Clinical Outcomes Following Glenoid Neck Fracture as Correlated With Quantitative Assessment of Osseous Injury

December 27, 2019 updated by: Boston Medical Center
A significant subset of patients with scapula fractures also involves the glenoid neck (bone joining the shoulder joint the scapular body). There is little evidence pertaining to the best treatment or precise definition of these lesions. This study will be designed as a prospective, non-randomized cohort study that will collect outcome and radiological data on patients who have sustained a fracture of the glenoid neck (bone joining the shoulder joint the scapular body) for a period of 1 year. All patients who have sustained extraarticular scapula fractures (any fracture not involving the glenoid surface) will be considered. Information will be collected with respect to the radiographic characteristics of osseous injuries as well as functional outcome over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Extraarticular fractures (fracture not involving the glenoid articular surface) of the scapula (shoulder blade) have been traditionally managed nonoperatively. The logic for this course of treatment was based on the healing potential of the extensive muscular envelop of the scapula, the inherent mobility of the shoulder joint, and the difficulty in objectively assessing the degree of injury given its irregular osseous architecture.

Scapular fractures specifically involving the glenoid neck have the potential to significantly change the geometry of glenohumeral joint (shoulder joint) as well as affect the actions of muscles and nerves that act across it. Although most reports indicate patients sustaining glenoid neck fractures did well following nonoperative treatment, there was little use of validated outcome measures. Additionally, the context of severe trauma may have lead to an underestimation of functional recovery.

Advances in imaging technology combined with the evolution of internal fixation techniques have resulted in sporadic attempts at fixation of glenoid neck fractures, usually when they occurred in concert with bony injury to other members of the shoulder girdle, as in the "floating shoulder". However, in the absence of a universal canon of radiograph measurements, there are no current recommendations for operative versus non-operative management based on the characteristics of osseous injury as correlated with probable clinical outcome. Moreover, the common assertion that nonoperative management of scapular fractures leads to adequate functional outcome has not been rigorously examined in a prospective fashion, despite this being the standard of care nationally.

Recent evidence suggests that nonoperative treatment may lead to significant decreases in strength and forelimb function despite the fact that the standard of care for the vast majority of these injuries does not involve surgery or reduction. The same may be true of glenoid neck fractures, as significant shortening or angulation of this metaphyseal isthmus may have a detrimental effect on the functional geometry of the glenohumeral (shoulder) joint. If so, surgical management may be indicated to restore a more physiologic geometry to the joint, and thereby give the best chance of recovery to a pre-injury level of function. It is our hope that these correlates of measurements and outcome will help codify an a priori set of radiograph evaluation criteria to help guide decisions for surgical versus non-operative management of glenoid neck fractures. The purpose of the study is to: 1) define the degree of forelimb dysfunction brought about by this specific injury and 2) the magnitude of osseous injury to the glenoid neck that can be tolerated before functional outcome is unacceptably impeded.

Study Type

Observational

Enrollment (Actual)

98

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

  • Canada
      • Halifax, Canada, B3H3A7
        • Qeii Health Science Center
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Grand Rapids, Michigan, United States, 49525
        • Orthopaedic Associates of Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Orthopaedic Associates of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Charlotte Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73190
        • University of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Orthopaedic Specialty Associates - Fort Worth
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • University of Utah

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

Gender: Both Age: Adult (18-64 yrs), Geriatric (65+ yrs) Ethnicity: All Ethnic Groups Languages: English Groups to be recruited will include: Patients only

Description

Inclusion Criteria:

  • Adults 18-65 and 65+
  • Extraarticular scapular fractures Scapular fracture is isolated or in concert with nondisplaced ipsilateral fractures of the clavicle, coracoid or acromion or has a clavicle fracture been operatively reduced or fixed?
  • Patient is free of preexisting neuromuscular or psychiatric dysfunction
  • Patient is free of previous upper extremity injury that would impede objective functional outcome evaluation
  • Patient received a CT scan as part of their initial clinical care
  • Patient is English speaking
  • Patient is signed the informed consent form

Exclusion Criteria:

  • Preexisting upper extremity injury or neuromuscular condition
  • Displaced fractures of the acromion, clavicle, or coracoid
  • Concomitant injury to the forelimb
  • Patients mentally or physically unable to perform the function evaluation
  • Patients unwilling or unable to follow up for 1 year
  • Patients with poor propensity to follow up; drug, alcohol issues, etc.
  • Non English speaking patients
  • Patients currently or pending incarceration in prison

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Scapular with glenoid neck fractures
Collect outcome and radiological data on patients with scapular fractures involving the glenoid neck (bone joining the shoulder joint and the scapular body) for a period of 1 year.
Other: Scapular with glenoid neck fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Displaced Fractures
Time Frame: 12 months, 24 months (optional)
12 months, 24 months (optional)

Collaborators and Investigators

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

Sponsor

Boston Medical Center

Investigators

  • Principal Investigator: Paul Tornetta, MD, Boston University / Boston Medical Center

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)

December 1, 2017

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-26863

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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