Trial Outcomes & Findings for Functional Outcomes Following Shoulder Surgery: A Prospective Database (NCT NCT00253864)
NCT ID: NCT00253864
Last Updated: 2024-06-24
Results Overview
The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
Recruitment status
COMPLETED
Target enrollment
90 participants
Primary outcome timeframe
10 year post operative
Results posted on
2024-06-24
Participant Flow
Eligible participants were screened from a large database of 1874 enrolled participants. For the purposes of this project, 90 participants were followed in each arm.
Participant milestones
| Measure |
Single-Row Fixation
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
42
|
|
Overall Study
COMPLETED
|
43
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Single-Row Fixation
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
Baseline Characteristics
Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
Baseline characteristics by cohort
| Measure |
Single-Row Fixation
n=43 Participants
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
n=34 Participants
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 8.2 • n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
57.2 years
STANDARD_DEVIATION 6.7 • n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
56.2 years
STANDARD_DEVIATION 7.6 • n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Sex: Female, Male
Female
|
12 Participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
10 Participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
22 Participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Sex: Female, Male
Male
|
31 Participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
24 Participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
55 Participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
43 participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
34 participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
77 participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Affected Shoulder
Left
|
10 participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
9 participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
19 participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Affected Shoulder
Right
|
33 participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
25 participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
58 participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Tear Size
Coronal
|
21.2 mm
STANDARD_DEVIATION 9.1 • n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
22.5 mm
STANDARD_DEVIATION 10.7 • n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
21.8 mm
STANDARD_DEVIATION 9.8 • n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Tear Size
Sagittal
|
18.8 mm
STANDARD_DEVIATION 7.4 • n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
18.7 mm
STANDARD_DEVIATION 7 • n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
18.8 mm
STANDARD_DEVIATION 7.2 • n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Smoking Status
Smoker
|
7 Participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
7 Participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
14 Participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Smoking Status
Nonsmoker
|
36 Participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
27 Participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
63 Participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Concomitant Biceps Procedure
No Biceps Procedure
|
35 Participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
25 Participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
60 Participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Concomitant Biceps Procedure
Biceps Tenodesis Procedure
|
8 Participants
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
9 Participants
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
17 Participants
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
|
Anchors
|
1 # anchors
n=43 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
2 # anchors
n=34 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
2 # anchors
n=77 Participants • Analysis was performed at the 10-year long term follow-up. 5 participants were lost to follow-up in the single row group, and 8 participants were lost to follow-up in the double-row group, and as such were removed from this analysis.
|
PRIMARY outcome
Timeframe: 10 year post operativeThe Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
Outcome measures
| Measure |
Single-Row Fixation
n=43 Participants
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
n=34 Participants
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
|---|---|---|
|
Western Ontario Rotator Cuff Index
|
72.9 score on a scale (0-100)
Standard Deviation 23.5
|
79.9 score on a scale (0-100)
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 10 year post operativeThe ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Outcome measures
| Measure |
Single-Row Fixation
n=43 Participants
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
n=34 Participants
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons Score
|
80.4 units on a scale (0-100)
Standard Deviation 23.6
|
83.0 units on a scale (0-100)
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: 10 year post operativePopulation: Not all participants wanted to return to have their strength tested, but agreed to complete questionnaires.
The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
Outcome measures
| Measure |
Single-Row Fixation
n=33 Participants
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
n=28 Participants
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
|---|---|---|
|
Constant Score
|
77.2 units on a scale (0-100)
Standard Deviation 16.7
|
71.3 units on a scale (0-100)
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: 10 year post operativePopulation: Not all participants wanted to return to have their strength tested, but agreed to complete questionnaires.
Strength will be measured using a handheld dynamometer in the abduction position which records kilograms of force. The higher the kilogram of force indicates a better result.
Outcome measures
| Measure |
Single-Row Fixation
n=33 Participants
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
n=28 Participants
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
|---|---|---|
|
Strength
|
7.1 kg
Standard Deviation 2.1
|
6.9 kg
Standard Deviation 2.7
|
Adverse Events
Single-Row Fixation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Double-Row Fixation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-Row Fixation
n=43 participants at risk
Single-Row anchor fixation in arthroscopic rotator cuff repair.
|
Double-Row Fixation
n=34 participants at risk
Double-Row anchor fixation in arthroscopic rotator cuff repair.
|
|---|---|---|
|
Surgical and medical procedures
Revision Surgery
|
2.3%
1/43 • Number of events 1 • 10 years
|
2.9%
1/34 • Number of events 1 • 10 years
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Coordinator
Ottawa Hospital Research Institute
Phone: 613-737-8899
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place