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Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

Primary Purpose

Slipped Capital Femoral Epiphysis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiographic skeletal age assessment
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Slipped Capital Femoral Epiphysis focused on measuring Slipped capital femoral epiphysis

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Slipped capital femoral epiphysis

Exclusion Criteria:

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

Sites / Locations

  • University of Medicine and Dentistry of New JerseyRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Radiographic skeletal age assessment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
August 19, 2010
Last Updated
December 24, 2013
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01220882
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Slipped Capital Femoral Epiphysis
Keywords
Slipped capital femoral epiphysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiographic skeletal age assessment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiographic skeletal age assessment
Intervention Description
bone age assessment from the elbow lateral radiograph
Primary Outcome Measure Information:
Title
Radiographic data on skeletal maturity and SCFE radiographic characteristics
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Clinical examination
Description
Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys).
Time Frame
Year 8
Title
Radiographic evaluation of Limb length discrepancy on Scanogram
Description
Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys).
Time Frame
Year 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Slipped capital femoral epiphysis Exclusion Criteria: Prior Slipped capital femoral epiphysis not initially treated at our institution
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamir Bloom, MD
Phone
973-972-0246
Email
bloomta@umdnj.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamir Bloom, MD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamir Bloom, MD
Email
bloomta@umdnj.edu
First Name & Middle Initial & Last Name & Degree
Tamir Bloom, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

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