Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis
|ClinicalTrials.gov Identifier: NCT01220882|
Recruitment Status : Unknown
Verified December 2013 by bone123, Rutgers, The State University of New Jersey.
Recruitment status was: Recruiting
First Posted : October 14, 2010
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Slipped Capital Femoral Epiphysis||Radiation: Radiographic skeletal age assessment||Not Applicable|
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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
No Intervention: Radiographic skeletal age assessment
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.
Radiation: Radiographic skeletal age assessment
bone age assessment from the elbow lateral radiograph
- 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.
- Clinical examination [ Time Frame: Year 8 ]Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys).
- Radiographic evaluation of Limb length discrepancy on Scanogram [ Time Frame: Year 8 ]Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220882
|Contact: Tamir Bloom, MDfirstname.lastname@example.org|
|United States, New Jersey|
|University of Medicine and Dentistry of New Jersey||Recruiting|
|Newark, New Jersey, United States, 07101|
|Contact: Tamir Bloom, MD email@example.com|
|Principal Investigator: Tamir Bloom, MD|
|Principal Investigator:||Tamir Bloom, MD||Rutgers New Jersey Medical School|