Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Clavicle Fracture

Treatments

Other: xrays

Study type

Observational

Funder types

Other

Identifiers

NCT01405703

36814

Details and patient eligibility

About

This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study.

Enrollment

35 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older
displaced (i.e., no cortical contact of fracture ends on two xray view) diaphyseal clavicle fracture
fracture pattern amenable to plate fixation
neurologic injury requiring open reduction
open clavicle fracture
clavicle nonunion (defined as an absence of radiographic bony union in the presence of neurologic, cosmetic, or functional complaints at six months duration
symptomatic malunion (defined as a healed, but shortened or angulated fracture in the presence of neurologic, cosmetic, or functional complaints)
clavicle fracture associated with a scapular of humeral fracture (floating shoulder)

Exclusion criteria

a nondisplaced or minimally displaced closed, neurovascularly intact clavicle fracture
fracture of the medial or lateral end of the clavicle
pathological fracture
patient is unable to medically tolerate general anesthesia
patient is unable to provide informed consent or comply with completing questionnaires