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Spinal Kinetics M6 Lumbar Disc Replacement Studies
The Spinal Kinetics M6 artificial disc replacement is designed to replicate the structure and performance of a healthy disc. Its innovative design incorporates an artificial nucleus to allow shock absorption and a woven fiber annulus for controlled motion in all directions.
These characteristics accurately replicate the healthy disc, allowing the implant to work in concert with the remaining human discs.
Unlike earlier implant designs with M6 the resulting natural functionality of the entire spinal curve should provide the best chance for a full recovery, and prevent additional adjacent level degeneration.
This "Quality of Motion" is a major benefit not available in any other implant we have seen!
From the Studies below:
"The kinematic signatures of the intact human disc and the M6 artificial disc are nearly identical"
"The disc remains fully intact
and functional after functional kinematic testing to 20 Million cycles of
combined motion; physiologic dynamic compression, compression
shear, and torsion; creep to the equivalent of 80 years".
Quality and Quantity of Motion of Lumbar Spine after M6 Disc Replacement
Quality of Motion assesses how well the motion of an implanted functional spine unit approximates the motion of a healthy one over the entire range of motion, not just its endpoints. Through biomechanical testing, a load vs. angular displacement curve (kinematic signature) is generated that allows assessment of the Quality of Motion parameters
Biomechanical testing with the M6-L artificial lumbar disc has demonstrated equivalent Quality of Motion compared to the healthy disc. The innovative artificial fiber annulus and nucleus construct of the M6-L is the critical component in replicating this physiologic motion, as it is designed to provide the necessary restraint and control needed throughout the spine's natural range of motion.
The "kinematic signatures" of the intact disc and M6-L lumbar disc are nearly identical. The M6-L lumbar disc maintained total ROM, vs. Intact , at 400N [9.4*+-2.2* vs. 8.8*+-1.1*, p=0.56], and at 800N [9.5*+-2.1* vs. 8.4*+-1.2*, p=0.32], with excellent Quality of Motion.
Patwardhan et al. Musculoskeletal Biomechanics Laboratory, Edward Hines Jr. VA Hospital, Hines, Illinois, USA.
Functional Testing and Lifespan of the
Spinal Kinetics M6-L Lumbar Disc Replacement
Lifespan of the Spinal Kinetics M6-L lumbar Disc Replacement
The Spinal Kinetics M6-L is an lumbar intervertebral disc replacement
designed to replicate the anatomic structure and biomechanical
performance of the natural disc. Its unique design allows for a
controlled range of motion in all 6 degrees of freedom. The
compressible viscoelastic polymer nucleus of the M6-L disc replacement is designed
to simulate the function of the native nucleus, while the surrounding
multi-layer high tensile strength Ultra-high-molecular-weight polyethylene fiber annulus provides
progressive resistance to motion and a physiologically restrained
construct.
Results
All testing indicated an extremely robust device that successfully
lasts the projected life of the implant. The functional kinematic
testing and physiologic dynamic testing demonstrated that the
M6-L passed all acceptance criteria. The assembly and all the
components remained fully intact and functional. The device
remained fully functional after 20 million cycles. The axial compressive
stiffness of the M6-L remained in the physiologic range throughout
and at completion of all cycles of testing. The results demonstrate
the durability of the M6-L: despite being subjected to highly
non-physiologic loading up to the limits of the test equipment,
no mechanical or functional failures were achieved.
The results of the creep testing and the worst case physiologic
sheath retention testing provide further verification of the
robustness of the M6-L.
Conclusion
The M6-L was subjected to rigorous testing which confirms the
inherent robustness of the device. The disc remains fully intact
and functional after functional kinematic testing to 20 Million cycles of
combined motion; physiologic dynamic compression, compression
shear, and torsion; creep to the equivalent of 80 years; and worst
case physiologic extension over 30,000 cycles. Even when highly
nonphysiologic static loads are applied, the device does not
exhibit any mechanical or functional failures.
The static and dynamic mechanical characterization of the M6-L
lumbar disc demonstrated that the device has the structural
integrity to last the life of the implant and that it exceeds the
necessary criteria for device safety over the life of the patient.
Why wait? We are scheduling surgeries now!
To begin your evaluation process; click the link below and complete the online form. Then, send images, patient data form (print and include), etc. to Dr. Ritter-Lang. In 2-3 weeks you will receive your diagnosis, surgery plan, cost, and scheduling options.
Click here to begin the evaluation process.
If you still have questions please contact our US Spokesperson,
Jim Rider, at 866-544-8252 (Pacific time zone).
Click here for more
information about costs and scheduling details.
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