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临床试验/NCT05929105
NCT05929105已完成不适用

Short-term Outcome of Artificial Intelligence-assisted Preoperative Three-dimensional Planning of Total Hip Arthroplasty for Developmental Dysplasia of the Hip Compared With Traditional Surgery

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2020年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
Type of acetabular cup and femoral stem

研究概览

简要总结

In this study, the investigators retrospectively collected DDH case data of THA assisted by AI 3D planning and THA assisted by traditional planning. The compliance between preoperative planning and the type of prosthesis used in the operation, the position of the acetabular prosthesis, the correction of LLD and the postoperative joint function score were analysed to evaluate the short-term effect of AI combined with preoperative 3D planning in THA for DDH.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • DDH was diagnosed by clinical signs and imaging examination, and a primary THA was planned;
  • the patient had persistent unilateral hip pain, which seriously affected their quality of life;
  • the standard posterolateral approach was used;
  • the contralateral hip was normal or had received THA;
  • the proximal femoral Dorr classification was type A or B;
  • The acetabular classification was Crowe type Ⅰ, Ⅱ, Ⅲ or IV;
  • all patients were treated with the bioartificial hip joint PINNACLE® cup or SUMMIT® stem, developed by Johnson & Johnson Biological.

排除标准

  • preoperative and postoperative imaging examinations did not meet the evaluation criteria (non-standard double-hip anteroposterior film, acetabular angle and LL length could not be accurately measured);
  • severe osteoporosis, tumour or metabolic disease around the affected hip joint;
  • spinal deformity by other causes or a history of lumbar internal fixation;
  • external deformity of the affected hip joint in the lower extremity;
  • neuromuscular insufficiency (with hip abduction weakness and poliomyelitis);
  • severe disease with intolerance to surgery.

结局指标

主要结局

Type of acetabular cup and femoral stem

时间窗: 31 months

Accuracy analysis of planning model and the practical model

Difference in the length of lower limbs before and after surgery

时间窗: 31 months

Prove the accuracy of the artificial intelligence planning group

次要结局

未报告次要终点

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peng Li

Deputy Director

General Hospital of Ningxia Medical University

研究点 (1)

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