An observational study in Osteomyelitis of Lower Extremities, sponsored by Southwest Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Southwest Hospital, China · 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
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 86 across 41 observational studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Southwest Hospital, China is the lead sponsor of 87 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Time frame: 8 weeks after operation
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）： 1. Scoring: The total score ranges from 0 to 100. 2. 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).
Time frame: 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. 1. Scoring: The total score ranges from 0 to 900. 2. 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.
Time frame: 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. 1. Scoring: The total score ranges from 0 to 80.The standard cutoff for anxiety is a score of 50. 2. Interpretation:Mild anxiety: 50-59；Moderate anxiety: 60-69；Severe anxiety: 70 and above.
Time frame: 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. 1. Scoring: The total score ranges from 0 to 10. 2. Interpretation: A score of 0 indicates "No Pain"；A score of 10 indicates "The Worst Possible Pain" (or "Severe/Excruciating Pain").
Time frame: 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）： 1. Scoring: The total score ranges from 0 to 80. 2. Interpretation: A higher score indicates a higher level of lower extremity function. Conversely, a lower score indicates greater functional limitation.
Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: January 2030-January 2031
Access criteria: 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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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Southwest Hospital, China