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

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: NCT00644813
Recruitment Status : Active, not recruiting
First Posted : March 27, 2008
Last Update Posted : September 6, 2018
Information provided by (Responsible Party):
Paul Tornetta, III, M.D., Boston Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Scapula Fracture Glenoid; Fracture Other: Scapular with glenoid neck fractures

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
Actual Enrollment : 136 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes Following Glenoid Neck Fracture as Correlated With Quantitative Assessment of Osseous Injury
Study Start Date : March 2008
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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

Primary Outcome Measures :
  1. Displaced Fractures [ Time Frame: 12 months, 24 months (optional) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

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): NCT00644813

United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Health system
Ann Arbor, Michigan, United States, 48109
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States, 49503
Orthopaedic associates of Michigan
Grand Rapids, Michigan, United States, 49525
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Charlotte Medical Center
Charlotte, North Carolina, United States, 28203
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73190
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
Orthopaedic Specialty Associates - Fort Worth
Fort Worth, Texas, United States, 76104
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84103
QEII Health Science Center
Halifax, Canada, B3H3A7
Sponsors and Collaborators
Boston Medical Center
Principal Investigator: Paul Tornetta, MD Boston University / Boston Medical Center

Responsible Party: Paul Tornetta, III, M.D., Paul Tornetta,III,M.D, Boston Medical Center Identifier: NCT00644813     History of Changes
Other Study ID Numbers: H-26863
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paul Tornetta, III, M.D., Boston Medical Center:
Scapula fracture involving glenoid neck
Forelimb dysfunction

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries