Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

Slipped Capital Femoral Epiphysis Clinical Trial

Official title:

Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01220882
• Other study ID #: 0120080287
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2010
• Last updated: December 24, 2013
• Start date: October 2008
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: Rutgers, The State University of New Jersey
• Contact: Tamir Bloom, MD
• Phone: 973-972-0246
• Email: bloomta[@]umdnj.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• Slipped capital femoral epiphysis

Exclusion Criteria:

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis

Intervention

Radiation:
• Radiographic skeletal age assessment
bone age assessment from the elbow lateral radiograph

Locations

Country	Name	City	State
United States	University of Medicine and Dentistry of New Jersey	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1	No
Secondary	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).	Year 8	No
Secondary	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).	Year 8	No