Intervertebral disc replacement is a surgical technique for the treatment of lower back pain related to degenerative disc disease. The advantage of this technique over traditional spinal fusion is that it preserves or restores motion in the spine and has the potential to delay the onset of degeneration of healthy discs at adjacent levels in the spine. Disc prostheses are designed to be load bearing over the physiological range of disc motion and to give years of pain- and trouble-free operation in the body. Understanding the static and dynamic characteristics of a particular device allows manufacturers and designers to ensure their product is proven and accepted.
ASTM F2346 provides a methodology for characterizing the static strength and dynamic fatigue behavior of disc prostheses. The rigorous testing regimes in this standard aim to scientifically validate any prosthesis design.
With a typical test run lasting for 10 million cycles and requiring both axial and torsional loading, it is vital that a testing system copes with these performance demands and delivers the highest quality of results. The requirement to conduct these tests in a wet environment adds to the complexity of the system.