Newark, New Jersey 07101


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Slipped capital femoral epiphysis Exclusion Criteria: - Prior Slipped capital femoral epiphysis not initially treated at our institution


NCT ID:

NCT01220882


Primary Contact:

Principal Investigator
Tamir Bloom, MD
Rutgers New Jersey Medical School

Tamir Bloom, MD
Phone: 973-972-0246
Email: bloomta@umdnj.edu


Backup Contact:

N/A


Location Contact:

Newark, New Jersey 07101
United States

Tamir Bloom, MD
Email: bloomta@umdnj.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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