Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score
Time Frame: 1+ year post-op
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.
Secondary Outcomes
- Incision numbness at surgical site.(2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op)
Investigators
Eric Kubiak
M.D.
University of Utah