Faster return to health with bone screws made from donated tissue

During fracture treatment, screws are frequently used to join bone fragments. Traditional metal screws can necessitate additional surgeries during follow-up treatment, extending the healing process. Shark Screw® bone screw, crafted from human tissue, presents significant benefits in this context.

In an interview with MEDICA-tradefair.com, Jürgen Ehlers explains why the Shark Screw® supports faster rehabilitation after fractures due to its nature.

Mr. Ehlers, what is special about bone screws?

Jürgen Ehlers: Bone screws are obtained from human donor tissue and are further processed after extensive screening. What is special about Shark-Screw® bone screws is that they are converted into the body's own tissue of the respective person undergoing treatment. This remodeling process makes the screw indistinguishable from other tissue on X-ray images after only a few months or after a year at the latest.

When the bone screws are placed in the body, they swell by two percent. In this way, they anchor themselves in the defect they are inserted into. This is very smart because it creates a stable connection without having to use a metal screw. The bone screw develops the contact pressure on the affected person's tissue which is important for rapid bony integration.

What are the advantages for patients?

Ehlers: Unlike a metal screw, the bone screw remains in the body. Metal screws often have to be removed again at a later date. However, with the usual surgical risks, this second procedure to remove the metal places an additional burden on patients. With the bone screw, there is no risk of infection from another surgery. Fewer surgical interventions also mean lower treatment costs and relief of the already limited clinical capacities. This also makes the screw interesting from an economic point of view and for those bearing the costs.

What are the advantages of use in hand and foot surgery?

Ehlers: Metal removal also plays a special role here, since hands and feet have very delicate structures. Therefore, a metal screw is more disruptive here; it is more noticeable to the affected person than in other regions of the body.

With this procedure, no foreign body reaction is to be expected, as can sometimes be observed with many metals. This further reduces the workload of the clinic staff since metal removal surgery and other accompanying procedures such as medical and nursing work and additional medication of the wound are eliminated.

How do the bone screws become tissue?

Ehlers: Human bone, as we process it, is largely preserved with its canal and cavity system due to a very gentle manufacturing process. This structure is in turn the basis for the natural bone remodeling process. In fact, it is a guidance system in the form of a guiding grid for the cells of the subject involved in bone remodeling. After insertion into the bone, the patient's own cells colonize and grow through the graft – the screw. In the course of the bone remodeling process, the bone screw then transforms from foreign tissue into the patient's own tissue. In the process known as remodeling, natural bone structures are created in turn, which can be supplied with nutrients by the patient's vascular system and defended against infection by the immune system.

How do bone screws promote rapid rehabilitation after fractures?

Ehlers: Bone screws need time to heal completely, just like all other surgical procedures. The described natural guiding structure of the bone screw provides the optimal space for remodeling and thus promotes rapid integration into the tissue, as a study from 2021 proves.

Is there potential for further development so that the bone screws can also be used in other areas of application?

Ehlers: In fact, the potential is there and is already being utilized. In Austria, the Shark Screw® is being used much more widely and comprehensively by our partner surgebright than it has been in Germany. For example, it is already used in the shoulder, elbow, knee, and also in pediatric surgery.

In order to make this possible in Germany as well, data is first required to apply to the relevant authority – in this case the Paul Ehrlich Institute - for an extension of indication and have it approved. Only then is it possible for us to refer specifically to these indications without violating the Heilmittelwerbegesetz (German Drug Advertising Act). This is because bone screws in Germany, as tissue preparations, fall under the German Medicines Act and are therefore very strictly regulated.

Are there other new products at DIZG that bring benefits for rehabilitation after an injury? For example, from the field of sports medicine?

Ehlers: Another innovation that we are now bringing out is actually the first allogeneic partial meniscus replacement in Germany. In Germany, we have about 80,000 meniscus injuries per year that are associated with severe pain and limited mobility. A significant proportion of these require removal of the meniscus or even suturing or reconstruction of the tissue damage because part of the meniscus is missing. We are now able to replace this missing part - something that has not been available in Germany until now. So far, the DIZG has already been able to successfully help around 100 patients and reduce the risk of a later artificial knee joint accordingly.