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临床试验/NCT07645508
NCT07645508进行中(未招募)不适用

Comparison of Conventional, Patient-Specific, and Augmented Reality Navigation in Reverse Total Shoulder Arthroplasty: CT-Based Glenoid Positioning Accuracy and Functional Outcomes

Krankenhaus Barmherzige Schwestern Linz1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1

研究概览

简要总结

This monocentric observational cohort study compares conventional instrumentation, patient-specific instrumentation, and augmented reality navigation in reverse total shoulder arthroplasty. The primary objective is to assess the accuracy of glenoid component positioning based on postoperative CT data. Secondary objectives include evaluation of functional outcomes and clinical performance at mid-term follow-up. Patients who underwent surgery between 2021 and 2024 are followed up clinically at 2 years postoperatively.

详细描述

This study investigates the accuracy and clinical relevance of different planning and implementation techniques in reverse total shoulder arthroplasty. Patients treated at a single orthopedic center between 2021 and 2024 were included. Three established surgical approaches were analyzed: conventional instrumentation, patient-specific instrumentation, and augmented reality navigation.

Initial data collection included retrospective and prospective assessment of preoperative planning parameters and their intraoperative implementation. Postoperative evaluation included low-dose CT imaging to assess glenoid component positioning accuracy.

The current phase of the study focuses on long-term clinical outcomes, with a standardized 2-year follow-up including clinical examination and validated functional outcome scores. No additional imaging is performed as part of the follow-up phase.

Patients were not randomized; group allocation reflects the surgical technique used at the time of treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • Age ≥ 18 years
  • Reverse total shoulder arthroplasty performed between 2021 and 2024
  • Available preoperative imaging and planning (X-ray and/or CT)
  • Available postoperative CT imaging
  • Written informed consent

排除标准

  • Major perioperative complications not related to the shoulder procedure affecting outcomes
  • Incomplete imaging or clinical data

研究者

发起方
Krankenhaus Barmherzige Schwestern Linz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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