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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic rotator cuff repair | Participants who underwent an arthroscopic rotator cuff repair between 2007-2009. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single row | Procedure | Fixation type in arthroscopic rotator cuff repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 year post operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who underwent an arthroscopic rotator cuff surgery between 2007-2009.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lapner, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Row Fixation | Single-Row anchor fixation in arthroscopic rotator cuff repair. |
| FG001 | Double-Row Fixation | Double-Row anchor fixation in arthroscopic rotator cuff repair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-Row Fixation | Single-Row anchor fixation in arthroscopic rotator cuff repair. |
| BG001 | Double-Row Fixation | Double-Row anchor fixation in arthroscopic rotator cuff repair. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale (0-100) | 10 year post operative |
|
10 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-Row Fixation | Single-Row anchor fixation in arthroscopic rotator cuff repair. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision Surgery | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Ottawa Hospital Research Institute | 613-737-8899 | 79839 | kmcilquham@ohri.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2023 | Jan 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| Double row | Procedure | Fixation type in arthroscopic rotator cuff repair. |
|
| 10 year post operative |
| 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). | 10 year post operative |
| 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. | 10 year post operative |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 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. | Number | participants |
|
| Affected Shoulder | 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. | Number | participants |
|
| Tear Size | 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. | Mean | Standard Deviation | mm |
|
| Smoking Status | 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. | Count of Participants | Participants |
|
| Concomitant Biceps Procedure | 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. | Count of Participants | Participants |
|
| Anchors | 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. | Median | Inter-Quartile Range | # anchors |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale (0-100) | 10 year post operative |
|
|
|
| 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). | Not all participants wanted to return to have their strength tested, but agreed to complete questionnaires. | Posted | Mean | Standard Deviation | units on a scale (0-100) | 10 year post operative |
|
|
|
| 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. | Not all participants wanted to return to have their strength tested, but agreed to complete questionnaires. | Posted | Mean | Standard Deviation | kg | 10 year post operative |
|
|
|
| 0 |
| 43 |
| 1 |
| 43 |
| 0 |
| 43 |
| EG001 | Double-Row Fixation | Double-Row anchor fixation in arthroscopic rotator cuff repair. | 0 | 34 | 1 | 34 | 0 | 34 |
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