Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

This study is currently recruiting participants.
Verified January 2013 by University of Medicine and Dentistry New Jersey
Sponsor:
Information provided by (Responsible Party):
bone123, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01220882
First received: August 19, 2010
Last updated: January 27, 2013
Last verified: January 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
Other: Radiographs for skeletal 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 University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Clinical assessment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    initial presentation (i.e. when the patient first presents to the hospital or emergency room)

  • 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 Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Diagnostics: x-rays for bone age assessment
Patients with a slipped capital femoral epiphysis
Other: Radiographs for skeletal assessment
bone age assessment from pelvis, hand and elbow

  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
  Contacts and Locations
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
University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: bone123, Assistant Professor, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01220882     History of Changes
Other Study ID Numbers: 0120080287
Study First Received: August 19, 2010
Last Updated: January 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Slipped capital femoral epiphysis

ClinicalTrials.gov processed this record on May 19, 2013