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This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.
The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis peel versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subscapularis peel | Active Comparator |
| |
| osteotomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subscapularis peel | Procedure | Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subscapularis Strength | Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario Osteoarthritis of the Shoulder Index | The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lapner, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hosptial | Ottawa | Ontario | K1y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22944077 | Result | Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Healing rates and subscapularis fatty infiltration after lesser tuberosity osteotomy versus subscapularis peel for exposure during shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Mar;22(3):396-402. doi: 10.1016/j.jse.2012.05.031. Epub 2012 Sep 1. | |
| 23318614 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subscapularis Peel | Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". |
| FG001 | Osteotomy | osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subscapularis Peel | Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". |
| BG001 | Osteotomy | osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Subscapularis Strength | Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force. | Posted | Mean | Standard Deviation | kg | 2 years |
|
|
Adverse events were monitored through to participant study completion up until 2-years post-operative
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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 | Subscapularis Peel | tenotomy: This treatment group will undergo a technique that involves division of the tendon to gain access to the shoulder. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Lapner | Ottawa Hospital Research Institute | 613-737-8899 | 74700 | plapner@toh.ca |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D010027 | Osteotomy |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| osteotomy | Procedure | This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder. |
|
|
| 2 Years |
| American Shoulder and Elbow 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. | 2 Years |
| Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Comparison of lesser tuberosity osteotomy to subscapularis peel in shoulder arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Dec 19;94(24):2239-46. doi: 10.2106/JBJS.K.01365. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | 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 | Count of Participants | Participants |
|
|
|
| Secondary | Western Ontario Osteoarthritis of the Shoulder Index | The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-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 | WOOS Score | 2 Years |
|
|
|
| Secondary | American Shoulder and Elbow 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 | ASES Score | 2 Years |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Osteotomy | osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder. | 0 | 43 | 0 | 43 |
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