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NCT Number: NCT06467734

Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection

Prosthetic Joint Infection (PJI) is one of the severe complications following arthroplasty. With the global aging population, the number of patients undergoing primary joint replacement surgeries is increasing, leading to a rise in PJI cases. Although the incidence of PJI is generally low, the impact on patients can be catastrophic. Once an infection occurs, it is further complicated by the rising global antibiotic resistance, imposing a significant economic burden on patients. Therefore, improving the diagnostic rate of PJI is crucial. Currently, various infection markers are used in the diagnosis of PJI. However, there is still a lack of highly sensitive and specific markers to effectively diagnose PJI, necessitating the exploration of new infection markers. This study aims to investigate novel infection markers for the diagnosis of PJI, providing evidence for its diagnosis and subsequent treatment. In this research, we will prospectively collect data from patients undergoing primary joint replacement and those developing PJI from June 2024 to December 2026. These patients will be categorized into non-infection and infection groups. By collecting and analyzing general patient data, surgery-related information, and infection-related indicators from preoperative joint fluid and blood samples, we aim to further evaluate the predictive value of these infection markers for PJI.

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Key information

Conditions

Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥18 years old, gender is not limited;
  • The experimental group met the diagnostic criteria of chronic periprosthesis infection after joint replacement according to the 2018 Musculoskeletal Infection Association; The control group was eligible for primary replacement patients who excluded periprosthesis infection.
  • Voluntary and signed informed consent.

Exclusion criteria

  • Patients with immune-related arthritis such as rheumatoid and rheumatism were excluded;
  • Radiotherapy and chemotherapy are required due to neoplastic diseases;
  • Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication);
  • Severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
  • Have a history of drug abuse;
  • Use immunosuppressive drugs to treat bone marrow or other transplants;
  • Pregnant, parturient and lactating women;
  • Participating in other clinical trials;
  • Researchers consider other reasons not appropriate for clinical trial participants.

Treatment and study plan

Joint aspiration

Device

Joint puncture to extract joint fluid.

Primary outcomes

  1. Joint fluid target protein detection

    Time frame: One day before surgery or one day after surgery

    To detect new target proteins by elisa test.

Secondary outcomes

  1. X-ray

    Time frame: One day before surgery and two years after surgery

    X-ray of surgery site.

  2. Erythrocyte sedimentation rate (ESR)

    Time frame: One day before sugery and two year after surgery

    It measures the rate at which red blood cells settle to the bottom of a test tube within one hour.

    Normal ranges:

    Male: 0 to 15 millimeters per hour (mm/hr) Female: 0 to 20 millimeters per hour (mm/hr)

  3. C-reactive protein (CRP)

    Time frame: One day before sugery and two year after surgery

    C-reactive protein (CRP) is a protein produced by the liver that significantly increases in response to inflammation or infection. Normal range for CRP is less than 10 milligrams per liter (mg/L).

  4. Synovial fluid white blood cell count (SF-WBC)

    Time frame: One day before surgery and one day after surgery

    Synovial fluid white blood cell count (SF-WBC)

  5. Synovial fluid polymorphonuclear cells (SF-PMN)

    Time frame: One day before surgery and one day after surgery

    Polymorphonuclear neutrophil percentage in synovial fluid refers to the proportion or percentage of polymorphonuclear neutrophils (PMN) present in the synovial fluid. This measurement is important in the assessment of joint health and inflammation, particularly in conditions such as arthritis and infections affecting the joints. Normal range: Less than 80%.

  6. Doppler lower extremity vascular color ultrasound

    Time frame: One day before surgery and three day after surgery

    Doppler lower extremity vascular color ultrasound to evaluate the deep vein thrombus development

  7. American Knee Society Score (AKS score)

    Time frame: One day before surgery, two years after surgery

    American Knee Society Score is used to evaluate the outcomes of knee replacement surgery. This scoring system consists of two main components: the knee score and the function score.

    Knee Score: This primarily assesses the condition of the knee joint itself, including pain, stability, and range of motion. The higher of the score, the better of the functional result.

  8. The Hip Harris Score (HHS)

    Time frame: One day before surgery, two years after surgery

    The Harris Hip Score (HHS) is a widely used clinical tool for assessing the outcomes of hip surgeries, particularly hip replacements. Developed by Dr. William Harris in 1969, it evaluates various aspects of hip function and pain to provide an overall score that reflects the patient's condition. The higher the score, the better the result is.

  9. Alanine Aminotransferase (ALT)

    Time frame: One day before surgery and one day after surgery

    An enzyme found in the liver that helps convert proteins into energy. Elevated levels indicate liver damage. Normal range: 10 to 40 units per liter (U/L)

  10. Aspartate Aminotransferase (AST)

    Time frame: One day before surgery and one day after surgery

    An enzyme found in the liver and other tissues. High levels can indicate liver damage but are less specific than ALT. Normal range: 10 to 40 units per liter (U/L)

  11. Serum Creatinine

    Time frame: One day before surgery and one day after surgery

    Measures the level of creatinine in the blood. Elevated levels can indicate impaired kidney function. Normal range: 62 to 115 micromoles per liter (µmol/L).

  12. Blood Urea Nitrogen （BUN）

    Time frame: One day before surgery and one day after surgery

    Measures the amount of nitrogen in the blood that comes from urea. Elevated BUN levels can indicate impaired kidney function. Normal range: 2.5 to 7.1 millimoles per liter (mmol/L).

Study contacts

Contact information is provided by the study sponsor or research team.

Li Cao, M.D.

CONTACT

[email protected]

+8613909915960

Long Hua, M.D.

CONTACT

[email protected]

+8615099182364

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Xinjiang Medical University

Other

Registry information

Acronym: Yes

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Jun 21, 2024

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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