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NCT Number: NCT07358455

Preop Biomarkers as Outcome Predictors in 2 Stage Revision Surgery for PJI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Biomarkers' capacity to predict the likelihood of prosthetic reimplantation

    Time frame: 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

Secondary outcomes

  1. Acute kidney injury

    Time frame: From enrollment for at least one year

    Incidence of acute kidney injury

  2. ADL/IADL

    Time frame: From enrollment for at least one year

    Activities of Daily Living (ADL) assess basic self-care functions (e.g., bathing, dressing, feeding, toileting, transferring), whereas Instrumental Activities of Daily Living (IADL) evaluate more complex skills required for independent living (e.g., managing medications, finances, transportation, shopping, meal preparation)

  3. SF-12

    Time frame: From enrollment for at least one year

    The 12-Item Short Form Health Survey (SF-12) is a validated patient-reported outcome measure that provides a concise assessment of health-related quality of life, generating two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: ARKO-PJI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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