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临床试验/NCT07358455
NCT07358455尚未招募不适用

Identification of Pre-prosthetic Revision Markers Predictive of Outcome in Patients With Periprosthetic Infection

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 200 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Biomarkers' capacity to predict the likelihood of prosthetic reimplantation

研究概览

简要总结

With the progressive ageing of the population, a significant increase in the incidence of skeletal fractures-particularly of the proximal femur-as well as degenerative conditions such as osteoarthritis has been observed, for which joint arthroplasty represents the treatment of choice. However, this procedure is not free from complications; beyond technical and mechanical issues related to potential implant malpositioning, one of the most feared is periprosthetic joint infection (PJI), which poses a major challenge in terms of clinical management and prognostic impact. Therapeutic strategies for PJI range from debridement with retention of the implant and exchange of modular components (DAIR/DAPRI) to complete implant removal with insertion of an articulating spacer, often followed by a subsequent reimplantation procedure. These approaches require prolonged antibiotic regimens, potentially exerting a negative effect on renal function, particularly in cases of extended exposure to nephrotoxic agents. Despite the clinical relevance of this issue, the current literature still provides limited evidence regarding the identification of inexpensive and readily available biomarkers capable of predicting treatment outcomes in PJI, especially in patients undergoing spacer implantation followed by reimplantation. Recent literature has increasingly explored the use of biomarkers such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic inflammation response index (SIRI), and others to characterize inflammatory and nutritional status, and to investigate possible associations between these markers and the outcomes of selected surgical procedures. The availability of predictive markers could optimize therapeutic management by reducing the risk of infection recurrence and improving postoperative risk stratification.

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
  • Diagnosis of an orthopaedic periprosthetic joint infection (PJI)
  • Surgical treatment
  • Minimum follow-up of 12 months
  • Written informed consent to participate in the study

排除标准

  • Age < 18 years
  • Patients undergoing prosthetic revision without evidence of periprosthetic joint infection
  • Treatment with antibiotic therapy alone (non-surgical management)
  • Follow-up < 12 months
  • Incomplete dataset
  • Lack of informed consent to participate in the study

结局指标

主要结局

Biomarkers' capacity to predict the likelihood of prosthetic reimplantation

时间窗: From enrollment for at least one year

The ability of selected preoperative biomarkers (e.g., NLR, PLR) to predict reimplantation outcomes in patients undergoing two-stage revision procedures

次要结局

  • Acute kidney injury(From enrollment for at least one year)
  • ADL/IADL(From enrollment for at least one year)
  • SF-12(From enrollment for at least one year)

研究者

申办方类型
Other
责任方
Sponsor

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