Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures

NCT01405703 | Completed

• 1 other identifier: 36814
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Clavicle Fracture

Keywords

Clavicle Fractures; Numbness; Percutaneous plate fixation; open plate fixation; incision related numbness; union rates; subjective; questionnaire based outcomes; Diaphyseal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incision numbness at surgical site.

  2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op

Study Arms (2)

percuataneous plate fixation

an approach with three small longitudinal incisions

Other: xrays

open plate fixation

large transverse incision

Other: xrays

Interventions

xrays OTHER

xrays from 2 week postop to 5 year postop

open plate fixation; percuataneous plate fixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated surgically for diaphysial clavicle fracture.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedic Center

Salt Lake City, Utah, 84121, United States

Location

MeSH Terms

Conditions

Hypesthesia

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Erik Kubiak, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Thomas Christensen, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 29, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

US (1)