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

This study is currently recruiting participants.

Verified by Boston Medical Center, July 2009

First Received: March 24, 2008 Last Updated: July 2, 2009 History of Changes

Sponsor:	Boston Medical Center
Information provided by:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00644813

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:	Cohort, Prospective
Official Title:	Clinical Outcomes Following Glenoid Neck Fracture as Correlated With Quantitative Assessment of Osseous Injury

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644813

Contacts

Contact: Mark Zocchi

mark.zocchi@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
Orthopaedic Associates of Michigan	Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Cliff Jones, MD
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, 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

Sponsors and Collaborators

Boston Medical Center

Investigators

Principal Investigator:

Paul Tornetta, MD

Boston University / Boston Medical Center

More Information

No publications provided

Responsible Party:	Boston University / Boston Medical Center ( Paul Tornetta, III, MD )
Study ID Numbers:	H-26863
Study First Received:	March 24, 2008
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00644813 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 30, 2009