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Rotator Cuff Surgical Outcomes in Women

Rotator Cuff Surgical Outcomes in Women

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02725320
Acronym
RCSOW
Enrollment
192
Registered
2016-03-31
Start date
2016-02-29
Completion date
2020-12-31
Last updated
2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury of Shoulder Region, Rotator Cuff Syndrome

Keywords

rotator cuff, shoulder reconstruction

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.

Interventions

None listed

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Western Ontario Rotator Cuff score (WORC)1 yearWORC scores will be compared at 12 months between the groups (males versus females)

Secondary

MeasureTime frameDescription
Overall change in WORC (male versus female)1 yearEvaluation of the overall change in WORC score by gender
Rate of change in WORC (male versus female)1 yearEvaluation of the rate of change in WORC score over 1 year between male and female
Rate of change in visual analogue scale (VAS) (male versus female)1 yearEvaluation of the rate of change in VAS score over 1 year between male and female
Rate of change in SF-36 (short-form 36) response scores (male versus female)1 yearEvaluation 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 yearEvaluation of the rate of change in satisfaction with surgical outcome between male and female over 1 year
Prevalence of anxiety and depression at baselineBaseline dataEvaluation of the HADS (Hospital Anxiety and Depression Scale) at baseline to determine the prevalence of mood disorder
WORC score correlated to gender, PCS, HADS1 year
Improvement in HADS1 yearEvaluation of HADS scores over 1 year to determine improvement from baseline
Height (males versus females)baselineEvaluation of the difference in height between genders
Change in reach over time1 yearEvaluation of forward reach to determine the change from baseline to one year
WORC score by HADS score1 year
WORC score by PCS score1 year
WORC score by forward reach1 year
Prevalence of catastrophizing at baselineBaseline dataEvaluation of the PCS (Pain Catastrophizing Score) at baseline to determine the prevalence catastrophizing

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026