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NCT01549912 Clinical Trial

Results of Rotator Cuff Repair

Shoulder Dislocation Clinical Trial

Official title:
Results of Rotator Cuff Repair Following Acute Shoulder Dislocation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01549912
Other study ID # 54314
Secondary ID
Status Completed
Phase N/A
First received March 6, 2012
Last updated August 5, 2015
Start date February 2012
Est. completion date April 2015

Study information
Verified date August 2015
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years and older
Eligibility 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).

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Utah Salt Lake Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Levels of pain, range of motion and strength Patient are asked to complete ASES, SST, SF-12 questionaires. Clinical evaluation of bilateral range of motion and strength measurements. 1 year No
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