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Plating Clavicle Fractures

Primary Purpose

Clavicle Fracture, Non Union/Malunion

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
superior plate
anterior-inferior plate
Sponsored by
United States Army Institute of Surgical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Fracture, Non Union/Malunion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • William Beaumont Army Medical Center
  • US Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

superior plate

anterior inferior plate

Arm Description

Clavicle plate on the superior surface of the bone

plate placed on anterior inferior surface of bone

Outcomes

Primary Outcome Measures

Less irritation with anterior-inferior plating and less need for hardware removal.

Secondary Outcome Measures

DASH (Disability of Arm, Shoulder and Hand) and constant scores

Full Information

First Posted
March 26, 2009
Last Updated
October 11, 2017
Sponsor
United States Army Institute of Surgical Research
Collaborators
William Beaumont Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00871468
Brief Title
Plating Clavicle Fractures
Official Title
Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Institute of Surgical Research
Collaborators
William Beaumont Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture, Non Union/Malunion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
superior plate
Arm Type
Active Comparator
Arm Description
Clavicle plate on the superior surface of the bone
Arm Title
anterior inferior plate
Arm Type
Experimental
Arm Description
plate placed on anterior inferior surface of bone
Intervention Type
Procedure
Intervention Name(s)
superior plate
Intervention Description
Open reduction internal fixation (ORIF) clavicle with superior plate
Intervention Type
Procedure
Intervention Name(s)
anterior-inferior plate
Intervention Description
ORIF clavicle with anterior inferior plate
Primary Outcome Measure Information:
Title
Less irritation with anterior-inferior plating and less need for hardware removal.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
DASH (Disability of Arm, Shoulder and Hand) and constant scores
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
William Beaumont Army Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920-5001
Country
United States
Facility Name
US Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

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Plating Clavicle Fractures

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