Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Materialise
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Change in baseline Constant-Murley Score after surgery
研究概览
简要总结
This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system
详细描述
The Glenius glenoid implant is a solution for patients who need a reversed glenoid reconstruction (primary or revision) because of a severely damaged glenoid associated with severe bone loss. In these cases, standard reconstruction of the glenoid is not possible because of the lack of body support of the glenoid rim or columns.
The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is designed based on a detailed 3D CT analysis of the defect with special reference to bone quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories are defined for each individual patient, which accommodate screws that are positioned and angled towards the best bone stock available in the glenoid/coracoid/scapula with each specific patient. The surgeon provides feedback on the the design and orientation of the implant needed to achieve the optimal inclination of the head and the position & offset of the joint's centre of rotation.
Because Glenius is a relatively new product and only for use in specific and complex cases of severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce. With this study we aim to collect long-term clinical and radiological follow-up data for patients treated with Glenius in a uniform, standardized way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients having primary or revision shoulder joint replacement with severe glenoid bone defects
- •Patient is 18 years of age or older
- •Patient can follow the Glenius system procedure that is standard of care
- •Patient is willing to cooperate in the required post-operative therapy
- •Patient has participated in the informed consent process and has signed the EC approved informed consent form
排除标准
- •Pregnant patients
- •Skeletally immature patients
- •Prisoners
结局指标
主要结局
Change in baseline Constant-Murley Score after surgery
时间窗: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
The Constant-Murley score is a clinical outcome scale composed of a number of individual parameters, defining the level of pain, the ability to carry out the normal daily activities of the patient, mobility and strength of the arm. The scores range from 0 (worst clinical outcome) to 100 (best clinical outcome).
次要结局
- Change in baseline Oxford Shoulder Score (OSS) after surgery(6 weeks, 3 months, 1 year, 2 year, 5 years after surgery)
- Rotational deviation from initial implant position(1 year after surgery)
- Scapular notching(6 weeks, 3 months, 1 year, 2 years, 5 years after surgery)
- Radiolucensies(6 weeks, 3 months, 1 year, 2 years, 5 years after surgery)
- Complication rate(up to 5 year after surgery)
- rate of implant revision surgeries up to 5 years after surgery(up to 5 years after surgery)
- Translational deviation from planned implant position(6 weeks after surgery)
- Change in baseline Simple Shoulder Test (SST) after surgery(6 weeks, 3 months, 1 year, 2 year, 5 years after surgery)
- change in general health EQ5D score after surgery(6 weeks, 3 months, 1 year, 2 year, 5 years after surgery)
- Rotational deviation from planned implant position(6 weeks after surgery)
- change in baseline pain score using Visual Analogue Scales (VAS) after surgery(6 weeks, 3 months, 1 year, 2 year, 5 years after surgery)
- Translational deviation from initial implant position(1 year after surgery)
- Heterotopic ossifications(6 weeks, 3 months, 1 year, 2 years, 5 years after surgery)