bone defect
Conditions
Interventions
Experimental group:Surgery (implantation of bioactive ceramic materials in the patient's bone defect during Surgery)
Sponsors
the First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be enrolled in the study. (1) The subject's condition meets one of the following conditions: ? Single or multiple lacunar bone defects of limbs or pelvis; ? Segmental bone defects of extremities with short length (< 7cm); ? Due to the need to receive spinal intervertebral or laminar fusion; (2) Men and women aged from 8 to 75; (3) The subject (or legal representative) agrees to receive the treatment and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: Participants were not included in the study under any of the following conditions: (1) Serious bone defects, such as segmental bone defects =7cm in length and bone defects with local soft tissue coverage that cannot be implemented immediately. (2) Systemic or local acute or chronic infection of uncontrolled lesions. (3) Bone defects caused by open wounds. (4) After biopsy or diagnostic resection of malignant bone tumor. (5) Uncontrolled diabetic patients (HBA1c=8.0% and fasting glucose GLU=7.0mmol/L). (6) Abnormal liver and renal function (such as ALT and AST exceeding 1.5 times of the upper limit of the standard, Cr exceeding the upper limit of the normal value, and the abnormality was clinically significant as judged by the researcher); (7) Subjects with other systemic diseases such as malignant tumors of other organs; (8) Previous history of myeloproliferative diseases, such as chronic myelogenous leukemia and essential thrombocytopenia; (9) suffer from systemic inflammatory disease and/or coagulation disorders; (10) Uncontrolled severe anemia patients (HGB=89g/L); (11) The subject is being treated with steroid drugs and thyroxine; (12) Subjects who have received or plan to receive radiotherapy; (13) Expected survival time < 12 months; (14) pregnant, lactating or planning to become pregnant; (15) Poor health status, KPS score < 70, ECOG score (only for tumor patients) =3; (16) Patients who are participating in other clinical studies or have participated in other clinical studies within 30 days prior to the screening visit; (17) Other situations deemed inappropriate by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the fixed place of the implant and its internal fixation device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the SF-12 quality of Life rating from baseline;Postoperative change in visual analogue pain score (VAS) from baseline during exercise/resting;The good and good rate of functional recovery of adjacent joint after operation (if applicable);Degradation of implant material and change in new bone formation from baseline;MSTS93 Function Score (if applicable); | — |
Countries
China
Contacts
Public ContactWang Zhen
the First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed