The Bone Anchoring Device for Artificial Limbs (BADAL X™) is a modular medical device to be used as a permanent transcutaneous (through the skin) fixation system to directly connect an exoprosthetic lower limb (artificial leg) to the bone in respectively above- and below knee amputees. The BADAL X attachment method is also known as osseointegration and is an alternative for the conventional attachment of artificial limbs with a stump socket. BADAL X makes use of the ability of human bone cells to attach to a rough metal(titanium) surface of the implant of BADAL X. During a surgical procedure, one side a titanium rod (implant) is press fit placed into the residual bone of the stump. The other side of the implant protrudes through the skin and is used to attach an artificial limb with a quick attach-release-connector.
The advantage for amputees
In Europe, there are around 150.000 major lower limb amputations per year (Hughes et al Eur J Vasc Endovasc Surg, 2020). Approximately one-third of persons with lower limb amputation have chronic skin problems associated with socket attachment of the prosthetic limb (Meulenbelt et al, Arch Phys Med Rehabil, 2009). These skin problems often cause serious limitations of mobility and quality of life and as a result, 50% of the people with above knee amputation do not use their prosthetic limb or use their prosthetic limb less than 7 hours per day (Pohjolainen et al, POI 1990). Despite new materials and improved sockets designs, skin problems remain an important burden because the skin in weight-bearing areas of the socket is not always resistant to the pressure and friction caused by the socket during standing and ambulation.
For persons with lower limb amputation, bone anchoring devices may offer many advantages compared to a socket attached prosthesis. A bone anchored prosthesis is much more stable and this enables improved walking ability with less energy consumption and offers better sitting comfort. Because of direct skeletal attachment, the prosthesis no longer causes skin breakdown. You’ll experience the prosthesis more as part of your own body by natural osseoperception. This highly innovative device contributes to a significant improvement in your quality of life.
Bone anchoring devices for amputees are on the European market for 3 decades now. This health care product is not longer experimental and is acknowledged by health care authorities and insurers in several European countries.
BADAL X™ and amputation level
BADAL X™ consists of a press fit implants with an extensive range of implant types and sizes and is therefore suitable for all above and below knee amputation levels. The advantage of BADAL X™ is that it consists of a press fit titanium implant with a very rough surface which allows a rapid integration with the bone in 4 to 6 weeks.
BADAL X™ is safe and offers clearly better mobility, less complaints and significant better quality of life (Attalah et al, Plos One, 2020). Persons with lower limb amputation and chronic complaints associated with socket attachment of the prosthetic limb are perfect candidates for BADAL X™. OTN Implants supports and supplies a network of these specilized clinics in Europe. In Canada and the US, BADAL X™ is sold in limited numbers to orthopedic clinics with custom device exemption.
The area where the BADAL X stem penetrates the skin –the so called ‘stoma’– needs daily attention: cleaning with water and soap twice daily is required. This cleaning action is comparable to brushing your teeth. In some cases the skin at the penetration area may become irritated and needs extra care.
In the first year after implantation you may experience muscle pain. This muscle pain will disappear as soon as the stump muscles become fitter and stronger. Although very rare, deep inflammation with implant loosening is a small risk. In that case implant replacement is required.
Can I do everything with BADAL X ?
All daily activities can be carried out with BADAL X, including having a bath, swimming (in the sea, river, lake or a swimming pool), taking a sauna, long distance walking, cycling, sailing etc. Contact sports like fighting, soccer and skiing are not recommended.