NCT07226388Enrolling By Invitation不适用
Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis: The Impact of Modern Implant Options
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Single Assessment Numeric Evaluation score
研究概览
简要总结
This is a multi-center study assessing postoperative outcomes associated with hemiarthroplasty with pyrocarbon (hPYC) versus anatomic total shoulder arthroplasty (aTSA). Once eligibility criteria is met, the subject will be randomized to one of the two study arms. Subjects will be followed for ten years. Clinical and patient-reported outcome measures (PROMs) will be assessed.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English language
- •Willing to sign an informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Age 40 to 65 years
- •In good general health as evidenced by medical history
- •Surgical indication of glenohumeral osteoarthritis
- •In the opinion of the surgeon, there is clinical equipoise for the subject to be implanted with a humeral hemiarthroplasty with pyrocarbon or anatomic total shoulder arthroplasty
排除标准
- •Presence of Walch Type C or D glenoid
- •Presence of a glenoid that could not be reconstructed with the anatomic glenoid resurfacing components
- •Presence of extreme preoperative glenoid deformity including uniplanar retroversion deformity >30 o or severe biplanar deformity (retroversion >20 o and inclination > 10 o).
- •Workers' compensation case
- •Presence of full-thickness rotator cuff tear
- •Known allergic reactions to components of the study product(s)
- •History of consistent narcotic use within three months of surgery
- •History of chronic oral corticosteroid use
- •History or current drug or alcohol abuse
- •In the surgeon's opinion, the subject will be non-compliant with the study protocol.
研究组 & 干预措施
Hemiarthroplasty with pyrocarbon
Active Comparator
干预措施: Hemiarthroplasty with pyrocarbon (Device)
Anatomic total shoulder arthroplasty
Active Comparator
干预措施: Anatomic total shoulder arthroplasty (Device)
结局指标
主要结局
Single Assessment Numeric Evaluation score
时间窗: 2-years
Assess shoulder pain and function. The score ranges from 0 to 100 with higher scores indicating a better shoulder function and less pain.
次要结局
- American Shoulder and Elbow Visual Analog Pain Score(2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years)
- Forgotten Joint score(2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years)
- Range of motion(2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years)
- Assess rates of glenoid erosion(2-years, 5-years, 10-years)
- Assess rates of aseptic glenoid loosening(2-years, 5-years, 10-years)
- Single Assessment Numeric Evaluation Score(5-years, 10-years)
研究者
Benjamin Zmistowski
Assistant Professor
Washington University School of Medicine
研究点 (1)
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