Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Difference in glenoid center
研究概览
简要总结
This is a two steps observational study
In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide. As a secondary goal, the problems detected during the design phase will be described.
Once the accuracy of the guide is acceptable, we will implant the glenosphere of future patients using the PSG guide following the same engineering design process.
详细描述
Reverse shoulder arthroplasty is a treatment for both non-synthesizable fractures and arthropathy degenerative. This implant is based on two main components: glenosphere and stem. The stem in turn is integrated in its upper part by a polyethylene that reduces the friction torque between the glenosphere and the stem.
Correct positioning of the glenosphere is critical for functionality and survival of the implant. Malpositioning of glenosphere can be related to:
In recent years, given the
- The scapula is a flat bone, without any reference axis;
- Surgical approaches expose only the glenoid cavity, with few bone landmarks;
- The humerus and deltoid make access to the glenoid difficult;
- The morphology of the scapula is very variable.
Preoperative planning even without PSG improves the positioning accuracy of the guide in the glenoid. In glenoids with only a slight deformity, PSGs improve the accuracy of the guide entry point (<1 mm error, compared to > 4 mm under visual control) and orientation (< 3◦ error compared to > 7◦). In glenoids with more significant deformities, planning also showed superiority.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
- •Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty
排除标准
- •Previous surgeries on the proximal humerus or glenoid
- •No desire to participate in the study
- •Lack of ability to accept the study (tutored patients)
- •Open fractures
结局指标
主要结局
Difference in glenoid center
时间窗: months
Difference in glenoid center (mm): distance between the points of entry on the surface of the scapula, the planned center versus the finally drawn
Glenoid version deviation (α)
时间窗: months
Glenoid version deviation (α): defined as the angle between the real trajectory of the drilling and the scapular anatomical plane, projected about the axis of neutral inclination (defined as that which goes from the center of the glenoid to the trigonum spinae).
Glenoid inclination deviation (β)
时间窗: months
Glenoid inclination deviation (β): defined as the angle between the actual milling path and the plane of the neutral tilt axis, projected on the SP axis
次要结局
未报告次要终点