Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- positioning of the metaglene of the reverse shoulder prostheses
研究概览
简要总结
To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.
详细描述
Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.
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
- Single (Outcomes Assessor)
盲法说明
given the fact that the different approaches come with different scars, just the outcomes assessor can be blinded
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
- •Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses
- •No previous surgeries of the affected shoulder
- •Acceptance by the patient to participate in the study
排除标准
- •Fractures> 2 weeks of evolution
- •Previous surgeries on the affected shoulder
- •Not signing the informed consent
- •Cognitive impairment
- •Institutionalization of the patient
研究组 & 干预措施
deltopectoral
deltopectoral surgical approach
干预措施: Reverse Shoulder Arthroplasty (Procedure)
antero-superior
antero-superior approach
干预措施: Reverse Shoulder Arthroplasty (Procedure)
结局指标
主要结局
positioning of the metaglene of the reverse shoulder prostheses
时间窗: 2 years
to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.
次要结局
- scapular notch(2 years)
- functional outcome(2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.)
研究者
Carlos Torrens
Principal investigator
Hospital del Mar
