Rotator Cuff Surgical Outcomes in Women

Rotator Cuff Syndrome Clinical Trial

— RCSOW  

Official title:

Rotator Cuff Surgical Outcomes in Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02725320
• Other study ID #: REB15-1229
• Status: Active, not recruiting
• Start date: February 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Injury of Shoulder Region
• Rotator Cuff Syndrome
• Shoulder Injuries

Locations

Country	Name	City	State
Canada	South Health Campus	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Rotator Cuff score (WORC)	WORC scores will be compared at 12 months between the groups (males versus females)	1 year
Secondary	Overall change in WORC (male versus female)	Evaluation of the overall change in WORC score by gender	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Prevalence of catastrophizing at baseline	Evaluation of the PCS (Pain Catastrophizing Score) at baseline to determine the prevalence catastrophizing	Baseline data
Secondary	Improvement in HADS	Evaluation of HADS scores over 1 year to determine improvement from baseline	1 year
Secondary	Height (males versus females)	Evaluation of the difference in height between genders	baseline
Secondary	Change in reach over time	Evaluation of forward reach to determine the change from baseline to one year	1 year
Secondary	WORC score by HADS score		1 year
Secondary	WORC score by PCS score		1 year
Secondary	WORC score by forward reach		1 year
Secondary	WORC score correlated to gender, PCS, HADS		1 year