NCT07251374

Osteomyelitis Multi-center Prospective Cohort Study

Construction of a Multicenter Disease-Specific Database and Prospective Cohort for Osteomyelitis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. Unique subject identifier and basic demographic information. 2. Baseline status and information prior to treatment. 3. Key information related to the surgery. 4. Post-operative follow-up information, including: （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: 1. Surgical incision complications (e.g., dehiscence, skin necrosis). 2. Pin tract infection. 3. Fixation failure or breakage. 4. Reduced joint range of motion. 5. Other discomforts deemed by the investigator to be related to the surgery. 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.

Conditions

• Osteomyelitis of Lower Extremities

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-12-31
• Completion: 2028-09-30
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: China