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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Xinjiang Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.);

Trial population

Patients diagnosed with periprosthesis infection or non-periprosthesis infection

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Joint aspiration

    Device

    Joint puncture to extract joint fluid.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Infection group1 intervention
Group B: None infection group1 intervention

Trial outcomes

Primary outcomes

1

Joint fluid target protein detection

To detect new target proteins by elisa test.

Time frame
One day before surgery or one day after surgery

Secondary outcomes

1

X-ray

X-ray of surgery site.

Time frame
One day before surgery and two years after surgery
2

Erythrocyte sedimentation rate (ESR)

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)

Time frame
One day before sugery and two year after surgery
3

C-reactive protein (CRP)

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).

Time frame
One day before sugery and two year after surgery
4

Synovial fluid white blood cell count (SF-WBC)

Synovial fluid white blood cell count (SF-WBC)

Time frame
One day before surgery and one day after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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