Comparison of Shoulder Arthroplasty Techniques in the Treatment of Glenohumeral Osteoarthritis: Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
研究概览
简要总结
Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can produce pain and dysfunction at the affected joint and is a growing occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment used to treat patients with shoulder OA which involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent particularly when the arthritis is associated with bone erosion on the glenoid (socket).
Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone erosion, a number of surgical strategies have been developed. These surgical techniques include eccentric reaming which involves removing bone from the front of the socket, augmented glenoid component implantation, and posterior bone grafting to compensate for glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared these different surgical techniques to one another. Previous studies have been limited to case series with small sample sizes and respective designs. This study is being conducted to determine which approach produces better outcomes. For the purpose of this study we will be comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric reaming and b) augmented glenoid component and bone grafting in participants with advanced glenohumeral osteoarthritis.
详细描述
Patients who have 10-15 degrees of retroversion will be randomly assigned to one of two standard of care treatment groups: TSA with eccentric glenoid reaming or TSA with augmented glenoid component implantation.
Patients whose condition involves > 15 degrees of retroversion will be randomly assigned to one of two standard of care treatment groups: TSA with augmented glenoid component implantation or posterior glenoid bone grafting.
The primary objective will be measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24 months).
Secondary Objectives: i) To determine the survivorship of the components as measured by the degree of radiographic lucencies and component alignment determined by a CT scan at 1 and 5 years post-surgery between study arms in both age groups.
ii) To determine the difference in disease specific quality of life between treatment allocations in both age groups as measured by the Constant score, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the EuroQol Group EQ-5D-5L score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24 months), as well as adverse events, and health care utilization.
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)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
时间窗: 5-Years Post-Operative
The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
次要结局
- Shoulder Health Utilization(5-Years Post-Operative)
- Constant Score(5-Years Post-Operative)
- Adverse Events (AE) and Serious Adverse Events (SAE)(5-Years Post-Operative)
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)(5-Years Post-Operative)
- EuroQol EQ-5D-5L(5-Years Post-Operative)