Rotator Cuff Surgical Outcomes in Women

Study Overview
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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.

Official Title
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Rotator Cuff Surgical Outcomes in Women

Conditions
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Injury of Shoulder Region, Rotator Cuff Syndrome

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female Rotator Cuff Surgical Group<br>Females, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome | |
| Male Rotator Cuff Surgical Group<br>Males, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff score (WORC) | WORC scores will be compared at 12 months between the groups (males versus females) | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff, shoulder reconstruction