Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-07 @ 10:53 AM
Study NCT ID:
NCT06467734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069237', 'term': 'Arthrocentesis'}], 'ancestors': [{'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Synovial fluid aspirating from patients' joint."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-15', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-15', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint fluid target protein detection', 'timeFrame': 'One day before surgery or one day after surgery', 'description': 'To detect new target proteins by elisa test.'}], 'secondaryOutcomes': [{'measure': 'X-ray', 'timeFrame': 'One day before surgery and two years after surgery', 'description': 'X-ray of surgery site.'}, {'measure': 'Erythrocyte sedimentation rate (ESR)', 'timeFrame': 'One day before sugery and two year after surgery', 'description': 'It measures the rate at which red blood cells settle to the bottom of a test tube within one hour.\n\nNormal ranges:\n\nMale: 0 to 15 millimeters per hour (mm/hr) Female: 0 to 20 millimeters per hour (mm/hr)'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'One day before sugery and two year after surgery', 'description': '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).'}, {'measure': 'Synovial fluid white blood cell count (SF-WBC)', 'timeFrame': 'One day before surgery and one day after surgery', 'description': 'Synovial fluid white blood cell count (SF-WBC)'}, {'measure': 'Synovial fluid polymorphonuclear cells (SF-PMN)', 'timeFrame': 'One day before surgery and one day after surgery', 'description': '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%.'}, {'measure': 'Doppler lower extremity vascular color ultrasound', 'timeFrame': 'One day before surgery and three day after surgery', 'description': 'Doppler lower extremity vascular color ultrasound to evaluate the deep vein thrombus development'}, {'measure': 'American Knee Society Score (AKS score)', 'timeFrame': 'One day before surgery, two years after surgery', 'description': '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.\n\nKnee 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.'}, {'measure': 'The Hip Harris Score (HHS)', 'timeFrame': 'One day before surgery, two years after surgery', 'description': "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."}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': 'One day before surgery and one day after surgery', 'description': '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)'}, {'measure': 'Aspartate Aminotransferase (AST)', 'timeFrame': 'One day before surgery and one day after surgery', 'description': '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)'}, {'measure': 'Serum Creatinine', 'timeFrame': 'One day before surgery and one day after surgery', 'description': '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).'}, {'measure': 'Blood Urea Nitrogen （BUN）', 'timeFrame': 'One day before surgery and one day after surgery', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prospective cohort study', 'synovial biomarkers', 'diagnosis', 'prediction', 'periprosthetic joint infection'], 'conditions': ['Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with periprosthesis infection or non-periprosthesis infection', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old, gender is not limited;\n2. 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.\n3. Voluntary and signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with immune-related arthritis such as rheumatoid and rheumatism were excluded;\n2. Radiotherapy and chemotherapy are required due to neoplastic diseases;\n3. Receiving systemic glucocorticoid therapy (prednisone \\> 10mg/ day or equivalent hormone medication);\n4. Severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);\n5. Have a history of drug abuse;\n6. Use immunosuppressive drugs to treat bone marrow or other transplants;\n7. Pregnant, parturient and lactating women;\n8. Participating in other clinical trials;\n9. Researchers consider other reasons not appropriate for clinical trial participants.'}, 'identificationModule': {'nctId': 'NCT06467734', 'acronym': 'Yes', 'briefTitle': 'Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Xinjiang Medical University'}, 'officialTitle': 'Prospective Cohort Study of Synovial Biomarkers in the Diagnosis and Prediction of Periprosthetic Joint Infection', 'orgStudyIdInfo': {'id': 'XJ202405-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infection group', 'description': 'Joint puncture to extract joint fluid', 'interventionNames': ['Device: Joint aspiration']}, {'label': 'None infection group', 'description': 'Joint puncture to extract joint fluid', 'interventionNames': ['Device: Joint aspiration']}], 'interventions': [{'name': 'Joint aspiration', 'type': 'DEVICE', 'description': 'Joint puncture to extract joint fluid.', 'armGroupLabels': ['Infection group', 'None infection group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Long Hua, M.D.', 'role': 'CONTACT', 'email': 'hualong_xmu@163.com', 'phone': '+8615099182364'}, {'name': 'Li Cao, M.D.', 'role': 'CONTACT', 'email': 'xjbone@sina.com', 'phone': '+8613909915960'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After our paper published.', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) will be acquired from corresponding author by reasonable reason.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Long Hua', 'investigatorAffiliation': 'First Affiliated Hospital of Xinjiang Medical University'}}}}