traumatic bone defects
Conditions
Interventions
test group:Autologous Bone Slurry Composite with Artificial Bone for Repairing Traumatic Bone Defects
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 80 years, male or female; 2.Clinically diagnosed with limb bone defects requiring bone defect repair and who refuse autologous bone grafting; 3.Good compliance, voluntarily participate and sign the informed consent form, and are able to follow up as required;
Exclusion criteria
Exclusion criteria: 1.Patients with local or systemic infections that cannot be effectively controlled; 2.Patients with primary malignant tumors or metastatic tumors of the skeletal system; 3.Patients with fractures accompanied by severe soft tissue damage, vascular injury, or compartment syndrome; 4.Patients with long-segment bone defects in the diaphysis or bone defects that affect the stability of the bone structure; 5.Patients with craniocerebral injury accompanied by impaired consciousness; 6.Patients with known allergies to implant components; 7.Patients currently using chemotherapy drugs, undergoing radiotherapy, or systemically using corticosteroids, or using growth factors, or long-term use of sedative-hypnotic drugs (for more than 3 consecutive months), or long-term use of non-steroidal anti-inflammatory drugs (for more than 3 consecutive months); 8.Pregnant or lactating women; 9.Patients with multiple arterial occlusions of the lower limbs (multiple atherosclerosis, multiple vasculitis) accompanied by limb ischemia; 10.Patients with a history of severe alcoholism (average daily intake >100 mL) or heavy smoking (average daily >=40 cigarettes) or drug abuse within the past year; 11.Patients who have participated in other clinical trials within the past 3 months; 12.Patients deemed unsuitable for inclusion by the investigator due to other conditions, such as metabolic bone disease or hypercalcemia; 13.Patients judged by the investigator to have poor compliance and unable to complete the trial according to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical healing rate of fractures at 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS);36-Item Short Form Health Survey (SF-36);Exploratory indicators;Paley score;Fracture nonunion and perioperative complications; | — |
Countries
China
Contacts
Public ContactGuo Fu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed