Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT01405703

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clavicle Fracture	Other: xrays

Study Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
percuataneous plate fixation an approach with three small longitudinal incisions	Other: xrays xrays from 2 week postop to 5 year postop
open plate fixation large transverse incision	Other: xrays xrays from 2 week postop to 5 year postop

Arm

Intervention/Treatment

percuataneous plate fixation

an approach with three small longitudinal incisions

Other: xrays

xrays from 2 week postop to 5 year postop

open plate fixation

large transverse incision

Other: xrays

xrays from 2 week postop to 5 year postop

Outcome Measures

Primary Outcome Measures

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

Incision numbness at surgical site. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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