Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators purpose of this study are to perform a prospective clinical study to determine the following after subscapularis-sparing anatomic total shoulder arthroplasty performed for glenohumeral osteoarthritis:
Anatomic total shoulder arthroplasty (TSA) provides excellent pain relief and restoration of shoulder function in the setting of glenohumeral osteoarthritis. However, the surgical approach requires the subscapularis to be cut and repaired, via either a lesser tuberosity osteotomy, a subscapularis tenotomy, or a subscapularis peel.This repair must be protected post-operatively, even with a lesser tuberosity osteotomy, or it can displace or fail to heal, which complicates rehabilitation. Failure of the subscapularis repair occurs in 10-25% of patients. Failure of the subscapularis repair is often devastating for shoulder function and often requires revision to a reverse total shoulder arthroplasty. Even when muscle-tendon-bone healing does occur there is post-operative atrophy of the subscapularis that may compromise function and strength. Atrophy of the subscapularis may lead to imbalance of the rotator cuff musculature, leading to subluxation and glenoid loosening. While there have been attempts to develop approaches that do not involve cutting the subscapularis, they have been plagued by osteophyte retention, component malposition, damage to the deltoid, or damage to the supraspinatus.
The principal investigator has spent four years developing a technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons and has been through the learning curve with this technique by completing >20 cases and at least as many cadaver surgeries during that time period. This technique has been designed to avoid the potential issues with prior attempts and utilizes purpose designed instrumentation and retractors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subscapularis-Sparing Total Shoulder Arthroplasty | Procedure | A surgical technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | Pre-operative |
| Patient-reported outcome (Simple Shoulder Test (SST)) | There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score. | Pre-operative |
| Patient-reported outcome (Visual Analogue Score (VAS)) | VAS pain score (0 no pain - 10 severe pain) | Pre-operative |
| Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 6-weeks post-operative |
| Patient-reported outcome (Simple Shoulder Test (SST)) | There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score. | 6-weeks post-operative |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Chalmers, M.D. | University of Utah Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopedics | Salt Lake City | Utah | 84108 | United States |
Not provided
Not provided
Not provided
Not provided
| Patient-reported outcome (Visual Analogue Score (VAS)) | VAS pain score (0 no pain - 10 severe pain) | 6-weeks post-operative |
| Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 3-months post-operative |
| Patient-reported outcome (Simple Shoulder Test (SST)) | There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score. | 3-months post-operative |
| Patient-reported outcome (Visual Analogue Score (VAS)) | VAS pain score (0 no pain - 10 severe pain) | 3-months post-operative |
| Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 1-year post-operative |
| Patient-reported outcome (Simple Shoulder Test (SST)) | There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score. | 1-year post-operative |
| Patient-reported outcome (Visual Analogue Score (VAS)) | VAS pain score (0 no pain - 10 severe pain) | 1-year post-operative |
| Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score | Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100. | 2-years post-operative |
| Patient-reported outcome (Simple Shoulder Test (SST)) | There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score. | 2-years post-operative |
| Patient-reported outcome (Visual Analogue Score (VAS)) | VAS pain score (0 no pain - 10 severe pain) | 2-years post-operative |