Infectious bone defects
Conditions
Interventions
Control group:The subject underwent debridement, standard surgical debridement procedure, and antibiotic bone cement implantation.
experimental group:The subject underwent debridement and was treated with transplantation of an acellular, demineralized bone repair material loaded with antibiotics.
Sponsors
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years old (inclusive). 2. Diagnosed with non-weight-bearing limb bone defects. 3. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known allergy to pig-derived materials, gentamicin, this product, or any component in bone cement products. 2. Patients have uncontrolled systemic infections or sepsis; have coagulation disorders that are not effectively controlled (e.g., DIC); have severe heart, lung, liver, or kidney dysfunction and cannot tolerate surgery; or have metabolic or systemic diseases that are not effectively controlled (e.g., diabetes, rickets, thyroid diseases, etc.). 3. Based on preliminary imaging assessment, a single bone defect site does not exceed 5.5 cm³ or requires structural bone grafting. 4. There is severe nerve damage, severe soft tissue injury, or severe vascular injury at the implantation site. There is extensive bone and soft tissue necrosis that cannot be reconstructed, severe peripheral vascular disease requiring vascular reconstruction, presence of compartment syndrome or malignant tumors (including metastases) at the bone defect site, etc. 5. Patients who have systematically used corticosteroids within the past month, or have continuously used non-steroidal antibiotics, or have used growth factors for >=14 days. 6. Filter those who have received chemotherapy drugs or radiation therapy within the past three months or during the screening period. 7. Screen for participation in any other clinical trials or clinical research that may affect this study within the past three months. 8. The patient has situations such as drug abuse, alcoholism, and long-term use of sedative-hypnotic drugs (used continuously for more than 3 months). 9. Vulnerable groups other than illiterate people and the elderly include: people with mental illnesses, cognitive impairments, critically ill patients, pregnant women, and breastfeeding women. 10. The researchers believe there are other circumstances in which the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone healing rate 26 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional recovery;Bone healing time;Infection indicators such as blood and inflammation;Degradation and absorption time of Van-SDECM implant material;Infection clearance rate; | — |
Countries
China
Contacts
Public ContactChao Liu
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Outcome results
None listed