Injury of Shoulder RegionRCSOWNCT02725320
Rotator Cuff Surgical Outcomes in Women
An observational study of Injury of Shoulder Region and Rotator Cuff Syndrome, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Injury of Shoulder Region, Rotator Cuff Syndrome
- How many people
- 192 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants for this study will be selected from the practice of three shoulder reconstruction surgeons in their embedded clinical research practice.
Who may be able to join
- Referred for surgical treatment of predominantly unilateral rotator cuff syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Injury of Shoulder Region, Rotator Cuff Syndrome
- Keywords
- rotator cuff, shoulder reconstruction
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff score (WORC)
WORC scores will be compared at 12 months between the groups (males versus females)
Measured: 1 year
Secondary outcomes (14)
Overall change in WORC (male versus female)
Evaluation of the overall change in WORC score by gender
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline data
Prevalence of catastrophizing at baseline
Evaluation of the PCS (Pain Catastrophizing Score) at baseline to determine the prevalence catastrophizing
Measured: Baseline data
Improvement in HADS
Evaluation of HADS scores over 1 year to determine improvement from baseline
Measured: 1 year
Height (males versus females)
Evaluation of the difference in height between genders
Measured: baseline
Change in reach over time
Evaluation of forward reach to determine the change from baseline to one year
Measured: 1 year
WORC score by HADS score
Measured: 1 year
WORC score by PCS score
Measured: 1 year
WORC score by forward reach
Measured: 1 year
WORC score correlated to gender, PCS, HADS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Shoulder RegionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlis Sabo, University of Calgary
- Investigators
- Marlis Sabo, MD, FRCSC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725320
- Sponsor's protocol ID
- REB15-1229
- Acronym
- RCSOW
- Status last verified
- Apr 2019
- First submitted
- 3 Mar 2016
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Surgical Outcomes in Women
- ClinicalTrials.gov ID
- NCT02725320
- Acronym / sponsor ID
- RCSOW / REB15-1229
- Conditions
- Injury of Shoulder Region, Rotator Cuff Syndrome
- Keywords
- rotator cuff, shoulder reconstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants for this study will be selected from the practice of three shoulder reconstruction surgeons in their embedded clinical research practice.
Key inclusion criteria (1 listed)
- Referred for surgical treatment of predominantly unilateral rotator cuff syndrome
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Western Ontario Rotator Cuff score (WORC)
Time frame: 1 year
WORC scores will be compared at 12 months between the groups (males versus females)
14 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlis Sabo, MD, FRCSC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injury of Shoulder Region and Rotator Cuff Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff score (WORC) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.