Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

University of Utah35 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Clavicle Fracture

Interventions

xraysOTHER

xrays from 2 week postop to 5 year postop

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Utah Orthopedic Center

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score

The primary outcome measure for this study will be incision related numbness, based on clinical examination and the use of our skin numbness map. Our null hypothesis is that there will be no difference in incision related numbness between the two groups: percutaneous versus open approach. Our primary objective is to disprove this hypothesis, predicting that the percutaneously treated group will have less incisional numbness.

Time frame: 1+ year post-op

Secondary Outcomes

Incision numbness at surgical site.

Our secondary outcome measures will be union, malunion, and nonunion rates between these two methods, as well as infection rates and functional and satisfaction outcomes based on subjective questioning and the DASH and Constant shoulder score questionnaires. Our null hypothesis for these secondary outcomes is that there will be no difference between the two treatment groups.

Time frame: 2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op

Data from ClinicalTrials.gov

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