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

This study is currently recruiting participants.
Verified December 2016 by Paul Tornetta, III, M.D., Boston Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644813
First Posted: March 27, 2008
Last Update Posted: December 16, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul Tornetta, III, M.D., Boston Medical Center
March 24, 2008
March 27, 2008
December 16, 2016
March 2008
December 2017   (Final data collection date for primary outcome measure)
Displaced Fractures [ Time Frame: 12 months, 24 months (optional) ]
Not Provided
Complete list of historical versions of study NCT00644813 on ClinicalTrials.gov Archive Site
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Clinical Outcomes Following Glenoid Neck Fracture as Correlated With Quantitative Assessment of Osseous Injury
Clinical Outcomes Following Glenoid Neck Fracture as Correlated With Quantitative Assessment of Osseous Injury
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Gender: Both Age: Adult (18-64 yrs), Geriatric (65+ yrs) Ethnicity: All Ethnic Groups Languages: English Groups to be recruited will include: Patients only
Scapula
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1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Paul Tornetta 617-414-6295 heather.desjardin@bmc.org
Canada,   United States
 
 
NCT00644813
H-26863
Yes
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Paul Tornetta, III, M.D., Boston Medical Center
Boston Medical Center
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Principal Investigator: Paul Tornetta, MD Boston University / Boston Medical Center
Boston Medical Center
December 2016