[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612268":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":37,"interventions":31,"overallOfficials":44,"centralContacts":49,"locations":54,"responsibleParty":74,"collaborators":31,"id":77,"slug":31,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":31,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":89,"studyType":90,"phases":31,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Southwest Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Infection control rate at week 8 after treat","Patients will return for a follow-up visit at 8 weeks post-treatment. The assessment will include evaluation of the incision condition, documentation of afebrile status, and repeat laboratory tests including CBC (WBC count), ESR, and CRP","8 weeks after operation",[14,18,21,24,28],{"measure":15,"description":16,"timeFrame":17},"Disability of Arm Shoulder and Hand Scale（DASH）","This outcome measure is applicable only to patients presenting with upper extremity symptoms or dysfunction.Patients will be guided by study staff to complete the questionnaire based on their actual condition.\n\nDisability of Arm Shoulder and Hand Scale（DASH）：\n\n1. Scoring: The total score ranges from 0 to 100.\n2. Interpretation: A score of 0 indicates no disability (normal upper extremity function), while a score of 100 indicates severe disability (extremely limited upper extremity function).","Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment",{"measure":19,"description":20,"timeFrame":17},"The 36-Item Short Form Health Survey","Patients will be guided by study staff to complete the questionnaire based on their actual condition.\n\n1. Scoring: The total score ranges from 0 to 900.\n2. Interpretation:The 36-Item Short Form Health Survey（SF-36）assesses health status across nine dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), Mental Health (MH), and Health Transition (HT). For all scales, higher scores indicate a better health status for the respondent.",{"measure":22,"description":23,"timeFrame":17},"Self-Rating Anxiety Scale (SAS)","Patients will be guided by study staff to complete the questionnaire based on their actual condition.\n\n1. Scoring: The total score ranges from 0 to 80.The standard cutoff for anxiety is a score of 50.\n2. Interpretation:Mild anxiety: 50-59；Moderate anxiety: 60-69；Severe anxiety: 70 and above.",{"measure":25,"description":26,"timeFrame":27},"Pain score (assessed by Visual Analogue Scale)","Patients will be guided by study staff to complete the questionnaire based on their actual condition.\n\n1. Scoring: The total score ranges from 0 to 10.\n2. Interpretation: A score of 0 indicates \"No Pain\"；A score of 10 indicates \"The Worst Possible Pain\" (or \"Severe\u002FExcruciating Pain\").","Pre-treatment;At 2 weeks post-treatment; At 8 weeks post-treatment; At 12 months post-treatment",{"measure":29,"description":30,"timeFrame":17},"Lower Extremity Functional Scale","This outcome measure is applicable only to patients presenting with lower extremity symptoms or dysfunction. Patients will be guided by study staff to complete the questionnaire based on their actual condition.\n\nLower Extremity Functional Scale（LEFS）：\n\n1. Scoring: The total score ranges from 0 to 80.\n2. Interpretation: A higher score indicates a higher level of lower extremity function. Conversely, a lower score indicates greater functional limitation.",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","Study Design： This is a prospective, multi-center, real-world clinical study. Subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis.\n\nConservatively Treated Cohort: Patients with bone infection who do not meet the criteria for surgical intervention will receive conservative therapy, which includes intravenous (IV) and oral antibiotics.\n\nSurgically Treated Cohort: Patients meeting the surgical indications will undergo a staged surgical protocol. The first stage involves debridement and implantation of antibiotic-impregnated bone cement. The need for auxiliary internal or external fixation will be determined based on the patient's condition. The second stage, performed 8 weeks after the first, focuses on repairing the bone defect.\n\nAll treatments will be conducted in accordance with current clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the treatment process without interfering with any other clinical decisions.\n\nData Collection：\n\nThe following information will be recorded and collected:\n\n1. Unique subject identifier and basic demographic information.\n2. Baseline status and information prior to treatment.\n3. Key information related to the surgery.\n4. Post-operative follow-up information, including:\n\n（1）Pain score (Visual Analog Scale, VAS) （2)Quality of life (Short Form-36, SF-36) (3)Self-Rating Anxiety Scale (SAS) score (4)Limb function score (Disabilities of the Arm, Shoulder and Hand \u002F Lower Extremity Functional Scale, DASH\u002FLEFS) (5)Range of motion of adjacent joints (6)Occurrence of complications.\n\nComplications include:\n\n1. Surgical incision complications (e.g., dehiscence, skin necrosis).\n2. Pin tract infection.\n3. Fixation failure or breakage.\n4. Reduced joint range of motion.\n5. Other discomforts deemed by the investigator to be related to the surgery.\n\nCohort Stratification:\n\nTo comprehensively describe the clinical characteristics and outcomes of bone infection, the study data will be stratified into cohorts based on the real-world treatment received by the patients. Patients will be categorized into cohorts according to the actual treatment modality they received, with each treatment type constituting a separate cohort. All cohort classifications will be performed after data collection is complete, based on predefined criteria, and will not involve proactive intervention by the investigators.","The study population will consist of real-world patients with osteomyelitis from multiple centers. Based on the treatment received, participants will be retrospectively assigned to either a conservative therapy cohort or a surgical therapy cohort for analysis.",[38,41],{"label":39,"type":31,"description":40,"interventionNames":31},"Surgically Treated Cohort","All treatments will be conducted in accordance with existing clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the subjects' treatment process without interfering with any other clinical decisions.\n\nEnrolled subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis. Patients with bone infection who do meet the criteria for surgical intervention will receive conservative therapy.",{"label":42,"type":31,"description":43,"interventionNames":31},"Conservatively Treated Cohort","All treatments will follow current standards of care. This is an observational study that collects data on treatment outcomes without intervening in clinical management. Patients who meeting the surgical indications will undergo surgical treatment.",[45],{"name":46,"affiliation":47,"role":48},"Dong Sun, MD","The First Hospital Affiliated of Army Medical University","PRINCIPAL_INVESTIGATOR",[50],{"name":46,"role":51,"phone":52,"phoneExt":31,"email":53},"CONTACT","+86 151 2326 1488","sumersun07@126.com",[55],{"facility":56,"status":31,"city":57,"state":58,"zip":31,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"The First Hospital Affiliated to Army Medical University","Chongqing","Chongqing Municipality","China","CN",{"type":62,"coordinates":63},"Point",[64,65],106.55771,29.56026,{"lat":65,"lon":64},[68,69,73],{"name":46,"role":51,"phone":52,"phoneExt":31,"email":53},{"name":70,"role":51,"phone":71,"phoneExt":31,"email":72},"Jing Fu","+86 186 2300 0909","297114777@qq.com",{"name":46,"role":48,"phone":31,"phoneExt":31,"email":31},{"type":48,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Dong Sun","Associate Professor","100612268",false,"NCT07251374","Osteomyelitis Multi-center Prospective Cohort Study","Construction of a Multicenter Disease-Specific Database and Prospective Cohort for Osteomyelitis","Inclusion Criteria:\n\n1. Signed informed consent provided.\n2. Diagnosis of osteomyelitis confirmed by the site per guidelines (including definitive\u002Fsuggestive criteria).\n\nExclusion Criteria:\n\n1. Patients who, in the opinion of the investigator, are unable to comply with the entire study procedure (including postoperative management and regular follow-up) due to psychiatric, cognitive, or behavioral disorders, or other objective reasons.\n2. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.","ALL","18 Years","65 Years",{"count":87,"type":88},2000,"ESTIMATED","1 Year","OBSERVATIONAL","To establish a prospective, multicenter, real-world cohort of patients with osteomyelitis, by systematically collecting and analyzing detailed treatment and follow-up data, in order to provide clinical evidence for the standardization of its treatment",[93],"Osteomyelitis of Lower Extremities",[95,96,97,98],"Osteomyelitis","Multi-center","Prospective","Disease-Specific Database","NOT_YET_RECRUITING","2025-11-24",{"date":102,"type":103},"2025-11-26","ACTUAL",{"date":105,"type":88},"2025-12-10",{"date":107,"type":88},"2028-09-30",{"name":5,"class":6},1]