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Results of Rotator Cuff Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549912
First Posted: March 9, 2012
Last Update Posted: August 6, 2015
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.
Information provided by (Responsible Party):
Robert Tashjian, University of Utah
  Purpose
The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.

Condition
Shoulder Dislocation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Results of Rotator Cuff Repair Following Acute Shoulder Dislocation

Resource links provided by NLM:


Further study details as provided by Robert Tashjian, University of Utah:

Primary Outcome Measures:
  • Levels of pain, range of motion and strength [ Time Frame: 1 year ]
    Patient are asked to complete ASES, SST, SF-12 questionaires. Clinical evaluation of bilateral range of motion and strength measurements.


Enrollment: 2
Study Start Date: February 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rotator cuff tear

Detailed Description:
There is a higher risk of rotator cuff tears following dislocation when the individual is greater than 40 years old. Rotator cuff tears after dislocation of the shoulder are more of a challenge to repair particularly if there is a delay in diagnosis. Clinical experience would suggest that rotator cuff repair within the first month of injury allows for better results in acute rotator cuff tears without shoulder dislocation. There are no reported results for rotator cuff repairs following shoulder dislocation and timing of repair. If we find that early repair provides better results this will be important for Primary Care Providers and Emergency Department physicians to refer these patients early for evaluation and subsequently earlier treatment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study population will include patients age 35 years and older who have sustained an acute rotator cuff tear following shoulder dislocation who underwent a rotator cuff repair either by open or arthroscopic techniques between January 1, 2001 and June 1, 2011.
Criteria

Inclusion Criteria:

  • age 35 years or older with acute rotator cuff tear following documented shoulder dislocation requiring reduction, subjects sustained acute rotator cuff tear following shoulder dislocation that was treated surgically with open and/or arthroscopic technique between January 1, 2001 and June 1, 2011, surgical intervention within 6 months of dislocation, minimum follow up time of one year from surgery.

Exclusion Criteria:

  • rotator cuff tears without shoulder dislocation, known previous rotator cuff disease, history of other trauma to the shoulder, inability to provide informed consent, other suspect pathology (ie: tumor, infection).
  Contacts and Locations
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): NCT01549912


Locations
United States, Utah
University of Utah
Salt Lake, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Robert Z Tashjian, MD University of Utah Orthopaedic
  More Information

Responsible Party: Robert Tashjian, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01549912     History of Changes
Other Study ID Numbers: 54314
First Submitted: March 6, 2012
First Posted: March 9, 2012
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by Robert Tashjian, University of Utah:
Rotator Cuff Tears
Dislocation
Shoulder Dislocation

Additional relevant MeSH terms:
Joint Dislocations
Shoulder Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries