Rotator Cuff Surgical Outcomes in Women
RCSOW
1 other identifier
observational
192
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Longer than P75 for all trials
1 active site
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, 2016
CompletedFirst Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 26, 2019
April 1, 2019
4.8 years
March 3, 2016
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Western Ontario Rotator Cuff score (WORC)
WORC scores will be compared at 12 months between the groups (males versus females)
1 year
Secondary Outcomes (14)
Overall change in WORC (male versus female)
1 year
Rate of change in WORC (male versus female)
1 year
Rate of change in visual analogue scale (VAS) (male versus female)
1 year
Rate of change in SF-36 (short-form 36) response scores (male versus female)
1 year
Rate of change of satisfaction with surgical outcome (male versus female)
1 year
- +9 more secondary outcomes
Study Arms (2)
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
Eligibility Criteria
The participants for this study will be selected from the practice of three shoulder reconstruction surgeons in their embedded clinical research practice.
You may qualify if:
- Referred for surgical treatment of predominantly unilateral rotator cuff syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Health Campus
Calgary, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marlis Sabo, MD, FRCSC
University of Calgary
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 31, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 26, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share