Plating Clavicle Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871468
Recruitment Status : Active, not recruiting
First Posted : March 30, 2009
Last Update Posted : October 13, 2017
William Beaumont Army Medical Center
Information provided by (Responsible Party):
United States Army Institute of Surgical Research

Brief 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.

Condition or disease Intervention/treatment Phase
Clavicle Fracture, Non Union/Malunion Procedure: superior plate Procedure: anterior-inferior plate Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
Study Start Date : October 2008
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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

Primary Outcome Measures :
  1. Less irritation with anterior-inferior plating and less need for hardware removal. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. DASH (Disability of Arm, Shoulder and Hand) and constant scores [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871468

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

Responsible Party: United States Army Institute of Surgical Research Identifier: NCT00871468     History of Changes
Other Study ID Numbers: H-08-003
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Ununited
Wounds and Injuries