ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2013-03-11
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04250415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 10-18
  2. * Diagnosis of a primary diaphyseal clavicle fracture
  3. * Fracture must be completely displaced
  4. * Patient - BCH subjects must pursue follow-up at BCH main campus or Waltham must be 59 days or less from the primary fracture
  5. * 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.
  1. * Pathological fracture
  2. * Previous ipsilateral fracture
  3. * Unable to fill out outcome collection forms
  4. * Refusal to participate
  5. * Underlying neurologic or neurocognitive disorder that affects UE function
  6. * Underlying metabolic bone disorder (e.g. osteogenesis imperfecta) that significantly alters normal bone healing
  7. * Unable to project injury X-ray films if treated initially at an institution that is not a member of this register

Contacts and Locations

Principal Investigator

Benton E Heyworth, MD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

University of California San Francisco Benioff Children's Hospital Oakland
Oakland, California
United States
Rady Children's Hospital
San Diego, California
United States
Children's Healthcare of Atlanta
Atlanta, Georgia
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan Medical Center
Ann Arbor, Michigan
United States
Washington University at St. Louis
Saint Louis, Missouri
United States
Campbell Clinic Orthopaedics
Memphis, Tennessee
United States
Texas Scottish Rite Hospital
Dallas, Texas
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Benton E Heyworth, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-03-11
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2013-03-11
Study Completion Date2027-06-01

Terms related to this study

Keywords Provided by Researchers

  • Adolescent

Additional Relevant MeSH Terms

  • Clavicle Fracture