Overview

This trial is active, not recruiting.

Conditions injury of shoulder region, rotator cuff syndrome
Sponsor University of Calgary
Start date February 2016
End date December 2020
Trial size 184 participants
Trial identifier NCT02725320, REB15-1229

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Females, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome
Males, 35-75 receiving surgery for predominantly unilateral rotator cuff syndrome

Primary Outcomes

Measure
Western Ontario Rotator Cuff score (WORC)
time frame: 1 year

Secondary Outcomes

Measure
Overall change in WORC (male versus female)
time frame: 1 year
Rate of change in WORC (male versus female)
time frame: 1 year
Rate of change in visual analogue scale (VAS) (male versus female)
time frame: 1 year
Rate of change in SF-36 (short-form 36) response scores (male versus female)
time frame: 1 year
Rate of change of satisfaction with surgical outcome (male versus female)
time frame: 1 year
Prevalence of anxiety and depression at baseline
time frame: Baseline data
Prevalence of catastrophizing at baseline
time frame: Baseline data
Improvement in HADS
time frame: 1 year
Height (males versus females)
time frame: baseline
Change in reach over time
time frame: 1 year
WORC score by HADS score
time frame: 1 year
WORC score by PCS score
time frame: 1 year
WORC score by forward reach
time frame: 1 year
WORC score correlated to gender, PCS, HADS
time frame: 1 year

Eligibility Criteria

Male or female participants from 35 years up to 75 years old.

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

Additional Information

Official title Rotator Cuff Surgical Outcomes in Women
Principal investigator Marlis Sabo, MD, FRCSC
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Calgary.