Evaluation of Medical Equipment/Implant Materials
Vertebra Cage Subsidence Test
Evaluation of subsidence characteristics by placing the vertebra cage between simulated vertebral bodies and applying compression.
Outline of Vertebra Cage Subsidence Test
A vertebra cage is an artificial intervertebral spacer which is used in treatment of spinal disease. Methods of evaluating the characteristics of vertebra cages are provided in ASTM standards.
This test method, which one of the above-mentioned methods, is used to evaluate the subsidence characteristics of the vertebral bodies that occurs when a vertebra cage is fixed between two vertebral bodies. It is provided in ASTM F2267.
Measurement is performed by placing the vertebra cage between two simulated vertebral bodies and applying static compression. The stiffness of the system (simulated vertebral body - vertebra cage - simulated vertebral body), which is obtained from the load-displacement curve during compression, and the stiffness of the vertebra cage itself, which is measured separately in a compression test using stainless steel blocks, are obtained, and the indentation stiffness of the simulate vertebral bodies is calculated.
The stiffness of the vertebra cage is obtained in accordance with ASTM F2077, Test Methods For Intervertebral Body Fusion Devices.
Conditions of Vertebra Cage Subsidence Test
| Test body | Vertebra cage (intervertebral body fusion device) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test standard | ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | ||||||||||||
| Test environment | In atmosphere (temperature: (23 ± 2)℃, (50 ± 5)%RH) | ||||||||||||
| Compression block | Polyurethane foam (simulated bone 15 pcf, manufactured by Sawbones (Pacific Research Laboratories, Inc.)) | ||||||||||||
| Block shapes, etc. |
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| Compression rate | 6 mm/min | ||||||||||||
| Evaluation items | Stiffness of simulated vertebral body, stiffness of system, subsidence load and displacement at that time | ||||||||||||
| Related standard | ASTM F2077, Test Methods For Intervertebral Body Fusion Devices. The stiffness of the unit device is measured in accordance with this standard,and the result is used in this evaluation. |
Vertebra Cage Subsidence Test
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H : block-to-block spacing, B : block height -
Example of load-displacement curve
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