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

June 15, 2024 updated by: Long Hua, First Affiliated Hospital of Xinjiang Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Joint fluid target protein detection
Time Frame: One day before surgery or one day after surgery
To detect new target proteins by elisa test.
One day before surgery or one day after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
One day before surgery and one day after surgery
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)
One day before surgery and one day after surgery
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).
One day before surgery and one day after surgery
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).
One day before surgery and one day after surgery
X-ray
Time Frame: One day before surgery and two years after surgery
X-ray of surgery site.
One day before surgery and two years after surgery
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)
One day before sugery and two year after surgery
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).
One day before sugery and two year after surgery
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)
One day before surgery and one day after surgery
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%.
One day before surgery and one day after surgery
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
One day before surgery and three day after surgery
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.
One day before surgery, two years after surgery
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.
One day before surgery, two years after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Xinjiang Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings