Objective To evaluate the histocompatibil ity of porous hydroxyapatite (HAP) coating NiTi shape memory alloy and to provide a theoretical basis for its cl inical appl ication in bone defect repair. Methods Twenty-four Chinchilla rabbits weighing 2.0-2.5 kg were randomized into experimental group and control group (n=12). HAP coating NiTi shape memory alloy was implanted into the distal part of left femur of 12 rabbits in the experimental group, while holes without alloy implantation were performed on the control group. At 7, 14, 28 and 56 days after implantation, the animals werekilled (3 rabbits in each group at a time). Gross observation, histology observation, BMP-2 immunohistochemistry observation and image grey scale analysis were performed. And the histology observation was evaluated by GB/T16886.6-1997 in terms of inflammation, capsule wall of fibrous tissue, materials degradation and the response of peripheral tissue. Results All of the animals survived until being killed. The implants reached a peak embedded in bone tissue wholly, without loosening and bone absorption. The inflammatory cell infiltration and fibrous hyperplasia were at 7 days after implantation, with the formation of cyst wall of fibrous tissue and the implant wrapped by the cyst wall. The response of connective tissue proliferation was still obvious in partial samples of experimental group at 56 days after implantation, which was wrose than the control group but consistent with the in vivo implantation standard of GB/T16886.6-1997. Immunohistochemistry observation displayed the endogenous BMP-2 were in the cytoplasm of MSCs and osteoblast. The result of image analysis showed the expression of BMP-2 were staged in line with the repair of bone defect, two groups witnessed the peak expression of the BMP-2 at 14 days after implantation. There wereno significant differences among different time points in the staining gray scale of BMP-2 (P gt; 0.05). Conclusion HAP coating NiTi shape memory alloy, as a biomedical material, has excellent histocompatibility with bone.
Fixation of silicon-polyester fiber network on skull defect was usually difficult to handle and the fixation was unstable. In order to solve these problems, NiTi shape-memory alloy cramp was adopted and 101 patients with skull defects were selected for this clinical trial. Among them, there were 79 males and 22 females, and the age ranged from 12-55 years old. The area of skull defect ranged from 3 cm x 4 cm to 10 cm x 16 cm. All of these patients received repairing of the skull defects by silicon-polyester fiber network which was fixed by NiTi memory alloy cramps. After operation, there was no complication. One hundred patients were followed up for 1-8 years, in which 97 cases returned to their normal work, and only 2 cases had a transient dysfunction of frontal muscle for 2 months. In addition, There were no loosening of the cramps, displacement of plastic network and malignant degeneration. The NiTi shape-memory alloy cramps had the following advantages: 1. Simple operative procedure; 2. Rigid fixation; 3. Mild postoperative tissue reaction; 4. Few postoperative complication; 5. Favorable effect of skull repair; 6. No interference with CT and MRI image; 7. No carcinogenicity.