Multi-Center Adolescent Clavicle Fracture Trial: Operative Vs. Non-Operative Treatment

Last updated: November 12, 2024
Sponsor: Boston Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Surgery

Clinical Study ID

NCT04250415
IRB-P00004816
  • Ages 10-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-termfollow-up coordinator based out of Boston Children's Hospital for long-termfollow-up questions (out to the 2-year time point). This can/will be done via phone,mail, text message, and/or email.

Exclusion

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 significantlyalters normal bone healing

  • Unable to project injury X-ray films if treated initially at an institution that isnot a member of this register

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Surgery
Phase:
Study Start date:
March 11, 2013
Estimated Completion Date:
June 01, 2026

Connect with a study center

  • University of California San Francisco Benioff Children's Hospital Oakland

    Oakland, California
    United States

    Active - Recruiting

  • Rady Children's Hospital

    San Diego, California
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Michigan Medical Center

    Ann Arbor, Michigan
    United States

    Active - Recruiting

  • Washington University at St. Louis

    Saint Louis, Missouri
    United States

    Active - Recruiting

  • Campbell Clinic Orthopaedics

    Memphis, Tennessee
    United States

    Active - Recruiting

  • Texas Scottish Rite Hospital

    Dallas, Texas
    United States

    Active - Recruiting

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