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| Name | Class |
|---|---|
| St. Joseph's Health Care London | OTHER |
| Unity Health Toronto | OTHER |
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What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel.
It is the investigators' hypothesis that a peel of the subscapularis will result in greater strength, a higher healing rate, and a greater improvement in shoulder function and quality of life following shoulder replacement.
The primary research question is to determine the difference in subscapularis strength between two different methods of subscapularis mobilization in shoulder arthroplasty: intra-substance division of the tendon "tenotomy" versus direct detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". The primary outcome is strength as measured by a hand-held dynamometer in the belly-press position at one-year post operative. Secondary research questions include determination of the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus subscapularis peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), Constant score and the ASES score at one year post-operatively. Finally, the healing rate of the subscapularis, as measured by ultrasound at 1 year post-operative will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subscapularis Tenotomy | Active Comparator | This treatment group will undergo a technique that involves division of the tendon to gain access to the shoulder. After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. |
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| Subscapularis Peel | Experimental | This treatment group will use a technique that involves elevation of the tendon off the bone in order to gain access to the shoulder.The subscapularis will be elevated from the lesser tuberosity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subscapularis Tenotomy | Procedure | After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. The tendon will be tagged for later repair. Repair will take place with a combination of transosseous sutures (3) placed in a mattress configuration through the area of exposed lesser tuberosity. In addition, a soft tissue tendon to tendon repair will be carried out using figure-8 stitches using #2 (heavy) non-absorbable suture (Ticron). |
| Measure | Description | Time Frame |
|---|---|---|
| What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel | What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a hand-held dynamometer in the belly-press position at one year post operative? | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as measured by WORC, ASES and Constant |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lapner, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 1, 2023 | |
| Reset | Dec 13, 2023 | |
| Release | Jan 8, 2024 | |
| Reset | Jan 8, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 1, 2023 | Dec 13, 2023 | |||
| Jan 8, 2024 |
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| subscapularis peel | Procedure | The subscapularis will be elevated from the lesser tuberosity. The tendon will be tagged with stay sutures for later reattachment (3 sutures in mattress configuration). Reapproximation will take place with three non-absorbable mattress sutures placed in a trans-osseous fashion through the bicipital groove, exiting the greater tuberosity and tied over a 4-hole mini-fragment plate. |
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| 12 months |
| Jan 8, 2024 |