Bone defect
Conditions
Interventions
Experimental group:Natural bone repair material
Control group:Allogeneic bone repair material
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 65 years old, gender is not limited; 2) Patients with non-load-bearing bone defects in the extremities requiring filling repair; 3) The patient agrees to participate in this trial, is willing to return to the doctor on time, and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1) Local infection of the whole body or surgical site; 2) Malignant tumors (including metastases) at the defect site; 3) Open fracture of the defect site; 4) According to the preliminary evaluation of imaging, the length of the bone defect was 20cm3; 5) Severe nerve injury, severe soft tissue injury or severe vascular injury at the defect site; 6) osteonecrosis or osteofascial compartment syndrome at the defect site; 7) Structural bone grafting; 8) Severe multiple injuries (accompanied by severe craniocerebral injury or multiple organ injury, etc.); 9) Use of chemotherapy drugs or local radiotherapy; 10) Systematic use of corticosteroids or use of growth factors; 11) Long-term use of sedative hypnotics or non-steroidal anti-inflammatory drugs (continuous use of more than 3 months); 12) People who are allergic to porcine source materials; 13) Those who should not use pig-derived medical products due to religious and ethnic reasons; 14) Lactating or pregnant women; 15) Drug or alcohol abusers; 16) Patients with serious heart, lung, liver, kidney, blood system or metabolic diseases who cannot tolerate surgery; 17) People with cognitive dysfunction; 18) Participants who have participated in other clinical trials that may affect this trial within 3 months; 19) Other participants were deemed unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of bone graft fusion at 26 weeks after surgery;New bone formation rate;Score of SF-36 scale;Product performance; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of bone graft fusion at 12 weeks after surgery;Healing of bone defects; | — |
Countries
china
Contacts
Public Contactyezhaoming
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed