Summary

Eligibility
for people ages 10-18 (full criteria)
Location
at Oakland, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Coleen Sabatini, MD
Photo of Coleen Sabatini
Coleen Sabatini

Description

Summary

Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.

Official Title

Prospective, Multi-Center Adolescent Clavicle Fracture Registry

Keywords

Clavicle Fracture Adolescent Fractures, Bone Surgery

Eligibility

You can join if…

Open to people ages 10-18

  • Aged 10-18
  • Diagnosis of a primary diaphyseal clavicle fracture
  • Fracture must be completely displaced
  • Patient - BCH subjects must pursue follow-up at BCH main campus or Walthammust be 59 days or less from the primary fracture
  • All study patients (across all sites) must agree to be contacted by a long-term follow-up coordinator based out of Boston Children's Hospital for long-term follow-up questions (out to the 2-year time point). This can/will be done via phone, mail, text message, and/or email.

You CAN'T join if...

  • Pathological fracture
  • Previous ipsilateral fracture
  • Unable to fill out outcome collection forms
  • Refusal to participate
  • Underlying neurologic or neurocognitive disorder that affects UE function
  • Underlying metabolic bone disorder (e.g. osteogenesis imperfecta) that significantly alters normal bone healing
  • Unable to project injury X-ray films if treated initially at an institution that is not a member of this register

Locations

  • University of California San Francisco Benioff Children's Hospital Oakland accepting new patients
    Oakland California United States
  • Rady Children's Hospital accepting new patients
    San Diego California United States

Lead Scientist at UCSF

  • Coleen Sabatini, MD
    Professor, Orthopaedic Surgery. Authored (or co-authored) 28 research publications. Research interests: Pediatric orthopaedic surgery · Global surgery · Global health · Pediatric trauma · Health equity · Disparities in health · Musculoskeletal health disparities · Access to care · Clinical outcomes research · Clubfoot · Medical education · Dance medicine.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Children's Hospital
ID
NCT04250415
Study Type
Observational [Patient Registry]
Last Updated