Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405703
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : July 9, 2015
Information provided by (Responsible Party):
Eric Kubiak, 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.

Condition or disease Intervention/treatment
Clavicle Fracture Other: xrays

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 : July 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures X-Rays
Drug Information available for: X-Rays
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated surgically for diaphysial clavicle fracture.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405703

United States, Utah
University of Utah Orthopedic Center
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
University of Utah
Principal Investigator: Erik Kubiak, MD University of Utah
Principal Investigator: Thomas Christensen, MD University of Utah

Responsible Party: Eric Kubiak, M.D., University of Utah Identifier: NCT01405703     History of Changes
Other Study ID Numbers: 36814
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015

Keywords provided by Eric Kubiak, University of Utah:
Clavicle Fractures
Percutaneous plate fixation
open plate fixation
incision related numbness
union rates
questionnaire based outcomes

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries