Rotator Cuff Surgical Outcomes in Women (RCSOW)

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Syndrome; Injury of Shoulder Region

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • South Health Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants for this study will be selected from the practice of three shoulder reconstruction surgeons in their embedded clinical research practice.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Female Rotator Cuff Surgical Group; Females, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome
Male Rotator Cuff Surgical Group; Males, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Marlis Sabo, MD, FRCSC, University of Calgary

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 27, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: rotator cuff; shoulder reconstruction
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: REB15-1229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No