Clinical trial NCT01220882: Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis
Official title: Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Slipped Capital Femoral Epiphysis
Keywords: Slipped capital femoral epiphysis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Slipped capital femoral epiphysis

Exclusion Criteria:

* Prior Slipped capital femoral epiphysis not initially treated at our institution

Primary outcomes:
measure: Radiographic data on skeletal maturity and SCFE radiographic characteristics
timeFrame: Day 1
Secondary outcomes:
measure: Clinical examination
timeFrame: Year 8
measure: Radiographic evaluation of Limb length discrepancy on Scanogram
timeFrame: Year 8
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Tamir Bloom, MD
role: PRINCIPAL_INVESTIGATOR
References: