Rotator Cuff Surgical Outcomes in Women

NCT ID: NCT02725320

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-12-31

Brief Summary

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The overall purpose of this work is to use a prospective cohort study to examine patient-specific but shoulder-extrinsic factors and how they influence the results of rotator cuff surgery. There are undoubtedly many factors that play a role in patient outcome, however, this project will focus on three: the effect of gender on outcome, the effect of mood disorders and coping style on outcome, and the effect of patient height and reach on outcome after rotator cuff surgery. It is hypothesized that these factors will have a significant influence over outcomes.

Detailed Description

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Conditions

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Injury of Shoulder Region Rotator Cuff Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Female Rotator Cuff Surgical Group

Females, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome

No interventions assigned to this group

Male Rotator Cuff Surgical Group

Males, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Referred for surgical treatment of predominantly unilateral rotator cuff syndrome

Exclusion Criteria

* unable to speak or read English
* unable to complete 12 month follow-up
* significant cervicogenic arm and shoulder pain in the affected arm
* significant chronic pain diagnoses felt at least as likely to be the cause of the symptoms as the rotator cuff condition as evaluated by the surgeon
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Marlis Sabo

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marlis Sabo, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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South Health Campus

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB15-1229

Identifier Type: -

Identifier Source: org_study_id

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