Modulus
The Modulus System is a long-term, reconstructive prosthesis, designed to support and restore function to the unstable MSU, while it restores normal motion between the vertebrae and the surrounding spine joints. The Modulus may replicate the function of the intravertebral disc and may support and distribute a percentage of the load normally carried by the spine during normal translation and rotation that augments the support provided by cages and artificial discs.
Materials:
The modulus system is constructed of a proprietary carbon fiber composite architecture. Compliance is achieved by varying the composition. This unique composite, after static strength and fatigue testing, has shown to be superior to titanium in strength and fatigue resistance, resulting in longer life.
More importantly, Mekanika's FDA cleared biocompatible implant material has the same modulus of elasticity as bone itself, contributing to improved biomechanical compatibility and bone synthesis.
Sizes:
Unknown.
Surgical Procedure:
Mekanika management claim the implantation technique is extremely simple compare to the Dynesys system due to the one size fits all system and pre-curved assembly. It also has a snap fit bolt that is easy for a surgeon to apply quickly.
Indications:
Isolated lumbar inter-vertebrae instability such as:
- Herniated disc
- Modic I degenerative lesions
- Degenerative disc disease at level adjacent to a previous fusion
- Narrow canal treated without laminectomy
Effect:
This implant takes 35 to 65 percent of the load of the normal vertebrae. It is versatile as a fusion, augmentation, or stabilization device for the spine.
Studies:
Mekanika, the company the produces Modulus, claims that on a study using cadavers the Modulus was shown to carry up to fifty percent of the normal compressive load on the intervertebral disc. They also say the testing showed the system resists compressive, tensile, bending, and traslational loads on the disc.
Success Rates:
There is no controlled study of this device's success in treating lumbar spinal stenosis.
Availability:
This implant is not available in the US or anywhere else and is not known to be in the process of being approved by the FDA. The rigid version of the Modulus is available in Europe.