NCT01549912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

3.2 years

First QC Date

March 6, 2012

Last Update Submit

August 5, 2015

Conditions

Shoulder Dislocation

Keywords

Rotator Cuff TearsDislocationShoulder Dislocation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Rotator cuff tear

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Shoulder DislocationRotator Cuff InjuriesJoint Dislocations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder InjuriesRuptureTendon Injuries

Study Officials

  • Robert Z Tashjian, MD

    University of Utah Orthopaedic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 9, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

US(1)