Osteomyelitis Multi-center Prospective Cohort Study

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

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 Overview

• Status: Not yet recruiting
• Conditions: Osteomyelitis of Lower Extremities

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Dong Sun, MD; Phone Number: +86 151 2326 1488; Email: sumersun07@126.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • The First Hospital Affiliated to Army Medical University
      • Contact: Dong Sun, MD; Phone Number: +86 151 2326 1488; Email: sumersun07@126.com
      • Contact: Jing Fu; Phone Number: +86 186 2300 0909; Email: 297114777@qq.com
      • Principal Investigator: Dong Sun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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）： Scoring: The total score ranges from 0 to 100.; 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).	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.; Scoring: The total score ranges from 0 to 900.; 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.	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.; Scoring: The total score ranges from 0 to 80.The standard cutoff for anxiety is a score of 50.; Interpretation:Mild anxiety: 50-59；Moderate anxiety: 60-69；Severe anxiety: 70 and above.	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.; Scoring: The total score ranges from 0 to 10.; Interpretation: A score of 0 indicates "No Pain"；A score of 10 indicates "The Worst Possible Pain" (or "Severe/Excruciating Pain").	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）： Scoring: The total score ranges from 0 to 80.; Interpretation: A higher score indicates a higher level of lower extremity function. Conversely, a lower score indicates greater functional limitation.	Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: Dong Sun, MD, The First Hospital Affiliated of Army Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Multi-center; Osteomyelitis; Prospective; Disease-Specific Database
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Infections; Bone Diseases, Infectious; Osteomyelitis
• Other Study ID Numbers: (A)KY2025236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: January 2030-January 2031
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No