Slipped Capital Femoral EpiphysisSCFENCT05758051
Management of Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur Case Report.
A study testing subtrochanteric valgus osteotomy in people with Slipped Capital Femoral Epiphysis, run by Assiut University at 1 site in Egypt.
Trial summary
Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur managed by subtrochanteric valgus osteotomy Read more about this study
- Who is it for?
- Ages 3 to 14 years, men only
- Conditions the study is for
- Slipped Capital Femoral Epiphysis
- What is being tested?
- subtrochanteric valgus osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jan 2023
- Phase
- Interventional
- 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 3 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- scfe on top NOF
Who cannot join
- pathological fracture
Trial locations and contacts
1 site in 1 country.
About this study
Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur managed by subtrochanteric valgus osteotomy
Read the detailed description
The incidence of Slipped capital femoral epiphysis (SCFE) after management of femoral neck fracture in pediatrics is very rare. In this case report, a 9-year-old female child sustained left sided femur neck fracture after a motor car accident. The fracture was fixed by two cannulated screws and healing with mild varus occurred after 1.5 months. However, progressive slippage of femoral epiphysis was observed. This was treated by subtrochanteric valgus osteotomy
- Conditions
- Slipped Capital Femoral Epiphysis
- Being tested
- subtrochanteric valgus osteotomy
- Keywords
- Slipped capital femoral epiphysis, SCFE, coxa vara, fracture neck of femur
- Medical subject headings
- Slipped Capital Femoral Epiphyses, Coxa Vara, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subtrochanteric valgus osteotomyProcedure or surgery
subtrochanteric valgus osteotomy
| Study group | Role | What they receive |
|---|---|---|
| subtrochanteric valgus osteotomy | Other | subtrochanteric valgus osteotomy Receives: Procedure: subtrochanteric valgus osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified McKay's criteria
I excellent II Good III Fair IV Poor
Measured: one year
Secondary outcomes (1)
Rust union score
union
- absent callus visible fracture
- present callus visible fracture
- present callus invisible fracture
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
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 Slipped Capital Femoral EpiphysisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- subtrochanteric valgus osteotomy
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Elbaseet, Assiut University
- Investigators
- Hesaham M Elbaseet, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758051
- Sponsor's protocol ID
- SCFENOF
- Acronym
- SCFE
- Status last verified
- Mar 2023
- First submitted
- 5 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yerli M, Ocak O, Yuce A, Bayraktar TO, Kir MC, Imren Y, Dedeoglu SS, Gurbuz H. Retrospective analysis of 35 pediatric femoral neck fractures. Eur J Orthop Surg Traumatol. 2022 Oct;32(7):1385-1390. doi: 10.1007/s00590-021-03126-6. Epub 2021 Sep 20.
PubMed 34542716Li H, Zhao L, Huang L, Kuo KN. Delayed Slipped Capital Femoral Epiphysis After Treatment of Femoral Neck Fracture in Children. Clin Orthop Relat Res. 2015 Aug;473(8):2712-7. doi: 10.1007/s11999-014-4067-y. Epub 2014 Nov 27.
PubMed 25427426
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur Case Report.
- ClinicalTrials.gov ID
- NCT05758051
- Acronym / sponsor ID
- SCFE / SCFENOF
- Conditions
- Slipped Capital Femoral Epiphysis
- Keywords
- Slipped capital femoral epiphysis, SCFE, coxa vara, fracture neck of femur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 7 Mar 2023 (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.
Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur managed by subtrochanteric valgus osteotomy
Detailed description
The incidence of Slipped capital femoral epiphysis (SCFE) after management of femoral neck fracture in pediatrics is very rare. In this case report, a 9-year-old female child sustained left sided femur neck fracture after a motor car accident. The fracture was fixed by two cannulated screws and healing with mild varus occurred after 1.5 months. However, progressive slippage of femoral epiphysis was observed. This was treated by subtrochanteric valgus osteotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- subtrochanteric valgus osteotomy
| Arm | Type | Receives |
|---|---|---|
| subtrochanteric valgus osteotomy | Other | Procedure: subtrochanteric valgus osteotomysubtrochanteric valgus osteotomy |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- scfe on top NOF
Key exclusion criteria (1 listed)
- pathological fracture
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 |
|---|---|---|
| subtrochanteric valgus osteotomysubtrochanteric valgus osteotomy | Procedure or surgery | subtrochanteric valgus osteotomy |
Primary outcome
modified McKay's criteria
Time frame: one year
I excellent II Good III Fair IV Poor
1 secondary outcome
Rust union score
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 34542716Yerli M, Ocak O, Yuce A, Bayraktar TO, Kir MC, Imren Y, Dedeoglu SS, Gurbuz H. Retrospective analysis of 35 pediatric femoral neck fractures. Eur J Orthop Surg Traumatol. 2022 Oct;32(7):1385-1390. doi: 10.1007/s00590-021-03126-6. Epub 2021 Sep 20.
- Background: PubMed 25427426Li H, Zhao L, Huang L, Kuo KN. Delayed Slipped Capital Femoral Epiphysis After Treatment of Femoral Neck Fracture in Children. Clin Orthop Relat Res. 2015 Aug;473(8):2712-7. doi: 10.1007/s11999-014-4067-y. Epub 2014 Nov 27.
- 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. This study is not recruiting at the moment.
Hesaham M Elbaseet, MD principal investigator
Assiut 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 subtrochanteric valgus osteotomy in people with Slipped Capital Femoral Epiphysis, run by Assiut University 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 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: finished, as of the sponsor's last update on 7 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified McKay's criteria (time frame: one year). 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 NCT05758051, 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 7 Mar 2023.