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Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Slipped Capital Femoral Epiphysis

Intervention: Radiographic skeletal age assessment (Radiation)

Phase: N/A

Status: Recruiting

Sponsored by: Rutgers, The State University of New Jersey

Official(s) and/or principal investigator(s):
Tamir Bloom, MD, Principal Investigator, Affiliation: Rutgers New Jersey Medical School

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

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.

Clinical Details

Official title: Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis

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

Primary outcome: Radiographic data on skeletal maturity and SCFE radiographic characteristics

Secondary outcome:

Clinical examination

Radiographic evaluation of Limb length discrepancy on Scanogram

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

Minimum age: 8 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Slipped capital femoral epiphysis

Exclusion Criteria:

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

Locations and Contacts

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

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

Starting date: October 2008
Last updated: December 24, 2013

Page last updated: November 27, 2014

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