SCFENCT03229590
Slipped Capital Femoral Epiphysis Treatment
An observational study of SCFE, run by Assiut University.
Trial summary
Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children. The primary source for the blood supply of the head of the femur is the deep branch of the medial femoral circumflex artery. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- SCFE
- What is being tested?
- Surgical dislocation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Aug 2020
- 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 10 to 18 years
- All sexes
- Child, Adult
Study population: The purpose of this study is to evaluate management Of moderate and severe degrees Slipped capital femoral epiphysis cases by using surgical dislocation technique .
Who may be able to join
- 1- Patients with moderate Slipped capital femoral epiphysis 2- Patients with severe Slipped capital femoral epiphysis
Who cannot join
- Patients with mild Slipped capital femoral epiphysis
About this study
Official title: Safe Surgical Dislocation in Slipped Capital Femoral Epiphysis
Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children. The primary source for the blood supply of the head of the femur is the deep branch of the medial femoral circumflex artery. Loder described a classification for Slipped capital femoral epiphysis based on ability of the child to walk or not(walking=stable, non-walking=unstable).
Read the detailed description
In slipped capital femoral epiphyses (SCFE), the severity of slippage correlates with poor long-term clinical outcome scores and radiographic evidence of osteoarthritis . In situ fixation of higher-grade SCFE has a low surgical risk and has been advocated by authors who believe the deformed hip has the potential to remodel with some restoration of the disturbed anatomic axes ; however, the remodeling potential remains controversial . Despite remodeling, the head-neck offset will remain abnormal . This is the cause of potential impingement of the femoral neck with the acetabular cartilage . Impingement in SCFE has been associated with damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after SCFE .
Ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip osteotomy and anterior capsulotomy preserving the blood supply to femoral head. The technique is based on extensive study of blood supply to the proximal femur. This technique allows us to completely dislocate the joint which allows complete access to intra articular pathology and allow reduction of the slipped capital femoral epiphysis .
- Conditions
- SCFE
- Being tested
- Surgical dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical dislocationProcedure or surgery
Reduction of slipped epiphysis by surgical dislocation
| Study group | Role | What they receive |
|---|---|---|
| Surgical dislocation | Reduction of slipped epiphysis via surgical dislocation technique Receives: Procedure: Surgical dislocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
this is a score for post operative evaluation of the hip (it is evaluate pain, support, Distance walked, Limp, Activities - shoes, socks, Stairs, Public transportation, Sitting, Range of motion) every item take a number then the summation of all numbers which ranged from 0 to 100 : <70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (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 SCFEStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229590
- Sponsor's protocol ID
- SCFE
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song MH, Jang WY, Park MS, Yoo WJ, Choi IH, Cho TJ. Slipped capital femoral epiphysis in children younger than 10 years old: clinical characteristics and efficacy of physeal-sparing procedures. J Pediatr Orthop B. 2018 Sep;27(5):379-386. doi: 10.1097/BPB.0000000000000485.
PubMed 28704299
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Surgical Dislocation in Slipped Capital Femoral Epiphysis
- ClinicalTrials.gov ID
- NCT03229590
- Acronym / sponsor ID
- SCFE
- Conditions
- SCFE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 25 Jul 2017 (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 represents approximately 10.8 cases per 100,000 children. The primary source for the blood supply of the head of the femur is the deep branch of the medial femoral circumflex artery. Loder described a classification for Slipped capital femoral epiphysis based on ability of the child to walk or not(walking=stable, non-walking=unstable).
Detailed description
In slipped capital femoral epiphyses (SCFE), the severity of slippage correlates with poor long-term clinical outcome scores and radiographic evidence of osteoarthritis . In situ fixation of higher-grade SCFE has a low surgical risk and has been advocated by authors who believe the deformed hip has the potential to remodel with some restoration of the disturbed anatomic axes ; however, the remodeling potential remains controversial . Despite remodeling, the head-neck offset will remain abnormal . This is the cause of potential impingement of the femoral neck with the acetabular cartilage . Impingement in SCFE has been associated with damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after SCFE .
Ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip osteotomy and anterior capsulotomy preserving the blood supply to femoral head. The technique is based on extensive study of blood supply to the proximal femur. This technique allows us to completely dislocate the joint which allows complete access to intra articular pathology and allow reduction of the slipped capital femoral epiphysis .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical dislocation | – | Procedure: Surgical dislocationReduction of slipped epiphysis via surgical dislocation technique |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The purpose of this study is to evaluate management Of moderate and severe degrees Slipped capital femoral epiphysis cases by using surgical dislocation technique .
Key inclusion criteria (1 listed)
- 1- Patients with moderate Slipped capital femoral epiphysis 2- Patients with severe Slipped capital femoral epiphysis
Key exclusion criteria (1 listed)
- Patients with mild Slipped capital femoral epiphysis
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 |
|---|---|---|
| Surgical dislocationReduction of slipped epiphysis by surgical dislocation | Procedure or surgery | Surgical dislocation |
Primary outcome
Harris Hip Score
Time frame: 6 months
this is a score for post operative evaluation of the hip (it is evaluate pain, support, Distance walked, Limp, Activities - shoes, socks, Stairs, Public transportation, Sitting, Range of motion) every item take a number then the summation of all numbers which ranged from 0 to 100 : <70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Background: PubMed 28704299Song MH, Jang WY, Park MS, Yoo WJ, Choi IH, Cho TJ. Slipped capital femoral epiphysis in children younger than 10 years old: clinical characteristics and efficacy of physeal-sparing procedures. J Pediatr Orthop B. 2018 Sep;27(5):379-386. doi: 10.1097/BPB.0000000000000485.
Related trials for SCFE
RecruitingObservational study
SCFE Longitudinal International Prospective Registry
Slipped Capital Femoral Epiphyses, SCFE
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of SCFE, run by Assiut 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 25 Jul 2017. 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?
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?
Harris Hip Score (time frame: 6 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 NCT03229590, 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 25 Jul 2017.