Osteomyelitis Multi-center Prospective Cohort Study
ConditionOsteomyelitis of Lower Extremities
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSouthwest Hospital, China
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent provided.
Diagnosis of osteomyelitis confirmed by the site per guidelines (including definitive/suggestive criteria).
Disqualifiers
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.
Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 2 trial groupsGroup A: Surgically Treated Cohort
Group B: Conservatively Treated Cohort
Trial outcomes
Primary outcomes
1
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 operationSecondary outcomes
1
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-treatment2
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-treatment3
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-treatment4
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-treatmentSponsors and contacts
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Source ClinicalTrials.gov
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