Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Shoulder X-ray
研究概览
简要总结
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.
详细描述
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Minimum age of 18 years old
- •Total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) between 2007 and 2017 in UZ Leuven
- •Primary indication for surgery is rotator cuff arthropathy
- •Informed consent obtained
排除标准
- •Total shoulder replacement in post septic arthritis.
- •Total shoulder replacement in post-instability arthritis.
- •Revision total shoulder arthroplasty.
- •Posttraumatic total shoulder arthroplasty (after failed index operation)
结局指标
主要结局
Shoulder X-ray
时间窗: up to 20 months
To describe bony reaction at the bone-implant interface for the humeral component of a reverse shoulder arthroplasty. End-point radiographs will be compared to radiographs taken postoperatively in order to define stress shielding and/or bone resorption in the 5 humeral zones described by Nagels et al.
次要结局
- Constant-Murley score(up to 20 months)
- Anchor Question Shoulder Score(up to 20 months)
- Net Promotor Score (NPS)(one time visit)
- Clinical outcome(up to 20 months)
- Short Form 36 Health Survey Questionnaire (SF-36)(up to 20 months)