The M6-L artificial lumbar disc offers an innovative option compared to other artificial lumbar disc replacement because of its unique design, which is based on the qualities of the natural disc.
The M6-L is the only artificial disc that incorporates an artificial nucleus (made from polycarbonate urethane) and a woven fiber annulus (made from polyethylene). The M6-L artificial nucleus and annulus are designed to provide the same physiologic motion characteristics of a natural disc. Extensive biomechanical testing with the M6-L artificial lumbar disc has demonstrated equivalent Quality of Motion compared to the healthy disc.
Together, the M6-L’s artificial nucleus and annulus provide compressive capabilities and a controlled range of natural motion in all 6 degrees of freedom. This “natural” motion is designed to provide the freedom to move your back naturally.
The M6-L has two titanium outer plates with keels for anchoring the disc into the bone of the vertebral body. These outer plates are coated with a titanium plasma spray that promotes bone growth into the metal plates, providing long-term fixation and stability of the disc in the bone.
Quality of Motion
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 (red) and M6-L lumbar disc (blue) 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.
About Lumbar Artificial Disc
Artificial disc replacement (ADR) is newer type of spinal disc procedure that utilizes an anterior (front – through the abdominal region) approach to replace a painful, arthritic, worn-out intervertebral disc of the lumbar spine with a metal and plastic prosthesis (artificial disc). Artificial disc replacement is primarily considered for patients with isolated 1-level (one disc only) degenerative disc disease. Prior to the development of ADR, spinal fusion was the principal treatment for painful degenerative disc disease that failed to improve with nonoperative management. ADR is generally NOT recommended for patients with spinal fractures, instability, neurologic compression, or multiple level degenerative disc disease – spinal fusion remains the treatment of choice for these conditions. The advantages of ADR include a faster recovery time than spinal fusion and preserved motion at the disc level. The theoretical long-term advantage of ADR, which remains unproven, is the possibility of decreased adjacent level stress and arthritis compared with spinal fusion.
About Orthofix
Orthofix Medical Inc. is a global medical device and biologics company with a spine and extremities focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals on improving patients’ lives. Headquartered in Lewisville, Texas, Orthofix’s products are distributed in more than 70 countries via the Company’s sales representatives and distributors. For more information, please visit www.Orthofix.com.