Rotator Cuff Tear
Conditions
Keywords
shoulder surgery, prospective database, long term outcome
Brief summary
The purpose of this prospective database is to investigate the long-term functional status of patients who have undergone various types of rotator cuff repair surgery. Patients are asked to respond to questionnaires prior to surgery and at various post-operative visits in an attempt to quantify their functional outcomes. Responses are then linked to other data such as symptoms, prior treatments, previous surgery, complications, radiographic results, etc. These data may then be used as a basis for devising guidelines for future patients and surgeons. This particular project is interested in investigating long term results of arthroscopic rotator cuff repair techniques.
Detailed description
The purpose of the prospective database is to initiate data collection for a group of patients undergoing surgery of the shoulder. Long-term data collection will include information on the functional status of the patients' shoulder as well as quality of life information and radiographic results. For the purposes of this study, we are interested in the long-term outcomes of participants who underwent a double row versus single row fixation in arthroscopic rotator cuff repair procedures.
Interventions
PROCEDURESingle row
Fixation type in arthroscopic rotator cuff repair.
PROCEDUREDouble row
Fixation type in arthroscopic rotator cuff repair.
Sponsors
Ottawa Hospital Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* arthroscopic rotator cuff repairs that occurred between 2007-2009 * enrolled in previous study comparing single vs double-row fixation
Exclusion criteria
* withdrew from original study * unable or unwilling to provide written informed consent * excluded from original study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Index | 10 year post operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Score | 10 year post operative | The 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. |
| Constant Score | 10 year post operative | 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). |
| Strength | 10 year post operative | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Single-Row Fixation Single-Row anchor fixation in arthroscopic rotator cuff repair. | 43 |
| Double-Row Fixation Double-Row anchor fixation in arthroscopic rotator cuff repair. | 34 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 8 |
Baseline characteristics
| Characteristic | Single-Row Fixation | Total | Double-Row Fixation |
|---|---|---|---|
| Affected Shoulder Left | 10 participants | 19 participants | 9 participants |
| Affected Shoulder Right | 33 participants | 58 participants | 25 participants |
| Age, Continuous | 55.3 years STANDARD_DEVIATION 8.2 | 56.2 years STANDARD_DEVIATION 7.6 | 57.2 years STANDARD_DEVIATION 6.7 |
| Anchors | 1 # anchors | 2 # anchors | 2 # anchors |
| Concomitant Biceps Procedure Biceps Tenodesis Procedure | 8 Participants | 17 Participants | 9 Participants |
| Concomitant Biceps Procedure No Biceps Procedure | 35 Participants | 60 Participants | 25 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 43 participants | 77 participants | 34 participants |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 10 Participants |
| Sex: Female, Male Male | 31 Participants | 55 Participants | 24 Participants |
| Smoking Status Nonsmoker | 36 Participants | 63 Participants | 27 Participants |
| Smoking Status Smoker | 7 Participants | 14 Participants | 7 Participants |
| Tear Size Coronal | 21.2 mm STANDARD_DEVIATION 9.1 | 21.8 mm STANDARD_DEVIATION 9.8 | 22.5 mm STANDARD_DEVIATION 10.7 |
| Tear Size Sagittal | 18.8 mm STANDARD_DEVIATION 7.4 | 18.8 mm STANDARD_DEVIATION 7.2 | 18.7 mm STANDARD_DEVIATION 7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 34 |
| other Total, other adverse events | 0 / 43 | 0 / 34 |
| serious Total, serious adverse events | 1 / 43 | 1 / 34 |
Outcome results
Primary
Western Ontario Rotator Cuff Index
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.
Time frame: 10 year post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-Row Fixation | Western Ontario Rotator Cuff Index | 72.9 score on a scale (0-100) | Standard Deviation 23.5 |
| Double-Row Fixation | Western Ontario Rotator Cuff Index | 79.9 score on a scale (0-100) | Standard Deviation 23.4 |
Secondary
American Shoulder and Elbow Surgeons Score
The 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.
Time frame: 10 year post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-Row Fixation | American Shoulder and Elbow Surgeons Score | 80.4 units on a scale (0-100) | Standard Deviation 23.6 |
| Double-Row Fixation | American Shoulder and Elbow Surgeons Score | 83.0 units on a scale (0-100) | Standard Deviation 25.1 |
Secondary
Constant Score
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).
Time frame: 10 year post operative
Population: Not all participants wanted to return to have their strength tested, but agreed to complete questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-Row Fixation | Constant Score | 77.2 units on a scale (0-100) | Standard Deviation 16.7 |
| Double-Row Fixation | Constant Score | 71.3 units on a scale (0-100) | Standard Deviation 25.6 |
Secondary
Strength
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.
Time frame: 10 year post operative
Population: Not all participants wanted to return to have their strength tested, but agreed to complete questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-Row Fixation | Strength | 7.1 kg | Standard Deviation 2.1 |
| Double-Row Fixation | Strength | 6.9 kg | Standard Deviation 2.7 |