Osteomyelitis Multi-center Prospective Cohort Study

NCT07251374 | Not Yet Recruiting

• 1 other identifier: (A)KY2025236
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteomyelitis of Lower Extremities

Keywords

Osteomyelitis; Multi-center; Prospective; Disease-Specific Database

Outcome Measures

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

  8 weeks after operation

Secondary Outcomes (5)

• Disability of Arm Shoulder and Hand Scale（DASH）

  Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment

• The 36-Item Short Form Health Survey

  Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment

• Self-Rating Anxiety Scale (SAS)

  Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment

• Pain score (assessed by Visual Analogue Scale)

  Pre-treatment;At 2 weeks post-treatment; At 8 weeks post-treatment; At 12 months post-treatment

• Lower Extremity Functional Scale

  Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

The First Hospital Affiliated to Army Medical University

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dong Sun, MD

  The First Hospital Affiliated of Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Sun, MD

CONTACT

+86 151 2326 1488; sumersun07@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

CN (1)