Status:
UNKNOWN
Plating Clavicle Fractures
Lead Sponsor:
United States Army Institute of Surgical Research
Collaborating Sponsors:
William Beaumont Army Medical Center
Conditions:
Clavicle Fracture, Non Union/Malunion
Eligibility:
All Genders
18-65 years
Phase:
NA
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 scori...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00871468
Start Date
October 1 2008
End Date
August 1 2018
Last Update
October 13 2017
Active Locations (2)
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1
William Beaumont Army Medical Center
El Paso, Texas, United States, 79920-5001
2
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234