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临床试验/NCT06877936
NCT06877936招募中不适用

Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月29日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
主要终点
Kinematics evaluation

研究概览

简要总结

The shoulder is a site particularly affected by osteoarthritis since it affects up to 7% of the population aged over 65. To deal with osteoarthritis, total shoulder prosthesis is an increasingly used solution. Among the different types of total shoulder prostheses, the majority of surgical procedures involve the use of a reverse total shoulder prosthesis. This type of prosthesis modifies the anatomy of the shoulder in order to ensure better stability and mobility of the shoulder in patients while also compensating for potential significant lesions of certain deep muscles of the shoulder joint (i.e., rotator cuff).

Reverse prostheses have good short-term results but these are impaired in longer term with a Constant functional score of around 70% at 10 years and a survival rate of 70% after 20 years. Problems of bone conflicts between the scapula and the humerus can also be observed on these reverse total shoulder prostheses with variable rates from 4.6% to 47.3% depending on the position of the prosthesis.

In order to minimize the risk of complications, several tools are available to surgeons to optimize the positioning of the prosthesis. Planning software can be used to plan the kinematics of the shoulder after arthroplasty and quantify shoulder movements by 1/ estimating the scapulothoracic and glenohumeral angles, and 2/ determining the scapulohumeral rhythm (i.e., joint coordination index evaluating the relative contribution of these two joints to the total elevation of the arm). This prediction allows the surgeon to adapt the size, shape and position of the implants to each patient in order to ensure optimal shoulder kinematics, namely a maximum amplitude without bone conflicts (contacts) between the scapula and the humerus.

The main objective of this study is to evaluate the influence of a reverse shoulder arthroplasty on shoulder kinematics at 2 years postoperatively in comparison with the non-operated contralateral limb.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Reverse total shoulder arthroplasty surgery performed by Dr. Lionel Neyton (Jean Mermoz Private Hospital,69008 Lyon) 24±3 months prior to inclusion in the study.
  • Have had a CT scan of the operated shoulder prior to the operation
  • Patient having signed informed consent
  • Patient affiliated to a social security scheme or beneficiary of such a scheme, according to Article L.1124-1 of the Public Health Code

排除标准

  • Contraindication to the EOS® examination
  • Anthropometry incompatible with the production of EOS images
  • Pregnant, parturient, breastfeeding women
  • Have a history of fracture at the level of the humerus, scapula or clavicle
  • Have a history of surgery on the shoulder or contralateral upper limb to the limb with the prosthesis
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

结局指标

主要结局

Kinematics evaluation

时间窗: one month

The evaluation of kinematics will be done through the quantification of the scapulothoracic and glenohumeral angles.

次要结局

  • Scapulohumeral rhythm(one month)
  • Constant score on the operated side and the contralateral side.(one month)
  • ASES score(one month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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