跳至主要内容
临床试验/ChiCTR2600121733
ChiCTR2600121733已完成Unknown

At MRI, the minimally invasive direct anterior approach produces less muscle alterations compared to the minimally invasive direct lateral approach in uncemented total hip arthroplasty: a prospective quasi-randomized study

This study received no external funding.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Postoperative muscle fatty infiltration on MRI

研究概览

简要总结

The primary objective of this study is to compare postoperative muscle alterations between the minimally invasive direct anterior approach (DAA) and the minimally invasive direct lateral approach (DLA) in patients undergoing primary uncemented total hip arthroplasty, as assessed by magnetic resonance imaging at 12 months. Secondary objectives are to compare the trajectory of functional recovery and health-related quality of life between the two surgical approaches at 1, 3, 6, and 12 months postoperatively.

研究设计

研究类型
Interventional
主要目的
非随机对照试验
盲法
None

入排标准

年龄范围
40 至 90(—)
性别
All

入选标准

  • Adult patients undergoing primary THA for hip osteoarthritis
  • Eligibility for uncemented THA
  • Ability to complete clinical follow-up
  • Eligibility for MRI examination at 12 months

排除标准

  • Hip fracture or post-traumatic arthritis
  • Inflammatory or autoimmune joint disease
  • Neuromuscular disorders
  • Active malignancy or chronic immunosuppression
  • Contraindications to MRI

研究组 & 干预措施

MIS Direct Anterior Approach (DAA)

Primary uncemented total hip arthroplasty performed using a minimally invasive direct anterior approach

干预措施: Primary uncemented total hip arthroplasty performed using a minimally invasive direct anterior approach

Minimally Invasive Direct Lateral Approach (DLA)

Primary uncemented total hip arthroplasty performed via a minimally invasive direct lateral approach with partial gluteus medius detachment using the same implant system and perioperative protocol as the DAA group.

干预措施: Primary uncemented total hip arthroplasty performed via a minimally invasive direct lateral approach with partial gluteus medius detachment using the same implant system and perioperative protocol as the DAA group.

结局指标

主要结局

Postoperative muscle fatty infiltration on MRI

时间窗: 12 months postoperatively

次要结局

  • WOMAC Score(1, 3, 6, 12 months)
  • SF-12(1, 3, 6, 12 months)

研究者

发起方
This study received no external funding.

研究点 (1)

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