跳至主要内容
临床试验/NCT07621250
NCT07621250已完成不适用

Alexis O-Ring and Charnley Retrievers in Total Hip Arthroplasty Surgery. Is There Any Difference in Intraoperative Contamination Rates?

Hospital del Mar1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
1

研究概览

简要总结

Randomized, prospective, single-blind clinical trial comparing two static wound retractors - the Charnley retractor and the Alexis O-Ring retractor - in primary total hip arthroplasty (THA). The primary objective is to compare surgical site contamination rates between the two devices. Secondary objectives include comparison of incision length, surgical time, intraoperative skin lesions, and postoperative complications including periprosthetic joint infection. Patients will be randomized 1:1 to either retractor group. Surgical site contamination will be assessed through four intraoperative cultures taken at standardized timepoints. Follow-up will be conducted at 1 month postoperatively.

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, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with symptomatic hip osteoarthritis indicated for primary total hip arthroplasty (THA)

排除标准

  • Previous surgical interventions or scar tissue over the hip to be operated Subcapital femoral fractures requiring THA (non-primary indication) History of infection in any previous joint arthroplasty procedure Immunological disorders increasing the risk of periprosthetic joint infection (diagnosed immunodeficiencies, chemotherapy or immunosuppressive treatment) Advanced dementia or severe cognitive impairment precluding informed consent

研究者

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

Carlos Torrens

PhD

Hospital del Mar

研究点 (1)

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