Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis

NCT01220882 | Unknown DMC

• 1 other identifier: 0120080287
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Slipped Capital Femoral Epiphysis

Keywords

Slipped capital femoral epiphysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (2)

• Clinical examination

  Year 8

• Radiographic evaluation of Limb length discrepancy on Scanogram

  Year 8

Study Arms (1)

Radiographic skeletal age assessment

NO INTERVENTION

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

Interventions

Radiographic skeletal age assessment RADIATION

bone age assessment from the elbow lateral radiograph

Radiographic skeletal age assessment

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Slipped capital femoral epiphysis

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07101, United States

RECRUITING

MeSH Terms

Conditions

Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Epiphyses, Slipped

Study Officials

• Tamir Bloom, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamir Bloom, MD

CONTACT

973-972-0246; bloomta@umdnj.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

US (1)