Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Clavicle Fracture Clinical Trial

Official title:

Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405703
• Other study ID #: 36814
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: July 8, 2015
• Start date: July 2011
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Other:
• xrays
xrays from 2 week postop to 5 year postop

Locations

Country	Name	City	State
United States	University of Utah Orthopedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1+ year post-op	No
Secondary	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.	2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op	No