Subscapularis-Sparing Total Shoulder Arthroplasty: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah.
排除标准
- •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.
结局指标
主要结局
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
时间窗: 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))
时间窗: 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))
时间窗: Pre-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
时间窗: 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))
时间窗: 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))
时间窗: 6-weeks post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
时间窗: 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))
时间窗: 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))
时间窗: 3-months post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
时间窗: 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))
时间窗: 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))
时间窗: 1-year post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
时间窗: 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))
时间窗: 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))
时间窗: 2-years post-operative
VAS pain score (0 no pain - 10 severe pain)
次要结局
未报告次要终点
研究者
Peter Chalmers
Principle Investigator
University of Utah