Filling and repairing of non-structural bone defects in extremities
Conditions
Interventions
control group:Artificial bone substitute materials
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Subjects or guardians are willing and able to sign informed consent; (2) Aged from 18 to 70 years (inclusive), no gender limit; (3) Patients with non-structural bone defects in extremities requiring filling and repair, such as: a. Fracture with bone defect, bone nonunion; b. Osteotomy, orthopedic bone graft fusion; c. Bone defect repair after resection of benign bone tumors or tumor-like lesions; d. Other orthopedic non-weight-bearing part defect repair without bone grafting contraindications; if filling the bone defect of the weight-bearing part, internal/external fixation equipment must be used; (4) Good compliance, willing and able to conduct follow-up observation as required.
Exclusion criteria
Exclusion criteria: (1) Patients with local infections throughout the body or the surgical site; (2) Past or present suffering from malignant tumors (including metastatic tumors); (3) Patients with open fractures; (4) Serious nerve, soft tissue and blood vessel damage at the defect site; (5) Osteofascial compartment syndrome; (6) After the investigator evaluates the preliminary imaging, a single defect site needs to be filled with a volume greater than 20 square centimetre is not suitable for bone graft material filling; (7) After the investigator's preliminary judgment and evaluation through imaging, when the size of the defect site is less than 8 millimetre in length, it is usually self-healing, which is not suitable for bone graft material filling; (8) Structural bone grafting; (9) Severe multiple injuries (with severe head injury or multiple organ injuries, etc.); (10) Those who systematically use corticosteroids, use chemotherapy drugs and receive local radiotherapy; (11) Use growth factors; (12) Long-term use of sedatives and hypnotics (continuous use for more than 3 months); (13) Long-term use of non-steroidal anti-inflammatory drugs (continuous use for more than 3 months); (14) Those who are allergic to pig-derived materials; (15) Those who are not suitable to use pig-derived medical products due to religious ethnicity and other reasons; (16) Women during lactation or pregnancy; (17) Mental illness, drug abuse, alcoholism; (18) Severe heart, liver, kidney, lung, blood system and other diseases or metabolic diseases that cannot tolerate surgery; (19) Subjects participated in other clinical studies within 1 month before being selected; (20) Other situations the researcher believes that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Graft Fusion Rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone defect healing;New bone formation rate;bone density;SF-36;Operational evaluation; | — |
Countries
China
Contacts
Public ContactYun,Tian
49 Huayuan Road North, Haidian District, Beijing
Outcome results
None listed