Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Clavicle Fracture Hypesthesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopedic Center

Salt Lake City, Utah, 84121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

xrays

Other

xrays from 2 week postop to 5 year postop

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.

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

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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Jul 29, 2011
Registry last updated: Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed