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OpenTrials
Completed

NCT Number: NCT01549912

Results of Rotator Cuff Repair

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Results of Rotator Cuff Repair Following Acute Shoulder Dislocation

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2012
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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