How does the fully implantable distraction nail FITBONE work?
Inside the implant manufactured by Wittenstein intens (Igersheim) is a completely encapsulated, electromagnetic motor. Energy is transmitted to the motor via an antenna located under the skin by placing a transmitter over it. Therefore, there are no external connections or openings in the skin after surgery. The small external control unit is easily carried by the patient, and enables safe activation of the implanted motor. Malfunctions such as unintentional or uncontrolled lengthening are not possible. The built-in motor develops considerable force and is thus able to separate the bone fragments evenly in deliberate small steps, which is particularly important for healthy new bone formation. The lengthening process itself is completely painless and not noticed by the patient. Only the tightening of the soft tissues and pressure on the joints can become uncomfortable with greater amounts of lengthening. The ultimate result is very cosmetic compared to other bone lengthening methods, since the longest scar is only about 2 cm, and normally heals almost invisibly.
What can the fully implantable distraction nail FITBONE do?
FITBONE implants can perform lengthening up to 80 mm and have state-of-the-art drive technology and control functions. Lengthening greater than 80 mm require staged surgeries. The planning of deformity correction with lengthening (such as for bowlegs, knock knee, or abnormal twists of the leg) is very important, and accomplished with a planning technique (Reverse Planning Method) developed at ZEM-Germany. This planning, adapted to the FITBONE system and minimally invasive surgical techniques, permit complete correction of such deformities simultaneously, currently not possible with other implants with comparable accuracy. Even long bone defects, e.g. after accidents or bone tumors, can be treated with the FITBONE system, avoiding the need for an external fixator. If both upper (femur) and lower leg (tibial) lengthenings are to be performed, one fully implantable intramedullary distraction nail is usually placed in the upper leg and another intramedullary distraction nail in the lower leg. Both implants can be inserted through a single, small skin incision below the kneecap, which later heals almost invisibly parallel to the skin folds. Since the lengthening proceeds at 1 mm/day on both the upper and lower leg, the entire leg can thus be lengthened at 2 mm/day, which leads to a significant reduction in the total treatment time.
When is the FITBONE fully implantable intramedullary distraction nail used?
Whenever lengthening is to be performed with or without other deformity correction of a long bone and the bone is large enough to accommodate an intramedullary nail, a FITBONE intramedullary distraction nail is an advantageous option. This applies to not only to one or both legs, but also the upper arms.
Lengthening of one leg may be necessary after bone fractures or disturbed normal growth of a bone, resulting in its' shortening. Lengthening of both legs is medically indicated in cases of short stature such as achondroplasia, Turner syndrome or Silver-Russell syndrome. Lengthening of both legs can also be done using the FITBONE system in people who do not have pathological changes in their bones, but merely feel too short. In such cases, however, the costs for the entire treatment must be borne by the patient. The fully implantable FITBONE intramedullary distraction nail can also be used to rebuild missing bone that has been lost or removed, such as the result of an accident or after surgical removal of benign or malignant bone tumors.
Can the FITBONE distraction nail also be used in children?
The FITBONE intramedullary distraction nail can also be used on both the upper and lower leg in children starting at about the age of 10 if, for example, the leg length difference becomes so great that compensating shoe lifts become too cumbersome and hinder mobility excessively. However, the indication for lengthening must be studied carefully in each individual case. It is most advantageous to surgically correct leg length differences after the completion of leg growth, since the amount of difference in the leg lengths is known and won't change after that stage. Leg growth typically is finished by age 15 years in girls and 16 in boys.
How are bilateral leg lengthenings performed with the FITBONE intramedullary distraction nail?
Lengthening of both legs can be performed in different ways. The easiest and most comfortable way for the patient is to perform lengthening on one side, then the other, since the patient can be full weight-bearing on the sound side. To reduce the total time in treatment, simultaneous or overlapping treatment of both sides is often desired. After the first operation on the upper and lower leg of one side, surgery on the other side can be performed as early as 1 week later, although waiting 4 to 6 weeks is generally preferable. The advantages of simultaneous leg lengthening include treatment time saved and the ability to conduct physiotherapy of both legs in the same treatment sessions. However, these advantages are offset by the disadvantages that for some portion of the treatment course, the patient's mobility is restricted, with dependence on outside help and use of a wheelchair, since full weight-bearing on legs undergoing active lengthening is not allowed until the lengthened bone has hardened. The strategy of operating on both bones in both legs in the same operation is associated with a significantly increased risk of embolism and is therefore not performed at our center.
What are the different models of the FITBONE distraction nail?
The underlying technology is the same for all FITBONE distraction nails. An electromagnetic high-performance drive (or motor) is always incorporated in the nail. This drive is supplied with energy by reliable, easy-to-use and digitally-controlled electronics, so that malfunctions are prevented.
The most frequently-used FITBONE model is the telescopic intramedullary nail (TAA), which can be used for both the femur and tibia, with or without simultaneous correction of bone deformity. Upper arm lengthening can also be advantageously performed with the TAA model. A special capability - unique in Germany - is the treatment of high hip dislocation. In such cases, where the leg will not properly support the pelvis due to a malformed or non-formed hip joint, the FITBONE TAA can bring the leg into a correct anatomical position, so that hip joint replacement in the correct position is possible afterwards.
Another unique model is the solid slidehole (SAA) FITBONE, which has already resulted in excellent treatment outcomes in thigh deformities once thought hopeless to correct. This implant not only lengthens the bone but can also close bone defects biologically. This variant is mainly used for severe, accidentally damaged bones or extreme, congenital deformities.
Other model is the FITBONE-FTA, which combines some of the advantages of both systems and is used for bone defects and shortening of the upper and lower leg. Its use is reserved for special situations for which no other implants were previously available.
The FITBONE intramedullary distraction nail finds special application in combination with so-called growth prostheses (MUTARS) in children. Malignant bone tumors (bone cancer, osteosarcoma, Ewing's sarcoma) mainly occur near joints, particularly around the knee, during growth. In affected children, their own joint usually has to be resected (usually with the growth areas of the affected bone) and replaced by a joint prosthesis. As the other leg continues to grow, a difference in leg length will develop due to loss of the growth area, and this difference has to be compensated for. Until now, lengthening the bone or the prosthesis after tumor surgery was not feasible, so that these children had to endure a lifetime of cumbersome braces or shoes with lifts, or undergo disfiguring operations. The FITBONE Intramedullary distraction nail can extend both the prosthesis (Xpand) and the remaining bone (BioXpand), an innovation from ZEM-Germany in cooperation with the company Implantcast (Buxtehude) that opens up completely new perspectives for the affected children.
What are the possible complications of lengthening with FITBONE distraction nails?
Any leg lengthening in adulthood involves surgical cutting of the bone to be lengthened into two fragments, stabilization of the fragments, and gradual separation of the bone fragments after surgery. Even though the FITBONE system is the safest treatment option in our experience, all lengthening surgery techniques entail some risk of complication. Risks of a general nature include post-operative bleeding, vascular and nerve injuries, muscle and joint dysfunction, problems with wound healing and thromboses. With any type of intramedullary nailing, there is also a risk of pulmonary embolism, as the fatty marrow may be dislodged from inside the long bones. Although the risk of infection is significantly higher during lengthening treatment with an external fixator, infection can also occur after implantation of an intramedullary distraction nail, just as after any operation. Under certain circumstances, the bone fragments may have to be stabilized from the outside, at least temporarily. Such complications are extremely rare at ZEM-Germany, well below 0.1%. Slow formation of new bone in the distraction gap during lengthening may occur, particularly in the lower leg (shin, or tibia), as the blood supply to the bone is reduced here due to a smaller amount of soft tissue encasing the tibia, particularly in the front. If bone formation in the distraction gap is inadequate to allow full weight-bearing, some marrow from the iliac crest (pelvis) may have to be "injected" into the distraction gap, after which the bone will typically solidify within 6 weeks. This measure may be necessary in up to 15% of cases, especially with previously damaged bones or in people who smoke.
How can FITBONE be controlled?
The FITBONE distraction nail receives energy "transcutaneously" through intact skin. The FITBONE receiver is responsive only to the energy provided by the control unit. This means that neither your mobile phone nor any other electronic device can influence the function. Compared to magnetically driven intramedullary nails (Precice), the control unit is handy, lightweight, and easier to use because no magnets are required and the coupling always works reliably, even with a somewhat stronger soft tissue sheath. The FITBONE is also the only implant where the patient has an immediate check whether the lengthening process has actually taken place. In summary, FITBONE implants with their control and monitoring functions offer maximum safety and comfort.