Plating Clavicle Fractures

Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial

NCT00871468•United States Army Institute of Surgical Research

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Summary

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

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

William Beaumont Army Medical Center

El Paso, Texas, United States

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Key Dates

Start Date

October 1, 2008

Primary Completion Date

August 1, 2018

Completion Date

August 1, 2018

Last Updated

October 13, 2017

Enrollment

ESTIMATED participants

Conditions

Clavicle Fracture, Non Union/Malunion

Interventions

superior plate

PROCEDURE

anterior-inferior plate

PROCEDURE

Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes

NCT07414654

PseudarthrosisClavicle Fracture+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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