Osteomyelitis Multi-center Prospective Cohort Study

Army Medical University

Status: Not yet enrolling

Conditions: Osteomyelitis of Lower Extremities

Study type: Observational

Funder types: Other

Identifiers

NCT07251374

(A)KY2025236

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent provided.
2. Diagnosis of osteomyelitis confirmed by the site per guidelines (including definitive/suggestive criteria).

Exclusion criteria

1. 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.
2. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.

Trial design

2,000 participants in 2 patient groups

Surgically Treated Cohort

Description:

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

Description:

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.