Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
bone123, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01220882
First received: August 19, 2010
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Slipped Capital Femoral Epiphysis
Radiation: Radiographic skeletal age assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Radiographic data on skeletal maturity and SCFE radiographic characteristics [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Year 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Year 8 ] [ Designated as safety issue: No ]
    Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys).


Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Slipped capital femoral epiphysis

Exclusion Criteria:

  • Prior Slipped capital femoral epiphysis not initially treated at our institution
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220882

Contacts
Contact: Tamir Bloom, MD 973-972-0246 bloomta@umdnj.edu

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Newark, New Jersey, United States, 07101
Contact: Tamir Bloom, MD       bloomta@umdnj.edu   
Principal Investigator: Tamir Bloom, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Tamir Bloom, MD Rutgers New Jersey Medical School
  More Information

No publications provided

Responsible Party: bone123, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01220882     History of Changes
Other Study ID Numbers: 0120080287
Study First Received: August 19, 2010
Last Updated: December 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Slipped capital femoral epiphysis

Additional relevant MeSH terms:
Slipped Capital Femoral Epiphyses
Bone Diseases
Bone Diseases, Developmental
Epiphyses, Slipped
Musculoskeletal Diseases
Osteochondrodysplasias

ClinicalTrials.gov processed this record on November 20, 2014