Slipped Capital Femoral EpiphysisNCT01220882
Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis
A study testing Radiographic skeletal age assessment in people with Slipped Capital Femoral Epiphysis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study is being done for two reasons: 1) to evaluate growth problems in the hip in patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults, and 2) to help doctors determine which patients are at risk for developing a SCFE on their opposite hip. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Slipped Capital Femoral Epiphysis
- What is being tested?
- Radiographic skeletal age assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2015
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Slipped capital femoral epiphysis
Who cannot join
- Prior Slipped capital femoral epiphysis not initially treated at our institution
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07101
Tamir Bloom, MD, bloomta@umdnj.edu
Tamir Bloom, MD
About this study
Official title: Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis
This study is being done for two reasons: 1) to evaluate growth problems in the hip in patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults, and 2) to help doctors determine which patients are at risk for developing a SCFE on their opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a SCFE on their other side. Being able to better determine which patients are at risk for developing a SCFE on the other side will help physicians better monitor patients with a history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By studying the growth centers seen on X-rays of your child's legs and elbow, the investigators may be able to better predict which children with a SCFE are at risk for developing a SCFE on their opposite hip and potential growth problems as they continue to grow.
Read the detailed description
After obtaining informed consent, pediatric patients presenting to our institution with a SCFE will have a single radiograph of the elbow, in addition to those radiographs currently obtained as part of routine evaluation and treatment (e.g. AP pelvis, bilateral hip laterals, scanogram, and hand bone age). This additional radiograph, a single one-time lateral elbow radiograph taken on initial presentation with a SCFE, will be used to assess bone age and compared with other radiographic methods, i.e. hand bone age, currently used to assess skeletal maturity. Scanogram of the lower extremities, at initial presentation and at the completion of skeletal growth, will be used to accurately assess the length of the lower extremities and evaluate limb length discrepancy at maturity. Treatment of the patient's SCFE and post-operative management will be as per routine care at our institution. Patients will be followed until skeletal maturity.
The medical records and radiographs of patients with SCFE will be collected. Patient data will include:
- Patient demographics- chronologic age, gender, race/ethnicity, standing height, weight, BMI, clinical follow-up duration
- SCFE type- chronicity of symptoms prior to presentation, Loder classification of slip stability, laterality, time between sequential SCFEs
- Skeletal maturity data- bone age, triradiate closure, Risser sign, modified Oxford bone age, olecanon method and the Simplified skeletal maturity scoring system
- Radiographic data- slip severity, physeal slope angle, and leg length discrepancy
- Complications
- Additional procedures
In order to compare the various radiographic methods of skeletal age assessment, the elbow hand and AP pelvis radiographs will be reviewed once by three independent and experienced observers, two pediatric orthopaedic surgeons and one musculoskeletal radiology attending. The radiographic skeletal age assessment will be discussed by these three observers in order to minimize intraobserver and interobserver errors.
- Conditions
- Slipped Capital Femoral Epiphysis
- Being tested
- Radiographic skeletal age assessment
- Keywords
- Slipped capital femoral epiphysis
- Medical subject headings
- Slipped Capital Femoral Epiphyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic skeletal age assessmentRadiation
bone age assessment from the elbow lateral radiograph
| Study group | Role | What they receive |
|---|---|---|
| Radiographic skeletal age assessment | No intervention | Participant group studied will include all pediatric patients presenting to our institution with a unilateral or bilateral SCFE. Patients with metabolic and endocrine conditions will be included. Receives: Radiation: Radiographic skeletal age assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic data on skeletal maturity and SCFE radiographic characteristics
Radiographic assessment on initial presentation of SCFE on hip and pelvis x-rays, limb length discrepancy on Scanogram, and bone age measurement using hand AP radiograph and lateral view of the elbow.
Measured: Day 1
Secondary outcomes (2)
Clinical examination
Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys).
Measured: Year 8
Radiographic evaluation of Limb length discrepancy on Scanogram
Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys).
Measured: Year 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2008
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slipped Capital Femoral EpiphysisStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bone123, Rutgers, The State University of New Jersey
- Investigators
- Tamir Bloom, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220882
- Sponsor's protocol ID
- 0120080287
- Status last verified
- Dec 2013
- First submitted
- 19 Aug 2010
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis
- ClinicalTrials.gov ID
- NCT01220882
- Acronym / sponsor ID
- 0120080287
- Conditions
- Slipped Capital Femoral Epiphysis
- Keywords
- Slipped capital femoral epiphysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Oct 2010 (estimated)
- 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.
This study is being done for two reasons: 1) to evaluate growth problems in the hip in patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults, and 2) to help doctors determine which patients are at risk for developing a SCFE on their opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a SCFE on their other side. Being able to better determine which patients are at risk for developing a SCFE on the other side will help physicians better monitor patients with a history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By studying the growth centers seen on X-rays of your child's legs and elbow, the investigators may be able to better predict which children with a SCFE are at risk for developing a SCFE on their opposite hip and potential growth problems as they continue to grow.
Detailed description
After obtaining informed consent, pediatric patients presenting to our institution with a SCFE will have a single radiograph of the elbow, in addition to those radiographs currently obtained as part of routine evaluation and treatment (e.g. AP pelvis, bilateral hip laterals, scanogram, and hand bone age). This additional radiograph, a single one-time lateral elbow radiograph taken on initial presentation with a SCFE, will be used to assess bone age and compared with other radiographic methods, i.e. hand bone age, currently used to assess skeletal maturity. Scanogram of the lower extremities, at initial presentation and at the completion of skeletal growth, will be used to accurately assess the length of the lower extremities and evaluate limb length discrepancy at maturity. Treatment of the patient's SCFE and post-operative management will be as per routine care at our institution. Patients will be followed until skeletal maturity.
The medical records and radiographs of patients with SCFE will be collected. Patient data will include:
- Patient demographics- chronologic age, gender, race/ethnicity, standing height, weight, BMI, clinical follow-up duration
- SCFE type- chronicity of symptoms prior to presentation, Loder classification of slip stability, laterality, time between sequential SCFEs
- Skeletal maturity data- bone age, triradiate closure, Risser sign, modified Oxford bone age, olecanon method and the Simplified skeletal maturity scoring system
- Radiographic data- slip severity, physeal slope angle, and leg length discrepancy
- Complications
- Additional procedures
In order to compare the various radiographic methods of skeletal age assessment, the elbow hand and AP pelvis radiographs will be reviewed once by three independent and experienced observers, two pediatric orthopaedic surgeons and one musculoskeletal radiology attending. The radiographic skeletal age assessment will be discussed by these three observers in order to minimize intraobserver and interobserver errors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiographic skeletal age assessment | No intervention | Radiation: Radiographic skeletal age assessmentParticipant group studied will include all pediatric patients presenting to our institution with a unilateral or bilateral SCFE. Patients with metabolic and endocrine conditions will be included. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Slipped capital femoral epiphysis
Key exclusion criteria (1 listed)
- Prior Slipped capital femoral epiphysis not initially treated at our institution
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 |
|---|---|---|
| Radiographic skeletal age assessmentbone age assessment from the elbow lateral radiograph | Radiation | Radiographic skeletal age assessment |
Primary outcome
Radiographic data on skeletal maturity and SCFE radiographic characteristics
Time frame: Day 1
Radiographic assessment on initial presentation of SCFE on hip and pelvis x-rays, limb length discrepancy on Scanogram, and bone age measurement using hand AP radiograph and lateral view of the elbow.
2 secondary outcomes
Clinical examination
Time frame: Year 8
Radiographic evaluation of Limb length discrepancy on Scanogram
Time frame: Year 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
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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.
Tamir Bloom, MD principal investigator
Rutgers 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 Radiographic skeletal age assessment in people with Slipped Capital Femoral Epiphysis, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 Dec 2013. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamir Bloom, MD (973-972-0246, bloomta@umdnj.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic data on skeletal maturity and SCFE radiographic characteristics (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2013.