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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-11

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Clavicle Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Operative Arm

Surgery

Intervention Type PROCEDURE

Non-operative Arm

No interventions assigned to this group

Interventions

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Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No