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Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures

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.
 
ClinicalTrials.gov Identifier: NCT02212600
Recruitment Status : Recruiting
First Posted : August 8, 2014
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Emil Schemitsch, London Health Sciences Centre

Brief Summary:
The proposed project will be a multi-centre, prospective observational study to determine the prognosis and determinants of functional outcomes of patients with proximal humerus fractures. Approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.

Condition or disease Intervention/treatment
Humeral Fractures, Proximal Other: Observational

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Population
We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma
Other: Observational
observational cohort of proximal humerus fractures




Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder, and Hand (DASH) [ Time Frame: 2 years ]
    The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb.


Secondary Outcome Measures :
  1. Rate of complications [ Time Frame: 2 years ]
    Clinical outcomes will include range of motion measurements, standardized radiographic evaluation, assessment of complications, rate of re-operation, infections, osteonecrosis.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma and who provide written informed consent.
Criteria

Inclusion Criteria:

males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture

Exclusion Criteria:

pathologic fractures patients likely to be lost before completing follow-up patients who do not provide consent patients who do not speak English and who do not have a translator that will be available during consent discussion and at each follow-up.


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 ClinicalTrials.gov identifier (NCT number): NCT02212600


Contacts
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Contact: Milena Vicente 416-864-6060 milena.vicente@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Milena Vicente, RN, CCRP    416-864-6060 ext 2608    milena.vicente@lhsc.on.ca   
Principal Investigator: Emil Schemitsch, MD. FRCSC         
Sub-Investigator: David Sanders, MD, FRCSC         
Sub-Investigator: Abdel Lawendy, MD, FRCSC         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5C 1R6
Contact: Milena Vicente    416-864-6060 ext 2608    vicentem@smh.ca   
Principal Investigator: Jeremy Hall, MD, FRCSC         
Sub-Investigator: Aaron Nauth, MD, FRCSC         
Sponsors and Collaborators
London Health Sciences Centre
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Emil Schemitsch, MD, FRCSC London Health Scieneces Centre and St. Michael's Hospital

Additional Information:

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Responsible Party: Emil Schemitsch, MD, FRCSC, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02212600    
Other Study ID Numbers: DECIPHER
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries