Operative Versus Nonoperative Treatment for Scapula Fractures

November 10, 2015 updated by: William Obremskey, Vanderbilt University

Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures

The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.

The potential impact is a clearer set of choices in treatment options for this type of injury.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8774
        • Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subject population will include patients seen at participating facilities for the care of scapula fractures, who are 18 years of age or older, meet inclusion/exclusion criteria and are willing to consent.

Description

Inclusion Criteria:

  • 18 Years of Age or Older
  • Displacement of glenoid neck and scapula body of greater than 2 cm
  • Angular deformity between the fracture fragments of greater than 45 degrees.
  • A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees
  • A glenopolar angle less than 22 degrees
  • A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC)

Exclusion Criteria:

  • Age Less Than 18 years Old
  • Brachial Plexus Injury
  • Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation
  • Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage
  • Ipsilateral Upper Extremity Injury
  • Previous Shoulder Surgery
  • Insufficient English proficiency to complete the DASH Questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Operative Treatment (Open Reduction Internal Fixation)
2
Non-operative/Conservative Care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: William T. Obremskey, MD, MPH, Vanderbilt University Medical Center
  • Principal Investigator: Peter Cole, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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