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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Paul Tornetta, III, M.D., Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00644813
First received: March 24, 2008
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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
Scapula

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes Following Glenoid Neck Fracture as Correlated With Quantitative Assessment of Osseous Injury

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  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: NCT00644813

Contacts
Contact: Paul Tornetta 617-414-6295 heather.desjardin@bmc.org

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Brian Mullis, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Paul Tornetta, MD         
United States, Michigan
University of Michigan Health system Recruiting
Ann arbor, Michigan, United States, 48109
Contact: Jaimee Gauthier       jaimeeg@med.umich.edu   
Orthopaedic Associates of Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Cliff Jones, MD         
Orthopaedic associates of Michigan Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Deb Sietsma       dsietsma@oamichigan.com   
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Principal Investigator: Andrew Schmidt, MD         
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: William Ricci, MD         
United States, North Carolina
Charlotte Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: Mike Bosse, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma, Oklahoma, United States, 73190
Contact: Kathy Carl       kathy-carl@ouhsc.edu   
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Darin Friess, MD         
United States, Texas
Orthopaedic Specialty Associates - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Cory Collinge, MD         
United States, Utah
University of Utah Recruiting
Salt lake city, Utah, United States, 84103
Contact: Erik kubaik       erik.kubaik@hsc.utah.edu   
Canada
QEII Health Science Center Recruiting
Halifax, Canada, B3H3A7
Contact: Gwendolyn Dobbin       nmsgmd@cdha.nshealth.ca   
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Paul Tornetta, MD Boston University / Boston Medical Center
  More Information

No publications provided

Responsible Party: Paul Tornetta, III, M.D., Paul Tornetta,III,M.D, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00644813     History of Changes
Other Study ID Numbers: H-26863
Study First Received: March 24, 2008
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014