Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Active external rotation, 2 years
研究概览
简要总结
The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.
详细描述
This study aims to determine if active external rotation two years postoperatively varies based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty (RTSA). The study also aims to determine whether active forward elevation, abduction, scapular notching, and functional outcomes two years postoperatively vary based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty. Patients undergoing primary RTSA by Dr. J. Michael Wiater, Dr. Brett Wiater, or Dr. Alexander Martusiewicz at Beaumont Health will be screened for eligibility. Following informed consent, participants will be randomised (1:1) to one of the following groups: 1) RTSA with inlay humeral component (Tornier Perform Stem Reverse+) or 2) RTSA with onlay humeral component (Tornier Ascend Flex stem). At baseline, participants will complete study questionnaires, receive a range-of-motion (ROM) exam, and standard of care x-rays and computed tomography (CT) scans. These evaluations will be repeated at 3 months, 12 months and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Key personnel not collecting data will perform randomization and inform surgeon of the group assignment, keeping data collection blinded. The participant will also remain blinded to their assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary reverse total shoulder arthroplasty with the following components:
- •Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
- •Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
- •Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear
- •Negative external rotation lag sign, ability to externally rotate beyond neutral
- •Age 18 years or older
排除标准
- •Revision arthroplasty
- •Prior open shoulder surgery
- •Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius)
- •Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
- •Patients not willing to undergo a standardized physical therapy protocol or home therapy program after surgical intervention
- •Patient anatomy does not accommodate the study implants per surgeon discretion
- •Pregnant, patient-reported
- •Minors (under 18 years of age)
- •Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires
结局指标
主要结局
Active external rotation, 2 years
时间窗: 2 years postoperative
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
次要结局
- Active external rotation, 1 year(1 year postoperative)
- Strength during active external rotation, 1 year(1 year postoperative)
- Active external rotation, 3 months(3 months postoperative)
- Strength during Internal rotation, 2 years(2 years postoperative)
- Strength during active external rotation, 3 months(3 months postoperative)
- Active forward elevation, 1 year(1 year postoperative)
- Abduction, 3 months(3 months postoperative)
- Strength during abduction, 2 years(2 years postoperative)
- Internal rotation, 2 years(2 years postoperative)
- Drop arm test, 2 years(2 years postoperative)
- Lift off test, 3 months(3 months postoperative)
- Active forward elevation, 3 months(3 months postoperative)
- Active forward elevation, 2 years(2 years postoperative)
- Strength during active forward elevation, 1 year(1 year postoperative)
- Strength during abduction, 3 months(3 months postoperative)
- Strength during abduction, 1 year(1 year postoperative)
- Strength during active external rotation, 2 years(2 years postoperative)
- Strength during active forward elevation, 3 months(3 months postoperative)
- Strength during active forward elevation, 2 years(2 years postoperative)
- Abduction, 1 year(1 year postoperative)
- Abduction, 2 years(2 years postoperative)
- Strength during Internal rotation, 1 year(1 year postoperative)
- Lift off test, 1 year(1 year postoperative)
- Internal rotation, 3 months(3 months postoperative)
- Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 1 year(1 year postoperative)
- Internal rotation, 1 year(1 year postoperative)
- Strength during Internal rotation, 3 months(3 months postoperative)
- Drop arm test, 1 year(1 year postoperative)
- Belly press test, 1 year(1 year postoperative)
- Belly press test, 2 years(2 years postoperative)
- Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months(3 months postoperative)
- External rotation lag sign test, 3 months(3 months postoperative)
- External rotation lag sign test, 1 year(1 year postoperative)
- External rotation lag sign test, 2 years(2 years postoperative)
- Drop arm test, 3 months(3 months postoperative)
- Lift off test, 2 years(2 years postoperative)
- Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years(2 years postoperative)
- Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year(1 year postoperative)
- Belly press test, 3 months(3 months postoperative)
- Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year(1 year postoperative)
- Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 2 years(2 years postoperative)
- Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 2 years(2 years postoperative)
- Visual Analog Scale measure of pain, 1 year(1 year postoperative)
- Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months(3 months postoperative)
- Visual Analog Scale measure of pain, 2 years(2 years postoperative)
- Scapular notching, 3 months(3 months postoperative)
- Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 3 months(3 months postoperative)
- Visual Analog Scale measure of pain, 3 months(3 months postoperative)
- Scapular notching, 1 year(1 year postoperative)
- Scapular notching, 2 years(2 years postoperative)
- Reoperation(2 years postoperative)
- Study-related adverse events(2 years postoperative)
研究者
Dr. Alex Martusiewicz
staff physician
Corewell Health East