Preop Biomarkers as Outcome Predictors in 2 Stage Revision Surgery for PJI (ARKO-PJI)

January 22, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with PJI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment for at least one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: From enrollment for at least one year
Incidence of acute kidney injury
From enrollment for at least one year
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)
From enrollment for at least one year
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)
From enrollment for at least one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 7818

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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