Cerebral Palsy (CP)NCT06983353
Guided Growth Technique Use In Treatment Of Hip Sublaxation In CP Childern
A study testing transphyseal screw in people with Cerebral Palsy (CP) and Guided Growth, run by Mohamed Adel Fathy Abdel aleem at 1 site in Egypt.
Trial summary
To evaluate the change in femoral neck-shaft angle (coxa valga) following transphyseal screw insertion in children with CP. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Guided Growth
- What is being tested?
- transphyseal screw
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 May 2027
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 3-12 yrs diagnosed with CP ( GMFCS level l_lV )
- Neck-Shaft angle >150
- early hip sub laxation ( migration percentage < 50% )
Who cannot join
- Sever hip sub laxation ( migration percentage> 50 % )
- Children below 3 yrs and above 12
- Pathological bone
- medical contraindications to surgery
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
Official title: Evaluation of Transphyseal Screw Guided Growth Technique for Correction of Coxa Valga in Cerebral Palsy Children With Hip Sublaxation A Pilot Study
To evaluate the change in femoral neck-shaft angle (coxa valga) following transphyseal screw insertion in children with CP.
Read the detailed description
The hip is one of the most common involved joint in cerebral palsy. Hip displacement occurs in more than 33% of children with cerebral palsy, with a higher prevalence in nonambulatory children. Hip displacement in this population is typically progressive. Hip dislocation can result in pain and difficulty with sitting and perineal care. Hip Surveillance in Children with Cerebral Palsy.
Traditional surgical management, typically reserved for hips with a migration percentage of 40% or more, includes hip reconstruction involving soft tissue releases, femoral and pelvic osteotomies. These procedures are associated with significant perioperative morbidity, including pain; increased blood loss; and lengthy anesthetic and inpatient recovery times, often complicated with peri-operative infections. With improved surgical techniques, orthopedic implants and enhanced postoperative pathways, weightbearing can be resumed shortly after surgery; however, traditional treatment commonly included a period of non-weight-bearing, with some surgeons preferring to augment their reconstruction with a hip spica or abduction brace .
Guided growth procedures are well established in the treatment for the gradual correction of angular and rotational limb deformities in children. Anterior hemiepiphysiodesis of the distal femur has been shown to be effective in the treatment of fixed flexion deformity of the knee when compared to traditional osteotomies. shows intra-operative radiographs of this minimally invasive technique, which has been recently applied to the proximal femoral physis for various conditions. By placing a screw over the physis on the medial side, the tethering that occurs on the medial side will result in progressive varus of the proximal femur. It is understood that this manipulation of the proximal femoral anatomy can alter the course of secondary acetabular dysplasia .Furthermore, it is recognized that guided growth procedures of the proximal femoral physis can be carried out as day case procedures, require a shorter operating time and allow for immediate weight bearing/standing when performed in non-ambulatory patients.
Type of the study: Prospective cohort study Study Setting: Assiut University Hospitals, Department of Orthopaedics and Traumatology
Preoperative assessment :
A-Clinical for GMFCS B- Radiological AP and Lateral pelvis for the migration percentage (MP), head/neck-shaft angle (HSA/NSA) and acetabular index (AI) Procedure: Insertion of a transphyseal fully threaded cannulated screw at proper size across the infromedial proximal femoral physis under fluoroscopic guidance +/- soft tissue release , Abductor brace , hip spicca , and ankle foot orthosis .
- Postoperative Care:
- Weight-bearing as tolerated.
- Physical therapy to improve hip abductor strength and range of motion.
- Regular follow-up at 1.5, 3, 6, 12, and 24 months and uptill .
- Conditions
- Cerebral Palsy (CP), Guided Growth
- Being tested
- transphyseal screw
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transphyseal screwDevice
transphyseal screw in proximal femoral physis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in femoral neck-shaft angle (measured on anteroposterior pelvic radiographs).
Measured: - Regular follow-up at 1.5, 3, 6, 12, and 24 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Adel Fathy Abdel aleem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Adel Fathy Abdel aleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983353
- Sponsor's protocol ID
- guided growth in cp childern
- Status last verified
- Sep 2025
- First submitted
- 6 May 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsieh HC, Wang TM, Kuo KN, Huang SC, Wu KW. Guided Growth Improves Coxa Valga and Hip Subluxation in Children with Cerebral Palsy. Clin Orthop Relat Res. 2019 Nov;477(11):2568-2576. doi: 10.1097/CORR.0000000000000903.
PubMed 31425278Lebe M, van Stralen RA, Buddhdev P. Guided Growth of the Proximal Femur for the Management of the 'Hip at Risk' in Children with Cerebral Palsy-A Systematic Review. Children (Basel). 2022 Apr 25;9(5):609. doi: 10.3390/children9050609.
PubMed 35626786
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transphyseal Screw Guided Growth Technique for Correction of Coxa Valga in Cerebral Palsy Children With Hip Sublaxation A Pilot Study
- ClinicalTrials.gov ID
- NCT06983353
- Acronym / sponsor ID
- guided growth in cp childern
- Conditions
- Cerebral Palsy (CP), Guided Growth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mohamed Adel Fathy Abdel aleemUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 21 May 2025 (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.
To evaluate the change in femoral neck-shaft angle (coxa valga) following transphyseal screw insertion in children with CP.
Detailed description
The hip is one of the most common involved joint in cerebral palsy. Hip displacement occurs in more than 33% of children with cerebral palsy, with a higher prevalence in nonambulatory children. Hip displacement in this population is typically progressive. Hip dislocation can result in pain and difficulty with sitting and perineal care. Hip Surveillance in Children with Cerebral Palsy.
Traditional surgical management, typically reserved for hips with a migration percentage of 40% or more, includes hip reconstruction involving soft tissue releases, femoral and pelvic osteotomies. These procedures are associated with significant perioperative morbidity, including pain; increased blood loss; and lengthy anesthetic and inpatient recovery times, often complicated with peri-operative infections. With improved surgical techniques, orthopedic implants and enhanced postoperative pathways, weightbearing can be resumed shortly after surgery; however, traditional treatment commonly included a period of non-weight-bearing, with some surgeons preferring to augment their reconstruction with a hip spica or abduction brace .
Guided growth procedures are well established in the treatment for the gradual correction of angular and rotational limb deformities in children. Anterior hemiepiphysiodesis of the distal femur has been shown to be effective in the treatment of fixed flexion deformity of the knee when compared to traditional osteotomies. shows intra-operative radiographs of this minimally invasive technique, which has been recently applied to the proximal femoral physis for various conditions. By placing a screw over the physis on the medial side, the tethering that occurs on the medial side will result in progressive varus of the proximal femur. It is understood that this manipulation of the proximal femoral anatomy can alter the course of secondary acetabular dysplasia .Furthermore, it is recognized that guided growth procedures of the proximal femoral physis can be carried out as day case procedures, require a shorter operating time and allow for immediate weight bearing/standing when performed in non-ambulatory patients.
Type of the study: Prospective cohort study Study Setting: Assiut University Hospitals, Department of Orthopaedics and Traumatology
Preoperative assessment :
A-Clinical for GMFCS B- Radiological AP and Lateral pelvis for the migration percentage (MP), head/neck-shaft angle (HSA/NSA) and acetabular index (AI) Procedure: Insertion of a transphyseal fully threaded cannulated screw at proper size across the infromedial proximal femoral physis under fluoroscopic guidance +/- soft tissue release , Abductor brace , hip spicca , and ankle foot orthosis .
- Postoperative Care:
- Weight-bearing as tolerated.
- Physical therapy to improve hip abductor strength and range of motion.
- Regular follow-up at 1.5, 3, 6, 12, and 24 months and uptill .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 3-12 yrs diagnosed with CP ( GMFCS level l_lV )
- Neck-Shaft angle >150
- early hip sub laxation ( migration percentage < 50% )
Key exclusion criteria (4 listed)
- Sever hip sub laxation ( migration percentage> 50 % )
- Children below 3 yrs and above 12
- Pathological bone
- medical contraindications to surgery
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 |
|---|---|---|
| transphyseal screwtransphyseal screw in proximal femoral physis | Device | – |
Primary outcome
Change in femoral neck-shaft angle (measured on anteroposterior pelvic radiographs).
Time frame: - Regular follow-up at 1.5, 3, 6, 12, and 24 months .
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 16 Sep 2025.
- Results publication: PubMed 31425278Hsieh HC, Wang TM, Kuo KN, Huang SC, Wu KW. Guided Growth Improves Coxa Valga and Hip Subluxation in Children with Cerebral Palsy. Clin Orthop Relat Res. 2019 Nov;477(11):2568-2576. doi: 10.1097/CORR.0000000000000903.
- Results publication: PubMed 35626786Lebe M, van Stralen RA, Buddhdev P. Guided Growth of the Proximal Femur for the Management of the 'Hip at Risk' in Children with Cerebral Palsy-A Systematic Review. Children (Basel). 2022 Apr 25;9(5):609. doi: 10.3390/children9050609.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transphyseal screw in people with Cerebral Palsy (CP) and Guided Growth, run by Mohamed Adel Fathy Abdel aleem 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 3 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: opening soon, as of the sponsor's last update on 16 Sep 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 mohamed adel fathy, residant (01006775249, drmoadel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in femoral neck-shaft angle (measured on anteroposterior pelvic radiographs). (time frame: - Regular follow-up at 1.5, 3, 6, 12, and 24 months .). 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 NCT06983353, which also lists 2 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 16 Sep 2025.