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Results of Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT01549912
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Shoulder Dislocation

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.

Study Design

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Results of Rotator Cuff Repair Following Acute Shoulder Dislocation
Study Start Date : February 2012
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Rotator cuff tear


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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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

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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 Posted: March 9, 2012    Key Record Dates
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