Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

NCT ID: NCT01220882

Last Updated: 2013-12-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Slipped Capital Femoral Epiphysis

Keywords

Slipped capital femoral epiphysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

Radiographic skeletal age assessment

Intervention Type: RADIATION

bone age assessment from the elbow lateral radiograph

Interventions

Radiographic skeletal age assessment

bone age assessment from the elbow lateral radiograph

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Slipped capital femoral epiphysis

Exclusion Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

bone123

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamir Bloom, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tamir Bloom, MD

Role: CONTACT

Phone: 973-972-0246

Email: bloomta@umdnj.edu

Facility Contacts

Tamir Bloom, MD

Role: primary

Other Identifiers

0120080287

Identifier Type: -

Identifier Source: org_study_id