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临床试验/NCT04405947
NCT04405947已完成不适用

Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach

Hospital del Mar0 个研究点目标入组 100 人开始时间: 2016年1月13日最近更新:
适应症
干预措施

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

Other

deltopectoral surgical approach

干预措施: Reverse Shoulder Arthroplasty (Procedure)

antero-superior

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Torrens

Principal investigator

Hospital del Mar

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