Plating Clavicle Fractures

October 11, 2017 updated by: United States Army Institute of Surgical Research

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79920-5001
        • William Beaumont Army Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • US Army Institute of Surgical Research

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: superior plate
Clavicle plate on the superior surface of the bone
Procedure: superior plate
Open reduction internal fixation (ORIF) clavicle with superior plate
EXPERIMENTAL: anterior inferior plate
plate placed on anterior inferior surface of bone
Procedure: anterior-inferior plate
ORIF clavicle with anterior inferior plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Less irritation with anterior-inferior plating and less need for hardware removal.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
DASH (Disability of Arm, Shoulder and Hand) and constant scores
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Institute of Surgical Research

Collaborators

William Beaumont Army Medical Center

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 Major Dates

Study Start

October 1, 2008

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (ESTIMATE)

March 30, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-08-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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