Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Completed

• Conditions: Clavicle Fracture
• Interventions: Other: xrays

• Registration Number: NCT01405703
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-08
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
percuataneous plate fixation	xrays	an approach with three small longitudinal incisions
open plate fixation	xrays	large transverse incision

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Utah Orthopedic Center; 🇺🇸 Salt Lake City, Utah, United States