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临床试验/NCT05462691
NCT05462691尚未招募不适用

"It is Necessary to Suture the Tuberosities in Inverted Prostheses Implanted for Acute Fractures of the Proximal Humerus?. Prospective Randomized Study

Hospital del Mar0 个研究点目标入组 90 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Simple Shoulder Test

研究概览

简要总结

Complex fractures of the proximal humerus in elderly patients constitute a growing problem. Osteoporosis linked to these fractures prevents osteosynthesis correctly, so that if the offset between the fragments is large, it is necessary to implant a prosthesis. Inverted prostheses, normally used for the treatment of osteoarthritis with absence of the rotator cuff, have become the treatment of choice in these fractures obtaining very favorable results. Traditionally, once the prosthesis is implanted, they are sutured the tuberosities with the rotator cuff tendons to the prosthesis. This gesture is supposed to will improve patient function. However, this prosthesis was originally designed for use in patients without a rotator cuff, so the need for this suture, which lengthens surgical time and requires an increase in the number of sutures, which can potentially increase the risk of infection. With the results of this study, it would be possible to reduce the surgical time, the number of inert materials implanted, and potentially the risk of infection.

详细描述

Complex fractures of the proximal humerus in elderly patients constitute a growing problem. Osteoporosis linked to these fractures prevents osteosynthesis correctly, so that if the offset between the fragments is large, it is necessary to implant a prosthesis. Inverted prostheses, normally used for the treatment of osteoarthritis with absence of the rotator cuff, have become the treatment of choice in these fractures obtaining very favorable results. Traditionally, once the prosthesis is implanted, they are sutured the tuberosities with the rotator cuff tendons to the prosthesis. This gesture is supposed to will improve patient function. However, this prosthesis was originally designed for use in patients without a rotator cuff, so the need for this suture, which lengthens surgical time and requires an increase in the number of sutures, which can potentially increase the risk of infection. With the results of this study, it would be possible to reduce the surgical time, the number of inert materials implanted, and potentially the risk of infection.

Primary objective:

To determine if there are differences in the perception of quality of life measured by through the Simple Shoulder Test scale, among the patients in whom sutured the tuberosities and patients who have had the tuberosities excised tuberosities.

Secondary objectives:

To determine if there are differences between the patients in whom suturing has been the tuberosities and patients who have had their tuberosities excised about:

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
Double (Participant, Outcomes Assessor)

盲法说明

patients will be blinded to the assignment group. outcomes assessors will be blinded to the assignment group

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients > 65 yrs. and < 85 yrs.
  • Acute fracture of the proximal humerus.
  • implantation of inverted shoulder prosthesis.

排除标准

  • acute fractures of more than 3 weeks of evolution
  • Associated fractures.
  • senile dementia and/or cognitive alterations that prevent compliance protocols

结局指标

主要结局

Simple Shoulder Test

时间窗: 24 months

Primary objective: To determine if there are differences in the perception of quality of life measured by through the Simple Shoulder Test scale, among the patients in whom sutured the tuberosities and patients who have had the tuberosities excised tuberosities.

次要结局

未报告次要终点

研究者

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

Carlos Torrens

Clinical Professor

Hospital del Mar

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