Discover Hi-Tech Medical

Stainless steel and titanium are widely used in joint replacements such as hips and knees in the human body. Stainless steel is more common since the human body tends to reject titanium when it comes to bone trying to attach itself to the material.

The usage of ceramic seems to be the new, exciting future for joint replacements. With ceramic there could be offered joint replacements that would last substantially longer than anything used today. On top of that, this material offers not only a surface conditioning, but a solid joint replacement fully made of ceramic. Being able to offer a porous surface with transition to solid material in a joint such as a hip replacement allows the bone to not only bond to the new joint but to actually encapsulate the initial layer so that the joint is firmly held becoming part of the bone structure. This is not possible with anything else used today.

In a hip stem, the major problem patients face today is that over time, the stem loosens and begins to make noise, becomes instable and even breaks out of the bone. This is

Knee replacement - X-Ray

Knee Replacement

due to the inability of current materials to offer differing modulus of flex since the natural bone has this ability. With ceramics, this can be conditioned not only in the surface but throughout the material.

A side benefit using a ceramic joint would also be that for patients that go through security metal detection machines such as in airports. They would not set an alarm and would not require the documentation and time needed to explain their condition. This may seem trivial but speaking to patients, it sure would make it easier!

Analytic Phase

First of all the technical parameters should be proved. It is necessary to testify that the material is suitable for planned usage. The technical parameters as rigidity, flexibility, fragility and other should be tested for the planned usage. Except for the already existing test results of the technical parameters (required for the industrial application) the set of the biomechanical tests should be performed:

  • Biomechanical Simulation Test
  • Musculoskeletal Modeling Test
  • Computer Aided Ergonomics Test
  • Dual X-ray Absorptionity (DXA) Test
  • Compression Test
  • Extension Test
  • Biomaterials Test
  • Static Strain Test
  • Dynamic Strain Test
  • Dynamic Mechanical Analysis ( DMA ) Test
  • Fracture Toughness Test
  • Stress Test

Afterwards the usability of the material for medical purposes should be proved. This means a series of tests in medical laboratories and getting all the necessary medical certificates according to ISO 10993 applicable for implantable medical devices:

  • Cytotoxicity
  • Irritation
  • Sensitization
  • Toxicity
  • Genetic Toxicology
  • Haemocompatibility
  • Functional Implantation Study
  • Local Tolerance
  • Physico-Chemical Tests
  • Microbiological test
  • Other INDIVIDUAL Testing Strategies related to the specifics of the material and implanted final product

For Central Europe one of the leading laboratories in this area is company BSL BIOSERVICE, Munich having 25-years reference and certification according to EN, DIN, ISO as well as FDA.