Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

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

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-05-31

Brief Summary

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This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study.

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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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percuataneous plate fixation

an approach with three small longitudinal incisions

xrays

Intervention Type OTHER

xrays from 2 week postop to 5 year postop

open plate fixation

large transverse incision

xrays

Intervention Type OTHER

xrays from 2 week postop to 5 year postop

Interventions

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xrays

xrays from 2 week postop to 5 year postop

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* displaced (i.e., no cortical contact of fracture ends on two xray view) diaphyseal clavicle fracture
* fracture pattern amenable to plate fixation
* neurologic injury requiring open reduction
* open clavicle fracture
* clavicle nonunion (defined as an absence of radiographic bony union in the presence of neurologic, cosmetic, or functional complaints at six months duration
* symptomatic malunion (defined as a healed, but shortened or angulated fracture in the presence of neurologic, cosmetic, or functional complaints)
* clavicle fracture associated with a scapular of humeral fracture (floating shoulder)

Exclusion Criteria

* a nondisplaced or minimally displaced closed, neurovascularly intact clavicle fracture
* fracture of the medial or lateral end of the clavicle
* pathological fracture
* patient is unable to medically tolerate general anesthesia
* patient is unable to provide informed consent or comply with completing questionnaires

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No