Rotator Cuff Surgical Outcomes in Women

• Conditions: Injury of Shoulder Region; Rotator Cuff Syndrome

• Registration Number: NCT02725320
• Lead Sponsor: University of Calgary

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-27
• Study First Posted: 2016-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Referred for surgical treatment of predominantly unilateral rotator cuff syndrome

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff score (WORC)	1 year	WORC scores will be compared at 12 months between the groups (males versus females)

Secondary Outcome Measures

Name	Time	Method
Rate of change in WORC (male versus female)	1 year	Evaluation of the rate of change in WORC score over 1 year between male and female
WORC score correlated to gender, PCS, HADS	1 year
Height (males versus females)	baseline	Evaluation of the difference in height between genders
Rate of change in visual analogue scale (VAS) (male versus female)	1 year	Evaluation of the rate of change in VAS score over 1 year between male and female
Change in reach over time	1 year	Evaluation of forward reach to determine the change from baseline to one year
Overall change in WORC (male versus female)	1 year	Evaluation of the overall change in WORC score by gender
Prevalence of anxiety and depression at baseline	Baseline data	Evaluation of the HADS (Hospital Anxiety and Depression Scale) at baseline to determine the prevalence of mood disorder
Prevalence of catastrophizing at baseline	Baseline data	Evaluation of the PCS (Pain Catastrophizing Score) at baseline to determine the prevalence catastrophizing
Improvement in HADS	1 year	Evaluation of HADS scores over 1 year to determine improvement from baseline
Rate of change in SF-36 (short-form 36) response scores (male versus female)	1 year	Evaluation of the rate of change in SF-36 scores over 1 year between male and female
Rate of change of satisfaction with surgical outcome (male versus female)	1 year	Evaluation of the rate of change in satisfaction with surgical outcome between male and female over 1 year
WORC score by HADS score	1 year
WORC score by PCS score	1 year
WORC score by forward reach	1 year

Trial Locations

Locations (1)

South Health Campus; 🇨🇦 Calgary, Alberta, Canada