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: July 25, 2014
Last verified: July 2014
  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 University of Utah:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Robert Tashjian, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01549912     History of Changes
Other Study ID Numbers: 54314
Study First Received: March 6, 2012
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dislocations
Shoulder Dislocation
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014