Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis
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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 |
- 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.
- 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 |
Inclusion Criteria:
- Slipped capital femoral epiphysis
Exclusion Criteria:
- Prior Slipped capital femoral epiphysis
Contacts and Locations| Contact: Tamir Bloom, MD | 973-972-0246 | bloomta@umdnj.edu |
| 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 | |
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