Subscapularis-Sparing Total Shoulder Arthroplasty: A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Utah
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Study Overview
Brief Summary
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:
- patient-reported outcomes
- shoulder motion and strength
- rotator cuff integrity
- the accuracy of component placement and the completeness of osteophyte removal
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah.
Exclusion Criteria
- •Patients unwilling to consent and comply with study procedures (i.e. follow up visits).
- •Patients under the age of
- •Patients with contraindications to an anatomic total shoulder arthroplasty such as active infection, insufficient glenoid bone, damage to the rotator cuff, or a history of instability.
- •Patients with known prior shoulder arthroplasty.
- •Patients unable to undergo a magnetic resonance imaging study.
Outcomes
Primary Outcomes
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: Pre-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time Frame: Pre-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time Frame: Pre-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: 6-weeks post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time Frame: 6-weeks post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time Frame: 6-weeks post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: 3-months post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time Frame: 3-months post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time Frame: 3-months post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: 1-year post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time Frame: 1-year post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time Frame: 1-year post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: 2-years post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time Frame: 2-years post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time Frame: 2-years post-operative
VAS pain score (0 no pain - 10 severe pain)
Secondary Outcomes
No secondary outcomes reported
Investigators
Peter Chalmers
Principle Investigator
University of Utah