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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
• Intervention / Treatment: Device: Joint aspiration

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Long Hua, M.D.; Phone Number: +8615099182364; Email: hualong_xmu@163.com
• Study Contact Backup: Name: Li Cao, M.D.; Phone Number: +8613909915960; Email: xjbone@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with periprosthesis infection or non-periprosthesis infection

Description

Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. 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.
3. Voluntary and signed informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infection group; Joint puncture to extract joint fluid	Device: Joint aspiration; Joint puncture to extract joint fluid.
None infection group; Joint puncture to extract joint fluid	Device: Joint aspiration; Joint puncture to extract joint fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint fluid target protein detection	To detect new target proteins by elisa test.	One day before surgery or one day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine Aminotransferase (ALT)	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)	One day before surgery and one day after surgery
Aspartate Aminotransferase (AST)	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)	One day before surgery and one day after surgery
Serum Creatinine	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).	One day before surgery and one day after surgery
Blood Urea Nitrogen （BUN）	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).	One day before surgery and one day after surgery
X-ray	X-ray of surgery site.	One day before surgery and two years after surgery
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)	One day before sugery and two year after surgery
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).	One day before sugery and two year after surgery
Synovial fluid white blood cell count (SF-WBC)	Synovial fluid white blood cell count (SF-WBC)	One day before surgery and one day after surgery
Synovial fluid polymorphonuclear cells (SF-PMN)	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%.	One day before surgery and one day after surgery
Doppler lower extremity vascular color ultrasound	Doppler lower extremity vascular color ultrasound to evaluate the deep vein thrombus development	One day before surgery and three day after surgery
American Knee Society Score (AKS score)	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.	One day before surgery, two years after surgery
The Hip Harris Score (HHS)	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.	One day before surgery, two years after surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Xinjiang Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 15, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: diagnosis; prediction; periprosthetic joint infection; Prospective cohort study; synovial biomarkers
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Disease; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: XJ202405-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be acquired from corresponding author by reasonable reason.
• IPD Sharing Time Frame: After our paper published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No