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.

Study Overview

• Status: Completed
• Conditions: Clavicle Fracture
• Intervention / Treatment: Other: xrays

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • University of Utah Orthopedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated surgically for diaphysial clavicle fracture.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Erik Kubiak, MD, University of Utah; Principal Investigator: Thomas Christensen, MD, University of Utah

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (ESTIMATE): July 29, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 8, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Numbness; subjective; Clavicle Fractures; Percutaneous plate fixation; open plate fixation; incision related numbness; union rates; questionnaire based outcomes; Diaphyseal
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 36814