
- Cerebral palsy, McHale, dislocated hip, GMFCS IV, GMFCS V, Hip reconstruction surgery, HRS, Proximal femoral resection, valgus osteotomy
- Medical subject headings
- Cerebral Palsy, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip reconstruction surgery.Procedure or surgery
Also called Varus derotation shortening ostetomy.
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 resectionProcedure or surgery
Also called Castle shnider 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
Proximal femoral valgus ostetomyProcedure or surgery
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Proximal femoral valgus ostetomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological changes
Plain radiograph x-ray is used to assess the Migration percentage
Measured: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Radiological changes
Plain radiograph x-ray is used to assess Pelvic obliquity
Measured: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Radiological changes
Plain radiograph x-ray is used to asses Acetabular index.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Radiological changes
Plain radiograph x-ray is used to assess Heterotrophic ossification
Measured: 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.
Measured: 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.
Measured: 6 weeks post operative, 3 months postoperative, and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start18 Oct 2022
- Primary completion26 Oct 2025 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Ayoub
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Ayoub, Ain Shams University
- Investigators
- Mootaz Thakeb, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593887
- Sponsor's protocol ID
- cp dislocated hip
- Status last verified
- Aug 2025
- First submitted
- 17 Oct 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16534712Lins 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.
PubMed 31169645DiFazio 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.
PubMed 27440567Robin 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.
PubMed 19055594Braatz 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.
PubMed 24968787Min 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.
PubMed 33380203Shaw 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.
PubMed 31663909Dartnell 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.
PubMed 24788508Horsch 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.
PubMed 34943303McHale 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.
PubMed 2358491Rutz 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.
PubMed 25788307Waters 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.
PubMed 15715691Breau 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.
PubMed 12237214Shrader 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.
PubMed 29735134
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures
- ClinicalTrials.gov ID
- NCT05593887
- Acronym / sponsor ID
- cp dislocated hip
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral palsy, McHale, dislocated hip, GMFCS IV, GMFCS V, Hip reconstruction surgery, HRS, Proximal femoral resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Muhammad AyoubUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 26 Oct 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hip Reconstruction surgery. | Active comparator | Procedure: Hip reconstruction surgery.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. |
| Proximal femoral resection | Active comparator | Procedure: Proximal femoral resectionThis 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. |
| Proximal femur valgus osteotomy | Active comparator | Procedure: Proximal femoral valgus ostetomyThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip reconstruction surgery.Also: Varus derotation shortening ostetomy.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 | Procedure or surgery | Hip Reconstruction surgery. |
| Proximal femoral resectionAlso: Castle shnider procedureResection 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 or surgery | Proximal femoral resection |
| Proximal femoral valgus ostetomyAlso: McHale procedureThe 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 or surgery | Proximal femur valgus osteotomy |
Primary outcome
Radiological changes
Time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Plain radiograph x-ray is used to assess the Migration percentage
Radiological changes
Time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Plain radiograph x-ray is used to assess Pelvic obliquity
Radiological changes
Time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Plain radiograph x-ray is used to asses Acetabular index.
Radiological changes
Time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Plain radiograph x-ray is used to assess Femoral head sphericity
Radiological changes
Time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Plain radiograph x-ray is used to assess Femoral head deformity.
Radiological changes
Time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Plain radiograph x-ray is used to assess Proximal Femoral Migration.
Radiological changes
Time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
Plain radiograph x-ray is used to assess Heterotrophic ossification
Clinical changes
Time frame: 6 weeks post operative, 3 months postoperative, and 6 months postoperative
Cp quality of life Questionnaire ( preoperative and postoperative). No minimum or maximum score. Increase score means clinical improvement.
Clinical changes
Time frame: 6 weeks post operative, 3 months postoperative, and 6 months postoperative
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 16534712Terjesen 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.
- Background: PubMed 31169645Lins 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.
- Background: PubMed 27440567DiFazio 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.
- Background: PubMed 19055594Robin 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.
- Background: PubMed 24968787Braatz 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.
- Background: PubMed 33380203Min 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.
- Background: PubMed 31663909Shaw 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.
- Background: PubMed 24788508Dartnell 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.
- Background: PubMed 34943303Horsch 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.
- Background: PubMed 2358491McHale 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.
- Background: PubMed 25788307Rutz 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.
- Background: PubMed 15715691Waters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mootaz Thakeb, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip reconstruction surgery., Proximal femoral resection and Proximal femoral valgus ostetomy in people with Cerebral Palsy, Spastic, run by Muhammad Ayoub at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Ayoub, Master (+201093949792, Muhammad_ayoub@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological changes (time frame: Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593887, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.