Results of Rotator Cuff Repair

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Robert Tashjian, University of Utah
ClinicalTrials.gov Identifier:
NCT01549912
First received: March 6, 2012
Last updated: January 21, 2014
Last verified: January 2014

March 6, 2012
January 21, 2014
February 2012
February 2015   (final data collection date for primary outcome measure)
Levels of pain, range of motion and strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Patient are asked to complete ASES, SST, SF-12 questionaires. Clinical evaluation of bilateral range of motion and strength measurements.
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Complete list of historical versions of study NCT01549912 on ClinicalTrials.gov Archive Site
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Results of Rotator Cuff Repair
Results of Rotator Cuff Repair Following Acute Shoulder Dislocation

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample

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.

Shoulder Dislocation
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Rotator cuff tear
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
February 2015
February 2015   (final data collection date for primary outcome measure)

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).
Both
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01549912
54314
No
Robert Tashjian, University of Utah
University of Utah
Not Provided
Principal Investigator: Robert Z Tashjian, MD University of Utah Orthopaedic
University of Utah
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP