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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
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.
Conservatively 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.
Surgically 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.
All 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.
Data Collection:
The following information will be recorded and collected:
(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 / Lower Extremity Functional Scale, DASH/LEFS) (5)Range of motion of adjacent joints (6)Occurrence of complications.
Complications include:
Cohort Stratification:
To 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. Enrolled 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Disability of Arm Shoulder and Hand Scale(DASH):
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Sun, MD | Contact | +86 151 2326 1488 | sumersun07@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Sun, MD | The First Hospital Affiliated of Army Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital Affiliated to Army Medical University | Chongqing | Chongqing Municipality | China |
All IPD that underlie results in a publication
January 2030-January 2031
Data will be shared with qualified researchers who submit a methodologically sound proposal. Proposals must be directed to sumersun07@126.com. A data access agreement (DAA) must be signed. Data will be de-identified and the requestor must agree to the terms and conditions of the DAA, which include commitments to: 1) using the data only for the specified research purpose, 2) securing the data using appropriate computer technology, 3) destroying the data after analysis, and 4) not attempting to identify any individual participant. Requests for data will be reviewed by an internal review committee to ensure scientific validity and that the use of data is consistent with the informed consent provided by study participants.
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| ID | Term |
|---|---|
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment |
| The 36-Item Short Form Health Survey | Patients will be guided by study staff to complete the questionnaire based on their actual condition.
| Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment |
| Self-Rating Anxiety Scale (SAS) | Patients will be guided by study staff to complete the questionnaire based on their actual condition.
| Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment |
| Pain score (assessed by Visual Analogue Scale) | Patients will be guided by study staff to complete the questionnaire based on their actual condition.
| Pre-treatment;At 2 weeks post-treatment; At 8 weeks post-treatment; At 12 months post-treatment |
| 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. Lower Extremity Functional Scale(LEFS):
| Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment |