Five Year Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs.
研究概览
简要总结
We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.
详细描述
This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago.
排除标准
- •unable to comprehend the consent form information
- •pregnant women
结局指标
主要结局
Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs.
时间窗: 5 years after surgery
To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.) better functional outcomes.
次要结局
未报告次要终点