A prospective randomized controlled study on 3D-printed porous bioceramic artificial bone and artificial bone substitutes in the treatment of limb bone defect
10.3760/cma.j.cn121113-20241230-00779
- VernacularTitle:3D打印多孔生物陶瓷人工骨与人工骨替代物治疗四肢骨缺损的随机对照试验
- Author:
Taoran WANG
1
;
Zhuojing LUO
1
;
Long BI
1
;
Jiakai GAO
1
;
Xiang HE
1
;
Jingdi CHEN
1
;
Jingzhuo JIA
1
;
Hui ZHANG
1
;
Yu WANG
1
Author Information
1. 中国人民解放军空军军医大学附属西京医院骨科，西安 710032
- Publication Type:Journal Article
- Keywords:
Printing, three-dimensional;
Biocompatible materials;
Extremities;
Prospective studies;
Bone graft
- From:
Chinese Journal of Orthopaedics
2025;45(20):1298-1304
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the safety and efficacy of 3D-printed porous bioceramic artificial bone and artificial bone substitutes in the treatment of limb bone defects.Methods:A total of 220 patients with post-traumatic limb bone defects admitted to Xijing Hospital Affiliated to Air Force Medical University of the Chinese People's Liberation Army (34 cases), the Third Hospital of Hebei Medical University (60 cases), Xi'an Honghui Hospital (28 cases), the Third Hospital of Southern Medical University (18 cases), Changsha Third Hospital (28 cases), Foshan Traditional Chinese Medicine Hospital (16 cases), Foshan Fuxing Chancheng Hospital (12 cases), and Henan Provincial Orthopaedic Hospital (24 cases) from May 2022 to October 2023 were included as research subjects. According to the manufacturing method of the bone graft material, the subjects were randomly divided into the 3D printed porous bioceramic artificial bone group (3D printing group) and the artificial bone substitute group (non-3D printing group) at a ratio of 1:1 by the envelope method. Adverse events that might be related to the surgery were selected through correlation evaluation and classified as abnormal laboratory indicators, systemic or other site symptoms and abnormalities, and local symptoms and abnormalities of the affected limb. The safety of the two groups was compared. The bone graft fusion rate, bone defect repair and healing rate, and short form 12 (SF-12) score of the two groups were calculated to evaluate the postoperative recovery.Results:Thirty-two cases were excluded (4 cases refused to use their data after reconsideration, 7 cases were not used after preoperative assessment, and 21 cases exceeded the standard for body mass index and laboratory indicators upon re-examination). A total of 188 cases were randomly divided into the 3D printing group and the non-3D printing group according to the random method, with 94 cases in each group. Among them, 11 cases in the 3D printing group and 9 cases in the non-3D printing group dropped out due to loss to follow-up. Finally, 168 cases completed the follow-up, including 83 cases in the 3D printing group and 85 cases in the non-3D printing group. In the 3D printing group, there were 53 males and 30 females, with an average age of 47.9±12.7 years; in the non-3D printing group, there were 53 males and 32 females, with an average age of 48.6±12.9 years. A total of 51 cases in the two groups experienced adverse events related to the surgery, including 13 cases of abnormal laboratory indicators (5 cases in the 3D printing group and 8 cases in the non-3D printing group), 15 cases of systemic or other site symptoms and abnormalities (9 cases in the 3D printing group and 6 cases in the non-3D printing group), and 23 cases of local symptoms and abnormalities of the affected limb (13 cases in the 3D printing group and 10 cases in the non-3D printing group). There was no statistically significant difference in the incidence of adverse events between the two groups ( P>0.05). The bone graft fusion rates of the 3D printing group and the non-3D printing group at 6 months after surgery were 99%(82/83) and 99%(84/85), respectively, and the bone defect repair and healing rates were 89%(74/83) and 89%(76/85), respectively. At the time of 12 months after surgery, the bone graft fusion rates were 99%(82/83) and 99%(84/85), respectively, and the bone defect repair and healing rates were 94%(78/83) and 92%(78/85), respectively. There was no statistically significant difference in the bone graft fusion rate and bone defect repair and healing rate between the two groups ( P>0.05). The SF-12 scores during the screening period were 27.82±2.96 points and 27.22±4.23 points in the 3D printing group and the non-3D printing group, respectively, and at 3 months after surgery were 28.08±3.13 points and 27.64±3.16 points, at 6 months after surgery were 29.42±3.10 points and 28.55±3.45 points, and at 12 months after surgery were 29.78±2.80 points and 29.58±2.94 points, respectively. There was no statistically significant difference between the groups ( P>0.05). Both groups of surgeries were successfully completed without any serious surgical or bone graft-related complications. Conclusion:The safety and efficacy of 3D-printed porous bioceramic artificial bone in the treatment of limb bone defects are not significantly different from those of currently clinically applied artificial bone substitutes.
