Orthopedic DisorderNCT05194774
Greater Trochanter Epiphysiodesis In Hip Pathology
An observational study of Orthopedic Disorder, run by Al-Azhar University.
Trial summary
One of the most common problems in the treatment of pediatric patients with various disorders of the hip joint is the formation of deformity of the proximal femur, such as abnormal growth of the greater trochanter, which causes it to be positioned high in relation to the femoral head. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Greater Trochanter epiphysiodesis
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 10 years
- All sexes
- Child
Study population: The patients come to the outpatient clinic and underwent clinical and radiological examination will be done , then preparation to surgery by screw
Who may be able to join
- emerging deformities of the proximal femur with a high position of the greater trochanter, in which its apex was located above the center of the femoral head but below its superior pole; changes in the structure of the femoral neck, accompanied by its shortening; functioning growth zone of the greater trochanter at the time of intervention; and patients without surgical treatment history
Who cannot join
- hip dislocation upon examination; patients with varus deformity of the femoral neck (neck-shaft angle <120°), patients with complications of surgical interventions, trauma, rickets, and rheumatoid arthritis; and patients with neurological disorders and Refusal to participate in this study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of The Greater Trochanter Epiphysiodesis In Treatment Of Children With Hip Pathology
One of the most common problems in the treatment of pediatric patients with various disorders of the hip joint is the formation of deformity of the proximal femur, such as abnormal growth of the greater trochanter, which causes it to be positioned high in relation to the femoral head. This condition is called "relative overgrowth of the greater trochanter" (ROGT).
- Conditions
- Orthopedic Disorder
- Being tested
- Greater Trochanter epiphysiodesis
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greater Trochanter epiphysiodesisProcedure or surgery
epiphysiodesis by cortical screw and washer
| Study group | Role | What they receive |
|---|---|---|
| GT overgrowth group | pediatric patients with greater trochanter overgrowth Receives: Procedure: Greater Trochanter epiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological measurments
articulo-trochanteric distance
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Yasser, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194774
- Sponsor's protocol ID
- GTE
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCarthy JJ, Weiner DS. Greater trochanteric epiphysiodesis. Int Orthop. 2008 Aug;32(4):531-4. doi: 10.1007/s00264-007-0346-5. Epub 2007 Mar 10.
PubMed 17351775
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of The Greater Trochanter Epiphysiodesis In Treatment Of Children With Hip Pathology
- ClinicalTrials.gov ID
- NCT05194774
- Acronym / sponsor ID
- GTE
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Jan 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.
One of the most common problems in the treatment of pediatric patients with various disorders of the hip joint is the formation of deformity of the proximal femur, such as abnormal growth of the greater trochanter, which causes it to be positioned high in relation to the femoral head. This condition is called "relative overgrowth of the greater trochanter" (ROGT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT overgrowth group | – | Procedure: Greater Trochanter epiphysiodesispediatric patients with greater trochanter overgrowth |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- The patients come to the outpatient clinic and underwent clinical and radiological examination will be done , then preparation to surgery by screw
Key inclusion criteria (1 listed)
- emerging deformities of the proximal femur with a high position of the greater trochanter, in which its apex was located above the center of the femoral head but below its superior pole; changes in the structure of the femoral neck, accompanied by its shortening; functioning growth zone of the greater trochanter at the time of intervention; and patients without surgical treatment history
Key exclusion criteria (1 listed)
- hip dislocation upon examination; patients with varus deformity of the femoral neck (neck-shaft angle <120°), patients with complications of surgical interventions, trauma, rickets, and rheumatoid arthritis; and patients with neurological disorders and Refusal to participate in this study
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 |
|---|---|---|
| Greater Trochanter epiphysiodesisepiphysiodesis by cortical screw and washer | Procedure or surgery | GT overgrowth group |
Primary outcome
Radiological measurments
Time frame: 12 month
articulo-trochanteric distance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Background: PubMed 17351775McCarthy JJ, Weiner DS. Greater trochanteric epiphysiodesis. Int Orthop. 2008 Aug;32(4):531-4. doi: 10.1007/s00264-007-0346-5. Epub 2007 Mar 10.
- Individual participant dataSharing planned: No
Related trials for Orthopedic Disorder
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Al-Azhar University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Yasser, MD (0201061303076, docmuhammed1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological measurments (time frame: 12 month). 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 NCT05194774, which also lists 1 linked publication.
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 18 Jan 2022.