Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eric Kubiak, University of Utah
ClinicalTrials.gov Identifier:
NCT01405703
First received: July 27, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention
Clavicle Fracture
Other: xrays

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score [ Time Frame: 1+ year post-op ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 37
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated surgically for diaphysial clavicle fracture.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405703

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

No publications provided

Responsible Party: Eric Kubiak, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01405703     History of Changes
Other Study ID Numbers: 36814
Study First Received: July 27, 2011
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Clavicle Fractures
Numbness
Percutaneous plate fixation
open plate fixation
incision related numbness
union rates
subjective
questionnaire based outcomes
Diaphyseal

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014