Skip to content

A prospective multicenter clinical cohort study on internal/external fixation after debridement for type IV osteomyelitis of lower limb

A prospective multicenter clinical cohort study on internal/external fixation after debridement for type IV osteomyelitis of lower limb

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075903
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteomyelitis

Interventions

Internal fixation group:None

Sponsors

First affiliated hospital, Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.18-65 Y, male or female 2.Definitive diagnosis with chronic osteomyelitis of lower limb 3.Cierny-Mader Type IV osteomyelitis 4.Acceptance the staged therapeutic schedule(first stage: debridement and implanted with bone cement, second stage:repair the bone defects)

Exclusion criteria

Exclusion criteria: 1.Expected inability to achieve skin and soft tissue coverage after debridement 2.Acute onset of osteomyelitis; 3.Osteomyelitis combined with adjacent joint infection; 4.Multiple site bone infections; 5.Combined with other serious injuries (craniocerebral injury, lung blast injury, abdominal organ injury, etc.); 6.Moderate to severe anemia, hypoproteinemia, and unstable vital signs; 7.Accompanied with serious physical and mental illnesses, including uncontrolled metabolic disorders, immunodeficiency, mental illness, suspected malignant tumors, or with history of malignant tumors; 8.Have received corticosteroids, immunosuppressants, and chemotherapy drugs within 6 months prior to enrollment (using them for more than 2 weeks); 9.Expected inability to achieve complete debridement or uncontrollable infection before surgery; 10.The pathogenic bacteria are Pseudomonas aeruginosa; 11.The pathogenic bacteria are Fungi or tuberculosis bacteria; 12.Participating in other clinical trials; 13.Researchers thought the situations that are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Infection control rate;

Secondary

MeasureTime frame
Infection control rate;Complication rate;

Countries

China

Contacts

Public Contactluofei

First affiliated hospital, Third Military Medical University(Army Medical University),PLA

Luofeispine@126.com+86 138 8384 6917

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026