Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis

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 Overview

• Status: Unknown
• Conditions: Slipped Capital Femoral Epiphysis
• Intervention / Treatment: Radiation: Radiographic skeletal age assessment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamir Bloom, MD; Phone Number: 973-972-0246; Email: bloomta@umdnj.edu

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • Recruiting
      • University of Medicine and Dentistry of New Jersey
      • Contact: Tamir Bloom, MD; Email: bloomta@umdnj.edu
      • Principal Investigator: Tamir Bloom, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Slipped capital femoral epiphysis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Tamir Bloom, MD, Rutgers University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Slipped capital femoral epiphysis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Osteochondrodysplasias; Epiphyses, Slipped; Slipped Capital Femoral Epiphyses
• Other Study ID Numbers: 0120080287