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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07358455
Acronym
ARKO-PJI
Enrollment
200
Registered
2026-01-22
Start date
2026-01-01
Completion date
2026-12-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic Joint Infection (PJI)

Brief summary

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biomarkers' capacity to predict the likelihood of prosthetic reimplantationFrom enrollment for at least one yearThe ability of selected preoperative biomarkers (e.g., NLR, PLR) to predict reimplantation outcomes in patients undergoing two-stage revision procedures

Secondary

MeasureTime frameDescription
Acute kidney injuryFrom enrollment for at least one yearIncidence of acute kidney injury
ADL/IADLFrom enrollment for at least one yearActivities 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)
SF-12From enrollment for at least one yearThe 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026