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Plating Clavicle Fractures

NCT ID: NCT00871468

Last Updated: 2017-10-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2018-08-31

Brief Summary

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The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

Detailed Description

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Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.

Conditions

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Clavicle Fracture, Non Union/Malunion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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superior plate

Clavicle plate on the superior surface of the bone

Group Type ACTIVE_COMPARATOR

superior plate

Intervention Type PROCEDURE

Open reduction internal fixation (ORIF) clavicle with superior plate

anterior inferior plate

plate placed on anterior inferior surface of bone

Group Type EXPERIMENTAL

anterior-inferior plate

Intervention Type PROCEDURE

ORIF clavicle with anterior inferior plate

Interventions

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superior plate

Open reduction internal fixation (ORIF) clavicle with superior plate

Intervention Type PROCEDURE

anterior-inferior plate

ORIF clavicle with anterior inferior plate

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Active duty, Reservists, National Guard service members
* completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments)
* a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment)
* chronic nonunion and malunion fractures
* no medical contraindications to general anesthesia
* provided informed consent.

Exclusion Criteria

* an age of less than eighteen years or greater than sixty five years
* a fracture in the proximal or distal third of the clavicle not amenable to plating
* a pathological fracture
* an associated head injury (a Glasgow Coma Scale score of \<15 at 21 days after injury)
* an inability to comply with followup
* a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy)
* a lack of consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Army Medical Center

FED

Sponsor Role collaborator

United States Army Institute of Surgical Research

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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William Beaumont Army Medical Center

El Paso, Texas, United States

Site Status

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-08-003

Identifier Type: -

Identifier Source: org_study_id