Current Environment:

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.

Conditions

Clavicle Fracture

Recruitment Status

Recruiting

Eligibility Criteria

Inclusion Criteria:

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 Waltham must 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.

Exclusion Criteria:

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

Intervention

Intervention Type

Intervention Name

Procedure

Surgery

Gender

All

Minimum Age

10 Years

Maximum Age

18 Years

Download Date

February 11, 2022

Principal Investigator

Benton Heyworth

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: