Plating Clavicle Fractures

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
William Beaumont Army Medical Center
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00871468
First received: March 26, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention
Clavicle Fracture, Non Union/Malunion
Procedure: superior plate
Procedure: anterior-inferior plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Less irritation with anterior-inferior plating and less need for hardware removal. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DASH (Disability of Arm, Shoulder and Hand) and constant scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871468

Locations
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
  More Information

No publications provided

Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00871468     History of Changes
Other Study ID Numbers: H-08-003
Study First Received: March 26, 2009
Last Updated: March 4, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 23, 2014