Plating Clavicle Fractures

United States Army Institute of Surgical Research

Status

Unknown

Conditions

Clavicle Fracture, Non Union/Malunion

Treatments

Procedure: anterior-inferior plate

Procedure: superior plate

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00871468

H-08-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.