bone structure
Conditions
Interventions
The experimental group :Self-solidifying and degradable composite bone filler materials were filled for patients with bone defects
control group:Filling bone defects with OSTEOSET Calcium Sulfate (USA)
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age 18~70, men and women; (2) The bone structure do not affect the stability of the limbs and the bone defects need to be filled and repaired, such as: A. Fracture associated with bone defect and bone non-healingb. b.Bone defect filling is required after curettage of benign bone tumors or tumor-like lesions; c. Ostetomy orthopedic grafting and fusion; d. Other bone defects that are not contraindications to bone grafting do not affect the stability of the bone structure.If the stability of bone structure is affected, it should be used with strong internal fixation and / or external fixation instruments. (3) The patient was well compliant and willing and able to follow-up as required.
Exclusion criteria
Exclusion criteria: (1) Patients with local or systemic infection that cannot be effectively controlled; (2) Primary malignant tumor or metastatic tumor of the skeletal system; (3) Fracture accompanied by serious soft tissue injury, combined vascular injury, or bone compartment syndrome; (4) Backbone long-segment bone defects, or those that affect the stability of the bone structure; (5) Cranial brain injury combined with consciousness disorder; (6) Have known allergies to internal plant components; (7) Patients who are using chemotherapy drugs, or receiving radiotherapy, or systemic use of corticosteroids, or patients using growth factors, or long-term use of sedative and hypnotic drugs (continuous use for more than 3 months), or long-term use of non-steroidal anti-inflammatory drugs (continuous use for more than 3 months); (8) Women during pregnancy or lactation; (9) Combined with lower limb multiple artery occlusion disease (multiple atherosclerosis, multiple vasculitis), accompanied by limb ischemia manifestations; (10) The patient has severe alcoholism (an average of> 100mL a day), or severe smoking (an average of 40 cigarettes a day), or substance abusers within one year; (11) Patients who have participated in other clinical trials in the past 3 months; (12) Other conditions that the investigators judge that patients are not suitable for inclusion, such as metabolic bone disease or hypercalcemia; (13) The use volume is less than 1 cm3, or more than 30 cm3; (14) Researchers judge that the compliance is poor and they cannot complete the test according to the test plan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate of bone graft; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absorption rate of bone implant materials; | — |
Countries
China
Contacts
Public ContactHuang Wei
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed