Lacunar Bone Defect
Conditions
Interventions
GAIABONE Repair Material Group:None
Sponsors
Shanghai JiaoTong university Affiliated Sixth People‘s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–80 years, male or female; 2. Patients with lacunar bone defects caused by various reasons who require bone grafting; 3. Patients who, based on their own ,plan to use the moldable absorbable bone repair material produced by Lixin (Shenzhen) Medical Devices Co., Ltd. for bone defect repair; 4. Patients who voluntarily participate in the study, sign the informed consent form, and agree to attend clinical follow-ups; 5. It is recommended that each participating center be designated as a fixed follow-up site for its enrolled patients without changes to avoid patient mobility. Eligibility for enrollment requires meeting all the above five criteria simultaneously.
Exclusion criteria
Exclusion criteria: 1. Subjects expected to have poor compliance. 2. Patients participating in other clinical studies simultaneously. 3.Patients expected to be unable to attend follow-ups on time. 4. Subjects deemed unsuitable for this clinical study by the investigator for other reasons. If any of the above criteria are met, the subject will be excluded from enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Graft Fusion Rate at 24 Weeks Postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Defect Healing Rate at Fixed Postoperative Observation Time Points;Lane-Sandhu Imaging Score;Subject Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactYang Qingcheng
Shanghai JiaoTong university Affiliated Sixth People‘s Hospital
Outcome results
None listed